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U.K. COVID-19 variant doubling every 10 days in the U.S.: Study
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
The SARS-CoV-2 variant first detected in the United Kingdom is rapidly becoming the dominant strain in several countries and is doubling every 10 days in the United States, according to new data.
The findings by Nicole L. Washington, PhD, associate director of research at the genomics company Helix, and colleagues were posted Feb. 7, 2021, on the preprint server medRxiv. The paper has not been peer-reviewed in a scientific journal.
The researchers also found that the transmission rate in the United States of the variant, labeled B.1.1.7, is 30%-40% higher than that of more common lineages.
While clinical outcomes initially were thought to be similar to those of other SARS-CoV-2 variants, early reports suggest that infection with the B.1.1.7 variant may increase death risk by about 30%.
A coauthor of the current study, Kristian Andersen, PhD, told the New York Times , “Nothing in this paper is surprising, but people need to see it.”
Dr. Andersen, a virologist at the Scripps Research Institute in La Jolla, Calif., added that “we should probably prepare for this being the predominant lineage in most places in the United States by March.”
The study of the B.1.1.7 variant adds support for the Centers for Disease Control and Prevention prediction in January that it would dominate by March.
“Our study shows that the U.S. is on a similar trajectory as other countries where B.1.1.7 rapidly became the dominant SARS-CoV-2 variant, requiring immediate and decisive action to minimize COVID-19 morbidity and mortality,” the researchers wrote.
The authors pointed out that the B.1.1.7 variant became the dominant SARS-CoV-2 strain in the United Kingdom within a couple of months of its detection.
“Since then, the variant has been increasingly observed across many European countries, including Portugal and Ireland, which, like the U.K., observed devastating waves of COVID-19 after B.1.1.7 became dominant,” the authors wrote.
“Category 5” storm
The B.1.1.7 variant has likely been spreading between U.S. states since at least December, they wrote.
This news organization reported on Jan. 15 that, as of Jan. 13, the B.1.1.7 variant was seen in 76 cases across 12 U.S. states, according to an early release of the CDC’s Morbidity and Mortality Weekly Report.
As of Feb. 7, there were 690 cases of the B.1.1.7 variant in the US in 33 states, according to the CDC.
Dr. Washington and colleagues examined more than 500,000 coronavirus test samples from cases across the United States that were tested at San Mateo, Calif.–based Helix facilities since July.
In the study, they found inconsistent prevalence of the variant across states. By the last week in January, the researchers estimated the proportion of B.1.1.7 in the U.S. population to be about 2.1% of all COVID-19 cases, though they found it made up about 2% of all COVID-19 cases in California and about 4.5% of cases in Florida. The authors acknowledged that their data is less robust outside of those two states.
Though that seems a relatively low frequency, “our estimates show that its growth rate is at least 35%-45% increased and doubling every week and a half,” the authors wrote.
“Because laboratories in the U.S. are only sequencing a small subset of SARS-CoV-2 samples, the true sequence diversity of SARS-CoV-2 in this country is still unknown,” they noted.
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said last week that the United States is facing a “Category 5” storm with the spread of the B.1.1.7 variant as well as the variants first identified in South Africa and Brazil.
“We are going to see something like we have not seen yet in this country,” Dr. Osterholm said recently on NBC’s Meet the Press.
Lead author Nicole L. Washington and many of the coauthors are employees of Helix. Other coauthors are employees of Illumina. Three coauthors own stock in ILMN. The work was funded by Illumina, Helix, the Innovative Genomics Institute, and the New Frontiers in Research Fund provided by the Canadian Institutes of Health Research.
A version of this article first appeared on Medscape.com.
Are diagnosticians chasing COVID-linked zebras and missing horses?
The emergence of multiple inflammatory syndrome in children (MIS-C) in association with COVID-19 may be complicating the investigation and diagnosis of more common viral and bacterial infections, potentially delaying treatment and prolonging hospital stays.
Two recent articles published online in Hospital Pediatrics provide evidence of this phenomenon. The articles outlined case studies of children who underwent extensive investigation for MIS-C when in fact they had less severe and more common infections. MIS-C is a severe but rare syndrome that involves systemic hyperinflammation with fever and multisystem organ dysfunction similar to that of Kawasaki disease (KD).
In one of the articles, Matthew Molloy, MD, MPH, of the division of pediatric hospital medicine at Cincinnati Children’s Hospital Medical Center, and colleagues aptly asked: “What are we missing in our search for MIS-C?”
E. coli, not SARS-CoV-2
That question arose from a case involving a 3-year-old boy who had a 6-day history of fever and fatigue. Three days earlier, he had tested negative for strep antigen and COVID-19. He had a persistent, high fever, reduced appetite, and reduced urine output and was taken to the ED. On physical examination, there was no rash, skin peeling, redness of the eye or oral mucosa, congestion, rhinorrhea, cough, shortness of breath, chest pain, abdominal pain, nausea, vomiting, or diarrhea.
Urinalysis results and exam findings were suspicious for pyelonephritis. Other findings from an extensive laboratory workup raised the alarm that the boy was suffering from MIS-C as opposed to incomplete KD. After admission to hospital medicine, the cardiology, rheumatology, and infectious disease teams were called in to consult.
Repeat labs were planned for the following day before initiating therapy. On day 2, the child’s urine culture was positive for gram-negative rods, later identified as Escherichia coli. The boy was started on ceftriaxone. Left renal scarring was apparent on ultrasound. The patient’s condition resolved after 36 hours, and he was discharged home with antibiotics.
‘Diagnosis derailed’
Calling this a case of “diagnosis derailed,” the authors noted that, in the pre-COVID era, this child’s signs and symptoms would likely have triggered a more targeted and less costly evaluation for more common infectious and noninfectious causes, including pyelonephritis, absent any physical exam findings consistent with KD.
“However, the patient presented in the midst of the COVID-19 pandemic with growing awareness of a new clinical entity,” Dr. Molloy and colleagues wrote. “Anchored to the patient’s persistent fever, the medical team initiated an extensive, costly, and ultimately unnecessary workup to avoid missing the diagnosis of MIS-C; a not yet well-described diagnosis with potentially severe morbidity.”
Confirmation bias and diagnostic momentum likely contributed to the early focus on MIS-C rather than more common alternatives, the authors acknowledged. The addition of mildly abnormal laboratory data not typically obtained in the evaluation of fever led the team astray. “The diagnosis and definitive treatment may have been made earlier had the focus on concern for MIS-C not been present,” Dr. Molloy said in an interview.
Keeping value in care
The authors recognized that their initial approach to evaluating for MIS-C provided low-value care. “In our desire to not ‘miss’ MIS-C, we were performing costly evaluations that at times produced mildly abnormal, nonspecific results,” they wrote. That triggered a cascade of specialty consultations, follow-up testing, and an unwarranted diagnostic preoccupation with MIS-C.
Determining the extra price tag for the child’s workup would be complex and difficult because there is a difference in the cost to the hospital and the cost to the family, Dr. Molloy said. “However, there are potential cost savings that would be related to making a correct diagnosis in a timely manner in terms of preventing downstream effects from delayed diagnoses.”
Even as clinicians struggle with the challenging SARS-CoV-2 learning curve, Dr. Molloy and associates urged them to continue to strive for high-value care, with an unwavering focus on using only necessary resources, a stewardship the pandemic has shown to be critical.
“The COVID-19 pandemic has been an incredibly stressful time for physicians and for families,” Dr. Molloy said. “COVID-19 and related conditions like MIS-C are new, and we are learning more and more about them every week. These diagnoses are understandably on the minds of physicians and families when children present with fever.” Notwithstanding, the boy’s case underscores the need for clinicians to consider alternate diagnoses and the value of the care provided.
Impact of bias
Dr. Molloy’s group brings home the cognitive biases practitioners often suffer from, including anchoring and confirmation bias and diagnostic momentum, according to J. Howard Smart, MD, chief of pediatrics at Sharp Mary Birch Hospital for Women and Newborns, San Diego, and an assistant clinical professor of pediatrics at University of California, San Diego.
“But it is one thing to recognize these in retrospect and quite another to consider whether they may be happening to you yourself in real time,” he said in an interview. “It is almost as if we need to have a ‘time out,’ where we stop and ask ourselves whether there is something else that could be explaining our patient’s presentation, something that would be more common and more likely to be occurring.”
According to Dr. Smart, who was not involved in Dr. Molloy’s study, the team’s premature diagnostic focus on MIS-C was almost the inverse of what typically happens with KD. “It is usually the case that Kawasaki disease does not enter the differential diagnosis until late in the course of the fever, typically on day 5 or later, when it may have been better to think of it earlier,” he said.
In the second article, Andrea Dean, MD, of the department of pediatrics at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, and colleagues outlined the cases of five patients aged 8-17 years who were hospitalized in May 2020 for suspected MIS-C. They exhibited inflammatory and other concerning indicators but were eventually discharged with a diagnosis of murine typhus.
This flea-borne infection, most commonly reported in the United States in the southeastern Gulf Coast region, Hawaii, and California, is often associated with a triad of fever, rash, and headache.
Cases have been rising in southern Texas, and Dr. Dean and colleagues postulated that school closures and social distancing may have increased exposure as a result of children spending more time outdoors or with pets. “Alternatively, parental concern for SARS-CoV-2 infection could mean children with symptoms are presenting to care and being referred or admitted to the hospital more frequently due to provider concern for MIS-C,” they wrote.
