Pediatric News

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.

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.

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.

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.

Significant racial and ethnic differences in diagnostic imaging rates exist among children receiving care in pediatric EDs across the United States, Jennifer R. Marin, MD, of the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, and associates reported.

Specifically, visits with non-Hispanic Black and Hispanic patients less frequently included radiography, CT, ultrasonography, and MRI than those of non-Hispanic White patients. The findings persisted across most diagnostic groups, even when stratified according to insurance type, Dr. Marin and colleagues reported in a multicenter cross-sectional study in JAMA Network Open.

The authors collected administrative data from the Pediatric Health Information System on 44 tertiary care children’s hospitals in 17 major metropolitan areas across the United States. They evaluated a total of 13,087,522 ED visits by 6,230,911 patients that occurred between Jan. 1, 2016, and Dec. 31, 2019. Of these, 28.2% included at least one imaging study. Altogether, 33.5% were performed on non-Hispanic White children, compared with just 24.1% of non-Hispanic Black children (adjusted odds ratio, 0.82) and 26.1% of Hispanic children (aOR, 0.87). After adjusting for relevant confounding factors, non-Hispanic Black and Hispanic children were less likely to have any imaging at all during their visits.

“Our findings suggest that a child’s race and ethnicity may be independently associated with the decision to perform imaging during ED visits,” Dr. Marin and associates said, adding that “the differential use of diagnostic imaging by race/ethnicity may reflect underuse of imaging in non-Hispanic Black and Hispanic children, or alternatively, overuse in non-Hispanic White children.”
 

Overuse vs. underuse: Racial bias or parental anxiety?

Overuse of imaging carries its own risks, but underuse can lead to misdiagnosis, the need for additional care, and possibly worse outcomes in the long run, Dr. Marin and colleagues explained. “Although we were unable to discern underuse from overuse using an administrative database, it is likely that much of the imaging in White children is unnecessary.”

Higher parental anxiety was just one of the explanations the authors offered for excessive imaging in White children. Especially in cases of diagnostic imaging for head trauma, one survey of adult ED patients showed that the peace of mind CT offers with its more definitive diagnosis was worth the additional possible risk of radiation.

Language barriers in non–English-speaking patients may also affect likelihood of testing as part of an ED visit.

Implicit physician racial bias, which can be amplified under the stress of working in an ED, can affect patient interactions, treatment decisions and adherence, and ultimately overall health outcomes, the authors noted. The goal in ensuring parity is to routinely follow clinical guidelines and use objective scoring tools that minimize subjectivity. At the institutional level, internal quality assurance evaluations go a long way toward understanding and limiting bias.

Historically, White patients are more likely than minority patients to have a medical home, which can influence whether ED physicians order imaging studies and whether imaging of White patients may have been triggered by a primary care physician referral, Dr. Marin and associates said.

In an accompanying editorial, Anupam B. Kharbanda, MD, said these findings are “consistent with decades of previous research documenting inequalities in health care delivery ... [and] must be examined in the context of inequities within the social framework of a community.”
 

Going back to the drawing board

“Physicians, researchers, and health care leaders must partner with the communities they serve to develop and implement interventions to address these substantial inequities in care,” said Dr. Kharbanda, pediatric emergency medicine physician at Children’s Minnesota Hospital, Minneapolis. As previous studies have demonstrated, implicit bias and antiracism training are needed to help physicians develop empathy so they are better equipped to help patients and families in a multicultural environment. Partnering with community-based organizations to ensure that care is more community centered, as has been done successfully within the Kaiser Permanente health system, for example, and employing a more diverse workforce that mirrors the populations cared for will go a long way.

Citing a 1966 speech of the late Dr. Martin Luther King, Jr., in which he said: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane,” Dr. Kharbanda urged clinicians to not only hear but believe these words and act on them by working in partnerships with the communities they serve.

In a separate interview, Walter Palmer, MD, pediatric emergency medicine fellow at Children’s National Medical Center, Washington, noted: “This study’s findings are disappointing and yet not at all unexpected, as the authors convincingly identify yet another step at which patients of color are treated unequally in the U.S. health care system. It highlights a frightening truth: That we are all at risk of letting invisible implicit biases impact our clinical decision-making process. This is especially true in the busy emergency department environment, where pressure to make swift decisions regarding diagnostic workup and management invites the influence of imperceptible biases. It is now incumbent upon us as health care providers to monitor our personal and departmental patterns of practice for areas in which we can improve racial health equity and become advocates for the children and families who entrust us with their care.”

