MDedge Endocrinology

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

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

James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.

verbaska_studio/Getty Images

“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.

While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
 

Surprisingly productive

During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.

Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.

Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.

“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.

But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.

“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”

And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
 

“Most patients happy” with video visits

Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.

“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”

Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”

In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”

“It was obvious that this patient had a tremor by video,” Dr. Bernet said.

In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.

Starting to think about elective procedures again

As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”

Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.

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

James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.

verbaska_studio/Getty Images

“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.

While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
 

Surprisingly productive

During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.

Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.

Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.

“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.

But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.

“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”

And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
 

“Most patients happy” with video visits

Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.

“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”

Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”

In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”

“It was obvious that this patient had a tremor by video,” Dr. Bernet said.

In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.

Starting to think about elective procedures again

As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”

Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.

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

James V. Hennessey, MD, has been working from home, like so many others, since the lockdowns went into effect. The director of clinical endocrinology at Beth Israel Deaconess Medical Center in Boston has felt surprisingly heartened by his experience.

verbaska_studio/Getty Images

“So far, these [video-based] discussions have been reassuring,” he said in an interview. “The images generating the referral have been available for review, and we’ve been able to reassure the patients that there are no danger signs in their histories.” Dr. Hennessey noted that for patients who agree to thyroid nodule consultations via video consult, the arrangement has allowed for the assessment of difficulty swallowing and other obvious difficulties.

While Dr. Hennessey has not yet encountered anything serious during his virtual consults, such as a rapidly growing anaplastic thyroid cancer, “it will only take some time before we hear of one, I’m sure,” he observed.
 

Surprisingly productive

During the COVID-19 pandemic, many physicians have been forced to innovate and turn aspects of their practices virtual. Use of telehealth services has increased by 50% in the United States since the start of the pandemic, according to research by Frost and Sullivan consultants. Three endocrinologists report that telehealth, although not always ideal, may provide more information than expected.

Recent recommendations say physicians should defer biopsies of asymptomatic thyroid nodules until the risk for COVID-19 has passed. As a result, some patients may experience increased anxiety because of such delays. But cases determined to require more urgent care should not be delayed, says the guidance.

Trevor E. Angell, MD, concurred that it’s possible to safely defer thyroid nodule assessment. “I would agree that with appropriate risk stratification by symptom assessment, ultrasound, and lab testing, thyroid nodules can be safely triaged for delayed evaluation,” said Dr. Angell, an assistant professor of clinical medicine and associate medical director of the thyroid center at the University of Southern California, in Los Angeles.

“I have found that patients with thyroid nodules that are not highly suspicious are reasonably reassured that the delay in obtaining FNA [fine needle aspiration] is very unlikely to have an impact on the ultimate outcome,” he said in an interview.

But he does have concerns that many of the investigations needed to make a decision about whether treatment can be deferred are also on hold.

“In many settings, including my own institution, nonurgent radiology studies are not being performed,” he noted. And “patients are reluctant to go to an ultrasound evaluation or a laboratory to perform testing” because of worries about COVID-19. “For possible thyroid nodules that have not yet been evaluated, this presents difficulty in getting the accurate ultrasound risk stratification and/or calcitonin testing that would help determine the need for immediate FNA biopsy or surgical consideration.”

And for patients in whom surgery has already been recommended, because of “indeterminate FNA cytology or suspicious molecular test result,” there is likely to be even more anxiety, Dr. Angell said.
 

“Most patients happy” with video visits

Victor J. Bernet, MD, American Thyroid Association president-elect, noted that, while his practice already had planned to start doing some video visits in April, the process was by necessity jump-started in March.

“Currently, about 90%-95% of our appointments are video visit or phone-call based,” he said in an interview. “Most patients seem to actually be happy with the video visit experience,” he said. “Some patients were very happy that they were given the opportunity to not have to come into the clinic in person at this point in time.”

