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Whether physicians or advanced practice practitioners, we are the backbone of our nation’s network of acute care facilities, and on a daily basis, we see just about everything. We have valuable insight into how to improve our nation’s health care system, especially now, as our nation continues to battle COVID-19.

Our role, squarely on the front lines during this pandemic, has given us an important perspective that needs to be heard. We spend our days managing patients with complexity, coordinating with specialists and subspecialists, and advocating – at local, state, and national levels – so that our patients can more easily transition to their lives out of the hospital.

Our current polarized political climate makes it seem that individual voices will not make a difference. It is easy to feel frustrated and powerless. However, those in our specialty are actually in a perfect position to have an educated and influential say in how we move forward, not only about the immediate health crises, but also regarding future health care issues. That voice begins with voting.

Historically, physicians have had surprisingly low rates of voting. For example, a 2007 study found significantly lower rates of voting among physicians, compared with the general public.¹ While physician voter turnout may have improved in the past decade, given the substantial changes in health care and the increasing amount of physician engagement in the public sphere, our participation should be greater still. Elected officials listen to, and follow up with, constituents who make their voices heard. Each of us can ensure that the health care policy priorities of our fast-growing specialty are addressed by mobilizing to the voting booth.

Candidates we elect shape our health care system for the future, directly impacting us and our patients. Cost, coverage, access to health care, the Centers for Medicare & Medicaid Services inpatient fee schedules, the ongoing pandemic response, surprise billing, use of telehealth, observation status, and the three-midnight rule are just a few of the issues most important to hospital medicine.

Therefore, we, the SHM Public Policy Committee, urge all of our colleagues, regardless of political sway, to make your voice heard this and every election henceforth. The first step is to register to vote, if you have not done so already.² Next, exercise that privilege. Given the pandemic, this is not as simple a process as it has been in the past. Take the time to plan your approach to early voting, mail-in voting, or election day voting. Check your County Supervisor of Elections’ website for further information, including how to register, view candidate profiles, check your precinct, and request a mail-in ballot.

In addition to casting your vote, we encourage you to share your opinions and engage in dialogue about health care issues. Clinical fact can dispel rumor and misinformation, and daily experiences can personalize our patients’ health care stories and the impact laws and rules have on our ability to practice. We are part of a trusted profession and have a unique perspective; others need and want to hear it. They can only do that if we are part of the process. Arming yourself with information and voting are the first steps on the path of advocacy. Interpersonal advocacy can also be done on social media. For example, SHM has an active grassroots advocacy network on Twitter. Tag @SHMadvocacy in your tweets to share your thoughts with their network.

Finally, as advocates for our patients in health care, we can also help ensure their safety during this election, in particular regarding COVID-19. Some patients may not wish to engage us in politics, and we must respect their decision. Others may seek our counsel and we should provide it in an unbiased fashion. We can ask our patients if they have considered a safe voting plan, help patients review the alternatives to voting in person if desired, and inform those who wish to physically cast a vote on Election Day of how to mitigate the risk of in-person voting.

Every election is important and health care is front and center for a multitude of reasons. We who practice hospital medicine are integral to our communities and need to be more politically involved. This is our chance to share our voice through our vote, not just this year, but in future elections as well.

Ann Sheehy, MD, SFHM, is division chief of the Division of Hospital Medicine at the University of Wisconsin, Madison, and chair of the SHM Public Policy Committee. Other members of the SHM PPC include Marta Almli, MD; John Biebelhausen, MD; Robert Burke, MD, MS, FHM; George Cheely, MD; Hyung (Harry) Cho, MD, SFHM; Jennifer Cowart, MD, FHM; Suparna Dutta, MD, MS, MPH; Bradley Flansbaum, DO, MPH, MHM; Alain Folefack, MD; Rick Hilger MD SFHM; Melinda Johnson, MD; Sevan Karadolian, MD; Joshua D. Lenchus, DO, FACP, SFHM; Steve Phillipson, MD; Dahlia Rizk, DO; Kendall Rogers, MD, SFHM; Brett Stauffer, MD, MHS; Amit Vashist, MD, SFHM; Robert Zipper, MD, SFHM.

