In Case You Missed It: COVID

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CDC shortens COVID-19 quarantine time to 10 or 7 days, with conditions

Article Type
Changed
Thu, 08/26/2021 - 15:55

 

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

 

 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

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The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

 

 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

 

The Centers for Disease Control and Prevention announced two shorter quarantine options – 10 days or 7 days – for people exposed to COVID-19. Citing new evidence and an “acceptable risk” of transmission, the agency hopes reducing the 14-day quarantine will increase overall compliance and improve public health and economic constraints.

The agency also suggested people postpone travel during the upcoming winter holidays and stay home because of the pandemic.

These shorter quarantine options do not replace initial CDC guidance. “CDC continues to recommend quarantining for 14 days as the best way to reduce risk for spreading COVID-19,” said Henry Walke, MD, MPH, the CDC’s COVID-19 incident manager, during a media briefing on Wednesday.

However, “after reviewing and analyzing new research and data, CDC has identified two acceptable alternative quarantine periods.”

People can now quarantine for 10 days without a COVID-19 test if they have no symptoms. Alternatively, a quarantine can end after 7 days for someone with a negative test and no symptoms. The agency recommends a polymerase chain reaction test or an antigen assay within 48 hours before the end of a quarantine.

The agency also suggests people still monitor for symptoms for a full 14 days.

Reducing the length of quarantine “may make it easier for people to take this critical public health action, by reducing the economic hardship associated with a longer period, especially if they cannot work during that time,” Dr. Walke said. “In addition, a shorter quarantine period can lessen stress on the public health system and communities, especially when new infections are rapidly rising.”

The federal guidance leaves flexibility for local jurisdictions to make their own quarantine recommendations, as warranted, he added.
 

An ‘acceptable risk’ calculation

Modeling by the CDC and academic and public health partners led to the new quarantine recommendations, said John Brooks, MD, chief medical officer for the CDC’s COVID-19 response. Multiple studies “point in the same direction, which is that we can safely reduce the length of quarantine but accept there is a small residual risk that a person who is leaving quarantine early could transmit to someone else.”

The residual risk is approximately 1%, with an upper limit of 10%, when people quarantine for 10 days. A 7-day quarantine carries a residual risk of about 5% and an upper limit of 12%.

“Ten days is where the risk got into a sweet spot we like, at about 1%,” Dr. Brooks said. “That is a very acceptable risk, I think, for many people.”

Although it remains unknown what proportion of people spending 14 days in quarantine leave early, “we are hearing anecdotally from our partners in public health that many people are discontinuing quarantine ahead of time because there is pressure to go back to work, to get people back into school – and it imposes a burden on the individual,” Dr. Brooks said.

“One of our hopes is that ... if we reduce the amount of time they have to spend in quarantine, people will be more compliant,” he added.

A reporter asked why the CDC is shortening quarantines when the pandemic numbers are increasing nationwide. The timing has to do with capacity, Dr. Brooks said. “We are in situation where the number of cases is rising, the number of contacts is rising and the number of people who require quarantine is rising. That is a lot of burden, not just on the people who have to quarantine, but on public health.”
 

 

 

Home for the holidays

Similar to its pre-Thanksgiving advisory, the CDC also recommends people avoid travel during the upcoming winter holidays. “The best way to protect yourself and others is to postpone travel and stay home,” Dr. Walke said.

If people do decide to travel, the agency recommends COVID-19 testing 1-3 days prior to travel and again 3-5 days afterward, as well as reducing nonessential activities for a full 7 days after returning home. Furthermore, if someone does not have follow-up testing, the CDC recommends reducing nonessential activities for 10 days.

Testing does not eliminate all risk, Dr. Walke said, “but when combined with reducing nonessential activities, symptom screening and continuing with precautions like wearing masks, social distancing and hand washing, it can make travel safer.”

“We are trying to reduce the number of infections by postponing travel over the winter holiday,” Cindy Friedman, MD, chief of the CDC Travelers’ Health Branch, said during the media briefing.

“Travel volume was high during Thanksgiving,” she said, “and even if only a small percentage of those travelers were asymptomatically infected, this can translate into hundreds of thousands of additional infections moving from one community to another.”

This article first appeared on Medscape.com.

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Separating myth from reality: The role of cannabinoids in COVID-19

Article Type
Changed
Thu, 08/26/2021 - 15:55

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Dr. Faisal Islam

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.1

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.2 A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

Zaid Choudhry

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.3

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

Dr. Zia Choudhry

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.4 CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.5 As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.5 Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

 

 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.6

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

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An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Dr. Faisal Islam

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.1

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.2 A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

Zaid Choudhry

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.3

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

Dr. Zia Choudhry

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.4 CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.5 As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.5 Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

 

 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.6

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Dr. Faisal Islam

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.1

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.2 A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

Zaid Choudhry

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.3

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

Dr. Zia Choudhry

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.4 CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.5 As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.5 Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

 

 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.6

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

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Pandemic increases need for home-based care with remote monitoring of patients

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While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep
Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

 

 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

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While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep
Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

 

 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep
Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

 

 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

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Three pillars of a successful coronavirus vaccine program in minorities

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As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

Dr. Taru Saigal

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.1 Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.2 Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.3

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

 

 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.3 This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.10 Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.11 It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.12 Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

 

 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.13 However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

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As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

Dr. Taru Saigal

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.1 Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.2 Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.3

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

 

 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.3 This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.10 Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.11 It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.12 Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

 

 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.13 However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

Dr. Taru Saigal

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.1 Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.2 Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.3

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

 

 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.3 This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.10 Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.11 It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.12 Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

 

 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.13 However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

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U.S. passes 1.3 million COVID-19 cases in children

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Thu, 08/26/2021 - 15:55

The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.



Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

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The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.



Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

The news on children and COVID-19 for Thanksgiving week does not provide a lot of room for thankfulness.

“The number of new child COVID-19 cases reported this week, nearly 154,000, is the highest weekly increase since the pandemic began,” the American Academy of Pediatrics and the Children’s Hospital Association said in their latest weekly report.

For those not counting, the week ending Nov. 26 was the fifth in a row to show “the highest weekly increase since the pandemic began,” based on data the AAP and CHA have been collecting from 49 state health departments (New York does not report ages), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The 153,608 new cases bring the total number of COVID-19 cases in children to almost 1.34 million in those jurisdictions, which is 12% of the total number of cases (11.2 million) among all ages. For just the week ending Nov. 26, children represented 13.7% of all new cases in the United States, down from 14.1% the previous week, according to the AAP/CHA data.



Among the states reporting child cases, Florida has the lowest cumulative proportion of child cases, 6.4%, but the state is using an age range of 0-14 years (no other state goes lower than 17 years). New Jersey and Texas are next at 6.9%, although Texas “reported age for only 6% of total confirmed cases,” the AAP and CHA noted.

There are 35 states above the national number of 12.0%, the highest being Wyoming at 23.3%, followed by Tennessee at 18.3% and South Carolina at 18.2%. The two southern states are the only ones to use an age range of 0-20 years for child cases, the two groups said in this week’s report, which did not include the usual data on testing, hospitalization, and mortality because of the holiday.

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ACIP: Health workers, long-term care residents first tier for COVID-19 vaccine

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A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

 

 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

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A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

 

 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

 

A federal advisory panel recommends that health care workers and residents of long-term care facilities be the first to receive a COVID-19 vaccine when one is authorized for use by the Food and Drug Administration.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 that both groups be in the highest-priority group for vaccination. As such, ACIP recommends that both be included in phase 1a of the committee’s allocation plan.

The recommendation now goes to CDC director Robert Redfield, MD, for approval. State health departments are expected to rely on the recommendation, but ultimately can make their own decisions on how to allocate vaccine in their states.

“We hope that this vote gets us all one step closer to the day when we can all feel safe again and when this pandemic is over,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, at today’s meeting.

Health care workers are defined as paid and unpaid individuals serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care. Phase 1a would not include children who live in such facilities.

“Our goal in phase 1a with regard to health care personnel is to preserve the workforce and health care capacity regardless of where exposure occurs,” said ACIP panelist Grace Lee, MD, MPH, professor of paediatrics at Stanford (Calif.) University. Thus vaccination would cover clinical support staff, such as nursing assistants, environmental services staff, and food support staff.

“It is crucial to maintain our health care capacity,” said ACIP member Sharon Frey, MD, clinical director at the Center for Vaccine Development at Saint Louis University. “But it’s also important to prevent severe disease and death in the group that is at highest risk of those complications and that includes those in long-term care facilities.”

CDC staff said that staff and residents in those facilities account for 6% of COVID-19 cases and 40% of deaths.

But Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., voted against putting long-term care residents into the 1a phase. “We have traditionally tried a vaccine in a young healthy population and then hope it works in our frail older adults. So we enter this realm of ‘we hope it works and that it’s safe,’ and that concerns me on many levels particularly for this vaccine,” she said, noting that the vaccines closest to FDA authorization have not been studied in elderly adults who live in nursing homes or assisted living facilities.

She added: “I have no reservations for health care workers taking this vaccine.”
 

Prioritization could change

The phase 1a allocation fits within the “four ethical principles” outlined by ACIP and CDC staff Nov. 23: to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote transparency.

“My vote reflects maximum benefit, minimum harm, promoting justice and mitigating the health inequalities that exist with regard to distribution of this vaccine,” said ACIP Chair Jose Romero, MD. Romero, chief medical officer of the Arkansas Department of Health, voted in favor of the phase 1a plan.

He and other panelists noted, however, that allocation priorities could change after the FDA reviews and authorizes a vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet December 10 to review the Pfizer/BioNTech’s messenger RNA-based vaccine (BNT162b2). The companies filed for emergency use on November 20.

A second vaccine, made by Moderna, is not far behind. The company reported on Nov. 30 that its messenger RNA vaccine was 94.1% effective and filed for emergency use the same day. The FDA’s VRBPAC will review the safety and efficacy data for the Moderna vaccine on Dec. 17.

“If individual vaccines receive emergency use authorization, we will have more data to consider, and that could lead to revision of our prioritization,” said ACIP member Robert Atmar, MD, John S. Dunn Research Foundation Clinical Professor in Infectious Diseases at Baylor College of Medicine, Houston.

ACIP will meet again after the Dec. 10 FDA advisory panel. But it won’t recommend a product until after the FDA has authorized it, said Amanda Cohn, MD, senior advisor for vaccines at the CDC’s National Center for Immunization and Respiratory Diseases.
 