Dr. Bernet agreed that video consults can be productive in identifying some important clinical information. “I have had at least a few patients with obvious goiter or nodule,” said Dr. Bernet, an associate professor and chair of the division of endocrinology at the Mayo Clinic in Jacksonville, Fla. “I also had a patient with hyperthyroidism from Graves disease and we were able to assess her for tremor over video.”

In the latter case, “we had the patient place a sheet of paper on the top of her hand while her arm was extended, which is the technique that can be used in person as well, and helps amplify the ability to detect if a fine tremor is present.”

“It was obvious that this patient had a tremor by video,” Dr. Bernet said.

In addition to tremor, video visits can be helpful in “looking for the presence of thyroid eye disease, enlarged thyroid, and possibly even skin changes.” Video may also be useful in evaluating respiratory effort and some cognitive behaviors, Dr. Bernet noted.

Starting to think about elective procedures again

As centers in the United States begin to reopen and permit elective procedures again, patients being considered for FNAs will likely be reintroduced according to the level of need, Dr. Hennessey noted. “Those with clear indications for FNA will be the first (to be scheduled),” while those who had very-low-risk findings, such as small nodules and cysts, “have already been deferred to 6- or 12-month follow-up ultrasounds, and decisions regarding FNAs will be made based on clinical course.”

Dr. Angell agrees that efforts to address the most urgent cases once centers reopen will be of the utmost importance. “To the greatest extent possible, providers should work together to coordinate the rescheduling of patients for FNA or surgery to avoid any further delay for those at most risk,” he said.Dr. Hennessey, Dr. Angell, and Dr. Bernet have disclosed no relevant financial relationships.

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

Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.

During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.¹ Duke Health saw a decrease in stroke admissions in their hospitals by 34%.²

One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.² On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.³ Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.²

We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.

Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.⁴ There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.

Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.⁵

Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.⁶ How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.

The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.⁷ Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.

Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.

References

1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”

2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”

3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”

4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”

5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”

6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”

7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”

Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.

During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.¹ Duke Health saw a decrease in stroke admissions in their hospitals by 34%.²

One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.² On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.³ Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.²

We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.

Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.⁴ There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.

Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.⁵

Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.⁶ How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.

The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.⁷ Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.

Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.

References

1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”

2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”

3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”

4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”

5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”

6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”

7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”

Over the last several weeks, hospitals and health systems have focused on the COVID-19 epidemic, preparing and expanding bed capacities for the surge of admissions both in intensive care and medical units. An indirect impact of this has been the reduction in outpatient staffing and resources, with the shifting of staff for inpatient care. Many areas seem to have passed the peak in the number of cases and are now seeing a plateau or downward trend in the admissions to acute care facilities.

During this period, there has been a noticeable downtrend in patients being evaluated in the ED, or admitted for decompensation of chronic conditions like heart failure, COPD and diabetes mellitus, or such acute conditions as stroke and MI. Studies from Italy and Spain, and closer to home from Atlanta and Boston, point to a significant decrease in numbers of ST-elevation myocardial infarction (STEMI) admissions.¹ Duke Health saw a decrease in stroke admissions in their hospitals by 34%.²

One could argue that these patients are in fact presenting with COVID-19 or similar symptoms as is evidenced by the studies linking the severity of SARS-Co-V2 infection to chronic conditions like diabetes mellitus and obesity.² On the other hand, the message of social isolation and avoidance of nonurgent visits could lead to delays in care resulting in patients presenting sicker and in advanced stages.³ Also, this has not been limited to the adult population. For example, reports indicate that visits to WakeMed’s pediatric emergency rooms in Wake County, N.C., were down by 60%.²

We could well be seeing a calm before the storm. While it is anticipated that there may be a second surge of COVID-19 cases, health systems would do well to be prepared for the “third surge,” consisting of patients coming in with chronic medical conditions for which they have been, so far, avoiding follow-up and managing at home, and acute medical conditions with delayed diagnoses. The impact could likely be more in the subset of patients with limited access to health care, including medications and follow-up, resulting in a disproportionate burden on safety-net hospitals.