The authors reported multiple financial disclosures. Dr. Kharbanda and Dr. Palmer had no conflicts of interest and reported no disclosures.

Significant racial and ethnic differences in diagnostic imaging rates exist among children receiving care in pediatric EDs across the United States, Jennifer R. Marin, MD, of the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, and associates reported.

Specifically, visits with non-Hispanic Black and Hispanic patients less frequently included radiography, CT, ultrasonography, and MRI than those of non-Hispanic White patients. The findings persisted across most diagnostic groups, even when stratified according to insurance type, Dr. Marin and colleagues reported in a multicenter cross-sectional study in JAMA Network Open.

The authors collected administrative data from the Pediatric Health Information System on 44 tertiary care children’s hospitals in 17 major metropolitan areas across the United States. They evaluated a total of 13,087,522 ED visits by 6,230,911 patients that occurred between Jan. 1, 2016, and Dec. 31, 2019. Of these, 28.2% included at least one imaging study. Altogether, 33.5% were performed on non-Hispanic White children, compared with just 24.1% of non-Hispanic Black children (adjusted odds ratio, 0.82) and 26.1% of Hispanic children (aOR, 0.87). After adjusting for relevant confounding factors, non-Hispanic Black and Hispanic children were less likely to have any imaging at all during their visits.

“Our findings suggest that a child’s race and ethnicity may be independently associated with the decision to perform imaging during ED visits,” Dr. Marin and associates said, adding that “the differential use of diagnostic imaging by race/ethnicity may reflect underuse of imaging in non-Hispanic Black and Hispanic children, or alternatively, overuse in non-Hispanic White children.”
 

Overuse vs. underuse: Racial bias or parental anxiety?

Overuse of imaging carries its own risks, but underuse can lead to misdiagnosis, the need for additional care, and possibly worse outcomes in the long run, Dr. Marin and colleagues explained. “Although we were unable to discern underuse from overuse using an administrative database, it is likely that much of the imaging in White children is unnecessary.”

Higher parental anxiety was just one of the explanations the authors offered for excessive imaging in White children. Especially in cases of diagnostic imaging for head trauma, one survey of adult ED patients showed that the peace of mind CT offers with its more definitive diagnosis was worth the additional possible risk of radiation.

Language barriers in non–English-speaking patients may also affect likelihood of testing as part of an ED visit.

Implicit physician racial bias, which can be amplified under the stress of working in an ED, can affect patient interactions, treatment decisions and adherence, and ultimately overall health outcomes, the authors noted. The goal in ensuring parity is to routinely follow clinical guidelines and use objective scoring tools that minimize subjectivity. At the institutional level, internal quality assurance evaluations go a long way toward understanding and limiting bias.

Historically, White patients are more likely than minority patients to have a medical home, which can influence whether ED physicians order imaging studies and whether imaging of White patients may have been triggered by a primary care physician referral, Dr. Marin and associates said.

In an accompanying editorial, Anupam B. Kharbanda, MD, said these findings are “consistent with decades of previous research documenting inequalities in health care delivery ... [and] must be examined in the context of inequities within the social framework of a community.”
 

Going back to the drawing board

“Physicians, researchers, and health care leaders must partner with the communities they serve to develop and implement interventions to address these substantial inequities in care,” said Dr. Kharbanda, pediatric emergency medicine physician at Children’s Minnesota Hospital, Minneapolis. As previous studies have demonstrated, implicit bias and antiracism training are needed to help physicians develop empathy so they are better equipped to help patients and families in a multicultural environment. Partnering with community-based organizations to ensure that care is more community centered, as has been done successfully within the Kaiser Permanente health system, for example, and employing a more diverse workforce that mirrors the populations cared for will go a long way.

Citing a 1966 speech of the late Dr. Martin Luther King, Jr., in which he said: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane,” Dr. Kharbanda urged clinicians to not only hear but believe these words and act on them by working in partnerships with the communities they serve.