 

 

Staggered immunization subprioritization urged

The CDC staff said that given the potential that not enough vaccine will be available immediately, it was recommending that health care organizations plan on creating a hierarchy of prioritization within institutions. And, they also urged staggering vaccination for personnel in similar units or positions, citing potential systemic or other reactions among health care workers.

“Consider planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post vaccination,” said Sarah Oliver, MD, MSPH, from the CDC.

The CDC will soon be issuing guidance on how to handle systemic symptoms with health care workers, Dr. Oliver noted.

Some 40 million doses of the Pfizer/BioNTech and Moderna vaccines are expected to be available by the end of December, with 5 million to 10 million a week coming online after that, Dr. Cohn said. That means not all health care workers will be vaccinated immediately. That may require “subprioritization, but for a limited period of time,” she said.

Dr. Messonnier said that, even with limited supplies, most of the states have told the CDC that they think they can vaccinate all of their health care workers within 3 weeks – some in less time.

The ACIP allocation plan is similar to but not exactly the same as that issued by the National Academy of Sciences, Engineering, and Medicine, which issued recommendations in October. That organization said that health care workers, first responders, older Americans living in congregate settings, and people with underlying health conditions should be the first to receive a vaccine.

ACIP has said that phase 1b would include essential workers, including police officers and firefighters, and those in education, transportation, and food and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years or older.

This article first appeared on Medscape.com.

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2020: The year a viral asteroid collided with planet earth

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2020: The year a viral asteroid collided with planet earth

Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 20203) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million3) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States4). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

The multifaceted impacts of the COVID-19 pandemic

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,22 which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.23 Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

 

 

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.24 These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.

References

1. Baumeister D, Akhtar R, Ciufolini S, et al. Childhood trauma and adulthood inflammation: a meta-analysis of peripheral C-reactive protein, interleukin-6 and tumour necrosis factor-α. Mol Psychiatry. 2016;21(5):642-649.
2. Zatti C, Rosa V, Barros A, et al. Childhood trauma and suicide attempt: a meta-analysis of longitudinal studies from the last decade. Psychiatry Res. 2017;256:353-358.
3. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed November 11, 2020.
4. Centers for Disease Control and Prevention. 1918 Pandemic. https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html. Accessed November 4, 2020.
5. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.
6. Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-33.
7. Joshi KG. Taking care of ourselves during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):46-47.
8. Frank B, Peterson T, Gupta S, et al. Telepsychiatry: what you need to know. Current Psychiatry. 2020;19(6):16-23.
9. Chahal K. Neuropsychiatric manifestations of COVID-19. Current Psychiatry. 2020;19(6):31-33.
10. Arbuck D. Changes in patient behavior during COVID-19: what I’ve observed. Current Psychiatry. 2020;19(6):46-47.
11. Joshi KG. Telepsychiatry during COVID-19: understanding the rules. Current Psychiatry. 2020;19(6):e12-e14.
12. Komrad MS. Medical ethics in the time of COVID-19. Current Psychiatry. 2020;19(7):29-32,46.
13. Brooks V. COVID-19’s effects on emergency psychiatry. Current Psychiatry. 2020;19(7):33-36,38-39.
14. Desarbo JR, DeSarbo L. Anorexia nervosa and COVID-19. Current Psychiatry. 2020;19(8):23-28.
15. Freudenreich O, Kontos N, Querques J. COVID-19 and patients with serious mental illness. Current Psychiatry. 2020;19(9):24-27,33-39.
16. Ryznar E. Evaluating patients’ decision-making capacity during COVID-19. Current Psychiatry. 2020;19(10):34-40.
17. Saeed SA, Hebishi K. The psychiatric consequences of COVID-19: 8 studies. Current Psychiatry. 2020;19(11):22-24,28-30,32-35.
18. Lodhi S, Marett C. Using seclusion to prevent COVID-19 transmission on inpatient psychiatry units. Current Psychiatry. 2020;19(11):37-41,53.
19. Nasrallah HA. COVID-19 and the precipitous dismantlement of societal norms. Current Psychiatry. 2020;19(7):12-14,16-17.
20. Nasrallah HA. The cataclysmic COVID-19 pandemic: THIS CHANGES EVERYTHING! Current Psychiatry. 2020;19(5):7-8,16.
21. Nasrallah HA. During a viral pandemic, anxiety is endemic: the psychiatric aspects of COVID-19. Current Psychiatry. 2020;19(4):e3-e5.
22. Holmes TH, Rahe RH. The social readjustment rating scale. Journal of Psychosomatic Research. 1967;11(2):213-218.
23. Berkwits M, Flanagin A, Bauchner H, et al. The COVID-19 pandemic and the JAMA Network. JAMA. 2020;324(12):1159-1160.
24. Robins LN, Regier DA, eds. Psychiatric disorders in America. The Epidemiologic Catchment Area study. New York, NY: The Free Press; 1991.
25. Meninger KA. Psychosis associated with influenza. I. General data: statistical analysis. JAMA. 1919;72(4):235-241.
26. Simon NM, Saxe GN, Marmar CR. Mental health disorders related to COVID-19-related deaths. JAMA. 2020;324(15):1493-1494.

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Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 20203) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million3) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States4). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

The multifaceted impacts of the COVID-19 pandemic

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,22 which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.23 Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

 

 

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.24 These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.

