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In Case You Missed It: COVID
New-onset psychosis while being treated for coronavirus
CASE Agitated, psychotic, and COVID-19–positive
Mr. G, age 56, is brought to the emergency department (ED) by emergency medical services (EMS) after his girlfriend reports that he was trying to climb into the “fiery furnace” to “burn the devil within him.” Mr. G had recently tested positive for coronavirus disease 2019 (COVID-19) via polymerase chain reaction and had been receiving treatment for it. In the ED, he is distressed and repeatedly exclaims, “The devil is alive!” He insists on covering himself with blankets, despite diaphoresis and soaking through his clothing within minutes. Because he does not respond to attempted redirection, the ED clinicians administer a single dose of IM haloperidol, 2 mg, for agitation.
HISTORY Multiple ED visits and hospitalizations
Mr. G, who has no known psychiatric history, lives with his girlfriend of 10 years. His medical history includes chronic obstructive pulmonary disease and prostate cancer. In 2015, he had a radical prostatectomy, without chemotherapy. His social history includes childhood neglect, which prompted him to leave home when he was a teenager. Mr. G had earned his general education development certificate and worked at a small retail store.
Mr. G had no previous history of mental health treatment per self-report, collateral information from his girlfriend, and chart review. He reported no known family psychiatric history. He did not endorse past psychiatric admissions or suicide attempts, nor previous periods of mania, depression, or psychosis. He said he used illicit substances as a teen, but denied using alcohol, tobacco products, or illicit substances in the past 20 years.
Mr. G recently had multiple ED visits and hospitalizations due to ongoing signs and symptoms associated with his COVID-19 diagnosis, primarily worsening shortness of breath and cough. Eleven days before EMS brought him to the ED at his girlfriend’s request, Mr. G had presented to the ED with chief complaints of shortness of breath and dry cough (Day 0). He reported that he had been “running a fever” for 2 days. In the ED, his initial vital signs were notable only for a temperature of 100.9°F (38.28°C). He was diagnosed with “acute viral syndrome” and received 1 dose of IV ceftriaxone, 2 g, and IV azithromycin, 500 mg. On Day 2, the ED clinicians prescribed a 4-day course of oral azithromycin, 250 mg/d, and discharged him home.
On Day 3, Mr. G returned to the ED with similar complaints—congestion and productive cough. He tested positive for COVID-19, and the ED discharged him home with quarantine instructions. Hours later, he returned to the ED via EMS with chief complaints of chest pain, diarrhea, and myalgias. He was prescribed a 5-day course ofoseltamivir, 75 mg twice daily, and azithromycin, 250 mg/d. The ED again discharged him home.
On Day 4, Mr. G returned to the ED for a fourth time. His chief complaint was worsening shortness of breath. His oxygen saturation was 94% on room air; it improved to 96% on 2 L of oxygen. His chest X-ray showed diffuse reticulonodular opacities throughout his bilateral lung fields and increased airspace opacification in the bilateral lower lobes. The ED admitted Mr. G to an internal medicine unit, where the primary treatment team enrolled him in a clinical trial. As part of the trial, Mr. G received hydroxychloroquine, 400 mg, on Day 4 and Day 5. The placebo-controlled component of the trial involved Mr. G receiving daily infusions of either remdesivir or placebo on Day 6 through Day 8. On Day 8, Mr. G was discharged home.
On Day 9, Mr. G returned to the ED with a chief complaint that his “thermometer wasn’t working” at home. The ED readmitted him to the internal medicine unit. On Day 9 through Day 11, Mr. G received daily doses of
Continue to: During the second hospitalization...
During the second hospitalization, nursing staff reported that Mr. G seemed religiously preoccupied and once reported seeing angels and demons. He was observed sitting in a chair praying to Allah that he would “come in on a horse to chop all the workers’ heads off.”
On Day 11, Mr. G was discharged home. Later that evening, the EMS brought him back in the ED due to his girlfriend’s concerns about his mental state.
EVALUATION Talks to God
On Day 12, psychiatry is consulted to evaluate Mr. G’s new-onset psychosis. Mr. G is alert and oriented to person, place, and time. His speech is loud, though the amount and rate are unremarkable. He displays no psychomotor agitation. His thought process is tangential and focuses on religious themes, specifically referring to Islam. He reports auditory hallucinations of God speaking directly to him. Mr. G states, “I am here because of a miraculous transformation from death back to life. Do you believe in God? Which God do you believe in? There are 2 Gods and only one of them is the true God. He is the God of all the 7 heavens and His true name is Allah, only one God, one faith. Allah is a ball of energy.”
Mr. G’s girlfriend provides collateral information that Mr. G had been raised Christian but was not religious as an adult. She says that he had never spoken about being Muslim. She adds that she had never known him to speak much about religion.
[polldaddy:10572249]
The authors’ observations
The etiology of new-onset psychosis can be related to several factors, including primary psychiatric illnesses, use of illicit substances, sequelae of general medical conditions, or adverse effects of prescribed medications. We considered each of these in the differential diagnosis for Mr. G.
Continue to: Psychiatric illness or illicit substance use
Psychiatric illness or illicit substance use. Because Mr. G was 56 years old and had no known psychiatric history or family psychiatric history, a primary psychiatric illness seemed less likely. Substance-induced psychosis related to illicit substance use also seemed unlikely because he denied using illicit substances, and an expanded urine drug screen was negative.
Psychosis due to a general medical condition. Results from Mr. G’s laboratory workup show marked elevation in multiple inflammation-related biomarkers (Table 1), consistent with the inflammatory profile seen with COVID-19 infection. However, results from several laboratory tests for potential etiologies of new-onset psychosis due to a general medical condition were negative (Table 2). Based on Mr. G’s history of prostate cancer, we considered the possibility of metastatic space-occupying lesions of the brain; however, Mr. G’s head CT showed no acute intracranial abnormalities. Another possible etiology we considered was COVID-19–induced encephalitis; however, Mr. G’s brain MRI with and without contrast showed no evidence of acute or chronic intracranial changes.
Medication-induced psychosis. After largely ruling out primary psychiatric illnesses, illicit substances, and sequelae of general medical conditions, we turned our attention to prescribed medications as a potential etiology of Mr. G’s new-onset psychosis. During his initial hospitalization, Mr. G had been prescribed 2 doses of hydroxychloroquine, 400 mg, to treat his diagnosis of COVID-19. Because none of the other medications he received were reported to have neuropsychiatric adverse effects, including psychosis, hydroxychloroquine-induced psychosis was therefore the primary team’s working diagnosis.
EVALUATION Request to leave AMA
On Day 13, Mr. G requests to leave the hospital against medical advice (AMA). Until this point, he had voluntarily remained in the hospital, which he repeatedly referred to as “Heaven.” When asked to describe his medical condition, Mr. G replies, “God told me my condition is far beyond man’s understanding.” He denies that he is positive for COVID-19. He states, “I am cured, and the real fight has just begun.”
At the recommendation of the psychiatry consultation-liaison (C-L) service, the primary treatment team determines that Mr. G does not have capacity to leave AMA. The team is concerned that because of his psychotic symptoms, Mr. G would be unable to understand and follow his quarantine instructions. He remains hospitalized on a medical hold.
Continue to: The authors' observations
The authors’ observations
One important consideration this case highlighted was potential third-party responsibility clinicians and hospital systems may face if they discharge a patient with a communicable illness who is unable to follow precautions based on a psychiatric condition.1 That concern was based on Mr. G’s reported desire to pursue missions “beyond man’s understanding,” which he felt compelled to complete, and which could unnecessarily place the public at risk. The psychiatry C-L service consulted the local health department and conferred with the hospital’s legal representatives, who agreed with the plan to keep Mr. G in the hospital for his safety as well as for the public’s safety.
TREATMENT Oral haloperidol
The psychiatry C-L service recommends initiating an antipsychotic. On Day 13, Mr. G starts oral haloperidol, 2.5 mg twice a day, to address his ongoing psychotic symptoms. On Day 14, the treatment team increases the dosage to 5 mg twice a day. Mr. G tolerates the haloperidol and gradually begins to improve. He demonstrates improved sleep, normal speech volume, less religious preoccupation, and a considerably improved understanding of his medical condition.