Cardiac involvement
The most concerning of the five cases in terms of possible MIS-C, Dr. Dean said in an interview, was that of a 12-year-old boy who had fever for 6 days in association with headache, eczematous rash, dry lips, and conjunctivitis. Laboratory tests showed a mildly elevated C-reactive protein level, hyponatremia, and thrombocytopenia, as well as sterile pyuria and mildly elevated prothrombin time. He was treated empirically with doxycycline, and his fever resolved over the next 24 hours.
An echocardiogram at initial evaluation, however, revealed mild dilation of the left anterior descending and right coronary arteries, which led to the administration of intravenous immunoglobulin and aspirin for atypical KD, in contrast to MIS-C. The authors postulated that mild cardiac involvement in disorders other than MIS-C and KD may be underrecognized.
The lesson from these cases, Dr. Dean and associates concluded, is that hospitalists must maintain a wide differential diagnosis when assessing a child with prolonged fever and evidence of systemic inflammation. The CDC stipulates that a diagnosis of MIS-C requires the absence of a plausible alternative diagnosis.
In addition to common viral, bacterial, and noninfectious disorders, a range of regional endemic rickettsial and parasitic infections must be considered as alternative diagnoses to MIS-C. “Many of these diseases cannot be reliably differentiated from MIS-C on presentation, and as community exposure to SARS-CoV-2 grows, hospitalists should be prepared to admit febrile children with evidence of systemic inflammation for brief observation periods to evaluate for MIS-C,” Dr. Dean’s group wrote. In this context, however, empiric treatment for common or even uncommon infectious diseases may avoid overdiagnosis and overtreatment of MIS-C as well as improve patient outcomes.
“We do have specific MIS-C guidelines at our institution,” Dr. Dean said, “but like all institutions, we are dealing with the broad definition of MIS-C according to the World Health Organization and the CDC, which is really the takeaway from this paper.”
More difficult differentiation
Both groups of authors pointed out that, as SARS-CoV-2 spreads throughout a community, a higher percentage of the population will have positive results on antibody testing, and such results will become less useful for differentiating between MIS-C and other conditions.
Despite these series’ cautionary lessons, other experts point to the critical importance of including MIS-C early on in the interest of efficient diagnosis and therapy. “In the cases cited, other pathologies were evaluated for and treated accordingly,” said Kara Gross Margolis, MD, AGAF, an associate professor of pediatrics in the division of pediatric gastroenterology, hepatology, and nutrition at Morgan Stanley Children’s Hospital,New York. “These papers stress the need for a balance that is important, and all potential diagnoses need to be considered, but MIS-C, due to its potential severe consequences, also needs to be on our differential now.”
In her view, as this new high-morbidity entity becomes more widespread during the pandemic, it will be increasingly important to keep this condition on the diagnostic radar.
Interestingly, in a converse example of diagnostic clouding, Dr. Gross Margolis’s group reported (Gastroenterology. 2020 Oct;159[4]:1571-4.e2) last year on a pediatric case series in which the presence of gastrointestinal symptoms in children with COVID-19–related MIS-C muddied the diagnosis by confusing this potentially severe syndrome with more common and less toxic gastrointestinal infections.
According to Dr. Smart, although the two reports don’t offer evidence for a particular diagnostic practice, they can inform the decision-making process. “It may be that we will have enough evidence shortly to say what the best practice is regarding diagnostic evaluation of possible MIS-C cases,” he said. “Until then, we must remember that common things occur commonly, even during a global pandemic.”
Neither of the two reports received any specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The emergence of multiple inflammatory syndrome in children (MIS-C) in association with COVID-19 may be complicating the investigation and diagnosis of more common viral and bacterial infections, potentially delaying treatment and prolonging hospital stays.
Two recent articles published online in Hospital Pediatrics provide evidence of this phenomenon. The articles outlined case studies of children who underwent extensive investigation for MIS-C when in fact they had less severe and more common infections. MIS-C is a severe but rare syndrome that involves systemic hyperinflammation with fever and multisystem organ dysfunction similar to that of Kawasaki disease (KD).
In one of the articles, Matthew Molloy, MD, MPH, of the division of pediatric hospital medicine at Cincinnati Children’s Hospital Medical Center, and colleagues aptly asked: “What are we missing in our search for MIS-C?”
E. coli, not SARS-CoV-2
That question arose from a case involving a 3-year-old boy who had a 6-day history of fever and fatigue. Three days earlier, he had tested negative for strep antigen and COVID-19. He had a persistent, high fever, reduced appetite, and reduced urine output and was taken to the ED. On physical examination, there was no rash, skin peeling, redness of the eye or oral mucosa, congestion, rhinorrhea, cough, shortness of breath, chest pain, abdominal pain, nausea, vomiting, or diarrhea.
Urinalysis results and exam findings were suspicious for pyelonephritis. Other findings from an extensive laboratory workup raised the alarm that the boy was suffering from MIS-C as opposed to incomplete KD. After admission to hospital medicine, the cardiology, rheumatology, and infectious disease teams were called in to consult.
Repeat labs were planned for the following day before initiating therapy. On day 2, the child’s urine culture was positive for gram-negative rods, later identified as Escherichia coli. The boy was started on ceftriaxone. Left renal scarring was apparent on ultrasound. The patient’s condition resolved after 36 hours, and he was discharged home with antibiotics.
‘Diagnosis derailed’
Calling this a case of “diagnosis derailed,” the authors noted that, in the pre-COVID era, this child’s signs and symptoms would likely have triggered a more targeted and less costly evaluation for more common infectious and noninfectious causes, including pyelonephritis, absent any physical exam findings consistent with KD.
“However, the patient presented in the midst of the COVID-19 pandemic with growing awareness of a new clinical entity,” Dr. Molloy and colleagues wrote. “Anchored to the patient’s persistent fever, the medical team initiated an extensive, costly, and ultimately unnecessary workup to avoid missing the diagnosis of MIS-C; a not yet well-described diagnosis with potentially severe morbidity.”
Confirmation bias and diagnostic momentum likely contributed to the early focus on MIS-C rather than more common alternatives, the authors acknowledged. The addition of mildly abnormal laboratory data not typically obtained in the evaluation of fever led the team astray. “The diagnosis and definitive treatment may have been made earlier had the focus on concern for MIS-C not been present,” Dr. Molloy said in an interview.
Keeping value in care
The authors recognized that their initial approach to evaluating for MIS-C provided low-value care. “In our desire to not ‘miss’ MIS-C, we were performing costly evaluations that at times produced mildly abnormal, nonspecific results,” they wrote. That triggered a cascade of specialty consultations, follow-up testing, and an unwarranted diagnostic preoccupation with MIS-C.
Determining the extra price tag for the child’s workup would be complex and difficult because there is a difference in the cost to the hospital and the cost to the family, Dr. Molloy said. “However, there are potential cost savings that would be related to making a correct diagnosis in a timely manner in terms of preventing downstream effects from delayed diagnoses.”
Even as clinicians struggle with the challenging SARS-CoV-2 learning curve, Dr. Molloy and associates urged them to continue to strive for high-value care, with an unwavering focus on using only necessary resources, a stewardship the pandemic has shown to be critical.
“The COVID-19 pandemic has been an incredibly stressful time for physicians and for families,” Dr. Molloy said. “COVID-19 and related conditions like MIS-C are new, and we are learning more and more about them every week. These diagnoses are understandably on the minds of physicians and families when children present with fever.” Notwithstanding, the boy’s case underscores the need for clinicians to consider alternate diagnoses and the value of the care provided.
Impact of bias
Dr. Molloy’s group brings home the cognitive biases practitioners often suffer from, including anchoring and confirmation bias and diagnostic momentum, according to J. Howard Smart, MD, chief of pediatrics at Sharp Mary Birch Hospital for Women and Newborns, San Diego, and an assistant clinical professor of pediatrics at University of California, San Diego.
“But it is one thing to recognize these in retrospect and quite another to consider whether they may be happening to you yourself in real time,” he said in an interview. “It is almost as if we need to have a ‘time out,’ where we stop and ask ourselves whether there is something else that could be explaining our patient’s presentation, something that would be more common and more likely to be occurring.”
According to Dr. Smart, who was not involved in Dr. Molloy’s study, the team’s premature diagnostic focus on MIS-C was almost the inverse of what typically happens with KD. “It is usually the case that Kawasaki disease does not enter the differential diagnosis until late in the course of the fever, typically on day 5 or later, when it may have been better to think of it earlier,” he said.
In the second article, Andrea Dean, MD, of the department of pediatrics at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, and colleagues outlined the cases of five patients aged 8-17 years who were hospitalized in May 2020 for suspected MIS-C. They exhibited inflammatory and other concerning indicators but were eventually discharged with a diagnosis of murine typhus.
This flea-borne infection, most commonly reported in the United States in the southeastern Gulf Coast region, Hawaii, and California, is often associated with a triad of fever, rash, and headache.
Cases have been rising in southern Texas, and Dr. Dean and colleagues postulated that school closures and social distancing may have increased exposure as a result of children spending more time outdoors or with pets. “Alternatively, parental concern for SARS-CoV-2 infection could mean children with symptoms are presenting to care and being referred or admitted to the hospital more frequently due to provider concern for MIS-C,” they wrote.