Finally, 2020 is coming to an end, but the agony its viral pandemic inflicted on the entire world population will continue for a long time. And much as we would like to forget its damaging effects, it will surely be etched into our brains for the rest of our lives. The children who suffered the pain of the coronavirus disease 2019 (COVID-19) pandemic will endure its emotional scars for the rest of the 21st century.

Reading about the plagues of the past doesn’t come close to experiencing it and suffering through it. COVID-19 will continue to have ripple effects on every aspect of life on this planet, on individuals and on societies all over the world, especially on the biopsychosocial well-being of billions of humans around the globe.

Unprecedented disruptions

Think of the unprecedented disruptions inflicted by the trauma of the COVID-19 pandemic on our neural circuits. One of the wonders of the human brain is its continuous remodeling due to experiential neuroplasticity, and the formation of dendritic spines that immediately encode the memories of every experience. The turmoil of 2020 and its virulent pandemic will be forever etched into our collective brains, especially in our hippocampi and amygdalae. The impact on the developing brains of our children and grandchildren could be profound and may induce epigenetic changes that trigger psychopathology in the future.1,2

As with the dinosaurs, the 2020 pandemic is like a “viral asteroid” that left devastation on our social fabric and psychological well-being in its wake. We now have deep empathy with our 1918 ancestors and their tribulations, although so far, in the United States the proportion of people infected with COVID-19 (3% as of mid-November 20203) is dwarfed by the proportion infected with the influenza virus a century ago (30%). As of mid-November 2020, the number of global COVID-19 deaths (1.3 million3) was a tiny fraction of the 1918 influenza pandemic deaths (50 million worldwide and 675,000 in the United States4). Amazingly, researchers did not even know whether the killer germ was a virus or a bacterium until 1930, and it then took another 75 years to decode the genome of the influenza virus in 2005. In contrast, it took only a few short weeks to decode the genome of the virus that causes COVID-19 (severe acute respiratory syndrome-related coronavirus 2), and to begin developing multiple vaccines “at warp speed.” No vaccine or therapies were ever developed for victims of the 1918 pandemic.

An abundance of articles has been published about the pandemic since it ambushed us early in 2020, including many in Current Psychiatry.5-21 But these publications don’t do justice to the emotional toll of living through the pandemic and witnessing its multi­farious repercussions (Table). It was truly bizarre and shocking for us to see our society and all its components literally come to a standstill, forcing the population to stop working, reducing us to simply “existing” inside our homes, with no socializing, traveling, or interacting. More unbearable than the sudden emptiness and paralysis was the unremitting fear, laced with a profound uncertainty of what was to come or when it would end.

The multifaceted impacts of the COVID-19 pandemic

Most psychiatrists are familiar with the Holmes and Rahe Stress Scale,22 which contains 43 life events that cumulatively can progressively increase the odds of physical illness. It is likely that most of the world’s population will score very high on the Holmes and Rahe Stress Scale, which would predict an increased risk of medical illness, even after the pandemic subsides.

Exacerbating the situation is that hospitals and clinics had to shut down most of their operations to focus their resources on treating patients with COVID-19 in ICUs. This halted all routine screenings for cancer and heart, kidney, liver, lung, or brain diseases. In addition, diagnostic or therapeutic procedures such as endoscopies, colonoscopies, angiograms, or biopsies abruptly stopped, resulting in a surge of non–COVID-19 medical disorders and mortality as reported in several articles across many specialties.23 Going forward, in addition to COVID-19 morbidity and mortality, there is a significant likelihood of an increase in myriad medical disorders. The COVID-19 pandemic is obviously inflicting both direct and indirect casualties as it stretches into the next year and perhaps longer. The only hope for the community of nations is the rapid arrival of evidence-based treatments and vaccine(s).

Continue to: A progression of relentless stress

 

 

A progression of relentless stress

At the core of this pandemic is relentless stress. When it began in early 2020, the pandemic ignited an acute stress reaction due to the fear of death and the oddness of being isolated at home. Aggravating the acute stress was the realization that life as we knew it suddenly disappeared and all business or social activities had come to a screeching halt. It was almost surreal when streets usually bustling with human activity (such as Times Square in New York or Michigan Avenue in Chicago) became completely deserted and eerily silent. In addition, more stress was generated from watching television or scrolling through social media and being inundated with morbid and frightening news and updates about the number of individuals who became infected or died, and the official projections of tens of thousands or even hundreds of thousands of fatalities. Further intensifying the stress was hearing that there was a shortage of personal protective equipment (even masks), a lack of ventilators, and the absence of any medications to fight the overwhelming viral infection. Especially stressed were the front-line physicians and nurses, who heroically transcended their fears to save their patients’ lives. The sight of refrigerated trucks serving as temporary morgues outside hospital doors was chilling. The world became a macabre place where people died in hospitals without any relative to hold their hands or comfort them, and then were buried quickly without any formal funerals due to mandatory social distancing. The inability of families to grieve for their loved ones added another poignant layer of sadness and distress to the survivors who were unable to bid their loved ones goodbye. This was a jarring example of adding insult to injury.