The authors’ observations
Mr. G’s initial psychiatric evaluation demonstrated an acute onset of psychotic symptoms, without evidence of delirium. Psychosis secondary to a general medical condition (such as COVID-19) and hydroxychloroquine-induced psychotic disorder topped our initial considerations in the differential diagnosis of this case. While the exact neuropsychiatric sequelae of COVID-19 are not yet clear, previous experiences with viral pandemics and case studies from the current pandemic demonstrate a wide variety of possible neuropsychiatric manifestations. Mood symptoms, psychosis, and encephalopathy represent some of the neuropsychiatric complications observed with past viral pandemics.2 Neuropsychiatric symptoms may be triggered by the virus itself, or from the host’s immune response to the infection.3 To further complicate matters, neuropsychiatric symptoms may manifest during the acute viral infection, or may surface later, as subacute or chronic neuropsychiatric illness.
Neuropsychiatric adverse events
Mr. G developed psychotic symptoms within the first few days of receiving hydroxychloroquine, which is consistent with the scant literature on this topic.8 Based on the available information, hydroxychloroquine remains the most likely etiology of his new-onset psychotic symptoms. Mr. G’s case is one example of the possible neuropsychiatric presentations clinicians may face while treating a novel viral illness.
Continue to: OUTCOME Homeward-bound
OUTCOME Homeward-bound
By Day 18, Mr. G’s psychotic symptoms have significantly improved. He is able to rationally process information about his COVID-19 diagnosis and the recommended quarantine instructions he needs to follow after discharge. He is cleared by infection control and discharged home to return to living with his girlfriend.
Mr. G attends his follow-up psychiatric appointment remotely 2 weeks after discharge. He reports that since discharge, he has continued taking his prescribed haloperidol, 5 mg twice a day. He demonstrates improved insight into his medical condition, acknowledging his COVID-19–positive status, and confirms that he has been following quarantine instructions. He does not report ongoing auditory or visual hallucinations, and is no longer religiously preoccupied. He says he is looking forward to being medically cleared to return to work.
The authors’ observations
This case highlights the need for prospective, longitudinal screening and monitoring of neuropsychiatric symptoms as part of the public health response to COVID-19. The case also highlights the importance of careful monitoring for adverse events, including neuropsychiatric symptoms, during clinical trials that involve experimental treatments. The long-term prognosis for individuals such as Mr. G who develop neuropsychiatric symptoms during acute COVID-19 infection remains unknown. Similarly, subacute and chronic neuropsychiatric manifestations that may develop after resolution of acute COVID-19 infection are unknown at this time. However, we can learn from past viral pandemics and anticipate that neuropsychiatric sequelae are likely to occur and should be part of the public health response to the pandemic.
Bottom Line
The coronavirus disease 2019 pandemic provides multiple clinical challenges pertinent to psychiatry. Neuropsychiatric symptoms may manifest from delirium, viral infection, host immune response, or adverse reactions to experimental treatments. These potential neuropsychiatric symptoms may complicate medical treatment. They can also raise important ethical and legal considerations, such as weighing patient autonomy vs third-party responsibility to the public at large.
Related Resources
- Ferrando SJ, Klepacz L, Lynch S, et al. COVID-19 psychosis: a potential new neuropsychiatric condition triggered by novel coronavirus infection and the inflammatory response? [published online May 19, 2020]. Psychosomatics. 2020. doi: 10.1016/j.psym.2020.05.012.
- Vlessides M. COVID-19 and psychosis: is there a link? Medscape Medical News. https://www.medscape.com/viewarticle/930224. Published May 8, 2020.
Drug Brand Names
Azithromycin • Zithromax
Ceftriaxone • Rocephin
Chloroquine • Aralen
Haloperidol • Haldol
Hydroxychloroquine • Plaquenil
Levofloxacin • Levaquin
Oseltamivir • Tamiflu
1. Ghossoub E, Newman WJ. COVID-19 and the duty to protect from communicable diseases. [published online ahead of print, May 8, 2020]. J Am Acad Psychiatry Law.
2. Menninger Ka. Psychoses associated with influenza: I. general data: statistical analysis. JAMA. 1919;72(4):235-241.
3. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms. Brain, Behavior, and Immunity. 2020. doi:10.1016/j.bbi.2020.04.027.
4. Alkadi HO. Antimalarial drug toxicity: a review. Chemotherapy. 2007;53(6):385-391.
5. Bogaczewicz A, Sobów T. Psychiatric adverse effects of chloroquine. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-114.
6. Sato K, Mano T, Iwata A, et al. Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. Biosci Trends. 2020;14(2):139-143.
7. Cortegiani A, Ingoglia G, Ippolito M, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020;57:279-283.
8. Das P, Rai A, Chopra A, et al. Psychosis likely induced by hydroxychloroquine in a patient with chronic Q fever: a case report and clinically relevant review of pharmacology. Psychosomatics. 2014;55(4):409-413.
CASE Agitated, psychotic, and COVID-19–positive
Mr. G, age 56, is brought to the emergency department (ED) by emergency medical services (EMS) after his girlfriend reports that he was trying to climb into the “fiery furnace” to “burn the devil within him.” Mr. G had recently tested positive for coronavirus disease 2019 (COVID-19) via polymerase chain reaction and had been receiving treatment for it. In the ED, he is distressed and repeatedly exclaims, “The devil is alive!” He insists on covering himself with blankets, despite diaphoresis and soaking through his clothing within minutes. Because he does not respond to attempted redirection, the ED clinicians administer a single dose of IM haloperidol, 2 mg, for agitation.
HISTORY Multiple ED visits and hospitalizations
Mr. G, who has no known psychiatric history, lives with his girlfriend of 10 years. His medical history includes chronic obstructive pulmonary disease and prostate cancer. In 2015, he had a radical prostatectomy, without chemotherapy. His social history includes childhood neglect, which prompted him to leave home when he was a teenager. Mr. G had earned his general education development certificate and worked at a small retail store.
Mr. G had no previous history of mental health treatment per self-report, collateral information from his girlfriend, and chart review. He reported no known family psychiatric history. He did not endorse past psychiatric admissions or suicide attempts, nor previous periods of mania, depression, or psychosis. He said he used illicit substances as a teen, but denied using alcohol, tobacco products, or illicit substances in the past 20 years.
Mr. G recently had multiple ED visits and hospitalizations due to ongoing signs and symptoms associated with his COVID-19 diagnosis, primarily worsening shortness of breath and cough. Eleven days before EMS brought him to the ED at his girlfriend’s request, Mr. G had presented to the ED with chief complaints of shortness of breath and dry cough (Day 0). He reported that he had been “running a fever” for 2 days. In the ED, his initial vital signs were notable only for a temperature of 100.9°F (38.28°C). He was diagnosed with “acute viral syndrome” and received 1 dose of IV ceftriaxone, 2 g, and IV azithromycin, 500 mg. On Day 2, the ED clinicians prescribed a 4-day course of oral azithromycin, 250 mg/d, and discharged him home.
On Day 3, Mr. G returned to the ED with similar complaints—congestion and productive cough. He tested positive for COVID-19, and the ED discharged him home with quarantine instructions. Hours later, he returned to the ED via EMS with chief complaints of chest pain, diarrhea, and myalgias. He was prescribed a 5-day course ofoseltamivir, 75 mg twice daily, and azithromycin, 250 mg/d. The ED again discharged him home.
On Day 4, Mr. G returned to the ED for a fourth time. His chief complaint was worsening shortness of breath. His oxygen saturation was 94% on room air; it improved to 96% on 2 L of oxygen. His chest X-ray showed diffuse reticulonodular opacities throughout his bilateral lung fields and increased airspace opacification in the bilateral lower lobes. The ED admitted Mr. G to an internal medicine unit, where the primary treatment team enrolled him in a clinical trial. As part of the trial, Mr. G received hydroxychloroquine, 400 mg, on Day 4 and Day 5. The placebo-controlled component of the trial involved Mr. G receiving daily infusions of either remdesivir or placebo on Day 6 through Day 8. On Day 8, Mr. G was discharged home.