Cardiac involvement
The most concerning of the five cases in terms of possible MIS-C, Dr. Dean said in an interview, was that of a 12-year-old boy who had fever for 6 days in association with headache, eczematous rash, dry lips, and conjunctivitis. Laboratory tests showed a mildly elevated C-reactive protein level, hyponatremia, and thrombocytopenia, as well as sterile pyuria and mildly elevated prothrombin time. He was treated empirically with doxycycline, and his fever resolved over the next 24 hours.
An echocardiogram at initial evaluation, however, revealed mild dilation of the left anterior descending and right coronary arteries, which led to the administration of intravenous immunoglobulin and aspirin for atypical KD, in contrast to MIS-C. The authors postulated that mild cardiac involvement in disorders other than MIS-C and KD may be underrecognized.
The lesson from these cases, Dr. Dean and associates concluded, is that hospitalists must maintain a wide differential diagnosis when assessing a child with prolonged fever and evidence of systemic inflammation. The CDC stipulates that a diagnosis of MIS-C requires the absence of a plausible alternative diagnosis.
In addition to common viral, bacterial, and noninfectious disorders, a range of regional endemic rickettsial and parasitic infections must be considered as alternative diagnoses to MIS-C. “Many of these diseases cannot be reliably differentiated from MIS-C on presentation, and as community exposure to SARS-CoV-2 grows, hospitalists should be prepared to admit febrile children with evidence of systemic inflammation for brief observation periods to evaluate for MIS-C,” Dr. Dean’s group wrote. In this context, however, empiric treatment for common or even uncommon infectious diseases may avoid overdiagnosis and overtreatment of MIS-C as well as improve patient outcomes.
“We do have specific MIS-C guidelines at our institution,” Dr. Dean said, “but like all institutions, we are dealing with the broad definition of MIS-C according to the World Health Organization and the CDC, which is really the takeaway from this paper.”
More difficult differentiation
Both groups of authors pointed out that, as SARS-CoV-2 spreads throughout a community, a higher percentage of the population will have positive results on antibody testing, and such results will become less useful for differentiating between MIS-C and other conditions.
Despite these series’ cautionary lessons, other experts point to the critical importance of including MIS-C early on in the interest of efficient diagnosis and therapy. “In the cases cited, other pathologies were evaluated for and treated accordingly,” said Kara Gross Margolis, MD, AGAF, an associate professor of pediatrics in the division of pediatric gastroenterology, hepatology, and nutrition at Morgan Stanley Children’s Hospital,New York. “These papers stress the need for a balance that is important, and all potential diagnoses need to be considered, but MIS-C, due to its potential severe consequences, also needs to be on our differential now.”
In her view, as this new high-morbidity entity becomes more widespread during the pandemic, it will be increasingly important to keep this condition on the diagnostic radar.
Interestingly, in a converse example of diagnostic clouding, Dr. Gross Margolis’s group reported (Gastroenterology. 2020 Oct;159[4]:1571-4.e2) last year on a pediatric case series in which the presence of gastrointestinal symptoms in children with COVID-19–related MIS-C muddied the diagnosis by confusing this potentially severe syndrome with more common and less toxic gastrointestinal infections.
According to Dr. Smart, although the two reports don’t offer evidence for a particular diagnostic practice, they can inform the decision-making process. “It may be that we will have enough evidence shortly to say what the best practice is regarding diagnostic evaluation of possible MIS-C cases,” he said. “Until then, we must remember that common things occur commonly, even during a global pandemic.”
Neither of the two reports received any specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The emergence of multiple inflammatory syndrome in children (MIS-C) in association with COVID-19 may be complicating the investigation and diagnosis of more common viral and bacterial infections, potentially delaying treatment and prolonging hospital stays.
Two recent articles published online in Hospital Pediatrics provide evidence of this phenomenon. The articles outlined case studies of children who underwent extensive investigation for MIS-C when in fact they had less severe and more common infections. MIS-C is a severe but rare syndrome that involves systemic hyperinflammation with fever and multisystem organ dysfunction similar to that of Kawasaki disease (KD).
In one of the articles, Matthew Molloy, MD, MPH, of the division of pediatric hospital medicine at Cincinnati Children’s Hospital Medical Center, and colleagues aptly asked: “What are we missing in our search for MIS-C?”
E. coli, not SARS-CoV-2
That question arose from a case involving a 3-year-old boy who had a 6-day history of fever and fatigue. Three days earlier, he had tested negative for strep antigen and COVID-19. He had a persistent, high fever, reduced appetite, and reduced urine output and was taken to the ED. On physical examination, there was no rash, skin peeling, redness of the eye or oral mucosa, congestion, rhinorrhea, cough, shortness of breath, chest pain, abdominal pain, nausea, vomiting, or diarrhea.
Urinalysis results and exam findings were suspicious for pyelonephritis. Other findings from an extensive laboratory workup raised the alarm that the boy was suffering from MIS-C as opposed to incomplete KD. After admission to hospital medicine, the cardiology, rheumatology, and infectious disease teams were called in to consult.
Repeat labs were planned for the following day before initiating therapy. On day 2, the child’s urine culture was positive for gram-negative rods, later identified as Escherichia coli. The boy was started on ceftriaxone. Left renal scarring was apparent on ultrasound. The patient’s condition resolved after 36 hours, and he was discharged home with antibiotics.
‘Diagnosis derailed’
Calling this a case of “diagnosis derailed,” the authors noted that, in the pre-COVID era, this child’s signs and symptoms would likely have triggered a more targeted and less costly evaluation for more common infectious and noninfectious causes, including pyelonephritis, absent any physical exam findings consistent with KD.
“However, the patient presented in the midst of the COVID-19 pandemic with growing awareness of a new clinical entity,” Dr. Molloy and colleagues wrote. “Anchored to the patient’s persistent fever, the medical team initiated an extensive, costly, and ultimately unnecessary workup to avoid missing the diagnosis of MIS-C; a not yet well-described diagnosis with potentially severe morbidity.”
Confirmation bias and diagnostic momentum likely contributed to the early focus on MIS-C rather than more common alternatives, the authors acknowledged. The addition of mildly abnormal laboratory data not typically obtained in the evaluation of fever led the team astray. “The diagnosis and definitive treatment may have been made earlier had the focus on concern for MIS-C not been present,” Dr. Molloy said in an interview.
Keeping value in care
The authors recognized that their initial approach to evaluating for MIS-C provided low-value care. “In our desire to not ‘miss’ MIS-C, we were performing costly evaluations that at times produced mildly abnormal, nonspecific results,” they wrote. That triggered a cascade of specialty consultations, follow-up testing, and an unwarranted diagnostic preoccupation with MIS-C.
Determining the extra price tag for the child’s workup would be complex and difficult because there is a difference in the cost to the hospital and the cost to the family, Dr. Molloy said. “However, there are potential cost savings that would be related to making a correct diagnosis in a timely manner in terms of preventing downstream effects from delayed diagnoses.”
Even as clinicians struggle with the challenging SARS-CoV-2 learning curve, Dr. Molloy and associates urged them to continue to strive for high-value care, with an unwavering focus on using only necessary resources, a stewardship the pandemic has shown to be critical.
“The COVID-19 pandemic has been an incredibly stressful time for physicians and for families,” Dr. Molloy said. “COVID-19 and related conditions like MIS-C are new, and we are learning more and more about them every week. These diagnoses are understandably on the minds of physicians and families when children present with fever.” Notwithstanding, the boy’s case underscores the need for clinicians to consider alternate diagnoses and the value of the care provided.
Impact of bias
Dr. Molloy’s group brings home the cognitive biases practitioners often suffer from, including anchoring and confirmation bias and diagnostic momentum, according to J. Howard Smart, MD, chief of pediatrics at Sharp Mary Birch Hospital for Women and Newborns, San Diego, and an assistant clinical professor of pediatrics at University of California, San Diego.
“But it is one thing to recognize these in retrospect and quite another to consider whether they may be happening to you yourself in real time,” he said in an interview. “It is almost as if we need to have a ‘time out,’ where we stop and ask ourselves whether there is something else that could be explaining our patient’s presentation, something that would be more common and more likely to be occurring.”
According to Dr. Smart, who was not involved in Dr. Molloy’s study, the team’s premature diagnostic focus on MIS-C was almost the inverse of what typically happens with KD. “It is usually the case that Kawasaki disease does not enter the differential diagnosis until late in the course of the fever, typically on day 5 or later, when it may have been better to think of it earlier,” he said.
In the second article, Andrea Dean, MD, of the department of pediatrics at Baylor College of Medicine and Texas Children’s Hospital, both in Houston, and colleagues outlined the cases of five patients aged 8-17 years who were hospitalized in May 2020 for suspected MIS-C. They exhibited inflammatory and other concerning indicators but were eventually discharged with a diagnosis of murine typhus.
This flea-borne infection, most commonly reported in the United States in the southeastern Gulf Coast region, Hawaii, and California, is often associated with a triad of fever, rash, and headache.
Cases have been rising in southern Texas, and Dr. Dean and colleagues postulated that school closures and social distancing may have increased exposure as a result of children spending more time outdoors or with pets. “Alternatively, parental concern for SARS-CoV-2 infection could mean children with symptoms are presenting to care and being referred or admitted to the hospital more frequently due to provider concern for MIS-C,” they wrote.