With the protraction of the exceptional changes imposed by the pandemic, the acute stress reaction transmuted into posttraumatic stress disorder (PTSD) on a wide scale. Millions of previously healthy individuals began to succumb to the symptoms of PTSD (irritability, hypervigilance, intrusive thoughts, avoidance, insomnia, and bad dreams). The heaviest burden was inflicted on our patients, across all ages, with preexisting psychiatric conditions, who comprise approximately 25% of the population per the classic Epidemiological Catchment Area (ECA) study.24 These vulnerable patients, whom we see in our clinics and hospitals every day, had a significant exacerbation of their psychopathology, including anxiety, depression, psychosis, binge eating disorder, obsessive-compulsive disorder, alcohol and substance use disorders, child abuse, and intimate partner violence.25,26 The saving grace was the rapid adoption of telepsychiatry, which our psychiatric patients rapidly accepted. Many of them found it more convenient than dressing and driving and parking at the clinic. It also enabled psychiatrists to obtain useful collateral information from family members or partners.

If something good comes from this catastrophic social stress that emotionally hobbled the entire population, it would be the dilution of the stigma of mental illness because everyone has become more empathic due to their personal experience. Optimistically, this may also help expedite true health care parity for psychiatric brain disorders. And perhaps the government may see the need to train more psychiatrists and fund a higher number of residency stipends to all training programs.

Quo vadis COVID-19?

So, looking through the dense fog of the pandemic fatigue, what will 2021 bring us? Will waves of COVID-19 lead to pandemic exhaustion? Will the frayed public mental health care system be able to handle the surge of frayed nerves? Will social distancing intensify the widespread emotional disquietude? Will the children be able to manifest resilience and avoid disabling psychiatric disorders? Will the survivors of COVID-19 infections suffer from post–COVD-19 neuropsychiatric and other medical sequelae? Will efficacious therapies and vaccines emerge to blunt the spread of the virus? Will we all be able to gather in stadiums and arenas to enjoy sporting events, shows, and concerts? Will eating at our favorite restaurants become routine again? Will engaged couples be able to organize well-attended weddings and receptions? Will airplanes and hotels be fully booked again? Importantly, will all children and college students be able to resume their education in person and socialize ad lib? Will we be able to shed our masks and hug each other hello and goodbye? Will scientific journals and social media cover a wide array of topics again as before? Will the number of deaths dwindle to zero, and will we return to worrying mainly about the usual seasonal flu? Will everyone be able to leave home and go to work again?

I hope that the thick dust of this 2020 viral asteroid will settle in 2021, and that “normalcy” is eventually restored to our lives, allowing us to deal with other ongoing stresses such as social unrest and political hyperpartisanship.

References

1. Baumeister D, Akhtar R, Ciufolini S, et al. Childhood trauma and adulthood inflammation: a meta-analysis of peripheral C-reactive protein, interleukin-6 and tumour necrosis factor-α. Mol Psychiatry. 2016;21(5):642-649.
2. Zatti C, Rosa V, Barros A, et al. Childhood trauma and suicide attempt: a meta-analysis of longitudinal studies from the last decade. Psychiatry Res. 2017;256:353-358.
3. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed November 11, 2020.
4. Centers for Disease Control and Prevention. 1918 Pandemic. https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html. Accessed November 4, 2020.
5. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.
6. Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-33.
7. Joshi KG. Taking care of ourselves during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):46-47.
8. Frank B, Peterson T, Gupta S, et al. Telepsychiatry: what you need to know. Current Psychiatry. 2020;19(6):16-23.
9. Chahal K. Neuropsychiatric manifestations of COVID-19. Current Psychiatry. 2020;19(6):31-33.
10. Arbuck D. Changes in patient behavior during COVID-19: what I’ve observed. Current Psychiatry. 2020;19(6):46-47.
11. Joshi KG. Telepsychiatry during COVID-19: understanding the rules. Current Psychiatry. 2020;19(6):e12-e14.
12. Komrad MS. Medical ethics in the time of COVID-19. Current Psychiatry. 2020;19(7):29-32,46.
13. Brooks V. COVID-19’s effects on emergency psychiatry. Current Psychiatry. 2020;19(7):33-36,38-39.
14. Desarbo JR, DeSarbo L. Anorexia nervosa and COVID-19. Current Psychiatry. 2020;19(8):23-28.
15. Freudenreich O, Kontos N, Querques J. COVID-19 and patients with serious mental illness. Current Psychiatry. 2020;19(9):24-27,33-39.
16. Ryznar E. Evaluating patients’ decision-making capacity during COVID-19. Current Psychiatry. 2020;19(10):34-40.
17. Saeed SA, Hebishi K. The psychiatric consequences of COVID-19: 8 studies. Current Psychiatry. 2020;19(11):22-24,28-30,32-35.
18. Lodhi S, Marett C. Using seclusion to prevent COVID-19 transmission on inpatient psychiatry units. Current Psychiatry. 2020;19(11):37-41,53.
19. Nasrallah HA. COVID-19 and the precipitous dismantlement of societal norms. Current Psychiatry. 2020;19(7):12-14,16-17.
20. Nasrallah HA. The cataclysmic COVID-19 pandemic: THIS CHANGES EVERYTHING! Current Psychiatry. 2020;19(5):7-8,16.
21. Nasrallah HA. During a viral pandemic, anxiety is endemic: the psychiatric aspects of COVID-19. Current Psychiatry. 2020;19(4):e3-e5.
22. Holmes TH, Rahe RH. The social readjustment rating scale. Journal of Psychosomatic Research. 1967;11(2):213-218.
23. Berkwits M, Flanagin A, Bauchner H, et al. The COVID-19 pandemic and the JAMA Network. JAMA. 2020;324(12):1159-1160.
24. Robins LN, Regier DA, eds. Psychiatric disorders in America. The Epidemiologic Catchment Area study. New York, NY: The Free Press; 1991.
25. Meninger KA. Psychosis associated with influenza. I. General data: statistical analysis. JAMA. 1919;72(4):235-241.
26. Simon NM, Saxe GN, Marmar CR. Mental health disorders related to COVID-19-related deaths. JAMA. 2020;324(15):1493-1494.

