COVID-19 Updates

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

We think of a patient’s recovery happening in multiple locations – in a hospital room or a rehabilitation facility, for example. But many clinicians may not consider the opportunity to aid healing that lies in the waiting room.

The waiting room is where a patient’s loved ones often are and they, sometimes more than anyone, can unlock the path to a patient’s quicker recovery. Friends and family can offer encouragement, as they have an existing bond of trust that can help if a patient needs reinforcement to take their medications or follow other health care advice. But if loved ones are going to help patients, they need help from clinicians. Beyond being potential allies, they are also hurting, experiencing worry or confusion in a world of medical jargon.

The coronavirus changes the relationship of patients and their loved ones, as patients are often isolated or limited in the number of visitors they are allowed to see. A smartphone replaces the smiling faces of friends and relatives at their bedside, and a text is a poor substitute for a hug.

The Hospitalist asked some experienced hospitalists for insight on how best to communicate with patients’ loved ones to improve outcomes for all, medically and emotionally.
 

Team approach

“Patients feel isolated, terrified, and vulnerable but still need an advocate in the hospital, so daily communication with a patient’s loved one is important to give a sense that the patient is looked after,” said Kari Esbensen, MD, PhD, a hospitalist and palliative care expert at Emory University Hospital Midtown, Atlanta.

Glenn Rosenbluth, MD, a pediatric hospitalist and director, quality and safety programs, at the University of California, San Francisco, Benioff Children’s Hospital, agreed. He said that the most important thing is to communicate, period.

“We fall into this pattern of ‘out of sight, out of mind,’ ” he said. “We need to take the extra step to find out who a patient’s loved ones are. If it is a clinical visit, ask the patient, or maybe get the information from a caseworker, or just pay attention to who is dropping in to see the patient. Having a second person available to jot down notes, or having a handy list of questions – it all helps the patient. We forget that sometimes it can seem like a whirlwind for the patient when they are hurting. We have to remember that a loved one is important to a patient’s care team and we need to include them, empower them, and show that we want to hear their voices.”

Dr. Esbensen said it is critical to start off on the right foot when communicating with a patient’s loved one, especially during the current pandemic.

“With COVID-19, the most important thing is to speak honestly, to say hope for the best but prepare for the worst-case scenario,” Dr. Esbensen said. “We’ve seen that conditions can shift dramatically in short periods of time. The loved one needs to have a sense of the positive and negative possibilities. Families tend to lack understanding of the changes in the patient that are caused by COVID-19. The patient can come out of the hospital debilitated, very different than when they entered the hospital, and we need to warn people close to them about this. Unrealistic expectations need to be guarded against if a patient’s loved ones are going to help.”

Perhaps the best form of communication with a patient’s loved ones is an often-forgotten skill: listening.

“Get an idea from the patient’s loved ones of what the issues are, as well as their idea of what they think of the disease and how it spreads,” Dr. Esbensen said. “Sometimes they are right on target but sometimes there are misinterpretations and we need to help them understand it better. It’s not a ‘one-size-fits-all’ speech that we should give, but try to say, ‘tell me what you think is going on, what you think you’ve heard, and what you’re worried about,’ and learn what is most important to the patient. Start on those terms and adapt; this way you can correct and address what makes them most fearful, which can be different for each loved one. For some, the concern could be that they have children or other vulnerable people in the house. Finding out these other issues is important.”

“A lot of people just want information and want to be helpful, but we also need to realize that, while we are caring for many patients, this one person is the patient they are focused on,” said Laura Nell Hodo, MD, a pediatric hospitalist at Kravis Children’s Hospital at Mount Sinai in New York. “Don’t rush, and if you know that a patient’s loved one needs more time, make sure it can be found – if not then, at least later on the phone. Fifteen to 20 minutes may be what’s needed, and you can’t shortchange them.”

Dr. Hodo said that a patient’s loved ones often do not realize it is possible to receive phone calls from hospitalists. “We need to remind them that they can get in touch with us. We have to remember how helpless they can feel and how they want to understand what is happening in the hospital.”

For medical adherence issues, sometimes it is best to communicate with the patient and loved one at the same time, Dr. Hodo advised. “Whether it’s for medication or postdischarge exercises, if they both receive the information together it can reinforce adherence. But you also need to remember that the patient may only want a loved one told about certain things, or possibly nothing at all. We need to make sure we understand the patient’s wishes, regardless of whether we think a person close to them can be an ally or not.”

Dr. Esbensen also noted that a loved one can give hospitalists important clues to the emotional components of a patient’s care.

“I remember a patient whose wife told me how he worked in a garage, how he was strong and did not want people to think he was a weak guy just because of what was happening to him,” Dr. Esbensen said. “I didn’t know that he felt he might be perceived in this way. I mentioned to him how I learned he was a good mechanic and he perked up and felt seen in a different light. These things make a difference.”

But when is the best time to speak with a patient’s loved ones? Since much communication is done via phone during the pandemic, there are different philosophies.

“We had a debate among colleagues to see how each of us did it,” Dr. Esbensen said. “Some try to call after each patient encounter, while they are outside the room and it’s fresh in their mind, but others find it better to make the call after their rounds, to give the person their full attention. Most of the time I try to do it that way.”

She noted that, in the current environment, a phone call may be better than a face-to-face conversation with patients’ loved ones.

“We’re covered in so much gear to protect us from the coronavirus that it can feel like a great distance exists between us and the person with whom we’re speaking,” she said. “It’s strange, but the phone can make the conversation seem more relaxed and may get people to open up more.”
 

Even when they leave

All the hospitalists affirmed that loved ones can make a big difference for the patient through all aspects of care. Long after a patient returns home, the support of loved ones can have a profound impact in speeding healing and improving long-term outcomes.

Dr. Esbensen said COVID-19 and other serious illnesses can leave a patient needing support, and maybe a “push” when feeling low keeps them from adhering to medical advice.

“It’s not just in the hospital but after discharge,” she said. “A person offering support can really help patients throughout their journey, and much success in recovering from illness occurs after the transition home. Having the support of that one person a patient trusts can be critical.”

Dr. Hodo believes that the coronavirus pandemic could forever change the way hospitalists communicate with patients and their loved ones.

“I work in pediatrics and we know serious medical decisions can’t be made without guardians or parents,” she said. “But in adult medicine doctors may not automatically ask the patient about calling someone for input on decision-making. With COVID, you cannot assume a patient is on their own, because there are protocols keeping people from physically being present in the patient’s room. My experience from working in adult coronavirus units is that the thinking about the loved ones’ role in patient care – and communication with them – might just change. … At least, I hope so.”
 