In a separate interview, Walter Palmer, MD, pediatric emergency medicine fellow at Children’s National Medical Center, Washington, noted: “This study’s findings are disappointing and yet not at all unexpected, as the authors convincingly identify yet another step at which patients of color are treated unequally in the U.S. health care system. It highlights a frightening truth: That we are all at risk of letting invisible implicit biases impact our clinical decision-making process. This is especially true in the busy emergency department environment, where pressure to make swift decisions regarding diagnostic workup and management invites the influence of imperceptible biases. It is now incumbent upon us as health care providers to monitor our personal and departmental patterns of practice for areas in which we can improve racial health equity and become advocates for the children and families who entrust us with their care.”

The authors reported multiple financial disclosures. Dr. Kharbanda and Dr. Palmer had no conflicts of interest and reported no disclosures.

Significant racial and ethnic differences in diagnostic imaging rates exist among children receiving care in pediatric EDs across the United States, Jennifer R. Marin, MD, of the University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, and associates reported.

Specifically, visits with non-Hispanic Black and Hispanic patients less frequently included radiography, CT, ultrasonography, and MRI than those of non-Hispanic White patients. The findings persisted across most diagnostic groups, even when stratified according to insurance type, Dr. Marin and colleagues reported in a multicenter cross-sectional study in JAMA Network Open.

The authors collected administrative data from the Pediatric Health Information System on 44 tertiary care children’s hospitals in 17 major metropolitan areas across the United States. They evaluated a total of 13,087,522 ED visits by 6,230,911 patients that occurred between Jan. 1, 2016, and Dec. 31, 2019. Of these, 28.2% included at least one imaging study. Altogether, 33.5% were performed on non-Hispanic White children, compared with just 24.1% of non-Hispanic Black children (adjusted odds ratio, 0.82) and 26.1% of Hispanic children (aOR, 0.87). After adjusting for relevant confounding factors, non-Hispanic Black and Hispanic children were less likely to have any imaging at all during their visits.

“Our findings suggest that a child’s race and ethnicity may be independently associated with the decision to perform imaging during ED visits,” Dr. Marin and associates said, adding that “the differential use of diagnostic imaging by race/ethnicity may reflect underuse of imaging in non-Hispanic Black and Hispanic children, or alternatively, overuse in non-Hispanic White children.”
 

Overuse vs. underuse: Racial bias or parental anxiety?

Overuse of imaging carries its own risks, but underuse can lead to misdiagnosis, the need for additional care, and possibly worse outcomes in the long run, Dr. Marin and colleagues explained. “Although we were unable to discern underuse from overuse using an administrative database, it is likely that much of the imaging in White children is unnecessary.”

Higher parental anxiety was just one of the explanations the authors offered for excessive imaging in White children. Especially in cases of diagnostic imaging for head trauma, one survey of adult ED patients showed that the peace of mind CT offers with its more definitive diagnosis was worth the additional possible risk of radiation.

Language barriers in non–English-speaking patients may also affect likelihood of testing as part of an ED visit.

Implicit physician racial bias, which can be amplified under the stress of working in an ED, can affect patient interactions, treatment decisions and adherence, and ultimately overall health outcomes, the authors noted. The goal in ensuring parity is to routinely follow clinical guidelines and use objective scoring tools that minimize subjectivity. At the institutional level, internal quality assurance evaluations go a long way toward understanding and limiting bias.

Historically, White patients are more likely than minority patients to have a medical home, which can influence whether ED physicians order imaging studies and whether imaging of White patients may have been triggered by a primary care physician referral, Dr. Marin and associates said.

In an accompanying editorial, Anupam B. Kharbanda, MD, said these findings are “consistent with decades of previous research documenting inequalities in health care delivery ... [and] must be examined in the context of inequities within the social framework of a community.”
 

Going back to the drawing board

“Physicians, researchers, and health care leaders must partner with the communities they serve to develop and implement interventions to address these substantial inequities in care,” said Dr. Kharbanda, pediatric emergency medicine physician at Children’s Minnesota Hospital, Minneapolis. As previous studies have demonstrated, implicit bias and antiracism training are needed to help physicians develop empathy so they are better equipped to help patients and families in a multicultural environment. Partnering with community-based organizations to ensure that care is more community centered, as has been done successfully within the Kaiser Permanente health system, for example, and employing a more diverse workforce that mirrors the populations cared for will go a long way.