On Day 9, Mr. G returned to the ED with a chief complaint that his “thermometer wasn’t working” at home. The ED readmitted him to the internal medicine unit. On Day 9 through Day 11, Mr. G received daily doses of
Continue to: During the second hospitalization...
During the second hospitalization, nursing staff reported that Mr. G seemed religiously preoccupied and once reported seeing angels and demons. He was observed sitting in a chair praying to Allah that he would “come in on a horse to chop all the workers’ heads off.”
On Day 11, Mr. G was discharged home. Later that evening, the EMS brought him back in the ED due to his girlfriend’s concerns about his mental state.
EVALUATION Talks to God
On Day 12, psychiatry is consulted to evaluate Mr. G’s new-onset psychosis. Mr. G is alert and oriented to person, place, and time. His speech is loud, though the amount and rate are unremarkable. He displays no psychomotor agitation. His thought process is tangential and focuses on religious themes, specifically referring to Islam. He reports auditory hallucinations of God speaking directly to him. Mr. G states, “I am here because of a miraculous transformation from death back to life. Do you believe in God? Which God do you believe in? There are 2 Gods and only one of them is the true God. He is the God of all the 7 heavens and His true name is Allah, only one God, one faith. Allah is a ball of energy.”
Mr. G’s girlfriend provides collateral information that Mr. G had been raised Christian but was not religious as an adult. She says that he had never spoken about being Muslim. She adds that she had never known him to speak much about religion.
[polldaddy:10572249]
The authors’ observations
The etiology of new-onset psychosis can be related to several factors, including primary psychiatric illnesses, use of illicit substances, sequelae of general medical conditions, or adverse effects of prescribed medications. We considered each of these in the differential diagnosis for Mr. G.
Continue to: Psychiatric illness or illicit substance use
Psychiatric illness or illicit substance use. Because Mr. G was 56 years old and had no known psychiatric history or family psychiatric history, a primary psychiatric illness seemed less likely. Substance-induced psychosis related to illicit substance use also seemed unlikely because he denied using illicit substances, and an expanded urine drug screen was negative.
Psychosis due to a general medical condition. Results from Mr. G’s laboratory workup show marked elevation in multiple inflammation-related biomarkers (Table 1), consistent with the inflammatory profile seen with COVID-19 infection. However, results from several laboratory tests for potential etiologies of new-onset psychosis due to a general medical condition were negative (Table 2). Based on Mr. G’s history of prostate cancer, we considered the possibility of metastatic space-occupying lesions of the brain; however, Mr. G’s head CT showed no acute intracranial abnormalities. Another possible etiology we considered was COVID-19–induced encephalitis; however, Mr. G’s brain MRI with and without contrast showed no evidence of acute or chronic intracranial changes.
Medication-induced psychosis. After largely ruling out primary psychiatric illnesses, illicit substances, and sequelae of general medical conditions, we turned our attention to prescribed medications as a potential etiology of Mr. G’s new-onset psychosis. During his initial hospitalization, Mr. G had been prescribed 2 doses of hydroxychloroquine, 400 mg, to treat his diagnosis of COVID-19. Because none of the other medications he received were reported to have neuropsychiatric adverse effects, including psychosis, hydroxychloroquine-induced psychosis was therefore the primary team’s working diagnosis.
EVALUATION Request to leave AMA
On Day 13, Mr. G requests to leave the hospital against medical advice (AMA). Until this point, he had voluntarily remained in the hospital, which he repeatedly referred to as “Heaven.” When asked to describe his medical condition, Mr. G replies, “God told me my condition is far beyond man’s understanding.” He denies that he is positive for COVID-19. He states, “I am cured, and the real fight has just begun.”
At the recommendation of the psychiatry consultation-liaison (C-L) service, the primary treatment team determines that Mr. G does not have capacity to leave AMA. The team is concerned that because of his psychotic symptoms, Mr. G would be unable to understand and follow his quarantine instructions. He remains hospitalized on a medical hold.
Continue to: The authors' observations
The authors’ observations
One important consideration this case highlighted was potential third-party responsibility clinicians and hospital systems may face if they discharge a patient with a communicable illness who is unable to follow precautions based on a psychiatric condition.1 That concern was based on Mr. G’s reported desire to pursue missions “beyond man’s understanding,” which he felt compelled to complete, and which could unnecessarily place the public at risk. The psychiatry C-L service consulted the local health department and conferred with the hospital’s legal representatives, who agreed with the plan to keep Mr. G in the hospital for his safety as well as for the public’s safety.
TREATMENT Oral haloperidol
The psychiatry C-L service recommends initiating an antipsychotic. On Day 13, Mr. G starts oral haloperidol, 2.5 mg twice a day, to address his ongoing psychotic symptoms. On Day 14, the treatment team increases the dosage to 5 mg twice a day. Mr. G tolerates the haloperidol and gradually begins to improve. He demonstrates improved sleep, normal speech volume, less religious preoccupation, and a considerably improved understanding of his medical condition.
The authors’ observations
Mr. G’s initial psychiatric evaluation demonstrated an acute onset of psychotic symptoms, without evidence of delirium. Psychosis secondary to a general medical condition (such as COVID-19) and hydroxychloroquine-induced psychotic disorder topped our initial considerations in the differential diagnosis of this case. While the exact neuropsychiatric sequelae of COVID-19 are not yet clear, previous experiences with viral pandemics and case studies from the current pandemic demonstrate a wide variety of possible neuropsychiatric manifestations. Mood symptoms, psychosis, and encephalopathy represent some of the neuropsychiatric complications observed with past viral pandemics.2 Neuropsychiatric symptoms may be triggered by the virus itself, or from the host’s immune response to the infection.3 To further complicate matters, neuropsychiatric symptoms may manifest during the acute viral infection, or may surface later, as subacute or chronic neuropsychiatric illness.
Neuropsychiatric adverse events
Mr. G developed psychotic symptoms within the first few days of receiving hydroxychloroquine, which is consistent with the scant literature on this topic.8 Based on the available information, hydroxychloroquine remains the most likely etiology of his new-onset psychotic symptoms. Mr. G’s case is one example of the possible neuropsychiatric presentations clinicians may face while treating a novel viral illness.
Continue to: OUTCOME Homeward-bound
OUTCOME Homeward-bound
By Day 18, Mr. G’s psychotic symptoms have significantly improved. He is able to rationally process information about his COVID-19 diagnosis and the recommended quarantine instructions he needs to follow after discharge. He is cleared by infection control and discharged home to return to living with his girlfriend.
Mr. G attends his follow-up psychiatric appointment remotely 2 weeks after discharge. He reports that since discharge, he has continued taking his prescribed haloperidol, 5 mg twice a day. He demonstrates improved insight into his medical condition, acknowledging his COVID-19–positive status, and confirms that he has been following quarantine instructions. He does not report ongoing auditory or visual hallucinations, and is no longer religiously preoccupied. He says he is looking forward to being medically cleared to return to work.
The authors’ observations
This case highlights the need for prospective, longitudinal screening and monitoring of neuropsychiatric symptoms as part of the public health response to COVID-19. The case also highlights the importance of careful monitoring for adverse events, including neuropsychiatric symptoms, during clinical trials that involve experimental treatments. The long-term prognosis for individuals such as Mr. G who develop neuropsychiatric symptoms during acute COVID-19 infection remains unknown. Similarly, subacute and chronic neuropsychiatric manifestations that may develop after resolution of acute COVID-19 infection are unknown at this time. However, we can learn from past viral pandemics and anticipate that neuropsychiatric sequelae are likely to occur and should be part of the public health response to the pandemic.
Bottom Line
The coronavirus disease 2019 pandemic provides multiple clinical challenges pertinent to psychiatry. Neuropsychiatric symptoms may manifest from delirium, viral infection, host immune response, or adverse reactions to experimental treatments. These potential neuropsychiatric symptoms may complicate medical treatment. They can also raise important ethical and legal considerations, such as weighing patient autonomy vs third-party responsibility to the public at large.