References

1. Grande D et al. Do doctors vote? J Gen Int Med. 2007 May;22(5):585-9.

2. How to register to vote, confirm or change your registration and get a voter registration card. https://www.usa.gov/voter-registration/.

Whether physicians or advanced practice practitioners, we are the backbone of our nation’s network of acute care facilities, and on a daily basis, we see just about everything. We have valuable insight into how to improve our nation’s health care system, especially now, as our nation continues to battle COVID-19.

Our role, squarely on the front lines during this pandemic, has given us an important perspective that needs to be heard. We spend our days managing patients with complexity, coordinating with specialists and subspecialists, and advocating – at local, state, and national levels – so that our patients can more easily transition to their lives out of the hospital.

Our current polarized political climate makes it seem that individual voices will not make a difference. It is easy to feel frustrated and powerless. However, those in our specialty are actually in a perfect position to have an educated and influential say in how we move forward, not only about the immediate health crises, but also regarding future health care issues. That voice begins with voting.

Historically, physicians have had surprisingly low rates of voting. For example, a 2007 study found significantly lower rates of voting among physicians, compared with the general public.¹ While physician voter turnout may have improved in the past decade, given the substantial changes in health care and the increasing amount of physician engagement in the public sphere, our participation should be greater still. Elected officials listen to, and follow up with, constituents who make their voices heard. Each of us can ensure that the health care policy priorities of our fast-growing specialty are addressed by mobilizing to the voting booth.

Candidates we elect shape our health care system for the future, directly impacting us and our patients. Cost, coverage, access to health care, the Centers for Medicare & Medicaid Services inpatient fee schedules, the ongoing pandemic response, surprise billing, use of telehealth, observation status, and the three-midnight rule are just a few of the issues most important to hospital medicine.

Therefore, we, the SHM Public Policy Committee, urge all of our colleagues, regardless of political sway, to make your voice heard this and every election henceforth. The first step is to register to vote, if you have not done so already.² Next, exercise that privilege. Given the pandemic, this is not as simple a process as it has been in the past. Take the time to plan your approach to early voting, mail-in voting, or election day voting. Check your County Supervisor of Elections’ website for further information, including how to register, view candidate profiles, check your precinct, and request a mail-in ballot.

In addition to casting your vote, we encourage you to share your opinions and engage in dialogue about health care issues. Clinical fact can dispel rumor and misinformation, and daily experiences can personalize our patients’ health care stories and the impact laws and rules have on our ability to practice. We are part of a trusted profession and have a unique perspective; others need and want to hear it. They can only do that if we are part of the process. Arming yourself with information and voting are the first steps on the path of advocacy. Interpersonal advocacy can also be done on social media. For example, SHM has an active grassroots advocacy network on Twitter. Tag @SHMadvocacy in your tweets to share your thoughts with their network.

Finally, as advocates for our patients in health care, we can also help ensure their safety during this election, in particular regarding COVID-19. Some patients may not wish to engage us in politics, and we must respect their decision. Others may seek our counsel and we should provide it in an unbiased fashion. We can ask our patients if they have considered a safe voting plan, help patients review the alternatives to voting in person if desired, and inform those who wish to physically cast a vote on Election Day of how to mitigate the risk of in-person voting.

Every election is important and health care is front and center for a multitude of reasons. We who practice hospital medicine are integral to our communities and need to be more politically involved. This is our chance to share our voice through our vote, not just this year, but in future elections as well.

Ann Sheehy, MD, SFHM, is division chief of the Division of Hospital Medicine at the University of Wisconsin, Madison, and chair of the SHM Public Policy Committee. Other members of the SHM PPC include Marta Almli, MD; John Biebelhausen, MD; Robert Burke, MD, MS, FHM; George Cheely, MD; Hyung (Harry) Cho, MD, SFHM; Jennifer Cowart, MD, FHM; Suparna Dutta, MD, MS, MPH; Bradley Flansbaum, DO, MPH, MHM; Alain Folefack, MD; Rick Hilger MD SFHM; Melinda Johnson, MD; Sevan Karadolian, MD; Joshua D. Lenchus, DO, FACP, SFHM; Steve Phillipson, MD; Dahlia Rizk, DO; Kendall Rogers, MD, SFHM; Brett Stauffer, MD, MHS; Amit Vashist, MD, SFHM; Robert Zipper, MD, SFHM.