Citing a 1966 speech of the late Dr. Martin Luther King, Jr., in which he said: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane,” Dr. Kharbanda urged clinicians to not only hear but believe these words and act on them by working in partnerships with the communities they serve.

In a separate interview, Walter Palmer, MD, pediatric emergency medicine fellow at Children’s National Medical Center, Washington, noted: “This study’s findings are disappointing and yet not at all unexpected, as the authors convincingly identify yet another step at which patients of color are treated unequally in the U.S. health care system. It highlights a frightening truth: That we are all at risk of letting invisible implicit biases impact our clinical decision-making process. This is especially true in the busy emergency department environment, where pressure to make swift decisions regarding diagnostic workup and management invites the influence of imperceptible biases. It is now incumbent upon us as health care providers to monitor our personal and departmental patterns of practice for areas in which we can improve racial health equity and become advocates for the children and families who entrust us with their care.”

The authors reported multiple financial disclosures. Dr. Kharbanda and Dr. Palmer had no conflicts of interest and reported no disclosures.

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

• The mRNA vaccines can alter human DNA.
• Vaccines will use microchip surveillance technology.
• COVID-19 vaccines cause infertility.
• The vaccine developed by Oxford University will turn people into monkeys.
• COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The gout drug colchicine appears to lower the severity of COVID-19, a small new Brazilian study finds, adding to evidence that the familiar medication holds promise as a treatment for hospitalized patients.

Patients who received colchicine in this randomized, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. ... Colchicine was safe and well tolerated,” the study authors wrote in RMD Open. However, deaths were rare in the trial, they added, and it is impossible to “evaluate the capacity of colchicine to avoid admission to ICU and reduce mortality.”

The oral anti-inflammatory colchicine, widely used as treatment in rheumatic disease, was first approved in the United States 60 years ago. Researchers began to explore its potential as a COVID-19 treatment in the early months of the pandemic.

On Jan. 25, an international team of researchers reported in a press release – but not yet a published paper – that the drug seemed to reduce hospitalizations, mechanical ventilation, and deaths in the ColCORONA trial. Earlier, a much-smaller, randomized, open-label, Greek trial linked the drug to reduced time to clinical deterioration and hospital stay.

The Brazilian authors of the new study, led by Maria Isabel Lopes of the University of São Paulo’s Ribeirão Preto Medical School, randomly assigned 75 hospitalized patients with moderate to severe COVID-19 to colchicine or placebo. A total of 72 subjects completed the April-August 2020 trial: 36 received colchicine (typically 0.5 mg three times for 5 days, then 0.5 mg twice daily for 5 days; doses were adjusted in low-weight patients and those with chronic kidney disease). The other 36 received the placebo.

(In the United States, 0.6-mg tablets of generic colchicine cost as little as $1.90 each with free coupons, according to goodrx.com.)

The median age in the groups was similar (55 years); and the placebo group had more women (61% vs. 47% in the colchicine group, P = .34). All 72 patients received the same COVID-19 treatment at the time of the trial: azithromycin, hydroxychloroquine, and unfractionated heparin. Most patients, about two-thirds in both groups, also received methylprednisolone because they needed higher amounts of supplemental oxygen.

Patients in the colchicine group needed supplemental oxygen for less time: Their median time of need was 4.0 days (interquartile range [IQR], 2.0-6.0) vs. 6.5 days (IQR, 4.0-9.0) for the placebo group (P < .001). The median time for hospitalization was also lower at 7.0 days (IQR, 5.0–9.0) for the colchicine group vs. 9.0 (IQR, 7.0–12.0) for the placebo group (log rank test, 10.6; P = .001).

The researchers also reported the percentage of patients who needed supplemental oxygen at day 2 as 67% with colchicine vs. 86% with placebo, and at day 7 as 9% vs. 42% (log rank test, 10.6; P = .001). Two patients in the placebo group died, both from ventilator-associated pneumonia.

As for side effects, new or worsened diarrhea was reported more often in the colchicine group (17% vs. 6% with placebo), but the difference was not statistically significant (P = .26), and diarrhea was controlled via medication.

The researchers reported that limitations include the exclusion criteria and their inability to link colchicine to rates of ICU admissions and death.