Quick takeaways for hospitalists

• Get beyond personal protective equipment. A conversation with a patient’s loved one might be easier to achieve via phone, without all the protective gear in the way.
• Encourage adherence. Speaking with patients and loved ones together may be more effective. They may reach agreement quicker on how best to adhere to medical advice.
• Loved ones offer clues. They might give you a better sense of a patient’s worries, or help you to connect better with those in your care.
• Be present. You have a long to-do list but do not let empathy fall off it, even if you feel overwhelmed.

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

A psychiatric diagnosis for patients hospitalized with COVID-19 is linked to a significantly increased risk for death, new research shows.

Investigators found that patients who were hospitalized with COVID-19 and who had been diagnosed with a psychiatric disorder had a 50% increased risk for a COVID-related death in comparison with COVID-19 patients who had not received a psychiatric diagnosis.

“Pay attention and potentially address/treat a prior psychiatric diagnosis if a patient is hospitalized for COVID-19, as this risk factor can impact the patient’s outcome – death – while in the hospital,” lead investigator Luming Li, MD, assistant professor of psychiatry and associate medical director of quality improvement, Yale New Haven Psychiatric Hospital, New Haven, Conn., said in an interview.

The study was published Sept. 30 in JAMA Network Open.
 

Negative impact

“We were interested to learn more about the impact of psychiatric diagnoses on COVID-19 mortality, as prior large cohort studies included neurological and other medical conditions but did not assess for a priori psychiatric diagnoses,” said Dr. Li.

“We know from the literature that prior psychiatric diagnoses can have a negative impact on the outcomes of medical conditions, and therefore we tested our hypothesis on a cohort of patients who were hospitalized with COVID-19,” she added.

To investigate, the researchers analyzed data on 1,685 patients hospitalized with COVID-19 between Feb. 15 and April 25, 2020, and whose cases were followed to May 27, 2020. The patients (mean age, 65.2 years; 52.6% men) were drawn from the Yale New Haven Health System.

The median follow-up period was 8 days (interquartile range, 4-16 days) .

Of these patients, 28% had received a psychiatric diagnosis prior to hospitalization. The patients with psychiatric disorders were significantly older and were more likely to be women, White, non-Hispanic, and to have medical comorbidities (i.e., cancer, cerebrovascular disease, heart failure, diabetes, kidney disease, liver disease, MI, and/or HIV).

Psychiatric diagnoses were defined in accordance with ICD codes that included mental and behavioral health, Alzheimer’s disease, and self-injury.
 

Vulnerability to stress

In the unadjusted model, the risk for COVID-19–related hospital death was greater for those who had received any psychiatric diagnosis, compared with those had not (hazard ratio, 2.3; 95% CI, 1.8-2.9; P < .001).

In the adjusted model that controlled for demographic characteristics, other medical comorbidities, and hospital location, the mortality risk somewhat decreased but still remained significantly higher (HR, 1.5; 95% CI, 1.1-1.9; P = .003).

Dr. Li noted a number of factors that might account for the higher mortality rate among psychiatric patients who had COVID-19 in comparison with COVD-19 patients who did not have a psychiatric disorder. These included “potential inflammatory and stress responses that the body experiences related to prior psychiatric conditions,” she said.

Having been previously diagnosed with a psychiatric disorder may also “reflect existing neurochemical differences, compared to those who do not have a prior psychiatric diagnosis, [and] these differences may make the population with the prior psychiatric diagnosis more vulnerable to respond to an acute stressor such as COVID-19,” she said.
 

Quality care

Harold Pincus, MD, professor and vice chair of the department of psychiatry at Columbia University, New York, said it “adds to the fairly well-known and well-established phenomenon that people with mental illnesses have a high risk of all sorts of morbidity and mortality for non–mental health conditions.”

The researchers “adjusted for various expected [mortality] risks that would be independent of the presence of COVID-19,” so “there was something else going on associated with mortality,” said Dr. Pincus, who is also codirector of the Irving Institute for Clinical and Translation Research. He was not involved with the study.

Beyond the possibility of “some basic immunologic process affected by the presence of a mental disorder,” it is possible that the vulnerability is “related to access to quality care for the comorbid general condition that is not being effectively treated,” he said.

“The take-home message is that people with mental disorders are at higher risk for death, and we need to make sure that, irrespective of COVID-19, they get adequate preventive and chronic-disease care, which would be the most effective way to intervene and protect the impact of a serious disease like COVID-19,” he noted. This would include being appropriately vaccinated and receiving preventive healthcare to reduce smoking and encourage weight loss.

No source of funding for the study was provided. Dr. Li reported receiving grants from a Health and Aging Policy Fellowship during the conduct of the study. Dr. Pincus reported no relevant financial relationships.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

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.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

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.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

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.

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

Among COVID-19 patients who undergo mechanical ventilation, lying in the prone position has been associated with lasting nerve damage. A new case series describes peripheral nerve injuries associated with this type of positioning and suggests ways to minimize the potential damage.

“Physicians should remain aware of increased susceptibility to peripheral nerve damage in patients with severe COVID-19 after prone positioning, since it is surprisingly common among these patients, and should refine standard protocols accordingly to reduce that risk,” said senior author Colin Franz, MD, PhD, director of the Electrodiagnostic Laboratory, Shirley Ryan AbilityLab, Chicago.

The article was published online Sept. 4 in the British Journal of Anaesthesiology.
 

Unique type of nerve injury

Many patients who are admitted to the intensive care unit with COVID-19 undergo invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). Clinical guidelines recommend that such patients lie in the prone position 12-16 hours per day.

“Prone positioning for up to 16 hours is a therapy we use for patients with more severe forms of ARDS, and high-level evidence points to mortality benefit in patients with moderate to severe ARDS if [mechanical] ventilation occurs,” said study coauthor James McCauley Walter, MD, of the pulmonary division at Northwestern University, Chicago.

With a “significant number of COVID-19 patients flooding the ICU, we quickly started to prone a lot of them, but if you are in a specific position for multiple hours a day, coupled with the neurotoxic effects of the SARS-CoV-2 virus itself, you may be exposed to a unique type of nerve injury,” he said.

Dr. Walter said that the “incidence of asymmetric neuropathies seems out of proportion to what has been reported in non–COVID-19 settings, which is what caught our attention.”

Many of these patients are discharged to rehabilitation hospitals, and “what we noticed, which was unique about COVID-19 patients coming to our rehab hospital, was that, compared with other patients who had been critically ill with a long hospital stay, there was a significantly higher percentage of COVID-19 patients who had peripheral nerve damage,” Dr. Franz said.

The authors described 12 of these patients who were admitted between April 24 and June 30, 2020 (mean age, 60.3 years; range, 23-80 years). The sample included White, Black, and Hispanic individuals. Eleven of the 12 post–COVID-19 patients with peripheral nerve damage had experienced prone positioning during acute management.