References

1. Grande D et al. Do doctors vote? J Gen Int Med. 2007 May;22(5):585-9.

2. How to register to vote, confirm or change your registration and get a voter registration card. https://www.usa.gov/voter-registration/.

Whether physicians or advanced practice practitioners, we are the backbone of our nation’s network of acute care facilities, and on a daily basis, we see just about everything. We have valuable insight into how to improve our nation’s health care system, especially now, as our nation continues to battle COVID-19.

Our role, squarely on the front lines during this pandemic, has given us an important perspective that needs to be heard. We spend our days managing patients with complexity, coordinating with specialists and subspecialists, and advocating – at local, state, and national levels – so that our patients can more easily transition to their lives out of the hospital.

Our current polarized political climate makes it seem that individual voices will not make a difference. It is easy to feel frustrated and powerless. However, those in our specialty are actually in a perfect position to have an educated and influential say in how we move forward, not only about the immediate health crises, but also regarding future health care issues. That voice begins with voting.

Historically, physicians have had surprisingly low rates of voting. For example, a 2007 study found significantly lower rates of voting among physicians, compared with the general public.¹ While physician voter turnout may have improved in the past decade, given the substantial changes in health care and the increasing amount of physician engagement in the public sphere, our participation should be greater still. Elected officials listen to, and follow up with, constituents who make their voices heard. Each of us can ensure that the health care policy priorities of our fast-growing specialty are addressed by mobilizing to the voting booth.

Candidates we elect shape our health care system for the future, directly impacting us and our patients. Cost, coverage, access to health care, the Centers for Medicare & Medicaid Services inpatient fee schedules, the ongoing pandemic response, surprise billing, use of telehealth, observation status, and the three-midnight rule are just a few of the issues most important to hospital medicine.

Therefore, we, the SHM Public Policy Committee, urge all of our colleagues, regardless of political sway, to make your voice heard this and every election henceforth. The first step is to register to vote, if you have not done so already.² Next, exercise that privilege. Given the pandemic, this is not as simple a process as it has been in the past. Take the time to plan your approach to early voting, mail-in voting, or election day voting. Check your County Supervisor of Elections’ website for further information, including how to register, view candidate profiles, check your precinct, and request a mail-in ballot.

In addition to casting your vote, we encourage you to share your opinions and engage in dialogue about health care issues. Clinical fact can dispel rumor and misinformation, and daily experiences can personalize our patients’ health care stories and the impact laws and rules have on our ability to practice. We are part of a trusted profession and have a unique perspective; others need and want to hear it. They can only do that if we are part of the process. Arming yourself with information and voting are the first steps on the path of advocacy. Interpersonal advocacy can also be done on social media. For example, SHM has an active grassroots advocacy network on Twitter. Tag @SHMadvocacy in your tweets to share your thoughts with their network.

Finally, as advocates for our patients in health care, we can also help ensure their safety during this election, in particular regarding COVID-19. Some patients may not wish to engage us in politics, and we must respect their decision. Others may seek our counsel and we should provide it in an unbiased fashion. We can ask our patients if they have considered a safe voting plan, help patients review the alternatives to voting in person if desired, and inform those who wish to physically cast a vote on Election Day of how to mitigate the risk of in-person voting.

Every election is important and health care is front and center for a multitude of reasons. We who practice hospital medicine are integral to our communities and need to be more politically involved. This is our chance to share our voice through our vote, not just this year, but in future elections as well.

