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COVID-19 and risk of clotting: ‘Be proactive about prevention’

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The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

Dr. Gregory Piazza

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimerfibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

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The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

Dr. Gregory Piazza

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimerfibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

Dr. Gregory Piazza

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimerfibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

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

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PPE shortage crisis continues at most hospitals, survey shows

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A majority of hospitals and health care facilities surveyed report operating according to “crisis standards of care” as they struggle to provide sufficient personal protective equipment (PPE).

For example, in a national survey, 73% of 1,083 infection prevention experts said respirator shortages related to care for patients with COVID-19 drove their facility to move beyond conventional standards of care. Furthermore, 69% of facilities are using crisis standards of care (CSC) to provide masks, and 76% are apportioning face shields or eye protection.

Almost 76% of respondents who report reusing respirators said their facility allows them to use each respirator either five times or as many times as possible before replacement; 74% allow similar reuse of masks.

Although the majority of institutions remain in this crisis mode, many health care providers have better access to PPE than they did in the spring 2020, the Association for Professionals in Infection Control and Epidemiology (APIC) noted in its latest national survey.

“It is disheartening to see our healthcare system strained and implementing PPE crisis standards of care more than eight months into the pandemic,” APIC President Connie Steed, MSN, RN, said in a December 3 news release.

The association surveyed experts online between Oct. 22 and Nov. 5. The survey was timed to gauge the extent of resource shortages as COVID-19 cases increase and the 2020-2021 flu season begins.

“Many of us on the front lines are waiting for the other shoe to drop. With the upcoming flu season, we implore people to do what they can to keep safe, protect our healthcare personnel, and lessen the strain on our health care system,” Ms. Steed said.
 

COVID-19 linked to more infections, too

APIC also asked infection prevention specialists about changes in health care–associated infection rates since the onset of the pandemic. The experts reported an almost 28% increase in central line–associated bloodstream infections and 21% more catheter-associated urinary tract infections. They also reported an 18% rise in ventilator-associated pneumonia or ventilator-associated events, compared with before the COVID-19 pandemic.

This is the second PPE survey the APIC has conducted during the pandemic. The organization first reported a dire situation in March. For example, the initial survey found that 48% of facilities were almost out or were out of respirators used to care for patients with COVID-19.

This article first appeared on Medscape.com.

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A majority of hospitals and health care facilities surveyed report operating according to “crisis standards of care” as they struggle to provide sufficient personal protective equipment (PPE).

For example, in a national survey, 73% of 1,083 infection prevention experts said respirator shortages related to care for patients with COVID-19 drove their facility to move beyond conventional standards of care. Furthermore, 69% of facilities are using crisis standards of care (CSC) to provide masks, and 76% are apportioning face shields or eye protection.

Almost 76% of respondents who report reusing respirators said their facility allows them to use each respirator either five times or as many times as possible before replacement; 74% allow similar reuse of masks.

Although the majority of institutions remain in this crisis mode, many health care providers have better access to PPE than they did in the spring 2020, the Association for Professionals in Infection Control and Epidemiology (APIC) noted in its latest national survey.

“It is disheartening to see our healthcare system strained and implementing PPE crisis standards of care more than eight months into the pandemic,” APIC President Connie Steed, MSN, RN, said in a December 3 news release.

The association surveyed experts online between Oct. 22 and Nov. 5. The survey was timed to gauge the extent of resource shortages as COVID-19 cases increase and the 2020-2021 flu season begins.

“Many of us on the front lines are waiting for the other shoe to drop. With the upcoming flu season, we implore people to do what they can to keep safe, protect our healthcare personnel, and lessen the strain on our health care system,” Ms. Steed said.
 

COVID-19 linked to more infections, too

APIC also asked infection prevention specialists about changes in health care–associated infection rates since the onset of the pandemic. The experts reported an almost 28% increase in central line–associated bloodstream infections and 21% more catheter-associated urinary tract infections. They also reported an 18% rise in ventilator-associated pneumonia or ventilator-associated events, compared with before the COVID-19 pandemic.