The average number of days patients received mechanical ventilation was 33.6 (range, 12-62 days). The average number of proning sessions was 4.5 (range, 1-16) with an average of 81.2 hours (range, 16-252 hours) spent prone.
 

A major contributor

Dr. Franz suggested that prone positioning is likely not the only cause of peripheral nerve damage but “may play a big role in these patients who are vulnerable because of viral infection and the critical illness that causes damage and nerve injuries.”

“The first component of lifesaving care for the critically ill in the ICU is intravenous fluids, mechanical ventilation, steroids, and antibiotics for infection,” said Dr. Walter.

“We are trying to come up with ways to place patients in prone position in safer ways, to pay attention to pressure points and areas of injury that we have seen and try to offload them, to see if we can decrease the rate of these injuries,” he added.

The researchers’ article includes a heat map diagram as a “template for where to focus the most efforts, in terms of decreasing pressure,” Dr. Walter said.

“The nerves are accepting too much force for gravely ill COVID-19 patients to handle, so we suggest using the template to determine where extra padding might be needed, or a protocol that might include changes in positioning,” he added.

Dr. Franz described the interventions used for COVID-19 patients with prone positioning–related peripheral nerve damage. “The first step is trying to address the problems one by one, either trying to solve them through exercise or teaching new skills, new ways to compensate, beginning with basic activities, such as getting out of bed and self-care,” he said.

Long-term recovery of nerve injuries depends on how severe the injuries are. Some nerves can slowly regenerate – possibly at the rate of 1 inch per month – which can be a long process, taking between a year and 18 months.

Dr. Franz said that therapies for this condition are “extrapolated from clinical trial work” on promoting nerve regeneration after surgery using electrical stimulation to enable nerves to regrow at a faster rate.

“Regeneration is not only slow, but it may not happen completely, leaving the patient with permanent nerve damage – in fact, based on our experience and what has been reported, the percentage of patients with full recovery is only 10%,” he said.

The most common symptomatic complaint other than lack of movement or feeling is neuropathic pain, “which may require medication to take the edge off the pain,” Dr. Franz added.
 

Irreversible damage?

Commenting on the study, Tae Chung, MD, of the departments of physical medicine, rehabilitation, and neurology, Johns Hopkins University, Baltimore, said the study “provides one of the first and the largest description of peripheral nerve injury associated with prone positioning for management of ARDS from COVID-19.”

Dr. Chung, who was not involved in the research, noted that “various neurological complications from COVID-19 have been reported, and some of them may result in irreversible neurological damage or delay the recovery from COVID-19 infection,” so “accurate and timely diagnosis of such neurological complications is critical for rehabilitation of the COVID-19 survivors.”

The study received no funding. Dr. Franz, Dr. Walter, study coauthors, and Dr. Chung report no relevant financial relationships.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

The coronavirus disease 2019 (COVID-19) pandemic has introduced many new clinical challenges. Consider the patient with fever and dyspnea who tests positive for COVID-19 but does not believe in COVID-19 and wants to leave the hospital against medical advice (AMA). Or the patient with numerous cardiovascular risk factors and crushing substernal chest pain who is too afraid of contracting COVID-19 to come to the emergency department. These challenging clinical scenarios can be addressed in the context of decision-making capacity (DMC), for which our medical colleagues often call upon psychiatrists to assist. This article reviews the framework for DMC assessment, describes how COVID-19 affects DMC assessment, and discusses approaches to these scenarios using the DMC framework.

Review of decision-making capacity

Assessment of DMC is a fundamental clinical skill. It allows a physician to balance autonomy with beneficence and non-maleficence. An autonomous decision is a decision that is made intentionally, with understanding, and without controlling influences (these are the elements of informed consent).¹ However, if a patient cannot make a decision with intention and understanding, then beneficence and non-maleficence must prevail in order to protect the patient. Capacity assessments evaluate a patient’s ability to make an intentional and understood choice.

In order to prove capacity, a patient must demonstrate 4 functional abilities:

• choice refers to the ability to communicate a relatively stable choice^2,3
• understanding refers to the ability to convey information about the illness, risks/benefits of the chosen intervention, and risks/benefits of alternative options.^2,3 Understanding measures objective information about the medical situation
• appreciation refers to the patient’s ability to apply that information to his/her own life.^2,3 Appreciation requires insight into having the illness and the ability to anticipate how one’s life would be impacted by one’s condition and choice. This is where life experiences and values come into play
• reasoning is intimately tied to appreciation. It refers to the ability to explain how the decision was made and which factors were most important.^2,3

Most clinicians and ethicists endorse a “threshold” approach to decisional capacity, which specifies that the level of evidence required to prove capacity depends on the gravity of the medical situation (Figure 1A).^1,4,5 The gravity of the situation is based on the risk/benefit analysis. Consider two treatments with equal benefit: one has minimal adverse effects (gastrointestinal upset) and the second has significant adverse effects (myelosuppression). Accepting the first treatment requires less intentionality and understanding than accepting the second because the risk is much lower and thus has a lower capacity threshold (Figure 1B). The capacity to refuse these treatments results in the opposite ranking (Figure 1C).

Establishing a threshold helps guide the physician in determining how robust the patient’s responses must be to have decisional capacity. For a high-threshold decision, the patient must have a well-developed and highly detailed level of understanding, appreciation, and reasoning.

How COVID-19 affects assessment of decision-making capacity

Three characteristics of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 illness impact decision-making assessment:

• high level of contagiousness
• high health-care utilization
• the uncertainty about its clinical course and outcomes.

The high level of contagiousness stems from this virus’s estimated basic reproduction number (R₀) of 2.2 to 5.7 (which indicates the expected number of cases from any single case), its long incubation period, and the potential for asymptomatic and pre-symptomatic shedding.^6-9 Decision-making capacity assessments must therefore consider community-level effects in the risk/benefit analysis. Because SARS-CoV-2 is a new virus affecting humans, it can easily overwhelm existing hospital systems. This happened in Wuhan, China; Lombardy, Italy; and New York. In a stressed system, physicians will have to factor health-care utilization into the risk/benefit analysis. Finally, because this is a novel virus, there is still considerable uncertainty about the epidemiology, clinical course, and outcomes.¹⁰ The minimal dose of virus needed to cause illness is unknown. Patients can deteriorate quickly and unpredictably into needing ventilator support.¹¹ Treatment options are limited, and many candidates are being investigated.¹² This uncertainty hinders physicians’ ability to accurately estimate risks and benefits for an individual patient when discussing various medical decisions. As our understanding of SARS-CoV-2 improves, this uncertainty will lessen.