Ann Sheehy, MD, SFHM, is division chief of the Division of Hospital Medicine at the University of Wisconsin, Madison, and chair of the SHM Public Policy Committee. Other members of the SHM PPC include Marta Almli, MD; John Biebelhausen, MD; Robert Burke, MD, MS, FHM; George Cheely, MD; Hyung (Harry) Cho, MD, SFHM; Jennifer Cowart, MD, FHM; Suparna Dutta, MD, MS, MPH; Bradley Flansbaum, DO, MPH, MHM; Alain Folefack, MD; Rick Hilger MD SFHM; Melinda Johnson, MD; Sevan Karadolian, MD; Joshua D. Lenchus, DO, FACP, SFHM; Steve Phillipson, MD; Dahlia Rizk, DO; Kendall Rogers, MD, SFHM; Brett Stauffer, MD, MHS; Amit Vashist, MD, SFHM; Robert Zipper, MD, SFHM.

References

1. Grande D et al. Do doctors vote? J Gen Int Med. 2007 May;22(5):585-9.

2. How to register to vote, confirm or change your registration and get a voter registration card. https://www.usa.gov/voter-registration/.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

After increasing for several weeks, the proportion of new COVID-19 cases occurring in children has dropped for the second week in a row, according to data in a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

COVID-19 cases in children accounted for 12.3% of all new cases in the United States for the week ending Oct. 1, down from 15.2% the previous week. That measure had reached its highest point, 16.9%, just one week earlier (Sept. 17), the AAP and the CHA said in their weekly COVID-19 report.

The total number of COVID-19 cases in children now stands as 657,572, or 10.6% of the more than 6.2 million cases reported among Americans of all ages, based on data from the health departments of 49 states (New York does not provide ages on its website), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The child COVID-19 rate for the United States was 874 per 100,000 children as of Oct. 1, and that figure has doubled since the end of July. At the state level, the highest rates can be found in Tennessee (2,031.4 per 100,000), North Dakota (2,029.6), and South Carolina (2,002.6), with the lowest rates in Vermont (168.9), Maine (229.1), and New Hampshire (268.3), the AAP/CHA report shows.

The children of Wyoming make up the largest share, 22.4%, of any state’s COVID-19 cases, followed by North Dakota and Tennessee, both at 18.3%. New Jersey is lower than any other state at 3.9%, although New York City is a slightly lower 3.6%, the AAP and CHA said.

“The data are limited because the states differ in how they report the data, and it is unknown how many children have been infected but not tested. It is unclear how much of the increase in child cases is due to increased testing capacity,” the AAP said in an earlier statement.

[email protected]

After increasing for several weeks, the proportion of new COVID-19 cases occurring in children has dropped for the second week in a row, according to data in a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

COVID-19 cases in children accounted for 12.3% of all new cases in the United States for the week ending Oct. 1, down from 15.2% the previous week. That measure had reached its highest point, 16.9%, just one week earlier (Sept. 17), the AAP and the CHA said in their weekly COVID-19 report.

The total number of COVID-19 cases in children now stands as 657,572, or 10.6% of the more than 6.2 million cases reported among Americans of all ages, based on data from the health departments of 49 states (New York does not provide ages on its website), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The child COVID-19 rate for the United States was 874 per 100,000 children as of Oct. 1, and that figure has doubled since the end of July. At the state level, the highest rates can be found in Tennessee (2,031.4 per 100,000), North Dakota (2,029.6), and South Carolina (2,002.6), with the lowest rates in Vermont (168.9), Maine (229.1), and New Hampshire (268.3), the AAP/CHA report shows.

The children of Wyoming make up the largest share, 22.4%, of any state’s COVID-19 cases, followed by North Dakota and Tennessee, both at 18.3%. New Jersey is lower than any other state at 3.9%, although New York City is a slightly lower 3.6%, the AAP and CHA said.

“The data are limited because the states differ in how they report the data, and it is unknown how many children have been infected but not tested. It is unclear how much of the increase in child cases is due to increased testing capacity,” the AAP said in an earlier statement.

[email protected]

After increasing for several weeks, the proportion of new COVID-19 cases occurring in children has dropped for the second week in a row, according to data in a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

COVID-19 cases in children accounted for 12.3% of all new cases in the United States for the week ending Oct. 1, down from 15.2% the previous week. That measure had reached its highest point, 16.9%, just one week earlier (Sept. 17), the AAP and the CHA said in their weekly COVID-19 report.

