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Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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

Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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

Further details from multiple cases of myocarditis linked to the Pfizer and Moderna mRNA COVID vaccines have been described in recent papers in the medical literature.

The cases appear to occur almost exclusively in males and most often in younger age groups. While symptoms and signs of myocarditis mostly resolved with a few days of supportive care, long-term effects are unknown at present.

The authors of all the reports and of two accompanying editorials in JAMA Cardiology are unanimous in their opinion that the benefits of vaccination still outweigh the risks.  

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met June 23 to discuss this issue. At that meeting, it was reported that 323 cases of myocarditis or pericarditis in individuals aged 29 years and younger have been confirmed, but committee members delivered a strong endorsement for continuing to vaccinate young people with the mRNA vaccines.

The current case reports are published in two papers in JAMA Cardiology and in three in Circulation.
 

U.S. military reports 23 cases

In one report in JAMA Cardiology, authors led by Jay Montgomery, MD, from Walter Reed National Military Medical Center in Bethesda, Md., described 23 cases from the U.S. Military Health System of individuals with acute myocarditis who presented within 4 days after mRNA-based COVID-19 vaccination (7 Pfizer and 16 Moderna).

All patients were male, 22 of 23 were on active duty, and the median age was 25 years (range, 20-51); 20 of the 23 cases occurred after receipt of a second dose of an mRNA COVID-19 vaccine.

The patients all presented with acute onset of marked chest pain. All patients had significantly elevated cardiac troponin levels. Among eight patients who underwent cardiac MRI (cMRI), all had findings consistent with the clinical diagnosis of myocarditis.

Additional testing did not identify other possible causes of myocarditis. All patients received brief supportive care and were recovered or recovering.

The authors reported that the military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period, and while the observed number of myocarditis cases was small, the number was “substantially higher” than expected among male military members after a second vaccine dose.

They noted that, based on historical data, among the 544,000 second doses to military members there may have been 0-10 expected myocarditis cases, but they observed 19 cases.  

“All patients in this series reflect substantial similarities in demographic characteristics, proximate vaccine dose, onset interval, and character of vaccine-associated myocarditis. The consistent pattern of clinical presentation, rapid recovery, and absence of evidence of other causes support the diagnosis of hypersensitivity myocarditis,” they stated.

They added that presentation after a second vaccine dose or, in three patients, when vaccination followed SARS-CoV-2 infection, suggests that prior exposure was relevant in the hypersensitivity response.

“The spectrum of clinical presentation and reliance on patients seeking health care and on health care professionals recognizing a rare vaccine-associated adverse event limits determination of the true incidence of this condition,” the authors wrote.

They stressed that recognition of vaccine-associated myocarditis is clinically important because diagnosis impacts management, recommendations for exercise, and monitoring for cardiomyopathy.

But the authors also acknowledged that it is important to frame concerns about potential vaccine-associated myocarditis within the context of the current pandemic.

“Infection with SARS-CoV-2 is a clear cause of serious cardiac injury in many patients. ... Prevalence of cardiac injury may be as high as 60% in seriously ill patients. Notably, nearly 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on cMRI,” they wrote.

“Given that COVID-19 vaccines are remarkably effective at preventing infection, any risk of rare adverse events following immunization must be carefully weighed against the very substantial benefit of vaccination,” they concluded.
 

Four cases at Duke

In the second paper in JAMA Cardiology, a group led by Han W. Kim, MD, reported four patients with acute myocarditis occurring within days of mRNA COVID-19 vaccination (two Pfizer and two Moderna) in patients treated at Duke University Medical Center, Durham, N.C. The hospital courses of the four patients with myocarditis following COVID-19 vaccination were uneventful, and they were discharged within 2-4 days.

The authors said that, although a causal relationship cannot be established, none of the patients had a viral prodrome or had coincident testing that revealed an alternative explanation.

They stated that these four patients represent the majority of patients with acute myocarditis identified in the past 3 months at their institution, and this led to the highest total number of patients with acute myocarditis, compared with the same 3-month period for the past 5 years. 

“Additionally, we identified only those patients with severe unremitting chest pain who sought medical attention. Those with mild or moderate chest pain might not seek medical attention, and it is possible that subclinical myocarditis may occur and could be detected by active surveillance, as has been described with smallpox vaccination,” they wrote.
 

Further case reports

In one of the papers in Circulation, a group led by Kathryn F. Larson, MD, from the Mayo Clinic in Rochester, Minn., described eight patients hospitalized with chest pain who were diagnosed with myocarditis within 2-4 days of receiving either the Pfizer or Moderna vaccine.

Two of the patients had previously been infected by SARS-CoV-2 without need for hospitalization. All individuals were otherwise healthy males between the ages of 21 and 56 years. All but one patient developed symptoms after their second dose, and the one patient who developed myocarditis after the first vaccine dose had previously been infected with SARS-CoV-2.  

Systemic symptoms began within 24 hours after vaccine administration in five of eight patients, with chest pain presenting between 48 and 96 hours later. Troponin values were elevated in all individuals and appeared to peak the day after admission, whereas none had eosinophilia.

Cardiac MRI revealed findings consistent with myocarditis in all patients. All patients had resolution of their chest pain and were discharged from the hospital in stable condition.

“The patients presented here demonstrated typical signs, symptoms, and diagnostic features of acute myocarditis. The temporal association between receiving an mRNA-based COVID-19 vaccine and the development of myocarditis is notable,” the authors said.  

They added that they would consider the use of corticosteroids in these patients but cautioned that this could reduce the specific immune response against SARS-COV-2 triggered by the vaccine. “Thus, the duration of corticosteroid administration should be limited to the resolution of the symptoms or ventricular arrhythmias or the recovery of the left ventricular ejection fraction.”