Related Resources
- Ferrando SJ, Klepacz L, Lynch S, et al. COVID-19 psychosis: a potential new neuropsychiatric condition triggered by novel coronavirus infection and the inflammatory response? [published online May 19, 2020]. Psychosomatics. 2020. doi: 10.1016/j.psym.2020.05.012.
- Vlessides M. COVID-19 and psychosis: is there a link? Medscape Medical News. https://www.medscape.com/viewarticle/930224. Published May 8, 2020.
Drug Brand Names
Azithromycin • Zithromax
Ceftriaxone • Rocephin
Chloroquine • Aralen
Haloperidol • Haldol
Hydroxychloroquine • Plaquenil
Levofloxacin • Levaquin
Oseltamivir • Tamiflu
CASE Agitated, psychotic, and COVID-19–positive
Mr. G, age 56, is brought to the emergency department (ED) by emergency medical services (EMS) after his girlfriend reports that he was trying to climb into the “fiery furnace” to “burn the devil within him.” Mr. G had recently tested positive for coronavirus disease 2019 (COVID-19) via polymerase chain reaction and had been receiving treatment for it. In the ED, he is distressed and repeatedly exclaims, “The devil is alive!” He insists on covering himself with blankets, despite diaphoresis and soaking through his clothing within minutes. Because he does not respond to attempted redirection, the ED clinicians administer a single dose of IM haloperidol, 2 mg, for agitation.
HISTORY Multiple ED visits and hospitalizations
Mr. G, who has no known psychiatric history, lives with his girlfriend of 10 years. His medical history includes chronic obstructive pulmonary disease and prostate cancer. In 2015, he had a radical prostatectomy, without chemotherapy. His social history includes childhood neglect, which prompted him to leave home when he was a teenager. Mr. G had earned his general education development certificate and worked at a small retail store.
Mr. G had no previous history of mental health treatment per self-report, collateral information from his girlfriend, and chart review. He reported no known family psychiatric history. He did not endorse past psychiatric admissions or suicide attempts, nor previous periods of mania, depression, or psychosis. He said he used illicit substances as a teen, but denied using alcohol, tobacco products, or illicit substances in the past 20 years.
Mr. G recently had multiple ED visits and hospitalizations due to ongoing signs and symptoms associated with his COVID-19 diagnosis, primarily worsening shortness of breath and cough. Eleven days before EMS brought him to the ED at his girlfriend’s request, Mr. G had presented to the ED with chief complaints of shortness of breath and dry cough (Day 0). He reported that he had been “running a fever” for 2 days. In the ED, his initial vital signs were notable only for a temperature of 100.9°F (38.28°C). He was diagnosed with “acute viral syndrome” and received 1 dose of IV ceftriaxone, 2 g, and IV azithromycin, 500 mg. On Day 2, the ED clinicians prescribed a 4-day course of oral azithromycin, 250 mg/d, and discharged him home.
On Day 3, Mr. G returned to the ED with similar complaints—congestion and productive cough. He tested positive for COVID-19, and the ED discharged him home with quarantine instructions. Hours later, he returned to the ED via EMS with chief complaints of chest pain, diarrhea, and myalgias. He was prescribed a 5-day course ofoseltamivir, 75 mg twice daily, and azithromycin, 250 mg/d. The ED again discharged him home.
On Day 4, Mr. G returned to the ED for a fourth time. His chief complaint was worsening shortness of breath. His oxygen saturation was 94% on room air; it improved to 96% on 2 L of oxygen. His chest X-ray showed diffuse reticulonodular opacities throughout his bilateral lung fields and increased airspace opacification in the bilateral lower lobes. The ED admitted Mr. G to an internal medicine unit, where the primary treatment team enrolled him in a clinical trial. As part of the trial, Mr. G received hydroxychloroquine, 400 mg, on Day 4 and Day 5. The placebo-controlled component of the trial involved Mr. G receiving daily infusions of either remdesivir or placebo on Day 6 through Day 8. On Day 8, Mr. G was discharged home.
On Day 9, Mr. G returned to the ED with a chief complaint that his “thermometer wasn’t working” at home. The ED readmitted him to the internal medicine unit. On Day 9 through Day 11, Mr. G received daily doses of
Continue to: During the second hospitalization...
During the second hospitalization, nursing staff reported that Mr. G seemed religiously preoccupied and once reported seeing angels and demons. He was observed sitting in a chair praying to Allah that he would “come in on a horse to chop all the workers’ heads off.”
On Day 11, Mr. G was discharged home. Later that evening, the EMS brought him back in the ED due to his girlfriend’s concerns about his mental state.
EVALUATION Talks to God
On Day 12, psychiatry is consulted to evaluate Mr. G’s new-onset psychosis. Mr. G is alert and oriented to person, place, and time. His speech is loud, though the amount and rate are unremarkable. He displays no psychomotor agitation. His thought process is tangential and focuses on religious themes, specifically referring to Islam. He reports auditory hallucinations of God speaking directly to him. Mr. G states, “I am here because of a miraculous transformation from death back to life. Do you believe in God? Which God do you believe in? There are 2 Gods and only one of them is the true God. He is the God of all the 7 heavens and His true name is Allah, only one God, one faith. Allah is a ball of energy.”
Mr. G’s girlfriend provides collateral information that Mr. G had been raised Christian but was not religious as an adult. She says that he had never spoken about being Muslim. She adds that she had never known him to speak much about religion.
[polldaddy:10572249]
The authors’ observations
The etiology of new-onset psychosis can be related to several factors, including primary psychiatric illnesses, use of illicit substances, sequelae of general medical conditions, or adverse effects of prescribed medications. We considered each of these in the differential diagnosis for Mr. G.
Continue to: Psychiatric illness or illicit substance use
Psychiatric illness or illicit substance use. Because Mr. G was 56 years old and had no known psychiatric history or family psychiatric history, a primary psychiatric illness seemed less likely. Substance-induced psychosis related to illicit substance use also seemed unlikely because he denied using illicit substances, and an expanded urine drug screen was negative.
Psychosis due to a general medical condition. Results from Mr. G’s laboratory workup show marked elevation in multiple inflammation-related biomarkers (Table 1), consistent with the inflammatory profile seen with COVID-19 infection. However, results from several laboratory tests for potential etiologies of new-onset psychosis due to a general medical condition were negative (Table 2). Based on Mr. G’s history of prostate cancer, we considered the possibility of metastatic space-occupying lesions of the brain; however, Mr. G’s head CT showed no acute intracranial abnormalities. Another possible etiology we considered was COVID-19–induced encephalitis; however, Mr. G’s brain MRI with and without contrast showed no evidence of acute or chronic intracranial changes.
Medication-induced psychosis. After largely ruling out primary psychiatric illnesses, illicit substances, and sequelae of general medical conditions, we turned our attention to prescribed medications as a potential etiology of Mr. G’s new-onset psychosis. During his initial hospitalization, Mr. G had been prescribed 2 doses of hydroxychloroquine, 400 mg, to treat his diagnosis of COVID-19. Because none of the other medications he received were reported to have neuropsychiatric adverse effects, including psychosis, hydroxychloroquine-induced psychosis was therefore the primary team’s working diagnosis.
EVALUATION Request to leave AMA
On Day 13, Mr. G requests to leave the hospital against medical advice (AMA). Until this point, he had voluntarily remained in the hospital, which he repeatedly referred to as “Heaven.” When asked to describe his medical condition, Mr. G replies, “God told me my condition is far beyond man’s understanding.” He denies that he is positive for COVID-19. He states, “I am cured, and the real fight has just begun.”
At the recommendation of the psychiatry consultation-liaison (C-L) service, the primary treatment team determines that Mr. G does not have capacity to leave AMA. The team is concerned that because of his psychotic symptoms, Mr. G would be unable to understand and follow his quarantine instructions. He remains hospitalized on a medical hold.