The total number of COVID-19 cases in children now stands as 657,572, or 10.6% of the more than 6.2 million cases reported among Americans of all ages, based on data from the health departments of 49 states (New York does not provide ages on its website), as well as the District of Columbia, New York City, Puerto Rico, and Guam.

The child COVID-19 rate for the United States was 874 per 100,000 children as of Oct. 1, and that figure has doubled since the end of July. At the state level, the highest rates can be found in Tennessee (2,031.4 per 100,000), North Dakota (2,029.6), and South Carolina (2,002.6), with the lowest rates in Vermont (168.9), Maine (229.1), and New Hampshire (268.3), the AAP/CHA report shows.

The children of Wyoming make up the largest share, 22.4%, of any state’s COVID-19 cases, followed by North Dakota and Tennessee, both at 18.3%. New Jersey is lower than any other state at 3.9%, although New York City is a slightly lower 3.6%, the AAP and CHA said.

“The data are limited because the states differ in how they report the data, and it is unknown how many children have been infected but not tested. It is unclear how much of the increase in child cases is due to increased testing capacity,” the AAP said in an earlier statement.

[email protected]

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

According to the best available evidence, analagosedation remains the focus for managing COVID-19 ICU patients, according to Steven B. Greenberg, MD, FCCP, FCCM.

“The choice of sedation and analgesia is important,” Dr. Greenberg, vice chair of education in the department of anesthesiology at Evanston Hospital, part of NorthShore University Health System, Chicago, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. “We know that the right choice of these two components may increase liberation from ventilators, earlier ICU discharge, and return to normal brain function and independent functional status.”
 

Analgesia first

Prior to the current pandemic, the approach to sedation of patients in the ICU was based on the PADIS Guidelines of 2018, which call for an assessment-driven, protocol-based stepwise approach to pain and sedation management in critically ill adults (Crit Care Med. 2018;46:e825-73). “[A strategy for COVID-19 in the ICU] should focus on analagosedation defined as analgesia-first sedation rather than jumping to sedation first,” Dr. Greenberg said. “We know that pain management should be a priority of sedation, because pain may increase the risk of delirium, anxiety, and endocrine suppression, and may increase the risk of release of endogenous catecholamines, ischemia, and hypermetabolic states.”

Fentanyl appears to be the most common opioid analgesic used for patients in the ICU, “but fentanyl is a very lipophilic drug and has a long context-sensitive half-life,” he said. “There are components to fentanyl that allow it to become a very long-acting drug upon days and days of infusion. Another opioid used is remifentanil, which is typically short-acting because it is broken down in the blood by esterases, but may cause rigidity at higher doses. Dilaudid seems to be the least affected by organ dysfunction. In our very critically ill, prolonged mechanically ventilated COVID-19 patients, we’ve been using methadone for its NMDA [N-methyl-D-aspartate] antagonistic effect and its opioid-sparing effects.”

As for nonopioid analgesics, Dr. Greenberg said that clinicians have shied away from using NSAIDs because of their side effects. “Tramadol indirectly inhibits reuptake of norepinephrine and serotonin, and ketamine is being used a lot more because of its NMDA antagonist effect,” he said. “Lidocaine and gabapentin have also been used.”

In a recent systematic review and meta-analysis, researchers assessed 34 trials that examined adjuvant analgesic use with an opioid in critically ill patients versus an opioid alone (Crit Care Expl. 2020;2:e0157). They found that when using an adjuvant such as acetaminophen, clonidine, dexmedetomidine, gabapentin, ketamine, magnesium, nefopam, NSAIDs, pregabalin, and tramadol, there was a reduction in pain scores as well as a reduction in opioid consumption. “So, clinicians should consider using adjuvant agents to limit opioid exposure and improve pain scores in the critically ill,” Dr. Greenberg said.
 