Pending publication of long-term outcome data after SARS-CoV-2 vaccine–related myocarditis, they suggest adherence to the current consensus recommendation to abstain from competitive sports for a period of 3-6 months with reevaluation prior to sports participation. 

In another of the Circulation papers, a group led by Carolyn M. Rosner, MSN,  presented a case series of seven patients hospitalized for acute myocarditis-like illness following COVID-19 vaccination, from two U.S. medical centers, in Falls Church, Va., and Dallas. All patients were males below the age of 40 years and of White or Hispanic race/ethnicity. Only one patient reported prior history of COVID-19 infection. Six patients received mRNA (Moderna or Pfizer) and one received the adenovirus (Johnson & Johnson) vaccine. All patients presented 3-7 days post vaccination with acute onset chest pain and biochemical evidence of myocardial injury.

Hospital length of stay was 3 days, and all patients’ symptoms resolved by hospital discharge.

And finally, the third paper in Circulation reported a detailed description of one patient – a 52-year-old, previously healthy male who presented with acute myocarditis 3 days after the administration of the second dose of Moderna’s COVID-19 vaccine. The symptoms resolved, and there was a gradual improvement in cMRI findings. Ischemic injury and other potential causes of acute myocardial injury were excluded, as were other potential infectious causes of myocarditis, and there was no evidence of systemic autoimmune disease.

“Clinicians should be aware that myocarditis may be present in patients exhibiting cardiac signs and symptoms 2-4 days after COVID-19 vaccination,” the authors said.

They added that additional surveillance of such adverse events post–COVID-19 vaccination will help identify subgroups at higher risk for this vaccine-related effect, and whether additional precautions are necessary.
 

‘Benefits outweigh risk’

In an accompanying editorial in JAMA Cardiology, three doctors from the CDC cite several other reports of myocarditis after mRNA COVID vaccination. These include a case report published in Pediatrics of seven male adolescents aged 14-19 years who presented with myocarditis or myopericarditis within 4 days after receipt of a second dose of the Pfizer vaccine.

But the editorialists noted that the most comprehensive data about the risk for myocarditis following immunization with mRNA vaccines comes from Israel.

The Israeli Ministry of Health recently posted data describing 121 myocarditis cases occurring within 30 days of a second dose of mRNA vaccine among 5,049,424 persons, suggesting a crude incidence rate of approximately 24 cases per million.

On the current case reports, the CDC doctors wrote: “The striking clinical similarities in the presentations of these patients, their recent vaccination with an mRNA-based COVID-19 vaccine, and the lack of any alternative etiologies for acute myocarditis suggest an association with immunization.”

They said that acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism.

But SARS-CoV-2 infection also causes cardiac injury which may result in severe outcomes, and based on currently available data, myocarditis following immunization with current mRNA-based vaccines is rare.

“At present, the benefits of immunization in preventing severe morbidity favors continued COVID-19 vaccination, particularly considering the increasing COVID-19 hospitalization rates among adolescents reported during spring 2021,” the editorialists stated.

But they added that many questions remain. These include whether modifications are needed to the vaccine schedule among persons with a history of possible or confirmed myocarditis after COVID vaccine, how should postvaccine myocarditis be managed, how often should follow-up assessments be performed, how might follow-up assessments affect recommendations to avoid vigorous physical activity following the diagnosis of myocarditis, and do all likely cases of acute myocarditis that appear to be uncomplicated require cardiac MRI for more definitive diagnosis?

“While the data needed to answer such questions are being collected, there is an opportunity for researchers with expertise in myocarditis to develop a comprehensive, national assessment of the natural history, pathogenesis, and treatment of acute myocarditis associated with receipt of mRNA-based COVID-19 vaccines,” they concluded.

In a second editorial in JAMA Cardiology, a group of editors from the journal acknowledged that publication of the current case reports may contribute to additional public concern regarding immunization. But they added that clinicians discussing immunization with patients should recognize that these case series suggest that the symptomatic events consistent with myocarditis are still very rare and appear to be self-limiting.

“Given the risks of COVID-19, including the risk of myocarditis from COVID-19 infection, the editors do not believe these case reports are sufficient to interrupt the march toward maximal vaccination against SARS-CoV-2 as expeditiously as possible,” they said.

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

Background: In the United States, 5% of the population use half of the annual spending for health care services and 1% account for approximately a quarter of annual spending, considered “superutilizers” of U.S. health care services. The Camden Coalition of Healthcare Providers (the Coalition) developed a model using hospital admission data to identify superutilizers, termed “hotspotting,” which has gained national recognition. Unlike other similar programs, this model targets a more diverse population with higher utilization than other programs that have been studied.
 

Study design: Randomized, controlled trial.

Setting: Two hospitals in Camden, N.J., from June 2, 2014, to March 31, 2018.

Synopsis: Eight-hundred superutilizers (at least one hospital admission at any of the four Camden-area hospital systems in the past 6 months, greater than one chronic medical condition, more than one high-risk traits/conditions) were randomly assigned to the intervention group or usual care. Once enrolled in the hospital, a multidisciplinary team began working with the patient in the intervention group on discharge. Team members conducted home visits, scheduled/took patients to appointments, managed medications, monitored and coached patients in disease-specific self-care, and assisted with applying for social and other assistive programs.

The readmission rate within 180 days after hospital discharge (primary outcome) between groups was not significant, with 62.3% readmitted in the intervention group and 61.7% in the control group. There was also no effect on the defined secondary outcomes (number of readmissions, proportion of patients with more than two readmissions, hospital days, charges, payments received, mortality).

The trial was not powered to detect smaller reductions in readmissions or to analyze effects within specific subgroups.

Bottom line: The addition of the Coalition’s program to patients with very high use of health care services did not decrease hospital readmission rate when compared to usual care.