Cardiac involvement
The most concerning of the five cases in terms of possible MIS-C, Dr. Dean said in an interview, was that of a 12-year-old boy who had fever for 6 days in association with headache, eczematous rash, dry lips, and conjunctivitis. Laboratory tests showed a mildly elevated C-reactive protein level, hyponatremia, and thrombocytopenia, as well as sterile pyuria and mildly elevated prothrombin time. He was treated empirically with doxycycline, and his fever resolved over the next 24 hours.
An echocardiogram at initial evaluation, however, revealed mild dilation of the left anterior descending and right coronary arteries, which led to the administration of intravenous immunoglobulin and aspirin for atypical KD, in contrast to MIS-C. The authors postulated that mild cardiac involvement in disorders other than MIS-C and KD may be underrecognized.
The lesson from these cases, Dr. Dean and associates concluded, is that hospitalists must maintain a wide differential diagnosis when assessing a child with prolonged fever and evidence of systemic inflammation. The CDC stipulates that a diagnosis of MIS-C requires the absence of a plausible alternative diagnosis.
In addition to common viral, bacterial, and noninfectious disorders, a range of regional endemic rickettsial and parasitic infections must be considered as alternative diagnoses to MIS-C. “Many of these diseases cannot be reliably differentiated from MIS-C on presentation, and as community exposure to SARS-CoV-2 grows, hospitalists should be prepared to admit febrile children with evidence of systemic inflammation for brief observation periods to evaluate for MIS-C,” Dr. Dean’s group wrote. In this context, however, empiric treatment for common or even uncommon infectious diseases may avoid overdiagnosis and overtreatment of MIS-C as well as improve patient outcomes.
“We do have specific MIS-C guidelines at our institution,” Dr. Dean said, “but like all institutions, we are dealing with the broad definition of MIS-C according to the World Health Organization and the CDC, which is really the takeaway from this paper.”
More difficult differentiation
Both groups of authors pointed out that, as SARS-CoV-2 spreads throughout a community, a higher percentage of the population will have positive results on antibody testing, and such results will become less useful for differentiating between MIS-C and other conditions.
Despite these series’ cautionary lessons, other experts point to the critical importance of including MIS-C early on in the interest of efficient diagnosis and therapy. “In the cases cited, other pathologies were evaluated for and treated accordingly,” said Kara Gross Margolis, MD, AGAF, an associate professor of pediatrics in the division of pediatric gastroenterology, hepatology, and nutrition at Morgan Stanley Children’s Hospital,New York. “These papers stress the need for a balance that is important, and all potential diagnoses need to be considered, but MIS-C, due to its potential severe consequences, also needs to be on our differential now.”
In her view, as this new high-morbidity entity becomes more widespread during the pandemic, it will be increasingly important to keep this condition on the diagnostic radar.
Interestingly, in a converse example of diagnostic clouding, Dr. Gross Margolis’s group reported (Gastroenterology. 2020 Oct;159[4]:1571-4.e2) last year on a pediatric case series in which the presence of gastrointestinal symptoms in children with COVID-19–related MIS-C muddied the diagnosis by confusing this potentially severe syndrome with more common and less toxic gastrointestinal infections.
According to Dr. Smart, although the two reports don’t offer evidence for a particular diagnostic practice, they can inform the decision-making process. “It may be that we will have enough evidence shortly to say what the best practice is regarding diagnostic evaluation of possible MIS-C cases,” he said. “Until then, we must remember that common things occur commonly, even during a global pandemic.”
Neither of the two reports received any specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SARS-CoV-2 in hospitalized children and youth
Clinical syndromes and predictors of disease severity
Clinical questions: What are the demographics and clinical features of pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) syndromes, and which admitting demographics and clinical features are predictive of disease severity?
Background: In children, SARS-CoV-2 causes respiratory disease and multisystem inflammatory syndrome in children (MIS-C) as well as other clinical manifestations. The authors of this study chose to address the gap of identifying characteristics for severe disease caused by SARS-CoV-2, including respiratory disease, MIS-C and other manifestations.
Study design: Retrospective and prospective cohort analysis of hospitalized children
Setting: Participating hospitals in Tri-State Pediatric COVID-19 Consortium, including hospitals in New York, New Jersey, and Connecticut.
Synopsis: The authors identified hospitalized patients 22 years old or younger who had a positive SARS-CoV-2 test or met the U.S. Centers for Disease Control and Preventions’ MIS-C case definition. For comparative analysis, patients were divided into a respiratory disease group (based on the World Health Organization’s criteria for COVID-19), MIS-C group or other group (based on the primary reason for hospitalization).
The authors included 281 patients in the study. 51% of the patients presented with respiratory disease, 25% with MIS-C and 25% with other symptoms, including gastrointestinal, or fever. 51% of all patients were Hispanic and 23% were non-Black Hispanic. The most common pre-existing comorbidities amongst all groups were obesity (34%) and asthma (14%).
Patients with respiratory disease had a median age of 14 years while those with MIS-C had a median age of 7 years. Patients more commonly identified as non-Hispanic Black in the MIS-C group vs the respiratory group (35% vs. 18%). Obesity and medical complexity were more prevalent in the respiratory group relative to the MIS-C group. 75% of patients with MIS-C had gastrointestinal symptoms. 44% of respiratory patients had a chest radiograph with bilateral infiltrates on admission, and 18% or respiratory patients required invasive mechanical ventilation. The most common complications in the respiratory group were acute respiratory distress syndrome (17%) and acute kidney injury (11%), whereas shock (35%) and cardiac dysfunction (25%) were the most common complications in the MIS-C group. The median length of stay for all patients was 4 days (IQR 2-8 days).
Patients with MIS-C were more likely to be admitted to the intensive care unit (ICU) but all deaths (7 patients) occurred in the respiratory group. 40% of patients with respiratory disease, 56% of patients with MIS-C, and 6% of other patients met the authors’ definition of severe disease (ICU admission > 48 hours). For the respiratory group, younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph were independent predictors of severe disease based on multivariate analyses. For the MIS-C group, lower absolute lymphocyte count and increasing CRP at admission were independent predictors of severity.
Bottom line: Mortality in pediatric patients is low. Ethnicity and race were not predictive of disease severity in this model, even though 51% of the patients studied were Hispanic and 23% were non-Hispanic Black. Severity of illness for patients with respiratory disease was found to be associated with younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph. Severity of illness in patients with MIS-C was associated with lower absolute lymphocyte count and increasing CRP.
Citation: Fernandes DM, et al. Severe acute respiratory syndrome coronavirus 2 clinical syndromes and predictors of disease severity in hospitalized children and youth. J Pediatr. 2020 Nov 14;S0022-3476(20):31393-7. DOI: 10.1016/j.jpeds.2020.11.016.
Dr. Kumar is an assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
Clinical syndromes and predictors of disease severity
Clinical syndromes and predictors of disease severity
Clinical questions: What are the demographics and clinical features of pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) syndromes, and which admitting demographics and clinical features are predictive of disease severity?
Background: In children, SARS-CoV-2 causes respiratory disease and multisystem inflammatory syndrome in children (MIS-C) as well as other clinical manifestations. The authors of this study chose to address the gap of identifying characteristics for severe disease caused by SARS-CoV-2, including respiratory disease, MIS-C and other manifestations.
Study design: Retrospective and prospective cohort analysis of hospitalized children
Setting: Participating hospitals in Tri-State Pediatric COVID-19 Consortium, including hospitals in New York, New Jersey, and Connecticut.
Synopsis: The authors identified hospitalized patients 22 years old or younger who had a positive SARS-CoV-2 test or met the U.S. Centers for Disease Control and Preventions’ MIS-C case definition. For comparative analysis, patients were divided into a respiratory disease group (based on the World Health Organization’s criteria for COVID-19), MIS-C group or other group (based on the primary reason for hospitalization).
The authors included 281 patients in the study. 51% of the patients presented with respiratory disease, 25% with MIS-C and 25% with other symptoms, including gastrointestinal, or fever. 51% of all patients were Hispanic and 23% were non-Black Hispanic. The most common pre-existing comorbidities amongst all groups were obesity (34%) and asthma (14%).
Patients with respiratory disease had a median age of 14 years while those with MIS-C had a median age of 7 years. Patients more commonly identified as non-Hispanic Black in the MIS-C group vs the respiratory group (35% vs. 18%). Obesity and medical complexity were more prevalent in the respiratory group relative to the MIS-C group. 75% of patients with MIS-C had gastrointestinal symptoms. 44% of respiratory patients had a chest radiograph with bilateral infiltrates on admission, and 18% or respiratory patients required invasive mechanical ventilation. The most common complications in the respiratory group were acute respiratory distress syndrome (17%) and acute kidney injury (11%), whereas shock (35%) and cardiac dysfunction (25%) were the most common complications in the MIS-C group. The median length of stay for all patients was 4 days (IQR 2-8 days).
Patients with MIS-C were more likely to be admitted to the intensive care unit (ICU) but all deaths (7 patients) occurred in the respiratory group. 40% of patients with respiratory disease, 56% of patients with MIS-C, and 6% of other patients met the authors’ definition of severe disease (ICU admission > 48 hours). For the respiratory group, younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph were independent predictors of severe disease based on multivariate analyses. For the MIS-C group, lower absolute lymphocyte count and increasing CRP at admission were independent predictors of severity.