ICU delirium: Risk factors, prevention

Delirium in COVID-19 patients treated in the ICU of particular concern. According to a systematic review of 33 studies, 11 risk factors for delirium in the ICU were supported by strong or moderate levels of evidence (Crit Care Med. 2015;43:40-7). These include age, dementia, hypertension, emergency surgery, trauma, APACHE score of II, need for mechanical ventilation, metabolic acidosis, delirium on prior day, coma, and dexmedetomidine use. Risk factors for ICU delirium among COVID-19 patients, however, “are far different,” Dr. Greenberg said. “Why? First and foremost, we are restricting visitation of family,” he said. “That family connection largely can be lost. Second, there are limitations of nonpharmacologic interventions. There is less mobility and physical therapy employed because of the risk of health care workers’ exposure to the virus. There’s also uncertainty about the global pandemic. Anxiety and depression come with that, as well as disruptions to spiritual and religious services.”

Strategies for preventing delirium remain the same as before the pandemic and in accord with recent clinical practice guidelines: Reduce the use of certain drugs such as benzodiazepines and narcotics, reorient the patients, treat dehydration, use hearing aids and eyeglasses in patients who have them, use ear plugs to cancel noise, mobilize patients, maintain sleep/awake cycles, and encourage sedation holidays (Crit Care Med. 2018;46[9]:e825-73).

A recent study from France found that among 58 patients with COVID-19, 65% had positive Confusion Assessment Method (CAM)–ICU findings and 69% had agitation (N Engl J Med 2020;382:2268-70). Most of the patients (86%) received midazolam, 47% received propofol, and all received sufentanil. “In the pre-COVID days, we would use midazolam as a second-line agent for many of these patients,” Dr. Greenberg said. “So, times really have changed.”

The fate of COVID-19 patients following discharge from the ICU remains a concern, continued Dr. Greenberg, clinical professor of anesthesiology at the University of Chicago. A recent journal article by Michelle Biehl, MD, and Denise Sese, MD, noted that post–intensive care syndrome (PICS) or new or worsening impairment in any physical, cognitive, or mental domain is of significant concern among COVID-19 patients following their ICU stay (Cleveland Clin J Med 2020 Aug doi: 10.3949/ccjm.87a.ccc055). The authors stated that COVID-19 patients may face a higher risk of PICS because of restricted family visitation, prolonged mechanical ventilation, exposure to higher amounts of sedatives, and limited physical therapy during hospital stay.

No ideal sedative agent

The 2018 PADIS Guidelines on the use of ICU sedation suggested strong evidence for modifiable risk factors producing delirium in the context of benzodiazepines and blood transfusion. They recommend a light level of sedation and the use of propofol or dexmedetomidine over benzodiazepines. They also recommend routine delirium testing such as using the CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC) and nonpharmacologic therapies such as reorientation, cognitive stimulation, sleep improvement, and mobilization.

Several sedation-related factors may be related to an increased risk of delirium. “The type, dose, duration, and mode of delivery are very important,” Dr. Greenberg said. “The ideal sedative agent has a rapid, predictable onset; is short-acting; has anxiolytic, amnestic, and analgesic properties; is soluble; has a high therapeutic index; and no toxicity. The ideal sedative is also easy to administrate, contains no active metabolites, has minimal actions with other drugs, is reversible, and is cost effective. The problem is, there really is no ideal sedative agent. There is inadequate knowledge about the drugs [used to treat COVID-19 in the ICU] available to us, the dosage, and importantly, the pharmacokinetics and dynamics of these medications.”

The classic types of sedation being used in the ICU, he said, include the benzodiazepines midazolam, lorazepam, and diazepam, as well as propofol. Alternatives include dexmedetomidine, clonidine, ketamine, and the neuroleptics – haloperidol, quetiapine, olanzapine, ziprasidone, and risperidone. “The advantages of benzos are that they are anxiolytics, amnestics, and they are good sedatives with minimal hemodynamic effects,” Dr. Greenberg said.

Advantages of propofol include its sedative, hypnotic, and anxiolytic properties, he said. It reduces the cerebral metabolic rate and can relieve bronchospasm. “However, small studies have found that its use may be associated with an increased risk of delirium,” he said. “It is a respiratory depressant, and it can cause hypotension and decreased contractility. It has no analgesic properties, and two of the big concerns of its use in COVID-19 are the potential for hypertriglyceridemia and propofol infusion syndrome, particularly at doses of greater than 5 mg/kg per hour for greater than 48 hours. It is being given in high doses because patients are requiring higher doses to maintain ventilator synchrony.”
 