Citation: Finkelstein A et al. Health care hotspotting – a randomized, controlled trial. N Engl J Med. 2020;382:152-62.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: In the United States, 5% of the population use half of the annual spending for health care services and 1% account for approximately a quarter of annual spending, considered “superutilizers” of U.S. health care services. The Camden Coalition of Healthcare Providers (the Coalition) developed a model using hospital admission data to identify superutilizers, termed “hotspotting,” which has gained national recognition. Unlike other similar programs, this model targets a more diverse population with higher utilization than other programs that have been studied.
 

Study design: Randomized, controlled trial.

Setting: Two hospitals in Camden, N.J., from June 2, 2014, to March 31, 2018.

Synopsis: Eight-hundred superutilizers (at least one hospital admission at any of the four Camden-area hospital systems in the past 6 months, greater than one chronic medical condition, more than one high-risk traits/conditions) were randomly assigned to the intervention group or usual care. Once enrolled in the hospital, a multidisciplinary team began working with the patient in the intervention group on discharge. Team members conducted home visits, scheduled/took patients to appointments, managed medications, monitored and coached patients in disease-specific self-care, and assisted with applying for social and other assistive programs.

The readmission rate within 180 days after hospital discharge (primary outcome) between groups was not significant, with 62.3% readmitted in the intervention group and 61.7% in the control group. There was also no effect on the defined secondary outcomes (number of readmissions, proportion of patients with more than two readmissions, hospital days, charges, payments received, mortality).

The trial was not powered to detect smaller reductions in readmissions or to analyze effects within specific subgroups.

Bottom line: The addition of the Coalition’s program to patients with very high use of health care services did not decrease hospital readmission rate when compared to usual care.

Citation: Finkelstein A et al. Health care hotspotting – a randomized, controlled trial. N Engl J Med. 2020;382:152-62.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: In the United States, 5% of the population use half of the annual spending for health care services and 1% account for approximately a quarter of annual spending, considered “superutilizers” of U.S. health care services. The Camden Coalition of Healthcare Providers (the Coalition) developed a model using hospital admission data to identify superutilizers, termed “hotspotting,” which has gained national recognition. Unlike other similar programs, this model targets a more diverse population with higher utilization than other programs that have been studied.
 

Study design: Randomized, controlled trial.

Setting: Two hospitals in Camden, N.J., from June 2, 2014, to March 31, 2018.

Synopsis: Eight-hundred superutilizers (at least one hospital admission at any of the four Camden-area hospital systems in the past 6 months, greater than one chronic medical condition, more than one high-risk traits/conditions) were randomly assigned to the intervention group or usual care. Once enrolled in the hospital, a multidisciplinary team began working with the patient in the intervention group on discharge. Team members conducted home visits, scheduled/took patients to appointments, managed medications, monitored and coached patients in disease-specific self-care, and assisted with applying for social and other assistive programs.

The readmission rate within 180 days after hospital discharge (primary outcome) between groups was not significant, with 62.3% readmitted in the intervention group and 61.7% in the control group. There was also no effect on the defined secondary outcomes (number of readmissions, proportion of patients with more than two readmissions, hospital days, charges, payments received, mortality).

The trial was not powered to detect smaller reductions in readmissions or to analyze effects within specific subgroups.

Bottom line: The addition of the Coalition’s program to patients with very high use of health care services did not decrease hospital readmission rate when compared to usual care.

Citation: Finkelstein A et al. Health care hotspotting – a randomized, controlled trial. N Engl J Med. 2020;382:152-62.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

With vaccination rates increasing and new infections declining, we all hope the worst of the COVID-19 pandemic is over (fingers crossed really tight). Regardless, the post–COVID-19 syndrome pandemic has already begun. What is post–COVID-19 syndrome (or long-haulers or long-COVID)? Is it standard postviral fatigue? Prolonged deconditioning following debilitating illness? Permanent lung or vascular injury? Common sense and past experience say it’s all of these.

In theory, the burden of actual lung injury post COVID-19 should be the easiest to quantify, so let’s discuss what we think we know. I’ve heard experts break post–COVID-19 lung injury into three broad categories:

• Preexisting lung disease that is exacerbated by acute COVID-19 infection.
• Acute COVID-19 infection that causes acute respiratory distress syndrome (ARDS) or other acute lung injury (ALI).
• Non–critically ill acute COVID-19 with residual lung damage and abnormal repair.

These categories are necessarily imprecise, making it challenging to fit some patients neatly into a single definition.

For patients in the first category, management will be dictated largely by the nature of the preexisting lung disease. For those in category two, we already know a lot about what their recovery from ARDS will look like. There’s no longer reason to believe that COVID-19–related ARDS is particularly unique, and all things being equal, lung recovery should mimic that seen with non–COVID-19 ARDS.

It’s going to take patience and time, and beyond targeted rehabilitation it’s not clear that we have anything available to expedite the process.

The third category of patients is the most intriguing. Is there a group of patients who have residual lung injury but didn’t have evident ARDS/ALI during their acute COVID-19 infection? Anecdotally we think so, but we know little about prevalence and less about management. A recent study published in Annals of the American Thoracic Society addresses both issues. In an observational report on patients recovering after being hospitalized with COVID-19 infection, the authors found that 3.6% of patients had residual lung injury that improved with 3 weeks of corticosteroid treatment.

The report is timely and helpful but hardly definitive. It’s observational, and patients required extensive screening and identification by a multidisciplinary committee of experts in interstitial lung disease. Patients were diagnosed as having organizing pneumonia (OP) as their “lung injury” if certain radiographic criteria were met. There were no biopsies. Last, there was no control group. Still, this report is critically important. It tells us that at 6 weeks post discharge, about 3.6% of patients who were hospitalized for COVID-19 will have persistent symptoms, radiographic abnormalities, and a plateau in their recovery.