Continue to: The authors' observations
The authors’ observations
One important consideration this case highlighted was potential third-party responsibility clinicians and hospital systems may face if they discharge a patient with a communicable illness who is unable to follow precautions based on a psychiatric condition.1 That concern was based on Mr. G’s reported desire to pursue missions “beyond man’s understanding,” which he felt compelled to complete, and which could unnecessarily place the public at risk. The psychiatry C-L service consulted the local health department and conferred with the hospital’s legal representatives, who agreed with the plan to keep Mr. G in the hospital for his safety as well as for the public’s safety.
TREATMENT Oral haloperidol
The psychiatry C-L service recommends initiating an antipsychotic. On Day 13, Mr. G starts oral haloperidol, 2.5 mg twice a day, to address his ongoing psychotic symptoms. On Day 14, the treatment team increases the dosage to 5 mg twice a day. Mr. G tolerates the haloperidol and gradually begins to improve. He demonstrates improved sleep, normal speech volume, less religious preoccupation, and a considerably improved understanding of his medical condition.
The authors’ observations
Mr. G’s initial psychiatric evaluation demonstrated an acute onset of psychotic symptoms, without evidence of delirium. Psychosis secondary to a general medical condition (such as COVID-19) and hydroxychloroquine-induced psychotic disorder topped our initial considerations in the differential diagnosis of this case. While the exact neuropsychiatric sequelae of COVID-19 are not yet clear, previous experiences with viral pandemics and case studies from the current pandemic demonstrate a wide variety of possible neuropsychiatric manifestations. Mood symptoms, psychosis, and encephalopathy represent some of the neuropsychiatric complications observed with past viral pandemics.2 Neuropsychiatric symptoms may be triggered by the virus itself, or from the host’s immune response to the infection.3 To further complicate matters, neuropsychiatric symptoms may manifest during the acute viral infection, or may surface later, as subacute or chronic neuropsychiatric illness.
Neuropsychiatric adverse events
Mr. G developed psychotic symptoms within the first few days of receiving hydroxychloroquine, which is consistent with the scant literature on this topic.8 Based on the available information, hydroxychloroquine remains the most likely etiology of his new-onset psychotic symptoms. Mr. G’s case is one example of the possible neuropsychiatric presentations clinicians may face while treating a novel viral illness.
Continue to: OUTCOME Homeward-bound
OUTCOME Homeward-bound
By Day 18, Mr. G’s psychotic symptoms have significantly improved. He is able to rationally process information about his COVID-19 diagnosis and the recommended quarantine instructions he needs to follow after discharge. He is cleared by infection control and discharged home to return to living with his girlfriend.
Mr. G attends his follow-up psychiatric appointment remotely 2 weeks after discharge. He reports that since discharge, he has continued taking his prescribed haloperidol, 5 mg twice a day. He demonstrates improved insight into his medical condition, acknowledging his COVID-19–positive status, and confirms that he has been following quarantine instructions. He does not report ongoing auditory or visual hallucinations, and is no longer religiously preoccupied. He says he is looking forward to being medically cleared to return to work.
The authors’ observations
This case highlights the need for prospective, longitudinal screening and monitoring of neuropsychiatric symptoms as part of the public health response to COVID-19. The case also highlights the importance of careful monitoring for adverse events, including neuropsychiatric symptoms, during clinical trials that involve experimental treatments. The long-term prognosis for individuals such as Mr. G who develop neuropsychiatric symptoms during acute COVID-19 infection remains unknown. Similarly, subacute and chronic neuropsychiatric manifestations that may develop after resolution of acute COVID-19 infection are unknown at this time. However, we can learn from past viral pandemics and anticipate that neuropsychiatric sequelae are likely to occur and should be part of the public health response to the pandemic.
Bottom Line
The coronavirus disease 2019 pandemic provides multiple clinical challenges pertinent to psychiatry. Neuropsychiatric symptoms may manifest from delirium, viral infection, host immune response, or adverse reactions to experimental treatments. These potential neuropsychiatric symptoms may complicate medical treatment. They can also raise important ethical and legal considerations, such as weighing patient autonomy vs third-party responsibility to the public at large.
Related Resources
- Ferrando SJ, Klepacz L, Lynch S, et al. COVID-19 psychosis: a potential new neuropsychiatric condition triggered by novel coronavirus infection and the inflammatory response? [published online May 19, 2020]. Psychosomatics. 2020. doi: 10.1016/j.psym.2020.05.012.
- Vlessides M. COVID-19 and psychosis: is there a link? Medscape Medical News. https://www.medscape.com/viewarticle/930224. Published May 8, 2020.
Drug Brand Names
Azithromycin • Zithromax
Ceftriaxone • Rocephin
Chloroquine • Aralen
Haloperidol • Haldol
Hydroxychloroquine • Plaquenil
Levofloxacin • Levaquin
Oseltamivir • Tamiflu
1. Ghossoub E, Newman WJ. COVID-19 and the duty to protect from communicable diseases. [published online ahead of print, May 8, 2020]. J Am Acad Psychiatry Law.
2. Menninger Ka. Psychoses associated with influenza: I. general data: statistical analysis. JAMA. 1919;72(4):235-241.
3. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms. Brain, Behavior, and Immunity. 2020. doi:10.1016/j.bbi.2020.04.027.
4. Alkadi HO. Antimalarial drug toxicity: a review. Chemotherapy. 2007;53(6):385-391.
5. Bogaczewicz A, Sobów T. Psychiatric adverse effects of chloroquine. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-114.
6. Sato K, Mano T, Iwata A, et al. Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. Biosci Trends. 2020;14(2):139-143.
7. Cortegiani A, Ingoglia G, Ippolito M, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020;57:279-283.
8. Das P, Rai A, Chopra A, et al. Psychosis likely induced by hydroxychloroquine in a patient with chronic Q fever: a case report and clinically relevant review of pharmacology. Psychosomatics. 2014;55(4):409-413.
1. Ghossoub E, Newman WJ. COVID-19 and the duty to protect from communicable diseases. [published online ahead of print, May 8, 2020]. J Am Acad Psychiatry Law.
2. Menninger Ka. Psychoses associated with influenza: I. general data: statistical analysis. JAMA. 1919;72(4):235-241.
3. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms. Brain, Behavior, and Immunity. 2020. doi:10.1016/j.bbi.2020.04.027.
4. Alkadi HO. Antimalarial drug toxicity: a review. Chemotherapy. 2007;53(6):385-391.
5. Bogaczewicz A, Sobów T. Psychiatric adverse effects of chloroquine. Psychiatria i Psychologia Kliniczna. 2017;17(2):111-114.
6. Sato K, Mano T, Iwata A, et al. Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. Biosci Trends. 2020;14(2):139-143.
7. Cortegiani A, Ingoglia G, Ippolito M, et al. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020;57:279-283.
8. Das P, Rai A, Chopra A, et al. Psychosis likely induced by hydroxychloroquine in a patient with chronic Q fever: a case report and clinically relevant review of pharmacology. Psychosomatics. 2014;55(4):409-413.
Daily Recap: Docs are good at saving money; SARS-CoV-2 vaccine trials advance
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Phase 3 COVID-19 vaccine trials launching in July, expert says
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
FROM PEDIATRIC DERMATOLOGY 2020
Manage the pandemic with a multidisciplinary coalition
Implement a 6-P framework
The ongoing COVID-19 pandemic, arguably the biggest public health and economic catastrophe of modern times, elevated multiple deficiencies in public health infrastructures across the world, such as a slow or delayed response to suppress and mitigate the virus, an inadequately prepared and protected health care and public health workforce, and decentralized, siloed efforts.1 COVID-19 further highlighted the vulnerabilities of the health care, public health, and economic sectors.2,3 Irrespective of how robust health care systems may have been initially, rapidly spreading and deadly infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and the patients they serve to a breaking point.
Hospital systems in the United States are not only at the crux of the current pandemic but are also well positioned to lead the response to the pandemic. Hospital administrators oversee nearly 33% of national health expenditure that amounts to the hospital-based care in the United States. Additionally, they may have an impact on nearly 30% of the expenditure that is related to physicians, prescriptions, and other facilities.4
The two primary goals underlying our proposed framework to target COVID-19 are based on the World Health Organization recommendations and lessons learned from countries such as South Korea that have successfully implemented these recommendations.5
1. Flatten the curve. According to the WHO and the Centers for Disease Control and Prevention, flattening the curve means that we must do everything that will help us to slow down the rate of infection, so the number of cases do not exceed the capacity of health systems.