Choosing the right drug

The keys to success for sedation of ICU patients are choosing the right drug at the right dose for the right duration and the right mode of delivery, and applying them to the right population. However, as noted in a recent study, the pandemic poses unique challenges to clinicians in how they care for critically ill COVID-19 patients who require sedation (Anesth Analg. 2020 Apr 22. doi: 10.1213/ANE.0000000000004887). The use of provisional work areas “has escalated because of the amount of patients we’ve had to care for over the past nine months,” Dr. Greenberg said. “We’ve used alternate providers who are not necessarily familiar with the sedation and analgesic protocols and how to use these specific medications. Drug shortages have been on the rise, so there’s a need to understand alternative agents that can be used.”

COVID-19 patients face the potential risk for an increase in drug-drug interactions and side effects due to the polypharmacy that is often required to provide adequate sedation during mechanical ventilation. He noted that these patients may have “unusually high” analgesia and sedation requirements, particularly when they’re mechanically ventilated. A hypothesis as to why patients with COVID-19 require so much sedation and analgesia is that they often have a high respiratory drive and ventilator dyssynchrony, which requires increased neuromuscular blockade. “They also have an intense inflammatory response, which may be linked to tolerance of specific opioids and other medications,” Dr. Greenberg said. “Many ventilated COVID-19 patients are of younger age and previously in good health, and therefore, have an excellent metabolism. Health care providers are concerned about self-extubation. This prompts bedside providers to administer more sedatives to prevent this unwanted complication. There may also be a reduction of drip modifications by health care workers because of the potential risk of contracting COVID-19 when going into the room multiple times and for long periods of time” (Anesth Analg. 2020;131[1]:e34-e35).

According to a sedation resource on the SCCM website, about 5% of COVID-19 patients require mechanical ventilation. “There has been a massive shortage of the usual drugs that we use,” Dr. Greenberg said. “The demand for sedatives has increased by approximately 91%, while the demand for analgesics has increased by 79%, and neuromuscular blocker demand has increased by 105%.”

A retrospective study of 24 COVID-19 patients who required ventilation in the ICU found that the median daily dose of benzodiazepines was significantly higher, compared with the median daily dose used in the OSCILLATE trial (a median of 270 mg vs. 199 mg, respectively; Anesth Analg. 2020;131[4]e198-e200. doi: 10.1213/ane.0000000000005131). In addition, their median daily dose of opioid was approximately three times higher, compared with patients in the OSCILLATE trial (a median of 775 mg vs. 289 mg). Other agents used included propofol (84%), dexmedetomidine (53%), and ketamine (11%).

“A potential strategy for COVID-19 ICU patient sedation should be analgesia first, as indicated in the 2018 PADIS guidelines,” Dr. Greenberg advised. “We should also apply nonpharmacologic measures to reduce delirium. In nonintubated patients, we should use light to moderate sedation, targeting a RASS of –2 to +1, using hydromorphone or fentanyl boluses for analgesia and midazolam boluses or dexmedetomidine for sedation,.”

For intubated patients, he continued, target a RASS of –3 to –4, or –4 to –5 in those who require neuromuscular blockade. “Use propofol first then intermittent boluses of benzodiazepines,” said Dr. Greenberg, editor-in-chief of the Anesthesia Patient Safety Foundation newsletter. “For heavy sedation, use midazolam and supplement with ketamine and other analgesics and sedatives such as barbiturates, methadone, and even inhalation anesthetics in some cases.”

For analgesia in intubated patients, use fentanyl boluses then infusion. “Patients can easily become tachyphylactic to fentanyl, and it has a long context-sensitive half time,” he said. “Hydromorphone may be least affected by organ dysfunction.”

Dr. Greenberg concluded his presentation by stating that more studies are required “to delineate the best analgesia/sedation strategies and monitoring modalities for COVID-19 ICU patients.”