Beyond that, it tells us little. Did these patients really have OP? It’s impossible to know. The CT findings used to establish the diagnosis are nonspecific. Response to steroids is consistent with OP, but the treatment course was quite short. If truly OP, one would expect a high relapse rate after steroid withdrawal. Patients weren’t followed long enough to monitor recurrence rates. Also, as appropriately discussed in the accompanying editorial, there’s no control group so we can’t know whether the patients treated with steroids would have recovered without treatment. There was objective improvement in lung function for the two to three patients they followed who did not receive steroids. However, it was of lesser magnitude than in the steroid group.

Post–COVID-19 symptoms will remain a challenge for the foreseeable future. More than 30 million patients have been diagnosed with COVID-19 in the United States and close to half will experience persistent dyspnea. Putting the numbers together, I conclude that the vast majority will not have identifiable lung injury that will benefit from steroids. I wish I could prescribe patience to both physicians and patients.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine.
 

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

With vaccination rates increasing and new infections declining, we all hope the worst of the COVID-19 pandemic is over (fingers crossed really tight). Regardless, the post–COVID-19 syndrome pandemic has already begun. What is post–COVID-19 syndrome (or long-haulers or long-COVID)? Is it standard postviral fatigue? Prolonged deconditioning following debilitating illness? Permanent lung or vascular injury? Common sense and past experience say it’s all of these.

In theory, the burden of actual lung injury post COVID-19 should be the easiest to quantify, so let’s discuss what we think we know. I’ve heard experts break post–COVID-19 lung injury into three broad categories:

• Preexisting lung disease that is exacerbated by acute COVID-19 infection.
• Acute COVID-19 infection that causes acute respiratory distress syndrome (ARDS) or other acute lung injury (ALI).
• Non–critically ill acute COVID-19 with residual lung damage and abnormal repair.

These categories are necessarily imprecise, making it challenging to fit some patients neatly into a single definition.

For patients in the first category, management will be dictated largely by the nature of the preexisting lung disease. For those in category two, we already know a lot about what their recovery from ARDS will look like. There’s no longer reason to believe that COVID-19–related ARDS is particularly unique, and all things being equal, lung recovery should mimic that seen with non–COVID-19 ARDS.

It’s going to take patience and time, and beyond targeted rehabilitation it’s not clear that we have anything available to expedite the process.

The third category of patients is the most intriguing. Is there a group of patients who have residual lung injury but didn’t have evident ARDS/ALI during their acute COVID-19 infection? Anecdotally we think so, but we know little about prevalence and less about management. A recent study published in Annals of the American Thoracic Society addresses both issues. In an observational report on patients recovering after being hospitalized with COVID-19 infection, the authors found that 3.6% of patients had residual lung injury that improved with 3 weeks of corticosteroid treatment.

The report is timely and helpful but hardly definitive. It’s observational, and patients required extensive screening and identification by a multidisciplinary committee of experts in interstitial lung disease. Patients were diagnosed as having organizing pneumonia (OP) as their “lung injury” if certain radiographic criteria were met. There were no biopsies. Last, there was no control group. Still, this report is critically important. It tells us that at 6 weeks post discharge, about 3.6% of patients who were hospitalized for COVID-19 will have persistent symptoms, radiographic abnormalities, and a plateau in their recovery.

Beyond that, it tells us little. Did these patients really have OP? It’s impossible to know. The CT findings used to establish the diagnosis are nonspecific. Response to steroids is consistent with OP, but the treatment course was quite short. If truly OP, one would expect a high relapse rate after steroid withdrawal. Patients weren’t followed long enough to monitor recurrence rates. Also, as appropriately discussed in the accompanying editorial, there’s no control group so we can’t know whether the patients treated with steroids would have recovered without treatment. There was objective improvement in lung function for the two to three patients they followed who did not receive steroids. However, it was of lesser magnitude than in the steroid group.

Post–COVID-19 symptoms will remain a challenge for the foreseeable future. More than 30 million patients have been diagnosed with COVID-19 in the United States and close to half will experience persistent dyspnea. Putting the numbers together, I conclude that the vast majority will not have identifiable lung injury that will benefit from steroids. I wish I could prescribe patience to both physicians and patients.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine.
 

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

With vaccination rates increasing and new infections declining, we all hope the worst of the COVID-19 pandemic is over (fingers crossed really tight). Regardless, the post–COVID-19 syndrome pandemic has already begun. What is post–COVID-19 syndrome (or long-haulers or long-COVID)? Is it standard postviral fatigue? Prolonged deconditioning following debilitating illness? Permanent lung or vascular injury? Common sense and past experience say it’s all of these.

In theory, the burden of actual lung injury post COVID-19 should be the easiest to quantify, so let’s discuss what we think we know. I’ve heard experts break post–COVID-19 lung injury into three broad categories:

• Preexisting lung disease that is exacerbated by acute COVID-19 infection.
• Acute COVID-19 infection that causes acute respiratory distress syndrome (ARDS) or other acute lung injury (ALI).
• Non–critically ill acute COVID-19 with residual lung damage and abnormal repair.

These categories are necessarily imprecise, making it challenging to fit some patients neatly into a single definition.

For patients in the first category, management will be dictated largely by the nature of the preexisting lung disease. For those in category two, we already know a lot about what their recovery from ARDS will look like. There’s no longer reason to believe that COVID-19–related ARDS is particularly unique, and all things being equal, lung recovery should mimic that seen with non–COVID-19 ARDS.

It’s going to take patience and time, and beyond targeted rehabilitation it’s not clear that we have anything available to expedite the process.