Compounding this issue would be the economic impact of the current crisis on health systems, their staffing, and resources. Several major organizations have already proposed budget cuts and reduction of the workforce, raising significant concerns about the future of health care workers who put their lives at risk during this pandemic.⁴ There is no guarantee that the federal funding provided by the stimulus packages will save jobs in the health care industry. This problem needs new leadership thinking, and every organization that puts employees over profits margins will have a long-term impact on communities.

Another area of concern is a shift in resources and workflow from ambulatory to inpatient settings for the COVID-19 pandemic, and the need for revamping the ambulatory services with reshifting the workforce. As COVID-19 cases plateau, the resurgence of non-COVID–related admissions will require additional help in inpatient settings. Prioritizing the ambulatory services based on financial benefits versus patient outcomes is also a major challenge to leadership.⁵

Lastly, the current health care crisis has led to significant stress, both emotional and physical, among frontline caregivers, increasing the risk of burnout.⁶ How leadership helps health care workers to cope with these stressors, and the resources they provide, is going to play a key role in long term retention of their talent, and will reflect on the organizational culture. Though it might seem trivial, posttraumatic stress disorder related to this is already obvious, and health care leadership needs to put every effort in providing the resources to help prevent burnout, in partnership with national organizations like the Society of Hospital Medicine and the American College of Physicians.

The expansion of telemedicine has provided a unique opportunity to address several of these issues while maintaining the nonpharmacologic interventions to fight the epidemic, and keeping the cost curve as low as possible.⁷ Extension of these services to all ambulatory service lines, including home health and therapy, is the next big step in the new health care era. Virtual check-ins by physicians, advance practice clinicians, and home care nurses could help alleviate the concerns regarding delays in care of patients with chronic conditions, and help identify those at risk. This would also be of help with staffing shortages, and possibly provide much needed support to frontline providers.

Dr. Prasad is currently medical director of care management and a hospitalist at Advocate Aurora Health in Milwaukee. He was previously quality and utilization officer and chief of the medical staff at Aurora Sinai Medical Center. Dr. Prasad is cochair of SHM’s IT Special Interest Group, sits on the HQPS Committee, and is president of SHM’s Wisconsin Chapter. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist in the UMMC School of Medicine.

References

1. Wood S. TCTMD. 2020 Apr 2. “The mystery of the missing STEMIs during the COVID-19 pandemic.”

2. Stradling R. The News & Observer. 2020 Apr 21. “Fewer people are going to Triangle [N.C.] emergency rooms, and that could be a bad thing.”

3. Kasanagottu K. USA Today. 2020 Apr 15. “Don’t delay care for chronic illness over coronavirus. It’s bad for you and for hospitals.”

4. Snowbeck C. The Star Tribune. 2020 Apr 11. “Mayo Clinic cutting pay for more than 20,000 workers.”

5. LaPointe J. RevCycle Intelligence. 2020 Mar 31. “How much will the COVID-19 pandemic cost hospitals?”

6. Gavidia M. AJMC. 2020 Mar 31. “Sleep, physician burnout linked amid COVID-19 pandemic.”

7. Hollander JE and Carr BG. N Engl J Med. 2020 Apr 30;382(18):1679-81. “Virtually perfect? Telemedicine for COVID-19.”

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

As the COVID-19 pandemic continues to spread across the United States, several members of the Pediatric News Editorial Advisory Board shared how practices have been adapting to the pandemic, especially in terms of immunization.

Karalyn Kinsella, MD, a member of a four-pediatrician private practice in Cheshire, Conn., said in an interview that “we have been seeing only children under age 2 years for their well visits to keep them up to date on their vaccinations” as recommended by infectious disease departments at nearby hospitals such as Connecticut Children’s Medical Center. “We also are seeing the 4- and 5-year-old children for vaccinations.”

Dr. Kinsella explained that, in case parents don’t want to bring their children into the office, her staff is offering to give the vaccinations in the parking lot. But most families are coming into the office.