2. Establish a standardized, interdisciplinary approach to flattening the curve. Pandemics can have major adverse consequences beyond health outcomes (e.g., economy) that can impact adherence to advisories and introduce multiple unintended consequences (e.g., deferred chronic care, unemployment). Managing the current pandemic and thoughtful consideration of and action regarding its ripple effects is heavily dependent on a standardized, interdisciplinary approach that is monitored, implemented, and evaluated well.
To achieve these two goals, we recommend establishing an interdisciplinary coalition representing multiple sectors. Our 6-P framework described below is intended to guide hospital administrators, to build the coalition, and to achieve these goals.
Structure of the pandemic coalition
A successful coalition invites a collaborative partnership involving senior members of respective disciplines, who would provide valuable, complementary perspectives in the coalition. We recommend hospital administrators take a lead in the formation of such a coalition. While we present the stakeholders and their roles below based on their intended influence and impact on the overall outcome of COVID-19, the basic guiding principles behind our 6-P framework remain true for any large-scale population health intervention.
Although several models for staging the transmission of COVID-19 are available, we adopted a four-stage model followed by the Indian Council for Medical Research.6 Irrespective of the origin of the infection, we believe that the four-stage model can cultivate situational awareness that can help guide the strategic design and systematic implementation of interventions.
Our 6-P framework integrates the four-stage model of COVID-19 transmission to identify action items for each stakeholder group and appropriate strategies selected based on the stages targeted.
1. Policy makers: Policy makers at all levels are critical in establishing policies, orders, and advisories, as well as dedicating resources and infrastructure, to enhance adherence to recommendations and guidelines at the community and population levels.7 They can assist hospitals in workforce expansion across county/state/discipline lines (e.g., accelerate the licensing and credentialing process, authorize graduate medical trainees, nurse practitioners, and other allied health professionals). Policy revisions for data sharing, privacy, communication, liability, and telehealth expansion.82. Providers: The health of the health care workforce itself is at risk because of their frontline services. Their buy-in will be crucial in both the formulation and implementation of evidence- and practice-based guidelines.9 Rapid adoption of telehealth for care continuum, policy revisions for elective procedures, visitor restriction, surge, resurge planning, capacity expansion, effective population health management, and working with employee unions, professional staff organizations are few, but very important action items that need to be implemented.
3. Public health authorities: Representation of public health authorities will be crucial in standardizing data collection, management, and reporting; providing up-to-date guidelines and advisories; developing, implementing, and evaluating short- and long-term public health interventions; and preparing and helping communities throughout the course of the pandemic. They also play a key role in identifying and reducing barriers related to the expansion of testing and contact tracing efforts.
4. Payers: In the United States, the Centers for Medicare & Medicaid Services oversees primary federally funded programs and serves as a point of reference for the American health care system. Having representation from all payer sources is crucial for achieving uniformity and standardization of the care process during the pandemic, with particular priority given to individuals and families who may have recently lost their health insurance because of job loss from COVID-19–related business furloughs, layoffs, and closures. Customer outreach initiatives, revision of patients’ out of pocket responsibilities, rapid claim settlement and denial management services, expansion of telehealth, elimination of prior authorization barriers, rapid credentialing of providers, data sharing, and assisting hospital systems in chronic disease management are examples of time-sensitive initiatives that are vital for population health management.
5. Partners: Establishing partnerships with pharma, health IT, labs, device industries, and other ancillary services is important to facilitate rapid innovation, production, and supply of essential medical devices and resources. These partners directly influence the outcomes of the pandemic and long-term health of the society through expansion of testing capability, contact tracing, leveraging technology for expanding access to COVID-19 and non–COVID-19 care, home monitoring of cases, innovation of treatment and prevention, and data sharing. Partners should consider options such as flexible medication delivery, electronic prescription services, and use of drones in supply chain to deliver test kits, test samples, medication, and blood products.
6. People/patients: Lastly and perhaps most critically, the trust, buy-in, and needs of the overall population are needed to enhance adherence to guidelines and recommendations. Many millions more than those who test positive for COVID-19 have and will continue to experience the crippling adverse economic, social, physical, and mental health effects of stay-at-home advisories, business and school closures, and physical distancing orders. Members of each community need to be heard in voicing their concerns and priorities and providing input on public health interventions to enhance acceptance and adherence (e.g., wear mask/face coverings in public, engage in physical distancing, etc.). Special attention should be given to managing chronic or existing medical problems and seek care when needed (e.g., avoid delaying of medical care).
An interdisciplinary and multipronged approach is necessary to address a complex, widespread, disruptive, and deadly pandemic such as COVID-19. The suggested activities put forth in our table are by no means exhaustive, nor do we expect all coalitions to be able to carry them all out. Our intention is that the 6-P framework encourages cross-sector collaboration to facilitate the design, implementation, evaluation, and scalability of preventive and intervention efforts based on the menu of items we have provided. Each coalition may determine which strategies they are able to prioritize and when within the context of specific national, regional, and local advisories, resulting in a tailored approach for each community or region that is thus better positioned for success.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark. He is cofounder/president of SHM’s Arkansas chapter. Dr. Wang is assistant professor in the department of community health sciences at Boston University and adjunct assistant professor of health policy and management at the Harvard School of Public Health. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist at the University of Mississippi.
References
1. Powles J, Comim F. Public health infrastructure and knowledge, in Smith R et al. “Global Public Goods for Health.” Oxford: Oxford University Press, 2003.
2. Lombardi P, Petroni G. Virus outbreak pushes Italy’s health care system to the brink. Wall Street Journal. 2020 Mar 12. https://www.wsj.com/articles/virus-outbreak-pushes-italys-healthcare-system-to-the-brink-11583968769
3. Davies, R. How coronavirus is affecting the global economy. The Guardian. 2020 Feb 5. https://www.theguardian.com/world/2020/feb/05/coronavirus-global-economy
4. National Center for Health Statistics. FastStats. 2017. https://www.cdc.gov/nchs/fastats/health-expenditures.htm.
5. World Health Organization. Country & Technical Guidance–Coronavirus disease (COVID-19). https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
6. Indian Council of Medical Research. Stages of transmission of COVID-19. https://main.icmr.nic.in/content/covid-19
7. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19) – Prevention & treatment. 2020 Apr 24. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html
8. Ostriker R. Cutbacks for some doctors and nurses as they battle on the front line. Boston Globe. 2020 Mar 27. https://www.bostonglobe.com/2020/03/27/metro/coronavirus-rages-doctors-hit-with-cuts-compensation/
9. Centers for Medicare & Medicaid Services. News alert. 2020 Mar 26. https://www.cms.gov/newsroom/press-releases/cms-news-alert-march-26-2020
Implement a 6-P framework
Implement a 6-P framework
The ongoing COVID-19 pandemic, arguably the biggest public health and economic catastrophe of modern times, elevated multiple deficiencies in public health infrastructures across the world, such as a slow or delayed response to suppress and mitigate the virus, an inadequately prepared and protected health care and public health workforce, and decentralized, siloed efforts.1 COVID-19 further highlighted the vulnerabilities of the health care, public health, and economic sectors.2,3 Irrespective of how robust health care systems may have been initially, rapidly spreading and deadly infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and the patients they serve to a breaking point.
Hospital systems in the United States are not only at the crux of the current pandemic but are also well positioned to lead the response to the pandemic. Hospital administrators oversee nearly 33% of national health expenditure that amounts to the hospital-based care in the United States. Additionally, they may have an impact on nearly 30% of the expenditure that is related to physicians, prescriptions, and other facilities.4
The two primary goals underlying our proposed framework to target COVID-19 are based on the World Health Organization recommendations and lessons learned from countries such as South Korea that have successfully implemented these recommendations.5
1. Flatten the curve. According to the WHO and the Centers for Disease Control and Prevention, flattening the curve means that we must do everything that will help us to slow down the rate of infection, so the number of cases do not exceed the capacity of health systems.