The third category of patients is the most intriguing. Is there a group of patients who have residual lung injury but didn’t have evident ARDS/ALI during their acute COVID-19 infection? Anecdotally we think so, but we know little about prevalence and less about management. A recent study published in Annals of the American Thoracic Society addresses both issues. In an observational report on patients recovering after being hospitalized with COVID-19 infection, the authors found that 3.6% of patients had residual lung injury that improved with 3 weeks of corticosteroid treatment.

The report is timely and helpful but hardly definitive. It’s observational, and patients required extensive screening and identification by a multidisciplinary committee of experts in interstitial lung disease. Patients were diagnosed as having organizing pneumonia (OP) as their “lung injury” if certain radiographic criteria were met. There were no biopsies. Last, there was no control group. Still, this report is critically important. It tells us that at 6 weeks post discharge, about 3.6% of patients who were hospitalized for COVID-19 will have persistent symptoms, radiographic abnormalities, and a plateau in their recovery.

Beyond that, it tells us little. Did these patients really have OP? It’s impossible to know. The CT findings used to establish the diagnosis are nonspecific. Response to steroids is consistent with OP, but the treatment course was quite short. If truly OP, one would expect a high relapse rate after steroid withdrawal. Patients weren’t followed long enough to monitor recurrence rates. Also, as appropriately discussed in the accompanying editorial, there’s no control group so we can’t know whether the patients treated with steroids would have recovered without treatment. There was objective improvement in lung function for the two to three patients they followed who did not receive steroids. However, it was of lesser magnitude than in the steroid group.

Post–COVID-19 symptoms will remain a challenge for the foreseeable future. More than 30 million patients have been diagnosed with COVID-19 in the United States and close to half will experience persistent dyspnea. Putting the numbers together, I conclude that the vast majority will not have identifiable lung injury that will benefit from steroids. I wish I could prescribe patience to both physicians and patients.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He covers a wide range of topics in pulmonary, critical care, and sleep medicine.
 

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

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

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

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

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

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

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

Background: Fever is a common symptom in patients presenting to the ED. In patients with hemodialysis-dependent ESRD, the literature on febrile response during infection is scarce. In this study, authors compared ED triage temperatures of S. aureus bacteremic patients with and without hemodialysis-dependent ESRD.

Study design: Paired, retrospective cohort study.

Setting: Tertiary care referral center.

Synopsis: A total of 74 patients with methicillin-resistant or methicillin-susceptible S. aureus bacteremia were included in this study (37 patients with and 37 patients without hemodialysis-dependent ESRD). Upon triage, 54% (95% confidence interval, 38%-70%) and 82% (95% CI, 65%-91%) of hemodialysis and nonhemodialysis patients did not have a detectable fever (less than 100.4° F), respectively. The estimated mean ED triage temperatures were 100.5° F in the hemodialysis-dependent patients and 99.0° F in the non–hemodialysis-dependent patients (P < .001). The authors note the significant lack of fevers may be the result of insensitive methods for measuring body temperature, such as peripheral thermometers.

Bottom line: In this small retrospective cohort study, these data suggest a high incidence of afebrile bacteremia in patients with ESRD, especially those patients not dialysis dependent. This may lead to delays in obtaining blood cultures and initiating antibiotics. However, given the study design, the authors were unable to conclude a causal relationship between ESRD and febrile response.

Citation: Weatherall SL et al. Do bacteremic patients with end-stage renal disease have a fever when presenting to the emergency department? A paired, retrospective cohort study. BMC Emerg Med. 2020;20:2.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Fever is a common symptom in patients presenting to the ED. In patients with hemodialysis-dependent ESRD, the literature on febrile response during infection is scarce. In this study, authors compared ED triage temperatures of S. aureus bacteremic patients with and without hemodialysis-dependent ESRD.

Study design: Paired, retrospective cohort study.

Setting: Tertiary care referral center.

Synopsis: A total of 74 patients with methicillin-resistant or methicillin-susceptible S. aureus bacteremia were included in this study (37 patients with and 37 patients without hemodialysis-dependent ESRD). Upon triage, 54% (95% confidence interval, 38%-70%) and 82% (95% CI, 65%-91%) of hemodialysis and nonhemodialysis patients did not have a detectable fever (less than 100.4° F), respectively. The estimated mean ED triage temperatures were 100.5° F in the hemodialysis-dependent patients and 99.0° F in the non–hemodialysis-dependent patients (P < .001). The authors note the significant lack of fevers may be the result of insensitive methods for measuring body temperature, such as peripheral thermometers.

Bottom line: In this small retrospective cohort study, these data suggest a high incidence of afebrile bacteremia in patients with ESRD, especially those patients not dialysis dependent. This may lead to delays in obtaining blood cultures and initiating antibiotics. However, given the study design, the authors were unable to conclude a causal relationship between ESRD and febrile response.

Citation: Weatherall SL et al. Do bacteremic patients with end-stage renal disease have a fever when presenting to the emergency department? A paired, retrospective cohort study. BMC Emerg Med. 2020;20:2.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Fever is a common symptom in patients presenting to the ED. In patients with hemodialysis-dependent ESRD, the literature on febrile response during infection is scarce. In this study, authors compared ED triage temperatures of S. aureus bacteremic patients with and without hemodialysis-dependent ESRD.

Study design: Paired, retrospective cohort study.

Setting: Tertiary care referral center.

Synopsis: A total of 74 patients with methicillin-resistant or methicillin-susceptible S. aureus bacteremia were included in this study (37 patients with and 37 patients without hemodialysis-dependent ESRD). Upon triage, 54% (95% confidence interval, 38%-70%) and 82% (95% CI, 65%-91%) of hemodialysis and nonhemodialysis patients did not have a detectable fever (less than 100.4° F), respectively. The estimated mean ED triage temperatures were 100.5° F in the hemodialysis-dependent patients and 99.0° F in the non–hemodialysis-dependent patients (P < .001). The authors note the significant lack of fevers may be the result of insensitive methods for measuring body temperature, such as peripheral thermometers.