“We are only seeing well babies and take the parent and child back to a room as soon as they come in the office to avoid having patients sit in the waiting room. At this point, both parents and office staff are wearing masks; we are cleaning the rooms between patients,” Dr. Kinsella said.

“Most of our patients are coming in for their vaccines, so I don’t anticipate a lot of kids being behind. However, we will have a surge of all the physicals that need to be done prior to school in the fall. We have thought about opening up for the weekends for physicals to accommodate this. We also may need to start the day earlier and end later. I have heard some schools may be postponing the date the physicals are due.”

Because of a lack of full personal protective equipment, the practice has not been seeing sick visits in the office, but they have been doing a lot of telehealth visits. “We have been using doxy.me for that, which is free, incredibly easy to use, and Health Insurance Portability and Accountability Act (HIPAA)–compliant,” she said. “I am finding some visits, such as ADHD follow-ups and mental health follow-ups, very amenable to telehealth.”

“The hardest part – as I am sure is for most pediatricians – is the financial strain to a small business,” Dr. Kinsella noted. “We are down about 70% in revenue from this time last year. We have had to lay-off half our staff, and those who are working have much-reduced hours. We did not get the first round of funding for the paycheck protection program loan from the government and are waiting on the second round. We are trying to recoup some business by doing telehealth, but [the insurance companies] are only paying about 75%-80%. We also are charging for phone calls over 5 minutes. It will take a long time once we are up and running to recoup the losses.

“When this is all over, I’m hoping that we will be able to continue to incorporate telehealth into our schedules as I think it is convenient for families. I also am hoping that pediatricians continue to bill for phone calls as we have been giving out a lot of free care prior to this. I hope the American Academy of Pediatrics and all pediatricians work together to advocate for payment of these modalities,” she said.

J. Howard Smart, MD, who is chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego, said in an interview, “We have been bringing all of the infants and toddlers in for checkups and vaccines up to age 18 months.” These visits are scheduled in the morning, and sick patients are scheduled in the afternoon. “Well-child visits for older ages are being done by video, and the kindergarten and adolescent vaccines can be done by quick nurse visits. We will have some catching up to do once restrictions are lifted.”

“A fair amount of discussion went into these decisions. Is a video checkup better than no checkup? There is no clear-cut answer. Important things can be addressed by video: lifestyle, diet, exercise, family coping with stay-at-home orders, maintaining healthy childhood relationships, Internet use, ongoing education, among others. We know that we may miss things that can only be picked up by physical examination: hypertension, heart murmurs, abnormal growth, sexual development, abdominal masses, subtle strabismus. This is why we need to bring these children back for the physical exam later,” Dr. Smart emphasized.

“One possible negative result of doing the ‘well-child check’ by video would be if the parent assumed that the ‘checkup’ was done, never brought the child back for the exam, and something was missed that needed intervention. It will be important to get the message across that the return visit is needed. The American Academy of Pediatrics made this a part of their recommendations. It is going to be important for payers to realize that we need to do both visits – and to pay accordingly,” he concluded.

Francis E. Rushton Jr., MD, of Birmingham, Ala., described in an interview how the pediatricians in his former practice are looking for new ways to encourage shot administration in a timely manner during the COVID-19 pandemic, as well as exploring ways to partner with home visitors in encouraging timely infant and toddler vaccinations.

At South Carolina’s Beaufort Pediatrics, Joseph Floyd, MD, described a multipronged initiative. The practice’s well-child visit reminder system is being reprogrammed to check for lapses in vaccinations rather than just well-child visit attendance. For the most part, Dr. Floyd stated parents appreciate the reminders and accept the need for vaccination: “In the absence of immunizations for coronavirus, families seem to be more cognizant of the value of the vaccines we do have.” Beaufort Pediatrics is also partnering with their local hospital on a publicity campaign stressing the importance of staying up to date with currently available and recommended vaccines.