Bottom line: Mortality in pediatric patients is low. Ethnicity and race were not predictive of disease severity in this model, even though 51% of the patients studied were Hispanic and 23% were non-Hispanic Black. Severity of illness for patients with respiratory disease was found to be associated with younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph. Severity of illness in patients with MIS-C was associated with lower absolute lymphocyte count and increasing CRP.
Citation: Fernandes DM, et al. Severe acute respiratory syndrome coronavirus 2 clinical syndromes and predictors of disease severity in hospitalized children and youth. J Pediatr. 2020 Nov 14;S0022-3476(20):31393-7. DOI: 10.1016/j.jpeds.2020.11.016.
Dr. Kumar is an assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
Clinical questions: What are the demographics and clinical features of pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) syndromes, and which admitting demographics and clinical features are predictive of disease severity?
Background: In children, SARS-CoV-2 causes respiratory disease and multisystem inflammatory syndrome in children (MIS-C) as well as other clinical manifestations. The authors of this study chose to address the gap of identifying characteristics for severe disease caused by SARS-CoV-2, including respiratory disease, MIS-C and other manifestations.
Study design: Retrospective and prospective cohort analysis of hospitalized children
Setting: Participating hospitals in Tri-State Pediatric COVID-19 Consortium, including hospitals in New York, New Jersey, and Connecticut.
Synopsis: The authors identified hospitalized patients 22 years old or younger who had a positive SARS-CoV-2 test or met the U.S. Centers for Disease Control and Preventions’ MIS-C case definition. For comparative analysis, patients were divided into a respiratory disease group (based on the World Health Organization’s criteria for COVID-19), MIS-C group or other group (based on the primary reason for hospitalization).
The authors included 281 patients in the study. 51% of the patients presented with respiratory disease, 25% with MIS-C and 25% with other symptoms, including gastrointestinal, or fever. 51% of all patients were Hispanic and 23% were non-Black Hispanic. The most common pre-existing comorbidities amongst all groups were obesity (34%) and asthma (14%).
Patients with respiratory disease had a median age of 14 years while those with MIS-C had a median age of 7 years. Patients more commonly identified as non-Hispanic Black in the MIS-C group vs the respiratory group (35% vs. 18%). Obesity and medical complexity were more prevalent in the respiratory group relative to the MIS-C group. 75% of patients with MIS-C had gastrointestinal symptoms. 44% of respiratory patients had a chest radiograph with bilateral infiltrates on admission, and 18% or respiratory patients required invasive mechanical ventilation. The most common complications in the respiratory group were acute respiratory distress syndrome (17%) and acute kidney injury (11%), whereas shock (35%) and cardiac dysfunction (25%) were the most common complications in the MIS-C group. The median length of stay for all patients was 4 days (IQR 2-8 days).
Patients with MIS-C were more likely to be admitted to the intensive care unit (ICU) but all deaths (7 patients) occurred in the respiratory group. 40% of patients with respiratory disease, 56% of patients with MIS-C, and 6% of other patients met the authors’ definition of severe disease (ICU admission > 48 hours). For the respiratory group, younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph were independent predictors of severe disease based on multivariate analyses. For the MIS-C group, lower absolute lymphocyte count and increasing CRP at admission were independent predictors of severity.
Bottom line: Mortality in pediatric patients is low. Ethnicity and race were not predictive of disease severity in this model, even though 51% of the patients studied were Hispanic and 23% were non-Hispanic Black. Severity of illness for patients with respiratory disease was found to be associated with younger age, obesity, increasing white blood cell count, hypoxia, and bilateral infiltrates on chest radiograph. Severity of illness in patients with MIS-C was associated with lower absolute lymphocyte count and increasing CRP.
Citation: Fernandes DM, et al. Severe acute respiratory syndrome coronavirus 2 clinical syndromes and predictors of disease severity in hospitalized children and youth. J Pediatr. 2020 Nov 14;S0022-3476(20):31393-7. DOI: 10.1016/j.jpeds.2020.11.016.
Dr. Kumar is an assistant professor of pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and a pediatric hospitalist at Cleveland Clinic Children’s. She is the pediatric editor of The Hospitalist.
FROM THE JOURNAL OF PEDIATRICS
Mask mandates reduced COVID-19 hospitalizations
States that implemented mask mandates in 2020 saw a decline in the growth of COVID-19 hospitalizations between March and October 2020, according to a new study published Feb. 5 in the CDC’s Morbidity and Mortality Weekly Report.
Hospitalization growth rates declined by 5.5 percentage points for adults between ages 18-64 about 3 weeks after the mandates were implemented, compared with climbing growth rates in the 4 weeks before mandates.
CDC Director Rochelle Walensky said she was pleased to see the results, but that it’s “too early” to tell whether President Joe Biden’s recent mask orders have had an effect on cases and hospitalizations in 2021.
“We’re going to be watching the mask data very carefully,” she said during a news briefing with the White House COVID-19 Response Team on Feb. 5. “I think it’s probably still a bit too early to tell, but I’m encouraged with the decrease in case rates right now.”
In another study published Feb. 5 in the Morbidity and Mortality Weekly Report, trained observers tracked mask use at six universities with mask mandates between September and November 2020. Overall, observers reported that about 92% of people wore masks correctly indoors, which varied based on the type of mask.
About 97% of people used N95 masks correctly, compared with 92% who used cloth masks, and 79% who used bandanas, scarves, or neck gaiters. Cloth masks were most common, and bandanas and scarves were least common.
The Biden administration is considering whether to send masks directly to American households to encourage people to wear them, according to NBC News. The White House COVID-19 Response Team is debating the logistics of mailing out masks, including how many to send and what the mask material would be, the news outlet reported.
Wisconsin Gov. Tony Evers reissued a new statewide mask mandate on Feb. 4, just an hour after the Republican-controlled legislature voted to repeal his previous mandate, according to The Associated Press. Gov. Evers said his priority is to keep people safe and that wearing a mask is the easiest way to do so.
“If the legislature keeps playing politics and we don’t keep wearing masks, we’re going to see more preventable deaths,” he said. “It’s going to take even longer to get our state and our economy back on track.”
A version of this article first appeared on WebMD.com.
States that implemented mask mandates in 2020 saw a decline in the growth of COVID-19 hospitalizations between March and October 2020, according to a new study published Feb. 5 in the CDC’s Morbidity and Mortality Weekly Report.
Hospitalization growth rates declined by 5.5 percentage points for adults between ages 18-64 about 3 weeks after the mandates were implemented, compared with climbing growth rates in the 4 weeks before mandates.
CDC Director Rochelle Walensky said she was pleased to see the results, but that it’s “too early” to tell whether President Joe Biden’s recent mask orders have had an effect on cases and hospitalizations in 2021.
“We’re going to be watching the mask data very carefully,” she said during a news briefing with the White House COVID-19 Response Team on Feb. 5. “I think it’s probably still a bit too early to tell, but I’m encouraged with the decrease in case rates right now.”
In another study published Feb. 5 in the Morbidity and Mortality Weekly Report, trained observers tracked mask use at six universities with mask mandates between September and November 2020. Overall, observers reported that about 92% of people wore masks correctly indoors, which varied based on the type of mask.
About 97% of people used N95 masks correctly, compared with 92% who used cloth masks, and 79% who used bandanas, scarves, or neck gaiters. Cloth masks were most common, and bandanas and scarves were least common.
The Biden administration is considering whether to send masks directly to American households to encourage people to wear them, according to NBC News. The White House COVID-19 Response Team is debating the logistics of mailing out masks, including how many to send and what the mask material would be, the news outlet reported.
Wisconsin Gov. Tony Evers reissued a new statewide mask mandate on Feb. 4, just an hour after the Republican-controlled legislature voted to repeal his previous mandate, according to The Associated Press. Gov. Evers said his priority is to keep people safe and that wearing a mask is the easiest way to do so.
“If the legislature keeps playing politics and we don’t keep wearing masks, we’re going to see more preventable deaths,” he said. “It’s going to take even longer to get our state and our economy back on track.”
A version of this article first appeared on WebMD.com.
States that implemented mask mandates in 2020 saw a decline in the growth of COVID-19 hospitalizations between March and October 2020, according to a new study published Feb. 5 in the CDC’s Morbidity and Mortality Weekly Report.
Hospitalization growth rates declined by 5.5 percentage points for adults between ages 18-64 about 3 weeks after the mandates were implemented, compared with climbing growth rates in the 4 weeks before mandates.
CDC Director Rochelle Walensky said she was pleased to see the results, but that it’s “too early” to tell whether President Joe Biden’s recent mask orders have had an effect on cases and hospitalizations in 2021.
“We’re going to be watching the mask data very carefully,” she said during a news briefing with the White House COVID-19 Response Team on Feb. 5. “I think it’s probably still a bit too early to tell, but I’m encouraged with the decrease in case rates right now.”
In another study published Feb. 5 in the Morbidity and Mortality Weekly Report, trained observers tracked mask use at six universities with mask mandates between September and November 2020. Overall, observers reported that about 92% of people wore masks correctly indoors, which varied based on the type of mask.