The drug appears to help patients with COVID-19, the study authors wrote, by “inhibiting inflammasome, reducing neutrophil migration and activation, or preventing endothelial damage.”

A “well-conceived and well-designed” study

In an interview, NYU Langone Health rheumatologist Michael H. Pillinger, MD – an investigator with the ColCORONA trial – praised the Brazilian study. It “appears well-conceived and well-designed, and was enrolled at a rate that was greater than the sample size that was estimated to be needed based on power analysis,” he said.

The Brazilian study is small, he noted. (In contrast, the ColCORONA trial had 4,488 outpatient participants.) “This study differs from ColCORONA in several ways – the most important being that it is a study of inpatients with moderate to severe COVID (really mostly moderate),” he added. “ColCORONA is looking at a target audience that is much larger – outpatients with mild to moderate COVID with risk factors for hospitalization. Both questions are really important and certainly not mutually exclusive, since our care remains inadequate in both venues. This study also adds value in that several other studies have been conducted in hospital patients with enrollment criteria relatively similar to this one, and all showed benefit, but those were open-label or retrospective, and this is blinded and placebo-controlled.”
 

Using colchicine in patients with COVID-19

Should physicians turn to colchicine in patients with COVID-19? “I would rather that it still be used in the context of research until formal recommendations can be made by bodies like the NIH and CDC,” Dr. Pillinger said. “But certainly, there may be times when physicians feel compelled to treat patients off label.”

He cautioned, however, that colchicine should never be used with some other drugs. Its interaction with the antibiotic clarithromycin can be fatal, he noted. And, he said, the drug must be monitored in general since it can cause rare, severe problems.

“Overall, colchicine probably works on the overabundant inflammatory response to COVID, and it may be that it can be combined with other drugs that affect viral replication or promote immunity – e.g. vaccines,” Dr. Pillinger said. “So far, it seems as if there is no safety problem with combining colchicine with other approaches, but this has not been studied in a rigorous manner.”

Moving forward, he said, the drug’s very low price outside of the United States “could provide resource-poor countries with a way to help keep patients out of precious hospital beds – or help them go home sooner once admitted.” For now, however, “we need a large-scale inpatient study, and one is currently going on in Great Britain. We also need validation of the outpatient ColCORONA study, and studies to look at whether colchicine can work in conjunction with other strategies.”

The study was funded by grants from the São Paulo Research Foundation, Brazilian National Council for Scientific and Technological Development, and CAPES Foundation. No disclosures are reported. Dr. Pillinger reports serving as an investigator for the ColCORONA trial and receiving a unrelated investigator-initiated grant from Hikma, a colchicine manufacturer.

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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

The United States has now reported more than 450,000 COVID-19 deaths during the pandemic, adding 3,912 more on Wednesday, according to data from Johns Hopkins University.

Daily COVID-19 deaths still remain high in the United States, though they’ve decreased slightly from the peak of 4,466 deaths on Jan. 12.

The United States also reported more than 121,000 new COVID-19 cases on Wednesday, which is down from a peak of more than 300,000 new cases on Tuesday. In total, more than 26.5 million people in the United States have been diagnosed with COVID-19, making up a quarter of the 104.5 million cases reported worldwide.

The 7-day average for COVID-19 hospitalizations and deaths continues to decline, according to the COVID Tracking Project. The 7-day average for hospitalizations is around 96,500, and the 7-day average for deaths is about 3,000. With the exception of Vermont, all states and territories have reported declines or no changes in their hospitalizations and deaths.

“We have seen the 7-day average for new deaths decrease for over a week. At the same time, states are reporting an average of 3,000 people dying per day,” the COVID Tracking Project wrote in a post on Twitter. “The data is hopeful and devastating.”

More than 2.2 million COVID-19 deaths have been reported worldwide. The United States continues to report the most deaths, followed by Brazil with 227,500, Mexico with 161,200, and India with 154,700 deaths.

The U.S. COVID-19 death toll could reach 496,000-534,000 by the end of February, according to a new forecast by the CDC, which includes models from 36 national groups. Deaths will likely decrease during the next 4 weeks, with about 11,300-22,600 deaths possibly reported during the last week of February.

The 534,000 total would equal about 1 death for every minute of the pandemic, according to CNN, given that the first U.S. death was reported on Feb. 29 last year.

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