This is the second PPE survey the APIC has conducted during the pandemic. The organization first reported a dire situation in March. For example, the initial survey found that 48% of facilities were almost out or were out of respirators used to care for patients with COVID-19.

This article first appeared on Medscape.com.

A majority of hospitals and health care facilities surveyed report operating according to “crisis standards of care” as they struggle to provide sufficient personal protective equipment (PPE).

For example, in a national survey, 73% of 1,083 infection prevention experts said respirator shortages related to care for patients with COVID-19 drove their facility to move beyond conventional standards of care. Furthermore, 69% of facilities are using crisis standards of care (CSC) to provide masks, and 76% are apportioning face shields or eye protection.

Almost 76% of respondents who report reusing respirators said their facility allows them to use each respirator either five times or as many times as possible before replacement; 74% allow similar reuse of masks.

Although the majority of institutions remain in this crisis mode, many health care providers have better access to PPE than they did in the spring 2020, the Association for Professionals in Infection Control and Epidemiology (APIC) noted in its latest national survey.

“It is disheartening to see our healthcare system strained and implementing PPE crisis standards of care more than eight months into the pandemic,” APIC President Connie Steed, MSN, RN, said in a December 3 news release.

The association surveyed experts online between Oct. 22 and Nov. 5. The survey was timed to gauge the extent of resource shortages as COVID-19 cases increase and the 2020-2021 flu season begins.

“Many of us on the front lines are waiting for the other shoe to drop. With the upcoming flu season, we implore people to do what they can to keep safe, protect our healthcare personnel, and lessen the strain on our health care system,” Ms. Steed said.
 

COVID-19 linked to more infections, too

APIC also asked infection prevention specialists about changes in health care–associated infection rates since the onset of the pandemic. The experts reported an almost 28% increase in central line–associated bloodstream infections and 21% more catheter-associated urinary tract infections. They also reported an 18% rise in ventilator-associated pneumonia or ventilator-associated events, compared with before the COVID-19 pandemic.

This is the second PPE survey the APIC has conducted during the pandemic. The organization first reported a dire situation in March. For example, the initial survey found that 48% of facilities were almost out or were out of respirators used to care for patients with COVID-19.

This article first appeared on Medscape.com.

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Infant’s COVID-19–related myocardial injury reversed

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Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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FROM JACC CASE REPORTS

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Key clinical point: Children presenting with COVID-19 should be tested for heart failure.

Major finding: A 2-month-old infant with COVID-19 had acute but reversible myocardial injury.

Study details: Single case report.

Disclosures: Dr. Sharma, MD, has no relevant financial relationships to disclose.

Source: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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Obesity, hypoxia predict severity in children with COVID-19

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Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

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Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

 

Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

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An alternative path to recertification

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The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

Dr. Paul G. Mathew

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

 

 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

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The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

Dr. Paul G. Mathew

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

 

 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

Dr. Paul G. Mathew

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

 

 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

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COVID-19 vaccine distribution could start in 2 weeks, Pence says

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Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

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Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

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

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

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

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

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

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

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

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

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

An ‘acceptable risk’ calculation

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

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

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

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

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

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

 

 

Home for the holidays

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

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

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

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

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

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

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

An ‘acceptable risk’ calculation

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

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

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

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

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

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

 

 

Home for the holidays

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

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

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

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

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

This article first appeared on Medscape.com.

 

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

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

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

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

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

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

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

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

An ‘acceptable risk’ calculation

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

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

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

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

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

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

 

 

Home for the holidays

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

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

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

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

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

This article first appeared on Medscape.com.

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Blood vessels in the eye may diagnose Parkinson’s disease

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An eye exam may be all that is needed to diagnose Parkinson’s disease, new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.

The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.

Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.

The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
 

Machine learning on fundus eye images

Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.

“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?

“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
 

Eye vasculature reveals disease

“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”

Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”

Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.

Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.

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

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An eye exam may be all that is needed to diagnose Parkinson’s disease, new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.

The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.

Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.

The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
 

Machine learning on fundus eye images

Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.

“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?

“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
 

Eye vasculature reveals disease

“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”

Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”

Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.

Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.

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

 

An eye exam may be all that is needed to diagnose Parkinson’s disease, new research shows. Using an advanced machine-learning algorithm and fundus eye images, which depict the small blood vessels and more at the back of the eye, investigators are able to classify patients with Parkinson’s disease compared against a control group. “We discovered that micro blood vessels decreased in both size and number in patients with Parkinson’s disease,” said Maximillian Diaz, a PhD student at the University of Florida, Gainesville.

The simple eye examination may offer a way to diagnose Parkinson’s early in the disease progression.

Mr. Diaz said the test could be incorporated to a patient’s annual physical examination not only to look for Parkinson’s disease but also for other neurological diseases. Researchers at the University of Florida are also looking at whether the same technique can diagnose Alzheimer’s disease.

The beauty of this is that “the technique is simple,” he said. “What surprised us is that we can do this with fundus images, which can be taken in a clinical setting with a lens that attaches to your smartphone. It’s affordable and portable and it takes less than a minute.”
 

Machine learning on fundus eye images

Researchers, under the direction of Ruogu Fang, PhD, director of the J. Crayton Pruitt Department of Biomedical Engineering’s Smart Medical Informatics Learning and Evaluation Lab (SMILE) at the University of Florida, Gainesville, collected fundus eye images from 476 age- and gender-matched individuals, 238 diagnosed with Parkinson’s disease and 238 control group images. Another set of 100 images were collected from the University of Florida database using green color channels (UKB-Green and UF-UKB Green) and used to improve vessel segmentation. Of these, 28 were controls and 72 from patients with Parkinson’s disease. Researchers added 44 more control images from the U.K. Biobank to complete the second age- and gender-matched dataset.

“We used 80% of the images to develop the machine-learning network,” Mr. Diaz said. The other 20% of images, which were new to the algorithm, were used to test it, to determine true or false, Parkinson’s disease or control?

“We were able to achieve an accuracy of 85%,” Mr. Diaz said. Currently, there are no biomarkers to diagnose Parkinson’s disease. The disease is only recognizable once 80% of dopaminergic cells have already decayed. “Clinically, there’s no way to tell how long someone has had it,” Mr. Diaz said. He hopes that by doing additional research and testing earlier – with a longitudinal study of images – a pattern may be detected to better predict disease.
 

Eye vasculature reveals disease

“This concept [studying eye vasculature] is getting a lot of interest right now,” said Anant Madabhushi, PhD, Case Western Reserve University, Cleveland. “The eye is the proverbial window to the soul, and in this case, shows what’s happening in rest of the body.”

Dr. Madabhushi, who was not involved in the Parkinson’s research, has also been working with a team in Cleveland to look at how vessels in the eye predict response to drug therapies in diabetic macular edema, including treatment durability. “What we’ve found is the more twisted the vessels, the more constricted, and the less likely the person would respond to therapy,” he said, adding that studying the pathology of the eye makes a lot of sense. “The arrangement of vessels in the eye are likely to have implications in all kinds of diseases.”

Since Parkinson’s disease does not have any biomarkers, this technology could be very useful in diagnosis. “With specific quantitative measurements, we could have computational imaging biomarkers to predict the risk of onset of Parkinson’s, and the prognosis of disease. That’s the true utility of this approach,” he said.

Mr. Diaz disclosed no relevant financial relationships. Dr. Madabhushi has consulted for Aiforia and has had research sponsored by AstraZeneca, Bristol-Myers Squibb, and Boehringer Ingelheim.

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

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

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

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

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

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



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

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

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

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

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

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



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

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

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

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

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

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



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

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

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

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

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

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

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

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

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

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

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

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

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

Prioritization could change

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

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

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

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

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

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

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

 

 

Staggered immunization subprioritization urged

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

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

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

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

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

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

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

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

Prioritization could change

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

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

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

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

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

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

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

 

 

Staggered immunization subprioritization urged

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

 

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

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

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

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

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

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

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

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

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

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

Prioritization could change

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

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

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

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

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

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

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

 

 

Staggered immunization subprioritization urged

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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