Continue to: Effects of the sociopolitical climate

 

 

Effects of the sociopolitical climate

In the United States, the COVID-19 pandemic emerged during a time of deep sociopolitical divide. Accordingly, beliefs about viral infectivity, severity of illness, and precautionary measures have varied. Some politicians, media outlets, and physicians have shared information that contradicts guidelines and recommendations from mainstream national and international medical and scientific organizations. Patients who subscribe to these reports and beliefs may not meet the threshold for understanding, appreciation, or reasoning. For example, if a patient’s beliefs about the virus depart from well-established medical evidence, they would technically lack understanding. The usual remedy for addressing misunderstanding is education and time. However, because of the divisiveness of the sociopolitical climate, the limited time physicians have with patients, and the fact that many DMC assessments will occur in acute-care settings, it may be difficult or near impossible to correct the misunderstanding.

The sociopolitical climate and its accompanying potentially erroneous or imbalanced narrative may thus directly impact patients’ understanding, appreciation, and reasoning. However, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. Additionally, some clinicians and ethicists might object to declaring incapacity in a patient with no underlying mental or neurologic dysfunction. The United States has a functional approach to capacity, based solely on meeting criteria for the 4 functional abilities.^3,13 Mental or neurologic dysfunction is not legally required in the United States, but in practice, the consideration of incapacity is often closely linked to some form of cognitive impairment.¹⁴ Other countries do make dysfunction a specific criterion; for example, the United Kingdom dictates that mental incapacity can only occur in someone with “impairment of, or a disturbance in the functioning of, the mind or brain.”¹⁵

Leaving against medical advice

In the case of a patient who is COVID-19–positive, symptomatic, and wants to leave AMA, the threshold is automatically elevated because of societal-level risks (the risk of potential exposure or infection of others if a patient who is COVID-19–positive is not properly isolated). Further­more, the individual risk of the patient leaving AMA depends on his/her age, comorbidities, and current clinical status; because of the uncertainty and rapid deterioration seen with COVID-19 illness, the calculated risk may actually be higher than for a non-COVID-19–related illness. Thus, in order to leave AMA, the patient’s responses must be fairly robust (Figure 2). Table 1 describes the information needed for robust understanding, appreciation, and reasoning.

For patients who do not meet this threshold, it is important to determine why. If a patient has a psychiatric condition that not only impacts DMC but also meets criteria for a psychiatric hold (ie, an imminent risk of harm to self or others), a psychiatric hold should be placed. If the patient does not meet the threshold because of altered mental status or some other neurologic or cognitive comorbidity, a medical hold should be placed. Most states do not have an explicit legal basis for a medical hold, although it does fall under the incapacity laws in the United States; in the absence of a surrogate, declaration of medical emergency can also be used if applicable.^16,17 As a caveat, it can be difficult to detain someone on a medical hold because security officers may be afraid to physically detain someone without explicit legal paperwork.¹⁷

If a patient does not meet the capacity threshold but there does not seem to be a psychiatric, neurologic, or cognitive explanation, several options are possible. The first step would be to assess whether the patient is amenable to further discussion and compromise. A nonjudgmental and nonconfrontational approach that aims to further clarify the patient’s perspective and identify shared goals is key. Any plan that lowers the risks sufficiently would allow the patient to leave by lowering the capacity threshold. Enlisting the support of family and friends can be helpful. If this does not work, theoretically the patient should be detained in the hospital. Practically speaking, this may be difficult or unadvised. First, as described above, security officers may refuse to physically detain the patient.¹⁷ Second, the patient’s legally mandated surrogate may espouse similar COVID-related views as the patient; thus, this approach may not help keep the patient in the hospital. If the physician has serious concern about the risk of the patient leaving, he/she would have to consult the facility’s Ethics and Legal staff to determine capacity of the surrogate. Third, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. In the current sociopolitical climate, involuntary detention may elicit a political backlash. Using medical detention for impending deterioration of clinical status would be more acceptable than using medical detention for isolation. Presently, there are no such laws for patients with COVID-19 (although this is not without precedent, as with active tuberculosis or Ebola^18,19), but individual jurisdictions may have isolation or quarantine orders; the local health department could be contacted and may evaluate on a case-by-case basis.

Continue to: Refusing to seek medical care

Refusing to seek medical care

Anecdotally, many physicians have reported an increase in patients who are refusing clinic- or hospital-based treatment for a medical condition because they fear they may catch the virus. Although this is not strictly a capacity case—there is little recourse for action if a patient is refusing treatment from home (unless the patient requires a psychiatric hold or already has a guardian for medical decisions)—the same elements of thresholds apply and can be helpful in guiding conversations with the patient.

For the patient, the benefits of staying at home are to avoid potentially exposing themselves and the members of their household to the virus and COVID-19 illness. The risks of staying home include progression of the patient’s primary illness, which could lead to increased morbidity and mortality. Staying home has an ancillary benefit to the community of reducing health-care utilization, but at the risk of increasing utilization in the future.

The risk/benefit profile is shown on the thresholds graph in Figure 3. There is considerable variability. It is helpful to stratify the risk of progression of the primary condition as low (can be postponed indefinitely with minimal risk), medium (can be postponed for a short amount of time; risk of increased morbidity with ongoing delay and possibly increased mortality), or high (cannot be postponed; will have greater morbidity and/or higher risk of mortality). Because of the uncertainty about COVID-19, it is harder to quantify the benefits of refusing care and staying at home, although older patients and patients with underlying health issues are at higher risk of severe illness and death.²⁰ However, by taking appropriate precautions when seeking care, viral exposure and risk of infection can be mitigated.

This risk/benefit analysis will help set the threshold for whether staying at home is reasonable or whether it would incur more risk of harm. If the latter, then the physician must elicit the patient’s understanding, appreciation, and reasoning related to their current medical condition and COVID-19. It is likely they are undervaluing the former and overvaluing the latter. Table 2 lists important points to cover during these discussions.

Although there is no legal recourse to force patients at home to come to the clinic or hospital for medical treatment, there are several possible strategies to motivate them to do so. One is to ask patients how likely (on a scale of 0 to 100) they think they are to contract COVID-19 if they came for evaluation/treatment, and how likely they feel they are to experience a bad outcome from their primary condition. Then, after providing psychoeducation about their primary medical condition and COVID-19–related precautions and risk, repeat this question. Another strategy is to empathize with the patient’s fears while also expressing concern about the primary medical condition and connecting with the patient on the shared desire to protect his/her health. A third is to draw a risk/benefit diagram (similar to Figure 3) or reassure the patient by describing the ways in which the clinic or hospital is minimizing exposure and infection risk. A final strategy is to enlist the help of the patient’s family or friends.