Other child-service organizations are concerned as well. Dr. Francis E. Rushton Jr., as faculty with the Education Development Center’s Health Resources and Services Administration–funded home-visiting quality improvement collaborative (HV CoIIN 2.0), described efforts with home visitors in Alabama and other states. “Home visitors understand the importance of immunizations to the health and welfare of the infants they care for. They’re looking for opportunities to improve compliance with vaccination regimens.” Some of these home-visiting agencies are employing quality improvement technique to improve compliance. One idea they are working on is documenting annual training on updated vaccines for the home visitors. They are working on protocols for linking their clients with primary health care providers, referral relations, and relationship development with local pediatric offices. Motivational interviewing techniques for home visitors focused on immunizations are being considered. For families who are hesitant, home visitors are considering accompanying the family when they come to the doctor’s office while paying attention to COVID-19 social distancing policies at medical facilities.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The successful treatment of a patient with pulmonary arterial hypertension who contracted COVID-19 with self-administered inhaled nitrous oxide from a tankless device at home has caught the imagination of researchers investigating treatments for other patients.

It is not clear whether the team was treating the COVID or “some manifestation of her pulmonary hypertension exacerbation,” said Roham Zamanian, MD, a pulmonologist at Stanford Health in Palo Alto, California.

This is why a clinical trial is needed, he told Medscape Medical News.

“In this case, the COVID-19 respiratory infection led to a pulmonary hypertension exacerbation,” he explained. And the 34-year-old woman, who is also a physician, had demonstrated a response to nitric oxide before contracting the COVID-19 virus.

Zamanian and his colleagues describe the case in a letter published online in the American Journal of Respiratory and Critical Care. It will be discussed at the upcoming American Thoracic Society 2020 International Conference.

COVID-19 was confirmed in the patient, who had stable vasoreactive idiopathic pulmonary arterial hypertension, after she returned from a trip to Egypt. She did not want to travel the 350 miles from her home to the hospital for treatment, potentially infecting others, unless it was absolutely necessary.

“We had to make sure we were doing the right thing treating her at home, and we had to do it quickly,” Zamanian said. The patient was put on a remote routine – with vital monitoring in place – that included 6-minute walk tests twice daily and video conferencing. She also completed the EmPHasis-10 questionnaire, which is used to assess the status of patients with pulmonary hypertension.

The care team filed an Emergency Investigational New Drug application for the off-label at-home use of the tankless inhaled nitric oxide system (GENOSYL DS, VERO Biotech), which was approved by the US Food and Drug Administration. The system has so far been approved only for the treatment of newborns with persistent pulmonary hypertension.

Off-label inhaled nitric oxide has never been used in an outpatient setting. “That’s where this case is unique,” Zamanian explained.

“This case was very specific. We knew she was vasoreactive, and she knew how to use the device,” he said. “And we know nitric oxide is a quick-acting medication when it works, showing results in minutes, if not seconds.”

Within 24 hours of approval, the tankless system arrived at her home.

The patient’s therapy consisted of nitric oxide at a dose of 20 ppm plus supplemental oxygen delivered by nasal cannula at a dose of 2 L/min for 12 to 14 hours a day. After symptomatic improvement, a stepwise reduction in nitric oxide was implemented from day 13 to 17, with the dose dropping to 10 ppm, 5 ppm, and then 0 ppm.

“We quickly knew she was responding and feeling better. Without the medication, she would very likely have needed to be hospitalized,” Zamanian said.

“The real novelty of this case is demonstrating use in an outpatient system,” he pointed out. “My perspective is that this particular case was very specific, in a person who had been formally evaluated and known to be responsive to this treatment.”

The team is now preparing to launch a clinical trial of inhaled nitric oxide in COVID-19 patients without pulmonary hypertension, Zamanian reported.
 

Treating other patients

Nitric oxide could be useful for patients who come in with pulmonary hypertension, but “we have to test and figure that out. It could also be that patients with other underlying lung diseases could be helped with nitric oxide as well,” Zamanian said.

To treat on an outpatient basis, “we would need to make sure patients have established and reliable communications with an investigator or physician.” In addition, a protocol will have to be established that outlines how to administer the nitric oxide treatment and how to connect the nasal cannula.