About 97% of people used N95 masks correctly, compared with 92% who used cloth masks, and 79% who used bandanas, scarves, or neck gaiters. Cloth masks were most common, and bandanas and scarves were least common.
The Biden administration is considering whether to send masks directly to American households to encourage people to wear them, according to NBC News. The White House COVID-19 Response Team is debating the logistics of mailing out masks, including how many to send and what the mask material would be, the news outlet reported.
Wisconsin Gov. Tony Evers reissued a new statewide mask mandate on Feb. 4, just an hour after the Republican-controlled legislature voted to repeal his previous mandate, according to The Associated Press. Gov. Evers said his priority is to keep people safe and that wearing a mask is the easiest way to do so.
“If the legislature keeps playing politics and we don’t keep wearing masks, we’re going to see more preventable deaths,” he said. “It’s going to take even longer to get our state and our economy back on track.”
A version of this article first appeared on WebMD.com.
Children in ICU for COVID-19 likely to be older, Black, and asthmatic
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Little has been known about children sick enough with COVID-19 to require intensive care because such patients are relatively few, but preliminary data analyzed from a nationwide registry indicate that they are more likely to be older, to be Black, and to have asthma.
Gastrointestinal distress is also more common in children with severe COVID-19, according to research by Sandeep Tripathi, MD. Dr. Tripathi, a pediatric intensivist and associate professor at the University of Illinois at Peoria, presented the findings on Feb. 3 at the Society for Critical Care Medicine (SCCM) 2021 Critical Care Congress.
Registry data gathered from 49 sites
Results from the SCCM’s VIRUS: COVID-19 Registry, which involved data from 49 sites, included 181 children admitted to an intensive care unit between February and July 2020. Those in the ICU were older than patients who did not receive care in the ICU (10 years vs. 3.67 years; P < .01) and were more likely to be Black (28.8% vs. 17.8%; P = .02).
More of the patients who required intensive care had preexisting conditions (58.2% vs. 44.3%; P = .01), the most common of which was asthma.
For both the ICU patients and the non-ICU group, the most common presenting symptom was fever.
Symptoms that were more common among children needing ICU care included nausea/vomiting (38.4% vs. 22.1%; P < .01), dyspnea (31.8% vs. 17.7%; P < .01), and abdominal pain (25.2% vs. 14.1%; P < .01).
Significantly higher proportions of ICU patients had multisystem inflammatory syndrome of childhood (MIS-C) (44.2% vs. 6.8%; P < .01) and acute kidney injury (9.34% vs. 1.7%; P < .01).
“The children who presented with MIS-C tended to be much sicker than children who present with just COVID,” Dr. Tripathi said in an interview.
In this analysis, among children in ICUs with COVID, the mortality rate was 4%, Dr. Tripathi said.
He said he hopes the information, which will be periodically published with updated data, will raise awareness of which children might be likely to experience progression to severe disease.
“The information may help physicians be more mindful of deterioration in those patients and be more aggressive in their management,” he said. When children are brought to the emergency department with the features this analysis highlights, he said, “physicians should have a low threshold for treating or admitting the patients.”
Another study that was presented on Feb. 3 in parallel with the registry study described patterns of illness among 68 children hospitalized with COVID-19 in a tertiary-care pediatric center.
In that analysis, Meghana Nadiger, MD, a critical care fellow with Nicklaus Children’s Hospital in Miami, found that all patients admitted to the pediatric ICU (n = 17) had either MIS-C or severe illness and COVID-19-related Kawasaki-like disease.
The investigators also found that the patients with serious illness were more commonly adolescents with elevated body mass index (73%). In this study, 83.8% of the hospitalized children were Hispanic. They also found that 88.8% of the children older than 2 years who had been hospitalized with COVID-19 were overweight or obese, with a BMI >25 kg/m2.
Jerry Zimmerman, MD, PhD, SCCM’s immediate past president, said in an interview that he found it interesting that in the Nadiger study, “All of the children with severe illness had MIS-C as compared to adults, who typically are critically ill with severe acute respiratory distress syndrome.” Dr. Zimmerman was not involved in either study.
He said that although the high percentage of Hispanic patients in the hospitalized population may reflect the high percentage of Hispanic children in the Miami area, it may also reflect challenges of controlling the disease in the Hispanic community. Such challenges might include shortages of personal protective equipment, poorer access to health care, and difficulty in social distancing.
Dr. Zimmerman pointed out that obesity is an important risk factor for COVID-19 and that according to the Centers for Disease Control and Prevention, childhood obesity is much more common among Hispanics (25.8%) and non-Hispanic Blacks persons (22.0%) compared with non-Hispanic White persons (14.1%).
The VIRUS registry is funded in part by the Gordon and Betty Moore Foundation and Janssen Research and Development. Dr. Tripathi, Dr. Nadiger, and Dr. Zimmerman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA curbs use of COVID-19 convalescent plasma, citing new data
The Food and Drug Administration has revised its emergency use authorization for COVID-19 convalescent plasma on the basis of the latest available data.
The revision states that only high-titer COVID-19 convalescent plasma can be used and only in hospitalized patients who are early in the disease course and those with impaired humoral immunity who cannot produce an adequate antibody response.
The revisions stem from new clinical trial data analyzed or reported since the original EUA was issued in August 2020. The original EUA did not have these restrictions.
“This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing the revisions.
“COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its known and potential risks,” the FDA said.
The agency said it revoked use of low-titer COVID-19 convalescent plasma on the basis of new data from clinical trials, including randomized, controlled trials, that have failed to demonstrate that low-titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.
The FDA’s updated fact sheet for health care providers on the use of COVID-19 convalescent plasma also notes that transfusion of COVID-19 convalescent plasma late in the disease course, following respiratory failure requiring intubation and mechanical ventilation, hasn’t been found to have clinical benefit.
The revised EUA also includes several additional tests that can be used to manufacture COVID-19 convalescent plasma.
“With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release,” the FDA said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has revised its emergency use authorization for COVID-19 convalescent plasma on the basis of the latest available data.
The revision states that only high-titer COVID-19 convalescent plasma can be used and only in hospitalized patients who are early in the disease course and those with impaired humoral immunity who cannot produce an adequate antibody response.
The revisions stem from new clinical trial data analyzed or reported since the original EUA was issued in August 2020. The original EUA did not have these restrictions.
“This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing the revisions.
“COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its known and potential risks,” the FDA said.
The agency said it revoked use of low-titer COVID-19 convalescent plasma on the basis of new data from clinical trials, including randomized, controlled trials, that have failed to demonstrate that low-titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.
The FDA’s updated fact sheet for health care providers on the use of COVID-19 convalescent plasma also notes that transfusion of COVID-19 convalescent plasma late in the disease course, following respiratory failure requiring intubation and mechanical ventilation, hasn’t been found to have clinical benefit.
The revised EUA also includes several additional tests that can be used to manufacture COVID-19 convalescent plasma.
“With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release,” the FDA said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has revised its emergency use authorization for COVID-19 convalescent plasma on the basis of the latest available data.
The revision states that only high-titer COVID-19 convalescent plasma can be used and only in hospitalized patients who are early in the disease course and those with impaired humoral immunity who cannot produce an adequate antibody response.
The revisions stem from new clinical trial data analyzed or reported since the original EUA was issued in August 2020. The original EUA did not have these restrictions.
“This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing the revisions.
“COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its known and potential risks,” the FDA said.
The agency said it revoked use of low-titer COVID-19 convalescent plasma on the basis of new data from clinical trials, including randomized, controlled trials, that have failed to demonstrate that low-titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.
The FDA’s updated fact sheet for health care providers on the use of COVID-19 convalescent plasma also notes that transfusion of COVID-19 convalescent plasma late in the disease course, following respiratory failure requiring intubation and mechanical ventilation, hasn’t been found to have clinical benefit.
The revised EUA also includes several additional tests that can be used to manufacture COVID-19 convalescent plasma.
“With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release,” the FDA said.
A version of this article first appeared on Medscape.com.
The journey from burnout to wellbeing
A check-in for you and your peers
COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.
In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.
The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:
- Provide a framework for hospitalists to take their own emotional pulse
- Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress
While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:
- Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
- Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.
To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.
Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.
Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:
- Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
- Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
- Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.
Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”
The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.
Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.
A check-in for you and your peers
A check-in for you and your peers
COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.
In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.
The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:
- Provide a framework for hospitalists to take their own emotional pulse
- Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress
While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:
- Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
- Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.
To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.
Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.
Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:
- Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
- Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
- Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.
Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”
The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.
Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.
COVID-19 did not discriminate when it came to the impact it imposed on our hospitalist community. As the nomenclature moves away from the negative connotations of ‘burnout’ to ‘wellbeing,’ the pandemic has taught us something important about being intentional about our personal health: we must secure our own oxygen masks before helping others.
In February 2020, the Society of Hospital Medicine’s Wellbeing Taskforce efforts quickly changed focus from addressing general wellbeing, to wellbeing during COVID-19. Our Taskforce was commissioned by SHM’s Board with a new charge: Address immediate and ongoing needs of well-being and resiliency support for hospitalists during the COVID-19 pandemic. In this essay, I will discuss how our SHM Wellbeing Taskforce approached the overall topic of wellbeing for hospitalists during the COVID-19 pandemic, including some of our Taskforce group experiences.