Continue to: Bottom Line

 

 

Bottom Line

In order to have decision-making capacity, a patient must demonstrate choice, understanding, appreciation, and reasoning. The degree of understanding, appreciation, and reasoning required depends on the capacity threshold, which is determined by a risk/benefit analysis. Conducting a risk/benefit analysis during the coronavirus disease 2019 (COVID-19) pandemic requires consideration of societallevel factors (such as contagiousness to others and health-care utilization) and is complicated by a wide range of uncertainties and divisive sociopolitical views regarding COVID-19.

Related Resources

• Appelbaum PS. Clinical practice. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-1840.
• Ryznar E, Hamaoka D, Lloyd RB. Capacity evaluations. https://admsep.org/csi-emodules.php?c=capacity&v=y. Accessed March 30, 2020.

Acknowledgments

The author thanks Drs. Awais Aftab, Zackary D. Berger, and R. Brett Lloyd for their helpful discussions on the topic.

The coronavirus disease 2019 (COVID-19) pandemic has introduced many new clinical challenges. Consider the patient with fever and dyspnea who tests positive for COVID-19 but does not believe in COVID-19 and wants to leave the hospital against medical advice (AMA). Or the patient with numerous cardiovascular risk factors and crushing substernal chest pain who is too afraid of contracting COVID-19 to come to the emergency department. These challenging clinical scenarios can be addressed in the context of decision-making capacity (DMC), for which our medical colleagues often call upon psychiatrists to assist. This article reviews the framework for DMC assessment, describes how COVID-19 affects DMC assessment, and discusses approaches to these scenarios using the DMC framework.

Review of decision-making capacity

Assessment of DMC is a fundamental clinical skill. It allows a physician to balance autonomy with beneficence and non-maleficence. An autonomous decision is a decision that is made intentionally, with understanding, and without controlling influences (these are the elements of informed consent).¹ However, if a patient cannot make a decision with intention and understanding, then beneficence and non-maleficence must prevail in order to protect the patient. Capacity assessments evaluate a patient’s ability to make an intentional and understood choice.

In order to prove capacity, a patient must demonstrate 4 functional abilities:

• choice refers to the ability to communicate a relatively stable choice^2,3
• understanding refers to the ability to convey information about the illness, risks/benefits of the chosen intervention, and risks/benefits of alternative options.^2,3 Understanding measures objective information about the medical situation
• appreciation refers to the patient’s ability to apply that information to his/her own life.^2,3 Appreciation requires insight into having the illness and the ability to anticipate how one’s life would be impacted by one’s condition and choice. This is where life experiences and values come into play
• reasoning is intimately tied to appreciation. It refers to the ability to explain how the decision was made and which factors were most important.^2,3

Most clinicians and ethicists endorse a “threshold” approach to decisional capacity, which specifies that the level of evidence required to prove capacity depends on the gravity of the medical situation (Figure 1A).^1,4,5 The gravity of the situation is based on the risk/benefit analysis. Consider two treatments with equal benefit: one has minimal adverse effects (gastrointestinal upset) and the second has significant adverse effects (myelosuppression). Accepting the first treatment requires less intentionality and understanding than accepting the second because the risk is much lower and thus has a lower capacity threshold (Figure 1B). The capacity to refuse these treatments results in the opposite ranking (Figure 1C).

Establishing a threshold helps guide the physician in determining how robust the patient’s responses must be to have decisional capacity. For a high-threshold decision, the patient must have a well-developed and highly detailed level of understanding, appreciation, and reasoning.

How COVID-19 affects assessment of decision-making capacity

Three characteristics of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 illness impact decision-making assessment:

• high level of contagiousness
• high health-care utilization
• the uncertainty about its clinical course and outcomes.

The high level of contagiousness stems from this virus’s estimated basic reproduction number (R₀) of 2.2 to 5.7 (which indicates the expected number of cases from any single case), its long incubation period, and the potential for asymptomatic and pre-symptomatic shedding.^6-9 Decision-making capacity assessments must therefore consider community-level effects in the risk/benefit analysis. Because SARS-CoV-2 is a new virus affecting humans, it can easily overwhelm existing hospital systems. This happened in Wuhan, China; Lombardy, Italy; and New York. In a stressed system, physicians will have to factor health-care utilization into the risk/benefit analysis. Finally, because this is a novel virus, there is still considerable uncertainty about the epidemiology, clinical course, and outcomes.¹⁰ The minimal dose of virus needed to cause illness is unknown. Patients can deteriorate quickly and unpredictably into needing ventilator support.¹¹ Treatment options are limited, and many candidates are being investigated.¹² This uncertainty hinders physicians’ ability to accurately estimate risks and benefits for an individual patient when discussing various medical decisions. As our understanding of SARS-CoV-2 improves, this uncertainty will lessen.

Continue to: Effects of the sociopolitical climate

 

 

Effects of the sociopolitical climate

In the United States, the COVID-19 pandemic emerged during a time of deep sociopolitical divide. Accordingly, beliefs about viral infectivity, severity of illness, and precautionary measures have varied. Some politicians, media outlets, and physicians have shared information that contradicts guidelines and recommendations from mainstream national and international medical and scientific organizations. Patients who subscribe to these reports and beliefs may not meet the threshold for understanding, appreciation, or reasoning. For example, if a patient’s beliefs about the virus depart from well-established medical evidence, they would technically lack understanding. The usual remedy for addressing misunderstanding is education and time. However, because of the divisiveness of the sociopolitical climate, the limited time physicians have with patients, and the fact that many DMC assessments will occur in acute-care settings, it may be difficult or near impossible to correct the misunderstanding.

The sociopolitical climate and its accompanying potentially erroneous or imbalanced narrative may thus directly impact patients’ understanding, appreciation, and reasoning. However, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. Additionally, some clinicians and ethicists might object to declaring incapacity in a patient with no underlying mental or neurologic dysfunction. The United States has a functional approach to capacity, based solely on meeting criteria for the 4 functional abilities.^3,13 Mental or neurologic dysfunction is not legally required in the United States, but in practice, the consideration of incapacity is often closely linked to some form of cognitive impairment.¹⁴ Other countries do make dysfunction a specific criterion; for example, the United Kingdom dictates that mental incapacity can only occur in someone with “impairment of, or a disturbance in the functioning of, the mind or brain.”¹⁵

Leaving against medical advice

In the case of a patient who is COVID-19–positive, symptomatic, and wants to leave AMA, the threshold is automatically elevated because of societal-level risks (the risk of potential exposure or infection of others if a patient who is COVID-19–positive is not properly isolated). Further­more, the individual risk of the patient leaving AMA depends on his/her age, comorbidities, and current clinical status; because of the uncertainty and rapid deterioration seen with COVID-19 illness, the calculated risk may actually be higher than for a non-COVID-19–related illness. Thus, in order to leave AMA, the patient’s responses must be fairly robust (Figure 2). Table 1 describes the information needed for robust understanding, appreciation, and reasoning.