Bottom line: In this small retrospective cohort study, these data suggest a high incidence of afebrile bacteremia in patients with ESRD, especially those patients not dialysis dependent. This may lead to delays in obtaining blood cultures and initiating antibiotics. However, given the study design, the authors were unable to conclude a causal relationship between ESRD and febrile response.

Citation: Weatherall SL et al. Do bacteremic patients with end-stage renal disease have a fever when presenting to the emergency department? A paired, retrospective cohort study. BMC Emerg Med. 2020;20:2.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.

In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).

In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.

Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.

Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.

Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax. N Engl J Med. 2020; 382:405-15.

Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

Tim Oswalt had been in a Fort Worth, Texas, hospital for over a month, receiving treatment for a grapefruit-sized tumor in his chest that was pressing on his heart and lungs. It turned out to be stage 3 non-Hodgkin lymphoma. 

Then one day in January, he was moved from his semi-private room to an isolated one with special ventilation. The staff explained he had been infected by the virus that was once again surging in many areas of the country, including Texas.

“How the hell did I catch COVID?” he asked the staff, who now approached him in full moon-suit personal protective equipment (PPE).

The hospital was locked down, and Mr. Oswalt hadn’t had any visitors in weeks. Neither of his two roommates tested positive. He’d been tested for COVID several times over the course of his nearly 5-week stay and was always negative.

“‘Well, you know, it’s easy to [catch it] in a hospital,’” Mr. Oswalt said he was told by hospital staff. “‘We’re having a bad outbreak. So you were just exposed somehow.’”

Courtesy Tim Oswalt

Refusing vaccinations

In fact, nationwide, 1 in 4 hospital workers who have direct contact with patients had not yet received a single dose of a COVID vaccine by the end of May, according to a WebMD and Medscape Medical News analysis of data collected by the U.S. Department of Health and Human Services (HHS) from 2,500 hospitals across the United States.

Among the nation’s 50 largest hospitals, the percentage of unvaccinated health care workers appears to be even larger, about 1 in 3. Vaccination rates range from a high of 99% at Houston Methodist Hospital, which was the first in the nation to mandate the shots for its workers, to a low between 30% and 40% at some hospitals in Florida.

Memorial Hermann Texas Medical Center in Houston has 1,180 beds and sits less than half a mile from Houston Methodist Hospital. But in terms of worker vaccinations, it is farther away. 

Memorial Hermann reported to HHS that about 32% of its 28,000 workers haven’t been inoculated. The hospital’s PR office contests that figure, putting it closer to 25% unvaccinated across their health system. The hospital said it is boosting participation by offering a $300 “shot of hope” bonus to workers who start their vaccination series by the end of June.

Lakeland Regional Medical Center in Lakeland, Fla., reported to HHS that 63% of its health care personnel are still unvaccinated. The hospital did not return a call to verify that number.

To boost vaccination rates, more hospitals are starting to require the shots, after the Equal Employment Opportunity Commission gave its green light to mandates in May.

“It’s a real problem that you have such high levels of unvaccinated individuals in hospitals,” said Lawrence Gostin, JD, director of the O’Neill Institute for National and Global Health Law at Georgetown University, Washington.  

“We have to protect our health workforce, and we have to protect our patients. Hospitals should be the safest places in the country, and the only way to make them safe is to have a fully vaccinated workforce,” Mr. Gostin said.
 

Is the data misleading?

The HHS system designed to amass hospital data was set up quickly, to respond to an emergency. For that reason, experts say the information hasn’t been as carefully collected or vetted as it normally would have been. Some hospitals may have misunderstood how to report their vaccination numbers.

In addition, reporting data on worker vaccinations is voluntary. Only about half of hospitals have chosen to share their numbers. In other cases, like Texas, states have blocked the public release of these statistics.

AdventHealth Orlando, a 1,300-bed hospital in Florida, reported to HHS that 56% of its staff have not started their shots. But spokesman Jeff Grainger said the figures probably overstate the number of unvaccinated workers because the hospital doesn’t always know when people get vaccinated outside of its campus, at a local pharmacy, for example.  

For those reasons, the picture of health care worker vaccinations across the country is incomplete.
 

Where hospitals fall behind

Even if the data are flawed, the vaccination rates from hospitals mirror the general population. A May Gallup poll, for example, found 24% of Americans said they definitely won’t get the vaccine. Another 12% say they plan to get it but are waiting.

The data also align with recent studies. A review of 35 studies by researchers at New Mexico State University that assessed hesitancy in more than 76,000 health care workers around the world found about 23% of them were reluctant to get the shots. 

An ongoing monthly survey of more than 1.9 million U.S. Facebook users led by researchers at Carnegie Mellon University, Pittsburgh recently looked at vaccine hesitancy by occupation. It revealed a spectrum of hesitancy among health care workers corresponding to income and education, ranging from a low of 9% among pharmacists to highs of 20%-23% among nursing aides and emergency medical technicians. About 12% of registered nurses and doctors admitted to being hesitant to get a shot.

“Health care workers are not monolithic,” said study author Jagdish Khubchandani, professor of public health sciences at New Mexico State. 

“There’s a big divide between males, doctoral degree holders, older people and the younger low-income, low-education frontline, female, health care workers. They are the most hesitant,” he said. Support staff typically outnumbers doctors at hospitals about 3 to 1.

‘I am not vaccinated’ 

One reason some hospital staff say they are resisting COVID vaccination is because it’s so new and not yet fully approved by the FDA.

“I am not vaccinated,” said a social services worker for AdventHealth Gordon who asked that her name not be used because she was unauthorized to speak to this news organization and Georgia Health News (who collaborated on this project). “I just have not felt the need to do that at this time.”