“We envision patients being prescribed a certain dose and then working with either their healthcare provider or respiratory therapist to follow the standards we set,” he explained.

Although it is not a cure, nitric oxide could improve oxygenation for COIVD-19 patients in respiratory distress who have a component of abnormal pulmonary vascular function “largely driven” by ventilation perfusion – or V/Q – mismatch, he explained.

It is widely known that the gas, because it is a selective pulmonary vasodilator, can be used as rescue therapy in patients with refractory hypoxemia due to acute respiratory distress syndrome (ARDS).

“There is justification for studying it in both pulmonary hypertension and nonpulmonary hypertension patients,” Zamanian added. “The idea is that there is a component of pulmonary function and constriction with COVID-19 that may be at play here, which is not typical of regular ARDS.”
 

Several trials underway

In early April, an investigation into the use of high-dose nitric oxide therapy for the treatment of patients infected with SARS-CoV-2 who suffer lung complications was approved by the Therapeutic Products Directorate of Health Canada.

The NONTM – Inhaled Gaseous Nitric Oxide Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections – trial will test the use of Thiolanox, a high-concentration, 5000 ppm nitric oxide canister (Mallinckrodt Pharmaceuticals) administered with the INODD delivery device (Novoteris), at Vancouver Coastal Health Authority facilities. The open-label safety study will look at whether nitric oxide can reduce the bacterial load in the lungs of adults and adolescents.

Last week, two randomized multicenter clinical trials — also focused on the potential therapeutic benefits of nitric oxide in patients with COVID-19 in a hospital setting — were launched by teams at the Massachusetts General Hospital in Boston.

The NoCovid trial will look at nitric oxide for mild to moderate COVID-19 in 240 patients treated with a noninvasive CPAP system or a nonrebreathing mask system.

The NOSARSCOVID trial will look at the use of the INOmax (Mallinckrodt) nitric oxide inhalation system in 200 COVID-19 patients with severe acute respiratory syndrome.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, MD, from Massachusetts General Hospital, said in a news release from Mallinckrodt announcing NOSARSCOVID.

“The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients,” Berra explains.

INOmax has already been used to treat COVID-19 patients in more than 170 hospitals in the United States, according to the news release.

Still, for COVID-19 treatment, “it’s still all hypothetical, as it hasn’t been proven,” said Alex Stenzler, founder and president of Novoteris.

We’ve demonstrated that we are able to get more oxygen to the blood and that there are some pro- and anti-inflammatory properties, “but there’s no randomized evidence, and the numbers are small,” he told Medscape Medical News.

And if there is a response or benefit, “we won’t know the reason for that benefit – if it’s anti-inflammatory, antiviral, or a vascular effect,” he pointed out.

“Nitric oxide is one of the most important signaling molecules in the human body. Our own body uses it to kill organisms and cells, heal wounds,” he explained, but “we’re a long way off from knowing” whether it can help ARDS patients.

COVID-19 Ventilation Clinical Practice Guidelines, issued by the European Society of Intensive Care Medicine and the Society of Critical Care, warn that “in patients with ARDS who are on mechanical ventilation, routine use of inhaled nitric oxide is not recommended,” as reported by Medscape.
 

Antimicrobial, antiviral properties

Previous studies of nitric oxide have shown that it has antiviral and antimicrobial properties.

Nitric oxide was shown to reduce H1N1 in vitro in Madin-Darby canine kidney (MDCK) epithelial cells in a 2013 study conducted by Chris Miller, PhD, from the University of British Columbia in Vancouver, and colleagues. Miller is currently involved in the NONTM trial.

This could be an added benefit of treatment. “Nitric oxide has been shown to have antiviral properties,” Zamanian said. “We need to investigate it further to see how it can help us avoid negative outcomes.”

This article first appeared on Medscape.com.

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at dermnews@mdedge.com.

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at dermnews@mdedge.com.

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at dermnews@mdedge.com.

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.