For patients who do not meet this threshold, it is important to determine why. If a patient has a psychiatric condition that not only impacts DMC but also meets criteria for a psychiatric hold (ie, an imminent risk of harm to self or others), a psychiatric hold should be placed. If the patient does not meet the threshold because of altered mental status or some other neurologic or cognitive comorbidity, a medical hold should be placed. Most states do not have an explicit legal basis for a medical hold, although it does fall under the incapacity laws in the United States; in the absence of a surrogate, declaration of medical emergency can also be used if applicable.^16,17 As a caveat, it can be difficult to detain someone on a medical hold because security officers may be afraid to physically detain someone without explicit legal paperwork.¹⁷

If a patient does not meet the capacity threshold but there does not seem to be a psychiatric, neurologic, or cognitive explanation, several options are possible. The first step would be to assess whether the patient is amenable to further discussion and compromise. A nonjudgmental and nonconfrontational approach that aims to further clarify the patient’s perspective and identify shared goals is key. Any plan that lowers the risks sufficiently would allow the patient to leave by lowering the capacity threshold. Enlisting the support of family and friends can be helpful. If this does not work, theoretically the patient should be detained in the hospital. Practically speaking, this may be difficult or unadvised. First, as described above, security officers may refuse to physically detain the patient.¹⁷ Second, the patient’s legally mandated surrogate may espouse similar COVID-related views as the patient; thus, this approach may not help keep the patient in the hospital. If the physician has serious concern about the risk of the patient leaving, he/she would have to consult the facility’s Ethics and Legal staff to determine capacity of the surrogate. Third, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. In the current sociopolitical climate, involuntary detention may elicit a political backlash. Using medical detention for impending deterioration of clinical status would be more acceptable than using medical detention for isolation. Presently, there are no such laws for patients with COVID-19 (although this is not without precedent, as with active tuberculosis or Ebola^18,19), but individual jurisdictions may have isolation or quarantine orders; the local health department could be contacted and may evaluate on a case-by-case basis.

Continue to: Refusing to seek medical care

Refusing to seek medical care

Anecdotally, many physicians have reported an increase in patients who are refusing clinic- or hospital-based treatment for a medical condition because they fear they may catch the virus. Although this is not strictly a capacity case—there is little recourse for action if a patient is refusing treatment from home (unless the patient requires a psychiatric hold or already has a guardian for medical decisions)—the same elements of thresholds apply and can be helpful in guiding conversations with the patient.

For the patient, the benefits of staying at home are to avoid potentially exposing themselves and the members of their household to the virus and COVID-19 illness. The risks of staying home include progression of the patient’s primary illness, which could lead to increased morbidity and mortality. Staying home has an ancillary benefit to the community of reducing health-care utilization, but at the risk of increasing utilization in the future.

The risk/benefit profile is shown on the thresholds graph in Figure 3. There is considerable variability. It is helpful to stratify the risk of progression of the primary condition as low (can be postponed indefinitely with minimal risk), medium (can be postponed for a short amount of time; risk of increased morbidity with ongoing delay and possibly increased mortality), or high (cannot be postponed; will have greater morbidity and/or higher risk of mortality). Because of the uncertainty about COVID-19, it is harder to quantify the benefits of refusing care and staying at home, although older patients and patients with underlying health issues are at higher risk of severe illness and death.²⁰ However, by taking appropriate precautions when seeking care, viral exposure and risk of infection can be mitigated.

This risk/benefit analysis will help set the threshold for whether staying at home is reasonable or whether it would incur more risk of harm. If the latter, then the physician must elicit the patient’s understanding, appreciation, and reasoning related to their current medical condition and COVID-19. It is likely they are undervaluing the former and overvaluing the latter. Table 2 lists important points to cover during these discussions.

Although there is no legal recourse to force patients at home to come to the clinic or hospital for medical treatment, there are several possible strategies to motivate them to do so. One is to ask patients how likely (on a scale of 0 to 100) they think they are to contract COVID-19 if they came for evaluation/treatment, and how likely they feel they are to experience a bad outcome from their primary condition. Then, after providing psychoeducation about their primary medical condition and COVID-19–related precautions and risk, repeat this question. Another strategy is to empathize with the patient’s fears while also expressing concern about the primary medical condition and connecting with the patient on the shared desire to protect his/her health. A third is to draw a risk/benefit diagram (similar to Figure 3) or reassure the patient by describing the ways in which the clinic or hospital is minimizing exposure and infection risk. A final strategy is to enlist the help of the patient’s family or friends.

Continue to: Bottom Line

 

 

Bottom Line

In order to have decision-making capacity, a patient must demonstrate choice, understanding, appreciation, and reasoning. The degree of understanding, appreciation, and reasoning required depends on the capacity threshold, which is determined by a risk/benefit analysis. Conducting a risk/benefit analysis during the coronavirus disease 2019 (COVID-19) pandemic requires consideration of societallevel factors (such as contagiousness to others and health-care utilization) and is complicated by a wide range of uncertainties and divisive sociopolitical views regarding COVID-19.

Related Resources

• Appelbaum PS. Clinical practice. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-1840.
• Ryznar E, Hamaoka D, Lloyd RB. Capacity evaluations. https://admsep.org/csi-emodules.php?c=capacity&v=y. Accessed March 30, 2020.

Acknowledgments

The author thanks Drs. Awais Aftab, Zackary D. Berger, and R. Brett Lloyd for their helpful discussions on the topic.

The coronavirus disease 2019 (COVID-19) pandemic has introduced many new clinical challenges. Consider the patient with fever and dyspnea who tests positive for COVID-19 but does not believe in COVID-19 and wants to leave the hospital against medical advice (AMA). Or the patient with numerous cardiovascular risk factors and crushing substernal chest pain who is too afraid of contracting COVID-19 to come to the emergency department. These challenging clinical scenarios can be addressed in the context of decision-making capacity (DMC), for which our medical colleagues often call upon psychiatrists to assist. This article reviews the framework for DMC assessment, describes how COVID-19 affects DMC assessment, and discusses approaches to these scenarios using the DMC framework.

Review of decision-making capacity

Assessment of DMC is a fundamental clinical skill. It allows a physician to balance autonomy with beneficence and non-maleficence. An autonomous decision is a decision that is made intentionally, with understanding, and without controlling influences (these are the elements of informed consent).¹ However, if a patient cannot make a decision with intention and understanding, then beneficence and non-maleficence must prevail in order to protect the patient. Capacity assessments evaluate a patient’s ability to make an intentional and understood choice.