The Taskforce started with a framework to aide in cultivating open and authentic conversations within hospital medicine groups. Creating spaces for honest sharing around how providers are doing is a crucial first step to reducing stigma, building mutual support within a group, and elevating issues of wellbeing to the level where structural change can take place. The Taskforce established two objectives for normalizing and mitigating stressors we face as hospitalists during the COVID-19 pandemic:
- Provide a framework for hospitalists to take their own emotional pulse
- Provide an approach to reduce stigma of hospitalists who are suffering from pandemic stress
While a more typical approach to fix stress and burnout is using formal institutional interventions, we used the value and insight provided by SHM’s 7 Drivers of Burnout in Hospital Medicine to help guide the creation of SHM resources in addressing the severe emotional strain being felt across the country by hospitalists. The 7 Drivers support the idea that the social role peers and hospital leaders can make a crucial difference in mitigating stress and burnout. Two examples of social support come to mind from the Wellbeing Taskforce experience:
- Participate in your meetings. One example comes from a member of our group who had underestimated the “healing power” that our group meetings had provided to his psyche. The simple act of participating in our Taskforce meeting and being in the presence of our group had provided such a positive impact that he was better able to face the “death and misery” in his unit with a smile on his face.
- Share what is stressful. The second example of social support comes from an hour of Zoom-based facilitation meetings between the SHM’s Wellbeing Taskforce members and Chapter Leaders in late October. During our Taskforce debrief after the meeting, we came to realize the enormous burden of grief our peers were carrying as one hospitalist had lost a group colleague the previous week due to suicide. Our member who led this meeting was moved – as were we – at how this had impacted his small team, and he was reminded he was not alone.
To form meaningful relationships that foster support, there needs to be a space where people can safely come together at times that initially might feel awkward. After taking steps toward your peers, these conversations can become normalized and contribute to meaningful relationships, providing the opportunity for healthy exchanges on vulnerable topics like emotional and psychological wellbeing. A printable guide for this specific purpose (“HM COVID-19 Check-In Guide for Self and Peers”) was designed to help hospitalists move into safe and supportive conversations with each other. While it is difficult to place a value on the importance these types of conversations have on individual wellbeing, it is known that the quality of a positive work environment where people feel supported can moderate stress, morale, and depression. In other words, hospitalist groups can positively contribute to their social environment during stressful times by sharing meaningful and difficult experiences with one another.
Second, the Taskforce created a social media campaign to provide a public social space for sharing hospitalists’ COVID-19 experiences. We believed that sharing collective experiences with the theme of #YouAreNotAlone and a complementary social media campaign, SHM Cares, on SHM’s social media channels, would further connect the national hospitalist community and provide a different communication pathway to decrease a sense of isolation. This idea came from the second social support idea mentioned earlier to share what is stressful with others in a safe space. We understood that some hospitalists would be more comfortable sharing publicly their comments, photos, and videos in achieving a sense of hospitalist unity.
Using our shared experiences, we identified three pillars for the final structure of the HM COVID-19 Check-In Guide for Self and Peers:
- Pillar 1. Recognize your issues. Recall our oxygen mask metaphor and this is what we mean by recognizing symptoms of new stressors (e.g., sleeplessness, irritability, forgetfulness).
- Pillar 2. Know what to say. A simple open-ended question about how the other person is working through the pandemic is an easy way to start a connection. We learned from a mental health perspective that it is unlikely that you could say anything to make a situation worse by offering a listening ear.
- Pillar 3. Check in with others. Listen to others without trying to fix the person or the situation. When appropriate, offer humorous reflections without diminishing the problem. Be a partner and commit to check in regularly with the other person.
Cultivating human connections outside of your immediate peer group can be valuable and offer additional perspective to stressful situations. For instance, one of my roles as a hospitalist administrator has been offering support by regularly listening as my physicians ‘talk out’ their day confidentially for as long as they needed. Offering open conversation in a safe and confidential way can have a healing effect. As one of my former hospitalists used to say, if issues are not addressed, they will “ooze out somewhere else.”
The HM COVID-19 Check-In Guide for Self and Peers and the SHM Cares social media campaign was the result of the Taskforce’s collective observations to help others normalize the feeling that ‘it’s OK not to be OK.’ Using the pandemic as context, the 7 Drivers of Hospitalist Burnout reminded us that the increased burnout issues we face will require continued attention past the pandemic. The value in cultivating human connections has never been more important. The SHM Wellbeing Taskforce is committed to provide continued resources. Checking in with others and listening to peers are all part of a personal wellbeing and resilience strategy. On behalf of the SHM Wellbeing Taskforce, we hope the information in this article will highlight the importance of continued attention to personal wellbeing during and after the pandemic.
Dr. Robinson received her PhD in organizational learning, performance and change from Colorado State University in 2019. Her dissertation topic was exploring hospitalist burnout, engagement, and social support. She is administrative director of inpatient medicine at St. Mary’s Medical Center in Grand Junction, Colo., a part of SCL Health. She has volunteered in numerous SHM committees, and currently serves on the SHM Wellbeing Taskforce.
Rollout of COVID-19 monoclonal antibodies lacked unified plan: expert panel
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.
Monoclonal antibodies (mAbs) to treat COVID-19 are in ample supply, but scant evidence on their effectiveness, paltry reimbursement, and a lack of a planned infrastructure to administer them has led to major underutilization of these potentially useful therapies, according to a new report from The National Academies of Sciences, Engineering, and Medicine.
The 35-page report described missed opportunities to work with states and hospitals to establish trust with clinicians and patients and to set up an infusion infrastructure to funnel patients to sites. Though the therapies still need more study, they should be an option for the right patient at the right time, said the National Academies experts in their report, Rapid Expert Consultation on Allocating COVID-19 Monoclonal Antibody Therapies and Other Novel Therapeutics.
“No potentially eligible patient should be left uninformed, and no eligible patient should be denied access, if there are doses available and the patient and doctor agree it is a reasonable course,” they concluded. The report also noted that underuse, and in particular underuse by members of vulnerable and underserved communities “raises concerns about exacerbating already dramatic health disparities.”
The federal government has spent $375 million on Eli Lilly’s bamlanivimab and $450 million on Regeneron’s casirivimab plus imdevimab cocktail, and agreed last month to spend as much as $2.6 billion more on up to 1.25 million additional doses.
Some 785,000 doses of the two therapeutics have been produced and about a half million have been distributed to states. But about three quarters have gone unused. The U.S. Department of Health & Human Services has launched an online treatment locater to try to spur interest in the therapies.
But the federal government hasn’t addressed some of the basic barriers to use of the monoclonals, said the National Academies experts.
“Lack of awareness, interest, and confidence in COVID-19 mAb therapies among patients and providers are major issues,” they said in the report. Patients who have tested positive might not want to travel to an infusion site, while others might not have access to health care or only seek such treatments when it’s too late. Some who are eligible might not have the time, resources, or transportation to go to a site and sit through a 2-hour treatment.
In addition, “the supply and availability of infusion centers and personnel was identified as a greater constraint than the supply of COVID-19 mAbs,” said the report.
Cost a big impediment
While the federal government has covered the cost of the therapies, hospitals and patients inevitably incur related costs.
“The fragmented payment system in the United States has not provided adequate support to cover the spectrum of costs associated with COVID-19 mAb therapies,” said the report. That is compounded by chronic underfunding and restrictions on federally qualified health centers for community health, the report said.
Patients may have to pay for testing, office visits, follow-up appointments, transportation to and from the infusion site, and potentially a copay for the administration of the drug.
While Medicare pays hospitals $309 per infusion, that might not be enough, especially if a hospital or other site had to build out a new infusion center, the report shows. For clinicians, the administrative payment under Medicare Part B does “not cover the total practice cost to furnish infusion services, resulting in a substantial cost-reimbursement disparity,” the report states.
In addition, there are no specific codes for observing patients during the 2-hour procedure.
“The established Medicare payment rate for furnishing COVID-19 mAb therapies does not cover the cost associated with coordinating care for those patients, nor does it justify the risk and opportunity costs associated with investing in infrastructure modifications to safely integrate COVID-19 patients into existing facilities or building temporary infusion capacity,” the report concluded.
More data needed
The U.S. Food and Drug Administration issued emergency-use authorizations (EUAs) for the two monoclonal therapies based on phase 2 trial data, and that leaves a lot of uncertainty, noted the National Academies.
In trials, both therapies reduced COVID-19-related hospitalizations and emergency room visits within 28 days after treatment among patients at high risk of progression, compared with those who received placebo.
But clinicians aren’t certain about who should use the monoclonals, said the report. The underuse has in turn led to trouble collecting data – either through ongoing trials or in starting new trials.
The National Academies recommended allocating the monoclonal antibodies in a way that would give rise to better data collection to inform clinicians. Payers could support the development of a core data platform or registry, or Medicare could develop pilot trials, said the report.
Lilly and UnitedHealth Group are collaborating on a study in high-risk Medicare patients, according to Reuters. Patients who test positive will be given bamlanivimab at home.
“Building infusion capacity and developing the evidence base about the impact of COVID-19 mAbs on clinical outcomes other than hospitalization, including mortality, are the most promising strategies for increasing effective utilization moving forward,” stated the National Academies report.
A version of this article first appeared on Medscape.com.