References

1. Baumeister D, Akhtar R, Ciufolini S, et al. Childhood trauma and adulthood inflammation: a meta-analysis of peripheral C-reactive protein, interleukin-6 and tumour necrosis factor-α. Mol Psychiatry. 2016;21(5):642-649.
2. Zatti C, Rosa V, Barros A, et al. Childhood trauma and suicide attempt: a meta-analysis of longitudinal studies from the last decade. Psychiatry Res. 2017;256:353-358.
3. Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed November 11, 2020.
4. Centers for Disease Control and Prevention. 1918 Pandemic. https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html. Accessed November 4, 2020.
5. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.
6. Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-33.
7. Joshi KG. Taking care of ourselves during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):46-47.
8. Frank B, Peterson T, Gupta S, et al. Telepsychiatry: what you need to know. Current Psychiatry. 2020;19(6):16-23.
9. Chahal K. Neuropsychiatric manifestations of COVID-19. Current Psychiatry. 2020;19(6):31-33.
10. Arbuck D. Changes in patient behavior during COVID-19: what I’ve observed. Current Psychiatry. 2020;19(6):46-47.
11. Joshi KG. Telepsychiatry during COVID-19: understanding the rules. Current Psychiatry. 2020;19(6):e12-e14.
12. Komrad MS. Medical ethics in the time of COVID-19. Current Psychiatry. 2020;19(7):29-32,46.
13. Brooks V. COVID-19’s effects on emergency psychiatry. Current Psychiatry. 2020;19(7):33-36,38-39.
14. Desarbo JR, DeSarbo L. Anorexia nervosa and COVID-19. Current Psychiatry. 2020;19(8):23-28.
15. Freudenreich O, Kontos N, Querques J. COVID-19 and patients with serious mental illness. Current Psychiatry. 2020;19(9):24-27,33-39.
16. Ryznar E. Evaluating patients’ decision-making capacity during COVID-19. Current Psychiatry. 2020;19(10):34-40.
17. Saeed SA, Hebishi K. The psychiatric consequences of COVID-19: 8 studies. Current Psychiatry. 2020;19(11):22-24,28-30,32-35.
18. Lodhi S, Marett C. Using seclusion to prevent COVID-19 transmission on inpatient psychiatry units. Current Psychiatry. 2020;19(11):37-41,53.
19. Nasrallah HA. COVID-19 and the precipitous dismantlement of societal norms. Current Psychiatry. 2020;19(7):12-14,16-17.
20. Nasrallah HA. The cataclysmic COVID-19 pandemic: THIS CHANGES EVERYTHING! Current Psychiatry. 2020;19(5):7-8,16.
21. Nasrallah HA. During a viral pandemic, anxiety is endemic: the psychiatric aspects of COVID-19. Current Psychiatry. 2020;19(4):e3-e5.
22. Holmes TH, Rahe RH. The social readjustment rating scale. Journal of Psychosomatic Research. 1967;11(2):213-218.
23. Berkwits M, Flanagin A, Bauchner H, et al. The COVID-19 pandemic and the JAMA Network. JAMA. 2020;324(12):1159-1160.
24. Robins LN, Regier DA, eds. Psychiatric disorders in America. The Epidemiologic Catchment Area study. New York, NY: The Free Press; 1991.
25. Meninger KA. Psychosis associated with influenza. I. General data: statistical analysis. JAMA. 1919;72(4):235-241.
26. Simon NM, Saxe GN, Marmar CR. Mental health disorders related to COVID-19-related deaths. JAMA. 2020;324(15):1493-1494.

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Are more female physicians leaving medicine as pandemic surges?

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Thu, 08/26/2021 - 15:55

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

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For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

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

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Matching Wits With a Viral Enemy: How the VA Has Responded to COVID-19

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The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

 

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

 

 

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

 

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

 

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

 

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

 

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

 

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

 

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The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

 

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

 

 

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

 

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

 

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

 

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

 

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

 

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

 

The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

 

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

 

 

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

 

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

 

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

 

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

 

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

 

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

 

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Caring for outpatients during COVID-19: 4 themes

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Caring for outpatients during COVID-19: 4 themes

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.1 Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

  • isolation
  • uncertainty
  • household stress
  • grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.2 Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

 

 

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Isolation: Challenges, interventions, and rationales

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,9 benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.10 Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.11

Uncertainty: Challenges, interventions, and rationales

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

 

 

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.12

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Household stress: Challenges, interventions, and rationales

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,13 and a lack of preparation for loss14 are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,14 there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services15; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.16

Grief: Challenges, interventions, and rationales

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

  • Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
  • Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