In order to prove capacity, a patient must demonstrate 4 functional abilities:

• choice refers to the ability to communicate a relatively stable choice^2,3
• understanding refers to the ability to convey information about the illness, risks/benefits of the chosen intervention, and risks/benefits of alternative options.^2,3 Understanding measures objective information about the medical situation
• appreciation refers to the patient’s ability to apply that information to his/her own life.^2,3 Appreciation requires insight into having the illness and the ability to anticipate how one’s life would be impacted by one’s condition and choice. This is where life experiences and values come into play
• reasoning is intimately tied to appreciation. It refers to the ability to explain how the decision was made and which factors were most important.^2,3

Most clinicians and ethicists endorse a “threshold” approach to decisional capacity, which specifies that the level of evidence required to prove capacity depends on the gravity of the medical situation (Figure 1A).^1,4,5 The gravity of the situation is based on the risk/benefit analysis. Consider two treatments with equal benefit: one has minimal adverse effects (gastrointestinal upset) and the second has significant adverse effects (myelosuppression). Accepting the first treatment requires less intentionality and understanding than accepting the second because the risk is much lower and thus has a lower capacity threshold (Figure 1B). The capacity to refuse these treatments results in the opposite ranking (Figure 1C).

Establishing a threshold helps guide the physician in determining how robust the patient’s responses must be to have decisional capacity. For a high-threshold decision, the patient must have a well-developed and highly detailed level of understanding, appreciation, and reasoning.

How COVID-19 affects assessment of decision-making capacity

Three characteristics of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and COVID-19 illness impact decision-making assessment:

• high level of contagiousness
• high health-care utilization
• the uncertainty about its clinical course and outcomes.

The high level of contagiousness stems from this virus’s estimated basic reproduction number (R₀) of 2.2 to 5.7 (which indicates the expected number of cases from any single case), its long incubation period, and the potential for asymptomatic and pre-symptomatic shedding.^6-9 Decision-making capacity assessments must therefore consider community-level effects in the risk/benefit analysis. Because SARS-CoV-2 is a new virus affecting humans, it can easily overwhelm existing hospital systems. This happened in Wuhan, China; Lombardy, Italy; and New York. In a stressed system, physicians will have to factor health-care utilization into the risk/benefit analysis. Finally, because this is a novel virus, there is still considerable uncertainty about the epidemiology, clinical course, and outcomes.¹⁰ The minimal dose of virus needed to cause illness is unknown. Patients can deteriorate quickly and unpredictably into needing ventilator support.¹¹ Treatment options are limited, and many candidates are being investigated.¹² This uncertainty hinders physicians’ ability to accurately estimate risks and benefits for an individual patient when discussing various medical decisions. As our understanding of SARS-CoV-2 improves, this uncertainty will lessen.

Continue to: Effects of the sociopolitical climate

 

 

Effects of the sociopolitical climate

In the United States, the COVID-19 pandemic emerged during a time of deep sociopolitical divide. Accordingly, beliefs about viral infectivity, severity of illness, and precautionary measures have varied. Some politicians, media outlets, and physicians have shared information that contradicts guidelines and recommendations from mainstream national and international medical and scientific organizations. Patients who subscribe to these reports and beliefs may not meet the threshold for understanding, appreciation, or reasoning. For example, if a patient’s beliefs about the virus depart from well-established medical evidence, they would technically lack understanding. The usual remedy for addressing misunderstanding is education and time. However, because of the divisiveness of the sociopolitical climate, the limited time physicians have with patients, and the fact that many DMC assessments will occur in acute-care settings, it may be difficult or near impossible to correct the misunderstanding.

The sociopolitical climate and its accompanying potentially erroneous or imbalanced narrative may thus directly impact patients’ understanding, appreciation, and reasoning. However, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. Additionally, some clinicians and ethicists might object to declaring incapacity in a patient with no underlying mental or neurologic dysfunction. The United States has a functional approach to capacity, based solely on meeting criteria for the 4 functional abilities.^3,13 Mental or neurologic dysfunction is not legally required in the United States, but in practice, the consideration of incapacity is often closely linked to some form of cognitive impairment.¹⁴ Other countries do make dysfunction a specific criterion; for example, the United Kingdom dictates that mental incapacity can only occur in someone with “impairment of, or a disturbance in the functioning of, the mind or brain.”¹⁵

Leaving against medical advice

In the case of a patient who is COVID-19–positive, symptomatic, and wants to leave AMA, the threshold is automatically elevated because of societal-level risks (the risk of potential exposure or infection of others if a patient who is COVID-19–positive is not properly isolated). Further­more, the individual risk of the patient leaving AMA depends on his/her age, comorbidities, and current clinical status; because of the uncertainty and rapid deterioration seen with COVID-19 illness, the calculated risk may actually be higher than for a non-COVID-19–related illness. Thus, in order to leave AMA, the patient’s responses must be fairly robust (Figure 2). Table 1 describes the information needed for robust understanding, appreciation, and reasoning.

For patients who do not meet this threshold, it is important to determine why. If a patient has a psychiatric condition that not only impacts DMC but also meets criteria for a psychiatric hold (ie, an imminent risk of harm to self or others), a psychiatric hold should be placed. If the patient does not meet the threshold because of altered mental status or some other neurologic or cognitive comorbidity, a medical hold should be placed. Most states do not have an explicit legal basis for a medical hold, although it does fall under the incapacity laws in the United States; in the absence of a surrogate, declaration of medical emergency can also be used if applicable.^16,17 As a caveat, it can be difficult to detain someone on a medical hold because security officers may be afraid to physically detain someone without explicit legal paperwork.¹⁷

If a patient does not meet the capacity threshold but there does not seem to be a psychiatric, neurologic, or cognitive explanation, several options are possible. The first step would be to assess whether the patient is amenable to further discussion and compromise. A nonjudgmental and nonconfrontational approach that aims to further clarify the patient’s perspective and identify shared goals is key. Any plan that lowers the risks sufficiently would allow the patient to leave by lowering the capacity threshold. Enlisting the support of family and friends can be helpful. If this does not work, theoretically the patient should be detained in the hospital. Practically speaking, this may be difficult or unadvised. First, as described above, security officers may refuse to physically detain the patient.¹⁷ Second, the patient’s legally mandated surrogate may espouse similar COVID-related views as the patient; thus, this approach may not help keep the patient in the hospital. If the physician has serious concern about the risk of the patient leaving, he/she would have to consult the facility’s Ethics and Legal staff to determine capacity of the surrogate. Third, it can be problematic to declare incapacity in a patient whose understanding, appreciation, and reasoning arise from widely shared and relatively fixed sociopolitical values. In the current sociopolitical climate, involuntary detention may elicit a political backlash. Using medical detention for impending deterioration of clinical status would be more acceptable than using medical detention for isolation. Presently, there are no such laws for patients with COVID-19 (although this is not without precedent, as with active tuberculosis or Ebola^18,19), but individual jurisdictions may have isolation or quarantine orders; the local health department could be contacted and may evaluate on a case-by-case basis.