Cardiac activity not uncommon after lifesaving measures stop
Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.
Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.
“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.
“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”
About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.
Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.
The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.
As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.
A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.
The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.
Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.
In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.
“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”
In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”
The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.
“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”
He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.
“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”
Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.
“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”
The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.
Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.
“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.
“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”
About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.
Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.
The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.
As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.
A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.
The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.
Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.
In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.
“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”
In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”
The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.
“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”
He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.
“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”
Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.
“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”
The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Among critically ill patients pulseless after planned withdrawal of life-sustaining therapies, cardiac activity restarted in 14% of cases, research shows.
Reassuringly, most resumption of heart activity happened in the first 1-2 minutes and most lasted 1 or 2 seconds.
“The reason we wanted to look at death determination specifically is we know that the stories persist about people coming back to life following death, and that’s not just in the public, it’s in the medical community as well,” lead author Sonny Dhanani, MD, of Children’s Hospital of Eastern Ontario, Ottawa, said in an interview.
“We thought that if we provided scientific evidence of whether this happened or not, we might dispel some myths and misunderstanding, which would hopefully promote organ donation.”
About 70% of organ donations occur after brain death, but an increasing number follow circulatory determination of death, he noted. Most protocols recommend 5 minutes of apnea and pulselessness by arterial catheter monitor before declaring death. But practices vary from 10 minutes in some European countries to 75 seconds in infant heart donors at one Colorado hospital.
Reports of patients recovering 10 minutes after pulselessness have raised concerns about the Lazarus phenomenon, or autoresuscitation, but are based in patients after cardiopulmonary resuscitation was terminated.
The present study, known as Death Prediction and Physiology after Removal of Therapy (DePParRT), enrolled patients at 20 intensive care sites in Canada, the Czech Republic, and the Netherlands, only if surrogate decision-makers agreed on withdrawal of life-sustaining measures without CPR and imminent death was anticipated.
As reported Jan. 28 in the New England Journal of Medicine, physicians observed resumption of circulation or cardiac activity prospectively in 1% of 631 patients based on bedside ECG, arterial pressure catheter monitors, palpated arterial pulse, breaths, or physical movements.
A retrospective review of data from 480 patients with complete ECG and arterial waveforms and at least 5 minutes of continuous waveform monitoring after pulselessness showed resumption of cardiac activity in 14% of patients.
The longest period of pulselessness before the heart showed signs of activity again was 4 minutes and 20 seconds. “So that was a reassuring number, because that’s within our 5-minute window that we currently use,” Dr. Dhanani said.
Importantly, “nobody woke up, nobody ended up being resuscitated, and all of these individuals died. And I think that’s going to be very helpful in this context,” he added.
In all, there were 77 cessations and resumptions in 67 of the 480 patients. The median duration of resumed cardiac activity was 3.9 seconds but, notably, ranged from 1 second to 13 minutes and 14 seconds.
“Though surprising, I think maybe not unreasonable,” observed Dr. Dhanani. “The heart is a very robust organ, and we maybe should anticipate these things happening, where at the end of life the heart may restart for minutes.”
In this situation, it’s important to wait the 13 minutes for the heart to stop again and then “wait another 5 minutes to make sure it doesn’t restart before determining death,” he said. “I think that’s where this study is going to now inform policy makers and guidelines, especially in the context of donations.”
The findings will be taken as strong support for the 5-minute window, said Robert Truog, MD, director of the Harvard Medical School Center for Bioethics and the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, Boston.
“I think it’s a safe point, I think people will refer to it, and it will be used to support the 5-minute window, and that’s probably reasonable,” he told this news organization. “Certainly, if it’s read in Europe it will cut the time from 10 minutes to 5 minutes, and that’s a good thing because 10 minutes is a very long time to wait.”
He noted that the 5-minute window provides reasonable assurance to the public and, with new technologies, permits most organs to be usable for donation after cardiac death. That said, there’s nothing magical about the number.
“In some ways I see this paper as providing interesting data but not actually providing an answer, because from the patient’s perspective and from the recipient’s perspective, waiting until the heart has made its last squeeze may not be the most relevant ethical question,” Dr. Truog said. “It may be, once we know this patient is not going to have return of cardiorespiratory function, is not going to wake up, that’s the point at which we ought to focus on organ preservation and organ retrieval, and that can be much sooner than 5 minutes.”
Dr. Dhanani and colleagues note that the generalizability of the results might be limited because patients without arterial pressure catheters were excluded, and 24% of enrolled patients could not be included in the retrospective waveform analysis owing to incomplete data.
“Our study definition of cardiac activity used an arbitrary threshold of pulse pressure (less than 5 mm Hg) that does not imply meaningful circulation,” they add. “This conservative consensus definition may have been partially responsible for the ostensibly high incidence (14%) of transient resumptions of cardiac activity identified through waveform adjudication.”
The study was supported by the Canadian Institutes for Health Research as part of the Canadian Donation and Transplantation Research Program, CHEO Research Institute, and Karel Pavlík Foundation. Dr. Dhanani has consulted for Canadian Blood Services. Dr. Truog reports no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Poor sensitivity for blood cultures drawn after antibiotics
Background: Early antibiotic administration reduces mortality in patients with severe sepsis. Administering antibiotics before blood cultures could potentially decrease time to treatment and improve outcomes, but the diagnostic yield of blood cultures drawn shortly after antibiotics is unknown.
Study design: Prospective, patient-level, pre- and post-study.
Setting: Multicenter study in USA & Canada.
Synopsis: During 2013-2018, 330 adult patients were recruited from seven urban EDs. Patients with severe manifestations of sepsis (spontaneous bacterial peritonitis [SBP] less than 90 mm Hg and lactic acid of 4 or more) had blood cultures drawn before and after empiric antibiotic administration. Blood cultures were positive for one or more microbial pathogens in 31.4% of patients when drawn before antibiotics and in 19.4% of patients when drawn after antibiotics (absolute difference of 12.0% (95% confidence interval, 5.4%-18.6%; P less than .001). The sensitivity of blood cultures after antibiotic administration was 52.9% (95% CI, 43%-63%).
There were several study limitations including: lack of sequential recruitment, lower than expected proportion of bacteremic patients, and variation in blood culture collection. Despite this, the magnitude of the findings are convincing and support current practice.
Bottom line: Continue to obtain blood cultures before antibiotics.
Citation: Cheng MP et al. Blood culture results before and after antimicrobial administration in patients with severe manifestations of sepsis. Ann Intern Med. 2019 Oct 15;171(8):547-54.
Dr. Waner is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.
Background: Early antibiotic administration reduces mortality in patients with severe sepsis. Administering antibiotics before blood cultures could potentially decrease time to treatment and improve outcomes, but the diagnostic yield of blood cultures drawn shortly after antibiotics is unknown.
Study design: Prospective, patient-level, pre- and post-study.
Setting: Multicenter study in USA & Canada.
Synopsis: During 2013-2018, 330 adult patients were recruited from seven urban EDs. Patients with severe manifestations of sepsis (spontaneous bacterial peritonitis [SBP] less than 90 mm Hg and lactic acid of 4 or more) had blood cultures drawn before and after empiric antibiotic administration. Blood cultures were positive for one or more microbial pathogens in 31.4% of patients when drawn before antibiotics and in 19.4% of patients when drawn after antibiotics (absolute difference of 12.0% (95% confidence interval, 5.4%-18.6%; P less than .001). The sensitivity of blood cultures after antibiotic administration was 52.9% (95% CI, 43%-63%).
There were several study limitations including: lack of sequential recruitment, lower than expected proportion of bacteremic patients, and variation in blood culture collection. Despite this, the magnitude of the findings are convincing and support current practice.
Bottom line: Continue to obtain blood cultures before antibiotics.
Citation: Cheng MP et al. Blood culture results before and after antimicrobial administration in patients with severe manifestations of sepsis. Ann Intern Med. 2019 Oct 15;171(8):547-54.
Dr. Waner is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.
Background: Early antibiotic administration reduces mortality in patients with severe sepsis. Administering antibiotics before blood cultures could potentially decrease time to treatment and improve outcomes, but the diagnostic yield of blood cultures drawn shortly after antibiotics is unknown.
Study design: Prospective, patient-level, pre- and post-study.
Setting: Multicenter study in USA & Canada.
Synopsis: During 2013-2018, 330 adult patients were recruited from seven urban EDs. Patients with severe manifestations of sepsis (spontaneous bacterial peritonitis [SBP] less than 90 mm Hg and lactic acid of 4 or more) had blood cultures drawn before and after empiric antibiotic administration. Blood cultures were positive for one or more microbial pathogens in 31.4% of patients when drawn before antibiotics and in 19.4% of patients when drawn after antibiotics (absolute difference of 12.0% (95% confidence interval, 5.4%-18.6%; P less than .001). The sensitivity of blood cultures after antibiotic administration was 52.9% (95% CI, 43%-63%).
There were several study limitations including: lack of sequential recruitment, lower than expected proportion of bacteremic patients, and variation in blood culture collection. Despite this, the magnitude of the findings are convincing and support current practice.
Bottom line: Continue to obtain blood cultures before antibiotics.
Citation: Cheng MP et al. Blood culture results before and after antimicrobial administration in patients with severe manifestations of sepsis. Ann Intern Med. 2019 Oct 15;171(8):547-54.
Dr. Waner is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.