References

1. Bloom N. How working from home works out. Stanford Institute for Economic Policy Research Policy Brief. https://siepr.stanford.edu/research/publications/how-working-home-works-out. Published June 2020. Accessed October 28, 2020.
2. Linz SJ, Sturm BA. The phenomenon of social isolation in the severely mentally ill. Perspect Psychiatr Care. 2013;49(4):243-254.
3. Smith KP, Christakis NA. Social networks and health. Annual Review of Sociology. 2008;34(1):405-429.
4. Umberson D, Montez JK. Social relationships and health: a flashpoint for health policy. J Health Soc Behav. 2010;51(suppl):S54‐S66.
5. Mann F, Bone JK, Lloyd-Evans B. A life less lonely: the state of the art in interventions to reduce loneliness in people with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2017;52(6):627-638.
6. Choi M, Kong S, Jung D. Computer and internet interventions for loneliness and depression in older adults: a meta-analysis. Healthc Inform Res. 2012;18(3):191‐198.
7. Chen YF, Huang ZY, Chien CH, et al. The effectiveness of diaphragmatic breathing relaxation training for reducing anxiety. Perspect Psychiatr Care. 2017;53(4):329-336.
8. Hoge EA, Bui E, Marques L, et al. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013;74(8):786‐792.
9. Carberry JC, Grunstein RR, Eckert DJ. The effects of zolpidem in obstructive sleep apnea - an open-label pilot study. Sleep Res. 2019;28(6):e12853. doi: 10.1111/jsr.12853.
10. Markota M, Rummans TA, Bostwick JM, et al. Benzodiazepine use in older adults: dangers, management, and alternative therapies. Mayo Clin Proc. 2016;91(11):1632-1639.
11. Matheson E, Hainer BL. Insomnia: pharmacologic therapy. Am Fam Physician. 2017;96(1):29-35.
12. Dijkstra MT, Homan AC. Engaging in rather than disengaging from stress: effective coping and perceived control. Front Psychol. 2016;7:1415.
13. Romero MM, Ott CH, Kelber ST. Predictors of grief in bereaved family caregivers of person’s with Alzheimer’s disease: a prospective study. Death Stud. 2014;38(6-10):395-403.
14. Lobb EA, Kristjanson LJ, Aoun SM, et al. Predictors of complicated grief: a systematic review of empirical studies. Death Stud. 2010;34(8):673-698.
15. Wallace CL, Wladkowski SP, Gibson A, et al. Grief during the COVID-19 pandemic: considerations for palliative care providers. J Pain Symptom Manage. 2020;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012
16. Selman LE, Chao D, Sowden R, et al. Bereavement support on the frontline of COVID-19: recommendations for hospital clinicians. J Pain Symptom Manage. 2020;60(2):e81-e86. doi: 10.1016/j.jpainsymman.2020.04.024

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Peter H. Marcus, PsyD 
Psychologist 

Anne Emmerich, MD
Psychiatrist 

Katherine A. Koh, MD, MSc 
Psychiatrist 

Mahdi Razafsha, MD 
Psychiatrist 

Meaghan M. Rudolph, PCNS
Psychiatric Clinical Nurse Specialist

Michael S. Hanau, MD 
Psychiatrist 

• • • •

Department of Psychiatry
Massachusetts General Hospital
Boston, Massachusetts

Disclosures
The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

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Psychiatrist 

Katherine A. Koh, MD, MSc 
Psychiatrist 

Mahdi Razafsha, MD 
Psychiatrist 

Meaghan M. Rudolph, PCNS
Psychiatric Clinical Nurse Specialist

Michael S. Hanau, MD 
Psychiatrist 

• • • •

Department of Psychiatry
Massachusetts General Hospital
Boston, Massachusetts

Disclosures
The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

Author and Disclosure Information

Peter H. Marcus, PsyD 
Psychologist 

Anne Emmerich, MD
Psychiatrist 

Katherine A. Koh, MD, MSc 
Psychiatrist 

Mahdi Razafsha, MD 
Psychiatrist 

Meaghan M. Rudolph, PCNS
Psychiatric Clinical Nurse Specialist

Michael S. Hanau, MD 
Psychiatrist 

• • • •

Department of Psychiatry
Massachusetts General Hospital
Boston, Massachusetts

Disclosures
The authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.

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Article PDF

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.1 Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

  • isolation
  • uncertainty
  • household stress
  • grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.2 Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

 

 

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Isolation: Challenges, interventions, and rationales

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,9 benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.10 Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.11

Uncertainty: Challenges, interventions, and rationales

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

 

 

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.12

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Household stress: Challenges, interventions, and rationales

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,13 and a lack of preparation for loss14 are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,14 there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services15; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.16

Grief: Challenges, interventions, and rationales

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

  • Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
  • Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.1 Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

  • isolation
  • uncertainty
  • household stress
  • grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.2 Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

 

 

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Isolation: Challenges, interventions, and rationales

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,9 benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.10 Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.11

Uncertainty: Challenges, interventions, and rationales

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

 

 

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.12

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Household stress: Challenges, interventions, and rationales

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,13 and a lack of preparation for loss14 are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,14 there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services15; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.16

Grief: Challenges, interventions, and rationales

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

  • Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
  • Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