2. Establish a standardized, interdisciplinary approach to flattening the curve. Pandemics can have major adverse consequences beyond health outcomes (e.g., economy) that can impact adherence to advisories and introduce multiple unintended consequences (e.g., deferred chronic care, unemployment). Managing the current pandemic and thoughtful consideration of and action regarding its ripple effects is heavily dependent on a standardized, interdisciplinary approach that is monitored, implemented, and evaluated well.
To achieve these two goals, we recommend establishing an interdisciplinary coalition representing multiple sectors. Our 6-P framework described below is intended to guide hospital administrators, to build the coalition, and to achieve these goals.
Structure of the pandemic coalition
A successful coalition invites a collaborative partnership involving senior members of respective disciplines, who would provide valuable, complementary perspectives in the coalition. We recommend hospital administrators take a lead in the formation of such a coalition. While we present the stakeholders and their roles below based on their intended influence and impact on the overall outcome of COVID-19, the basic guiding principles behind our 6-P framework remain true for any large-scale population health intervention.
Although several models for staging the transmission of COVID-19 are available, we adopted a four-stage model followed by the Indian Council for Medical Research.6 Irrespective of the origin of the infection, we believe that the four-stage model can cultivate situational awareness that can help guide the strategic design and systematic implementation of interventions.
Our 6-P framework integrates the four-stage model of COVID-19 transmission to identify action items for each stakeholder group and appropriate strategies selected based on the stages targeted.
1. Policy makers: Policy makers at all levels are critical in establishing policies, orders, and advisories, as well as dedicating resources and infrastructure, to enhance adherence to recommendations and guidelines at the community and population levels.7 They can assist hospitals in workforce expansion across county/state/discipline lines (e.g., accelerate the licensing and credentialing process, authorize graduate medical trainees, nurse practitioners, and other allied health professionals). Policy revisions for data sharing, privacy, communication, liability, and telehealth expansion.82. Providers: The health of the health care workforce itself is at risk because of their frontline services. Their buy-in will be crucial in both the formulation and implementation of evidence- and practice-based guidelines.9 Rapid adoption of telehealth for care continuum, policy revisions for elective procedures, visitor restriction, surge, resurge planning, capacity expansion, effective population health management, and working with employee unions, professional staff organizations are few, but very important action items that need to be implemented.
3. Public health authorities: Representation of public health authorities will be crucial in standardizing data collection, management, and reporting; providing up-to-date guidelines and advisories; developing, implementing, and evaluating short- and long-term public health interventions; and preparing and helping communities throughout the course of the pandemic. They also play a key role in identifying and reducing barriers related to the expansion of testing and contact tracing efforts.
4. Payers: In the United States, the Centers for Medicare & Medicaid Services oversees primary federally funded programs and serves as a point of reference for the American health care system. Having representation from all payer sources is crucial for achieving uniformity and standardization of the care process during the pandemic, with particular priority given to individuals and families who may have recently lost their health insurance because of job loss from COVID-19–related business furloughs, layoffs, and closures. Customer outreach initiatives, revision of patients’ out of pocket responsibilities, rapid claim settlement and denial management services, expansion of telehealth, elimination of prior authorization barriers, rapid credentialing of providers, data sharing, and assisting hospital systems in chronic disease management are examples of time-sensitive initiatives that are vital for population health management.
5. Partners: Establishing partnerships with pharma, health IT, labs, device industries, and other ancillary services is important to facilitate rapid innovation, production, and supply of essential medical devices and resources. These partners directly influence the outcomes of the pandemic and long-term health of the society through expansion of testing capability, contact tracing, leveraging technology for expanding access to COVID-19 and non–COVID-19 care, home monitoring of cases, innovation of treatment and prevention, and data sharing. Partners should consider options such as flexible medication delivery, electronic prescription services, and use of drones in supply chain to deliver test kits, test samples, medication, and blood products.
6. People/patients: Lastly and perhaps most critically, the trust, buy-in, and needs of the overall population are needed to enhance adherence to guidelines and recommendations. Many millions more than those who test positive for COVID-19 have and will continue to experience the crippling adverse economic, social, physical, and mental health effects of stay-at-home advisories, business and school closures, and physical distancing orders. Members of each community need to be heard in voicing their concerns and priorities and providing input on public health interventions to enhance acceptance and adherence (e.g., wear mask/face coverings in public, engage in physical distancing, etc.). Special attention should be given to managing chronic or existing medical problems and seek care when needed (e.g., avoid delaying of medical care).
An interdisciplinary and multipronged approach is necessary to address a complex, widespread, disruptive, and deadly pandemic such as COVID-19. The suggested activities put forth in our table are by no means exhaustive, nor do we expect all coalitions to be able to carry them all out. Our intention is that the 6-P framework encourages cross-sector collaboration to facilitate the design, implementation, evaluation, and scalability of preventive and intervention efforts based on the menu of items we have provided. Each coalition may determine which strategies they are able to prioritize and when within the context of specific national, regional, and local advisories, resulting in a tailored approach for each community or region that is thus better positioned for success.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark. He is cofounder/president of SHM’s Arkansas chapter. Dr. Wang is assistant professor in the department of community health sciences at Boston University and adjunct assistant professor of health policy and management at the Harvard School of Public Health. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist at the University of Mississippi.
References
1. Powles J, Comim F. Public health infrastructure and knowledge, in Smith R et al. “Global Public Goods for Health.” Oxford: Oxford University Press, 2003.
2. Lombardi P, Petroni G. Virus outbreak pushes Italy’s health care system to the brink. Wall Street Journal. 2020 Mar 12. https://www.wsj.com/articles/virus-outbreak-pushes-italys-healthcare-system-to-the-brink-11583968769
3. Davies, R. How coronavirus is affecting the global economy. The Guardian. 2020 Feb 5. https://www.theguardian.com/world/2020/feb/05/coronavirus-global-economy
4. National Center for Health Statistics. FastStats. 2017. https://www.cdc.gov/nchs/fastats/health-expenditures.htm.
5. World Health Organization. Country & Technical Guidance–Coronavirus disease (COVID-19). https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
6. Indian Council of Medical Research. Stages of transmission of COVID-19. https://main.icmr.nic.in/content/covid-19
7. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19) – Prevention & treatment. 2020 Apr 24. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html
8. Ostriker R. Cutbacks for some doctors and nurses as they battle on the front line. Boston Globe. 2020 Mar 27. https://www.bostonglobe.com/2020/03/27/metro/coronavirus-rages-doctors-hit-with-cuts-compensation/
9. Centers for Medicare & Medicaid Services. News alert. 2020 Mar 26. https://www.cms.gov/newsroom/press-releases/cms-news-alert-march-26-2020
The ongoing COVID-19 pandemic, arguably the biggest public health and economic catastrophe of modern times, elevated multiple deficiencies in public health infrastructures across the world, such as a slow or delayed response to suppress and mitigate the virus, an inadequately prepared and protected health care and public health workforce, and decentralized, siloed efforts.1 COVID-19 further highlighted the vulnerabilities of the health care, public health, and economic sectors.2,3 Irrespective of how robust health care systems may have been initially, rapidly spreading and deadly infectious diseases like COVID-19 can quickly derail the system, bringing the workforce and the patients they serve to a breaking point.
Hospital systems in the United States are not only at the crux of the current pandemic but are also well positioned to lead the response to the pandemic. Hospital administrators oversee nearly 33% of national health expenditure that amounts to the hospital-based care in the United States. Additionally, they may have an impact on nearly 30% of the expenditure that is related to physicians, prescriptions, and other facilities.4
The two primary goals underlying our proposed framework to target COVID-19 are based on the World Health Organization recommendations and lessons learned from countries such as South Korea that have successfully implemented these recommendations.5
1. Flatten the curve. According to the WHO and the Centers for Disease Control and Prevention, flattening the curve means that we must do everything that will help us to slow down the rate of infection, so the number of cases do not exceed the capacity of health systems.