Continue to: Refusing to seek medical care

Refusing to seek medical care

Anecdotally, many physicians have reported an increase in patients who are refusing clinic- or hospital-based treatment for a medical condition because they fear they may catch the virus. Although this is not strictly a capacity case—there is little recourse for action if a patient is refusing treatment from home (unless the patient requires a psychiatric hold or already has a guardian for medical decisions)—the same elements of thresholds apply and can be helpful in guiding conversations with the patient.

For the patient, the benefits of staying at home are to avoid potentially exposing themselves and the members of their household to the virus and COVID-19 illness. The risks of staying home include progression of the patient’s primary illness, which could lead to increased morbidity and mortality. Staying home has an ancillary benefit to the community of reducing health-care utilization, but at the risk of increasing utilization in the future.

The risk/benefit profile is shown on the thresholds graph in Figure 3. There is considerable variability. It is helpful to stratify the risk of progression of the primary condition as low (can be postponed indefinitely with minimal risk), medium (can be postponed for a short amount of time; risk of increased morbidity with ongoing delay and possibly increased mortality), or high (cannot be postponed; will have greater morbidity and/or higher risk of mortality). Because of the uncertainty about COVID-19, it is harder to quantify the benefits of refusing care and staying at home, although older patients and patients with underlying health issues are at higher risk of severe illness and death.²⁰ However, by taking appropriate precautions when seeking care, viral exposure and risk of infection can be mitigated.

This risk/benefit analysis will help set the threshold for whether staying at home is reasonable or whether it would incur more risk of harm. If the latter, then the physician must elicit the patient’s understanding, appreciation, and reasoning related to their current medical condition and COVID-19. It is likely they are undervaluing the former and overvaluing the latter. Table 2 lists important points to cover during these discussions.

Although there is no legal recourse to force patients at home to come to the clinic or hospital for medical treatment, there are several possible strategies to motivate them to do so. One is to ask patients how likely (on a scale of 0 to 100) they think they are to contract COVID-19 if they came for evaluation/treatment, and how likely they feel they are to experience a bad outcome from their primary condition. Then, after providing psychoeducation about their primary medical condition and COVID-19–related precautions and risk, repeat this question. Another strategy is to empathize with the patient’s fears while also expressing concern about the primary medical condition and connecting with the patient on the shared desire to protect his/her health. A third is to draw a risk/benefit diagram (similar to Figure 3) or reassure the patient by describing the ways in which the clinic or hospital is minimizing exposure and infection risk. A final strategy is to enlist the help of the patient’s family or friends.

Continue to: Bottom Line

 

 

Bottom Line

In order to have decision-making capacity, a patient must demonstrate choice, understanding, appreciation, and reasoning. The degree of understanding, appreciation, and reasoning required depends on the capacity threshold, which is determined by a risk/benefit analysis. Conducting a risk/benefit analysis during the coronavirus disease 2019 (COVID-19) pandemic requires consideration of societallevel factors (such as contagiousness to others and health-care utilization) and is complicated by a wide range of uncertainties and divisive sociopolitical views regarding COVID-19.

Related Resources

• Appelbaum PS. Clinical practice. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-1840.
• Ryznar E, Hamaoka D, Lloyd RB. Capacity evaluations. https://admsep.org/csi-emodules.php?c=capacity&v=y. Accessed March 30, 2020.

Acknowledgments

The author thanks Drs. Awais Aftab, Zackary D. Berger, and R. Brett Lloyd for their helpful discussions on the topic.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

My role as a mother expands and contracts in hard-won harmony with my role as a psychiatry resident. The magnitude of this responsibility compounded on itself when, seemingly overnight, the world we once trusted suddenly became unsafe. Coronavirus disease 2019 (COVID-19), deadly to immunocompromised individuals and the harbinger of a lethal autoimmune syndrome in children, was at our doorstep.

COVID-19 and parents who work in health care

After COVID-19 reached the United States, my fellow residents and I began to exchange nervous text messages, wondering what we could expect. Not only did the biological threat of the virus loom at the limited hospital entry points, but news alerts about infected front-line health care professionals and supply shortages jammed our cellphones. We quickly learned that some front-line physicians and nurses in New York had decided to live separately from their families. One article reported that a resident who was 5 months postpartum had chosen to live separately from her infant to protect her from exposure. “What a fundamental conflict of identity,” I thought as I read the article. Looking at my own young family, I felt our vulnerability overcome me. Would I have to do the same?

Difficult choices that exemplify both excitement and fear seem to define parenthood. Only months ago, I was selecting a car seat. As I scoured consumer reports, I became aware of a harrowing irony: in the excitement of nesting, I was also preparing for a collision. In March, when the quarantine began, I found myself evaluating my options for how to protect my family during a pandemic that often feels like a car crash in slow motion.

Health care professionals began to separate from their families to reduce the risk of transmission. Whether children went to live with relatives or health care workers stopped snuggling their young children, a structural boundary was formed just as the roots of attachment were taking shape. When asked about the loss inherent in this separation, these young parents expressed sadness but also said the choice was clear: their need to protect their families was absolute.

Meanwhile, some residents found themselves in a crash course on telemedicine. Safe from coronavirus exposure at work and liberated from a daily commute, these parents saw their young children more than ever before. Young child­ren saw their parents who were residents more than ever before. Perhaps the isolation of a front-line resident was sadly not a new experience.

Reassessing priorities

Now that the first wave of infections has broken over our coastal cities, residents from the front lines of COVID-19 are reuniting with their families. The sacrifices they made are re-evaluated as they begin to recognize anew the value of physical closeness with their loved ones in a dangerous world. One family that separated during the first wave said they would plan an alternate strategy, perhaps invest in a babysitter, rather than divide the household a second time.

While COVID-19 hit us hard, it has also forced a rare opportunity for self-assessment of priorities that we as trainees rarely take. We don’t have a consumer report on the safety ratings of COVID-19 plans. There is no formula for success. Instead, we each balance work and personal life with individual strategies to cope with elements outside of our control. This coping strategy may look different for each family. I hope all training departments take this plurality into account when considering the new demands on residents that have emerged during COVID-19.

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.