References

1. Bloom N. How working from home works out. Stanford Institute for Economic Policy Research Policy Brief. https://siepr.stanford.edu/research/publications/how-working-home-works-out. Published June 2020. Accessed October 28, 2020.
2. Linz SJ, Sturm BA. The phenomenon of social isolation in the severely mentally ill. Perspect Psychiatr Care. 2013;49(4):243-254.
3. Smith KP, Christakis NA. Social networks and health. Annual Review of Sociology. 2008;34(1):405-429.
4. Umberson D, Montez JK. Social relationships and health: a flashpoint for health policy. J Health Soc Behav. 2010;51(suppl):S54‐S66.
5. Mann F, Bone JK, Lloyd-Evans B. A life less lonely: the state of the art in interventions to reduce loneliness in people with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2017;52(6):627-638.
6. Choi M, Kong S, Jung D. Computer and internet interventions for loneliness and depression in older adults: a meta-analysis. Healthc Inform Res. 2012;18(3):191‐198.
7. Chen YF, Huang ZY, Chien CH, et al. The effectiveness of diaphragmatic breathing relaxation training for reducing anxiety. Perspect Psychiatr Care. 2017;53(4):329-336.
8. Hoge EA, Bui E, Marques L, et al. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013;74(8):786‐792.
9. Carberry JC, Grunstein RR, Eckert DJ. The effects of zolpidem in obstructive sleep apnea - an open-label pilot study. Sleep Res. 2019;28(6):e12853. doi: 10.1111/jsr.12853.
10. Markota M, Rummans TA, Bostwick JM, et al. Benzodiazepine use in older adults: dangers, management, and alternative therapies. Mayo Clin Proc. 2016;91(11):1632-1639.
11. Matheson E, Hainer BL. Insomnia: pharmacologic therapy. Am Fam Physician. 2017;96(1):29-35.
12. Dijkstra MT, Homan AC. Engaging in rather than disengaging from stress: effective coping and perceived control. Front Psychol. 2016;7:1415.
13. Romero MM, Ott CH, Kelber ST. Predictors of grief in bereaved family caregivers of person’s with Alzheimer’s disease: a prospective study. Death Stud. 2014;38(6-10):395-403.
14. Lobb EA, Kristjanson LJ, Aoun SM, et al. Predictors of complicated grief: a systematic review of empirical studies. Death Stud. 2010;34(8):673-698.
15. Wallace CL, Wladkowski SP, Gibson A, et al. Grief during the COVID-19 pandemic: considerations for palliative care providers. J Pain Symptom Manage. 2020;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012
16. Selman LE, Chao D, Sowden R, et al. Bereavement support on the frontline of COVID-19: recommendations for hospital clinicians. J Pain Symptom Manage. 2020;60(2):e81-e86. doi: 10.1016/j.jpainsymman.2020.04.024

References

1. Bloom N. How working from home works out. Stanford Institute for Economic Policy Research Policy Brief. https://siepr.stanford.edu/research/publications/how-working-home-works-out. Published June 2020. Accessed October 28, 2020.
2. Linz SJ, Sturm BA. The phenomenon of social isolation in the severely mentally ill. Perspect Psychiatr Care. 2013;49(4):243-254.
3. Smith KP, Christakis NA. Social networks and health. Annual Review of Sociology. 2008;34(1):405-429.
4. Umberson D, Montez JK. Social relationships and health: a flashpoint for health policy. J Health Soc Behav. 2010;51(suppl):S54‐S66.
5. Mann F, Bone JK, Lloyd-Evans B. A life less lonely: the state of the art in interventions to reduce loneliness in people with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2017;52(6):627-638.
6. Choi M, Kong S, Jung D. Computer and internet interventions for loneliness and depression in older adults: a meta-analysis. Healthc Inform Res. 2012;18(3):191‐198.
7. Chen YF, Huang ZY, Chien CH, et al. The effectiveness of diaphragmatic breathing relaxation training for reducing anxiety. Perspect Psychiatr Care. 2017;53(4):329-336.
8. Hoge EA, Bui E, Marques L, et al. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013;74(8):786‐792.
9. Carberry JC, Grunstein RR, Eckert DJ. The effects of zolpidem in obstructive sleep apnea - an open-label pilot study. Sleep Res. 2019;28(6):e12853. doi: 10.1111/jsr.12853.
10. Markota M, Rummans TA, Bostwick JM, et al. Benzodiazepine use in older adults: dangers, management, and alternative therapies. Mayo Clin Proc. 2016;91(11):1632-1639.
11. Matheson E, Hainer BL. Insomnia: pharmacologic therapy. Am Fam Physician. 2017;96(1):29-35.
12. Dijkstra MT, Homan AC. Engaging in rather than disengaging from stress: effective coping and perceived control. Front Psychol. 2016;7:1415.
13. Romero MM, Ott CH, Kelber ST. Predictors of grief in bereaved family caregivers of person’s with Alzheimer’s disease: a prospective study. Death Stud. 2014;38(6-10):395-403.
14. Lobb EA, Kristjanson LJ, Aoun SM, et al. Predictors of complicated grief: a systematic review of empirical studies. Death Stud. 2010;34(8):673-698.
15. Wallace CL, Wladkowski SP, Gibson A, et al. Grief during the COVID-19 pandemic: considerations for palliative care providers. J Pain Symptom Manage. 2020;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012
16. Selman LE, Chao D, Sowden R, et al. Bereavement support on the frontline of COVID-19: recommendations for hospital clinicians. J Pain Symptom Manage. 2020;60(2):e81-e86. doi: 10.1016/j.jpainsymman.2020.04.024

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