The woman said she doesn’t have a problem with vaccines. She gets the flu shot every year. “I’ve been vaccinated all my life,” she said. But she doesn’t view COVID-19 vaccination in the same way.

“I want to see more testing done,” she said. “It took a long time to get a flu vaccine, and we made a COVID vaccine in 6 months. I want to know, before I start putting something into my body, that the testing is done.”

Staff at her hospital were given the option to be vaccinated or wear a mask. She chose the mask.

Many of her coworkers share her feelings, she said.

Mask expert Linsey Marr, PhD, a professor of civil and environmental engineering at Virginia Tech University, Blacksburg, Va., said N95 masks and vaccines are both highly effective, but the protection from the vaccine is superior because it is continuous.

“It’s hard to wear an N95 at all times. You have to take it off to eat, for example, in a break room in a hospital. I should point out that you can be exposed to the virus in other buildings besides a hospital – restaurants, stores, people’s homes – and because someone can be infected without symptoms, you could easily be around an infected person without knowing it,” she said.

Eventually, staff at AdventHealth Gordon may get a stronger nudge to get the shots. Chief Medical Officer Joseph Joyave, MD, said AdventHealth asks workers to get flu vaccines or provide the hospital with a reason why they won’t. He expects a similar policy will be adopted for COVID vaccines once they are fully licensed by the FDA.

In the meantime, he does not believe that the hospital is putting patients at risk with its low vaccination rate. “We continue to use PPE, masking in all clinical areas, and continue to screen daily all employees and visitors,” he said.

AdventHealth, the 12th largest hospital system in the nation with 49 hospitals, has at least 20 hospitals with vaccination rates lower than 50%, according to HHS data.

Other hospital systems have approached hesitation around the COVID vaccines differently.

When infectious disease experts at Vanderbilt Hospital in Nashville realized early on that many of their workers felt unsure about the vaccines, they set out to provide a wealth of information. 

“There was a lot of hesitancy and skepticism,” said William Schaffner, MD, a professor of preventive medicine and infectious disease at Vanderbilt. So the infectious disease division put together a multifaceted program including Q&As, educational sessions, and one-on-one visits with employees “from the custodians all the way up to the C-Suite,” he said.

Today, HHS data shows the hospital is 83% vaccinated. Dr. Schaffner thinks the true number is probably higher, about 90%. “We’re very pleased with that,” he said.

In his experience with flu vaccinations, it was extremely difficult in the first year to get workers to take flu shots. The second year it was easier. By the third year it was humdrum, he said, because it had become a cultural norm.  

Dr. Schaffner expects winning people over to the COVID vaccines will follow a similar course, but “we’re not there yet,” he said.
 

Protecting patients and caregivers

There is no question that health care workers carried a heavy load through the worst months of the pandemic. Many of them worked to the point of exhaustion and burnout. Some were the only conduits between isolated patients and their families, holding hands and mobile phones so distanced loved ones could video chat. Many were left inadequately protected because of shortages of masks, gowns, gloves, and other gear.

An investigation by Kaiser Health News and The Guardian recently revealed that more than 3,600 health care workers died in COVID’s first year in the United States.

Vaccination of health care workers is important to protect these frontline workers and their families who will continue to be at risk of coming into contact with the infection, even as the number of cases falls.

Hesitancy in health care is also dangerous because these clinicians and allied health workers – who may not show any symptoms – can also carry the virus to someone who wouldn’t survive an infection, including patients with organ transplants, those with autoimmune diseases, premature infants, and the elderly.  

It is not known how often patients in the United States are infected with COVID in health care settings, but case reports reveal that hospitals are still experiencing outbreaks.

On June 1, Northern Lights A.R. Gould Hospital in Presque Isle, Maine, announced a COVID outbreak on its medical-surgical unit. As of June 22, 13 residents and staff have caught the virus, according to the Maine Centers for Disease Control, which is investigating. Four of the first five staff members to test positive had not been fully vaccinated. 

According to HHS data, about 20% of the health care workers at that hospital are still unvaccinated.

Oregon Health & Science University experienced a COVID outbreak connected to the hospital’s cardiovascular care unit from April to mid-May of this year. According to hospital spokesperson Tracy Brawley, a patient visitor brought the infection to campus, where it ultimately spread to 14 others, including “patients, visitors, employees, and learners.” 

In a written statement, the hospital said “nearly all” health care workers who tested positive were previously vaccinated and experienced no symptoms or only minor ones. The hospital said it hasn’t identified any onward transmission from health care workers to patients, and also stated: “It is not yet understood how transmission may have occurred between patients, visitors, and health care workers.”

In March, an unvaccinated health care worker in Kentucky carried a SARS-CoV-2 variant back to the nursing home where the person worked. Some 90% of the residents were fully vaccinated. Ultimately, 26 patients were infected; 18 of them were fully vaccinated. And 20 health care workers, four of whom were vaccinated, were infected.   

Vaccines slowed the virus down and made infections less severe, but in this fragile population, they couldn’t stop it completely. One resident, who had survived a bout of COVID almost a year earlier, died. According to the CDC’s Morbidity and Mortality Weekly Report, 47% of the workers in that facility were unvaccinated.

In the United Kingdom, statistics collected through that country’s National Health Service also suggest a heavy toll. More than 32,300 patients caught COVID in English hospitals since March 2020. Up to 8,700 of them died, according to a recent analysis by The Guardian. The U.K. government recently made COVID vaccinations mandatory for health care workers.
 

COVID delays cancer care

When Mr. Oswalt, the Fort Worth, Texas man with non-Hodgkin lymphoma, contracted COVID-19, the virus took down his kidneys first. Toxins were building up in his blood, so doctors prescribed dialysis to support his body and buy his kidneys time to heal.

He was in one of these dialysis treatments when his lungs succumbed.