2. Establish a standardized, interdisciplinary approach to flattening the curve. Pandemics can have major adverse consequences beyond health outcomes (e.g., economy) that can impact adherence to advisories and introduce multiple unintended consequences (e.g., deferred chronic care, unemployment). Managing the current pandemic and thoughtful consideration of and action regarding its ripple effects is heavily dependent on a standardized, interdisciplinary approach that is monitored, implemented, and evaluated well.
To achieve these two goals, we recommend establishing an interdisciplinary coalition representing multiple sectors. Our 6-P framework described below is intended to guide hospital administrators, to build the coalition, and to achieve these goals.
Structure of the pandemic coalition
A successful coalition invites a collaborative partnership involving senior members of respective disciplines, who would provide valuable, complementary perspectives in the coalition. We recommend hospital administrators take a lead in the formation of such a coalition. While we present the stakeholders and their roles below based on their intended influence and impact on the overall outcome of COVID-19, the basic guiding principles behind our 6-P framework remain true for any large-scale population health intervention.
Although several models for staging the transmission of COVID-19 are available, we adopted a four-stage model followed by the Indian Council for Medical Research.6 Irrespective of the origin of the infection, we believe that the four-stage model can cultivate situational awareness that can help guide the strategic design and systematic implementation of interventions.
Our 6-P framework integrates the four-stage model of COVID-19 transmission to identify action items for each stakeholder group and appropriate strategies selected based on the stages targeted.
1. Policy makers: Policy makers at all levels are critical in establishing policies, orders, and advisories, as well as dedicating resources and infrastructure, to enhance adherence to recommendations and guidelines at the community and population levels.7 They can assist hospitals in workforce expansion across county/state/discipline lines (e.g., accelerate the licensing and credentialing process, authorize graduate medical trainees, nurse practitioners, and other allied health professionals). Policy revisions for data sharing, privacy, communication, liability, and telehealth expansion.82. Providers: The health of the health care workforce itself is at risk because of their frontline services. Their buy-in will be crucial in both the formulation and implementation of evidence- and practice-based guidelines.9 Rapid adoption of telehealth for care continuum, policy revisions for elective procedures, visitor restriction, surge, resurge planning, capacity expansion, effective population health management, and working with employee unions, professional staff organizations are few, but very important action items that need to be implemented.
3. Public health authorities: Representation of public health authorities will be crucial in standardizing data collection, management, and reporting; providing up-to-date guidelines and advisories; developing, implementing, and evaluating short- and long-term public health interventions; and preparing and helping communities throughout the course of the pandemic. They also play a key role in identifying and reducing barriers related to the expansion of testing and contact tracing efforts.
4. Payers: In the United States, the Centers for Medicare & Medicaid Services oversees primary federally funded programs and serves as a point of reference for the American health care system. Having representation from all payer sources is crucial for achieving uniformity and standardization of the care process during the pandemic, with particular priority given to individuals and families who may have recently lost their health insurance because of job loss from COVID-19–related business furloughs, layoffs, and closures. Customer outreach initiatives, revision of patients’ out of pocket responsibilities, rapid claim settlement and denial management services, expansion of telehealth, elimination of prior authorization barriers, rapid credentialing of providers, data sharing, and assisting hospital systems in chronic disease management are examples of time-sensitive initiatives that are vital for population health management.
5. Partners: Establishing partnerships with pharma, health IT, labs, device industries, and other ancillary services is important to facilitate rapid innovation, production, and supply of essential medical devices and resources. These partners directly influence the outcomes of the pandemic and long-term health of the society through expansion of testing capability, contact tracing, leveraging technology for expanding access to COVID-19 and non–COVID-19 care, home monitoring of cases, innovation of treatment and prevention, and data sharing. Partners should consider options such as flexible medication delivery, electronic prescription services, and use of drones in supply chain to deliver test kits, test samples, medication, and blood products.
6. People/patients: Lastly and perhaps most critically, the trust, buy-in, and needs of the overall population are needed to enhance adherence to guidelines and recommendations. Many millions more than those who test positive for COVID-19 have and will continue to experience the crippling adverse economic, social, physical, and mental health effects of stay-at-home advisories, business and school closures, and physical distancing orders. Members of each community need to be heard in voicing their concerns and priorities and providing input on public health interventions to enhance acceptance and adherence (e.g., wear mask/face coverings in public, engage in physical distancing, etc.). Special attention should be given to managing chronic or existing medical problems and seek care when needed (e.g., avoid delaying of medical care).
An interdisciplinary and multipronged approach is necessary to address a complex, widespread, disruptive, and deadly pandemic such as COVID-19. The suggested activities put forth in our table are by no means exhaustive, nor do we expect all coalitions to be able to carry them all out. Our intention is that the 6-P framework encourages cross-sector collaboration to facilitate the design, implementation, evaluation, and scalability of preventive and intervention efforts based on the menu of items we have provided. Each coalition may determine which strategies they are able to prioritize and when within the context of specific national, regional, and local advisories, resulting in a tailored approach for each community or region that is thus better positioned for success.
Dr. Lingisetty is a hospitalist and physician executive at Baptist Health System, Little Rock, Ark. He is cofounder/president of SHM’s Arkansas chapter. Dr. Wang is assistant professor in the department of community health sciences at Boston University and adjunct assistant professor of health policy and management at the Harvard School of Public Health. Dr. Palabindala is the medical director, utilization management and physician advisory services, at the University of Mississippi Medical Center, Jackson. He is an associate professor of medicine and academic hospitalist at the University of Mississippi.
References
1. Powles J, Comim F. Public health infrastructure and knowledge, in Smith R et al. “Global Public Goods for Health.” Oxford: Oxford University Press, 2003.
2. Lombardi P, Petroni G. Virus outbreak pushes Italy’s health care system to the brink. Wall Street Journal. 2020 Mar 12. https://www.wsj.com/articles/virus-outbreak-pushes-italys-healthcare-system-to-the-brink-11583968769
3. Davies, R. How coronavirus is affecting the global economy. The Guardian. 2020 Feb 5. https://www.theguardian.com/world/2020/feb/05/coronavirus-global-economy
4. National Center for Health Statistics. FastStats. 2017. https://www.cdc.gov/nchs/fastats/health-expenditures.htm.
5. World Health Organization. Country & Technical Guidance–Coronavirus disease (COVID-19). https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
6. Indian Council of Medical Research. Stages of transmission of COVID-19. https://main.icmr.nic.in/content/covid-19
7. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19) – Prevention & treatment. 2020 Apr 24. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html
8. Ostriker R. Cutbacks for some doctors and nurses as they battle on the front line. Boston Globe. 2020 Mar 27. https://www.bostonglobe.com/2020/03/27/metro/coronavirus-rages-doctors-hit-with-cuts-compensation/
9. Centers for Medicare & Medicaid Services. News alert. 2020 Mar 26. https://www.cms.gov/newsroom/press-releases/cms-news-alert-march-26-2020
Skin patterns of COVID-19 vary widely
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
FROM AAD 20
Daily Recap: Transgender patients turn to DIY treatments; ACIP plans priority vaccine groups
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
How racism contributes to the effects of SARS-CoV-2
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
Masks are a public health issue, not a political one
Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.
Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.
If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.
But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.
The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.
A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.
Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.
People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.
In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?
Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.
You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.
Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.
If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.
But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.
The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.
A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.
Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.
People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.
In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?
Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.
You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.
Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.
If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.
But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.
The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.
A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.
Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.
People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.
In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?
Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.
You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.
Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.
Endothelial injury may play a major role in COVID-19–associated coagulopathy
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).
A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.
George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.
Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.5-7
For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.
The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.
Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).
There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
Results and interpretation
Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.
Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).
Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.
Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).
Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.
The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
Influence on therapy
Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.
These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.
The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.
Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
Challenges and unanswered questions
Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.
Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.
Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.
It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.
The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.
Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.
The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.
Dr. Goshua disclosed no conflicts of interest.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.
References
1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.
2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028
3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024
4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869
5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.
6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134
7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.
FROM EHA CONGRESS
ACIP plans priority groups in advance of COVID-19 vaccine
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.