“Look, I can’t breathe,” he told the nurse who was supervising his treatment. The nurse gestured to an oxygen tank already hanging by his side, and said, “You should be OK.”

But he wasn’t.

“I can’t breathe,” Mr. Oswalt said again. Then the air hunger hit. Mr. Oswalt began gasping and couldn’t stop. Today, his voice breaks when he describes this moment. “A lot of it becomes a blur.”

When Mr. Oswalt, 61, regained consciousness, he was hooked up to a ventilator to ease his breathing.

For days, Mr. Oswalt clung to the edge of life. His wife, Molly, who wasn’t allowed to see him in the hospital, got a call that he might not make it through the night. She made frantic phone calls to her brother and sister and prayed.

Mr. Oswalt was on a ventilator for about a week. His kidneys and lungs healed enough so that he could restart his chemotherapy. He was eventually discharged home on January 22.

The last time he was scanned, the large tumor in his chest had shrunk from the size of a grapefruit to the size of a dime.

But having COVID on top of cancer has had a devastating effect on his life. Before he got sick, Molly said, he couldn’t stay still. He was busy all the time. After spending months in the hospital, his energy was depleted. He couldn’t keep his swimming pool installation business going.  

He and Molly had to give up their house in Fort Worth and move in with family in Amarillo. He has had to pause his cancer treatments while doctors wait for his kidneys to heal. Relatives have been raising money on GoFundMe to pay their bills.

Months after moving across the state to Amarillo and hoping for better days, Tim said he got good news this week: He no longer needs dialysis. A new round of tests found no signs of cancer. His white blood cell count is back to normal. His lymph nodes are no longer swollen.

He goes back for another scan in a few weeks, but the doctor told him she isn’t going to recommend any further chemo at this point.

“It was shocking, to tell you the truth. It still is. When I talk about it, I get kind of emotional” about his recovery, he said.

Tim said he was really dreading more chemotherapy. His hair has just started growing back. He can finally taste food again. He wasn’t ready to face more side effects from the treatments, or the COVID – he no longer knows exactly which diagnosis led to his most debilitating symptoms.

He said his ordeal has left him with no patience for health care workers who don’t think they need to be vaccinated.

The way he sees it, it’s no different than the electrical training he had to get before he could wire the lights and pumps in a swimming pool.

“You know, if I don’t certify and keep my license, I can’t work on anything electrical. So, if I’ve made the choice not to go down and take the test and get a license, then I made the choice not to work on electrical stuff,” he said.

He supports the growing number of hospitals that have made vaccination mandatory for their workers.

“They don’t let electricians put people at risk. And they shouldn’t let health care workers for sure,” he said.

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

Background: Exercise EKG is often integrated with stress echocardiography, but discordance with +EKG/–Echo has unknown significance.

Study design: Observational cohort study.

Setting: Duke University Medical Center, Durham, N.C.

Synopsis: 47,944 patients without known coronary artery disease underwent exercise stress echocardiogram (Echo) with stress EKG. Of those patients, 8.5% had +EKG/–Echo results, which was associated with annualized event rate of adverse cardiac events of 1.72%, which is higher than the 0.89% of patients with –EKG/–Echo results. This was most significant for composite major adverse cardiovascular events less than 30 days out, with an adjusted hazard ratio of 8.06 (95% confidence interval, 5.02-12.94). For major adverse cardiovascular events greater than 30 days out, HR was 1.25 (95% CI 1.02-1.53).

Bottom line: Patients with +EKG/–Echo findings appear to be at higher risk of adverse cardiac events, especially in the short term.

Citation: Daubert MA et al. Implications of abnormal exercise electrocardiography with normal stress echocardiography. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6958.

Dr. Ho is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Exercise EKG is often integrated with stress echocardiography, but discordance with +EKG/–Echo has unknown significance.

Study design: Observational cohort study.

Setting: Duke University Medical Center, Durham, N.C.

Synopsis: 47,944 patients without known coronary artery disease underwent exercise stress echocardiogram (Echo) with stress EKG. Of those patients, 8.5% had +EKG/–Echo results, which was associated with annualized event rate of adverse cardiac events of 1.72%, which is higher than the 0.89% of patients with –EKG/–Echo results. This was most significant for composite major adverse cardiovascular events less than 30 days out, with an adjusted hazard ratio of 8.06 (95% confidence interval, 5.02-12.94). For major adverse cardiovascular events greater than 30 days out, HR was 1.25 (95% CI 1.02-1.53).

Bottom line: Patients with +EKG/–Echo findings appear to be at higher risk of adverse cardiac events, especially in the short term.

Citation: Daubert MA et al. Implications of abnormal exercise electrocardiography with normal stress echocardiography. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6958.

Dr. Ho is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: Exercise EKG is often integrated with stress echocardiography, but discordance with +EKG/–Echo has unknown significance.

Study design: Observational cohort study.

Setting: Duke University Medical Center, Durham, N.C.

Synopsis: 47,944 patients without known coronary artery disease underwent exercise stress echocardiogram (Echo) with stress EKG. Of those patients, 8.5% had +EKG/–Echo results, which was associated with annualized event rate of adverse cardiac events of 1.72%, which is higher than the 0.89% of patients with –EKG/–Echo results. This was most significant for composite major adverse cardiovascular events less than 30 days out, with an adjusted hazard ratio of 8.06 (95% confidence interval, 5.02-12.94). For major adverse cardiovascular events greater than 30 days out, HR was 1.25 (95% CI 1.02-1.53).

Bottom line: Patients with +EKG/–Echo findings appear to be at higher risk of adverse cardiac events, especially in the short term.

Citation: Daubert MA et al. Implications of abnormal exercise electrocardiography with normal stress echocardiography. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6958.

Dr. Ho is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.