In commenting on the presentation, Mangala Narasimhan, DO, FCCP, senior vice president and director of critical care services at Northwell Health, said that the recommendations regarding sedation highlight a struggle that ICU providers have been dealing with during the COVID-19 epidemic.

“There have been unique challenges with COVID-19 and intubated patients. We have seen severe ventilator dyssynchrony and prolonged duration of mechanical ventilation. I think we can all agree that these patients have extremely high metabolic rates, have required high levels of sedation, have an increased need for neuromuscular blockade, and have high levels of delirium for extended periods of time. The recommendations provided here are reasonable. Strategies to prevent delirium should be employed, pain management should be prioritized, analgesics can help reduce the need for opioids. Alternatives to sedation are useful in this patient population and are well tolerated. Drug shortages have provided additional challenges to these strategies and have required us to think about the use of alternative agents. The recommendations echo the experience we have had with large numbers of intubated COVID-19 patients.”

Dr. Greenberg disclosed that he receives a stipend from the Anesthesia Patient Safety Foundation for serving as editor-in-chief of the foundation’s newsletter.

[email protected]

According to the best available evidence, analagosedation remains the focus for managing COVID-19 ICU patients, according to Steven B. Greenberg, MD, FCCP, FCCM.

“The choice of sedation and analgesia is important,” Dr. Greenberg, vice chair of education in the department of anesthesiology at Evanston Hospital, part of NorthShore University Health System, Chicago, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. “We know that the right choice of these two components may increase liberation from ventilators, earlier ICU discharge, and return to normal brain function and independent functional status.”
 

Analgesia first

Prior to the current pandemic, the approach to sedation of patients in the ICU was based on the PADIS Guidelines of 2018, which call for an assessment-driven, protocol-based stepwise approach to pain and sedation management in critically ill adults (Crit Care Med. 2018;46:e825-73). “[A strategy for COVID-19 in the ICU] should focus on analagosedation defined as analgesia-first sedation rather than jumping to sedation first,” Dr. Greenberg said. “We know that pain management should be a priority of sedation, because pain may increase the risk of delirium, anxiety, and endocrine suppression, and may increase the risk of release of endogenous catecholamines, ischemia, and hypermetabolic states.”

Fentanyl appears to be the most common opioid analgesic used for patients in the ICU, “but fentanyl is a very lipophilic drug and has a long context-sensitive half-life,” he said. “There are components to fentanyl that allow it to become a very long-acting drug upon days and days of infusion. Another opioid used is remifentanil, which is typically short-acting because it is broken down in the blood by esterases, but may cause rigidity at higher doses. Dilaudid seems to be the least affected by organ dysfunction. In our very critically ill, prolonged mechanically ventilated COVID-19 patients, we’ve been using methadone for its NMDA [N-methyl-D-aspartate] antagonistic effect and its opioid-sparing effects.”

As for nonopioid analgesics, Dr. Greenberg said that clinicians have shied away from using NSAIDs because of their side effects. “Tramadol indirectly inhibits reuptake of norepinephrine and serotonin, and ketamine is being used a lot more because of its NMDA antagonist effect,” he said. “Lidocaine and gabapentin have also been used.”

In a recent systematic review and meta-analysis, researchers assessed 34 trials that examined adjuvant analgesic use with an opioid in critically ill patients versus an opioid alone (Crit Care Expl. 2020;2:e0157). They found that when using an adjuvant such as acetaminophen, clonidine, dexmedetomidine, gabapentin, ketamine, magnesium, nefopam, NSAIDs, pregabalin, and tramadol, there was a reduction in pain scores as well as a reduction in opioid consumption. “So, clinicians should consider using adjuvant agents to limit opioid exposure and improve pain scores in the critically ill,” Dr. Greenberg said.
 

ICU delirium: Risk factors, prevention

Delirium in COVID-19 patients treated in the ICU of particular concern. According to a systematic review of 33 studies, 11 risk factors for delirium in the ICU were supported by strong or moderate levels of evidence (Crit Care Med. 2015;43:40-7). These include age, dementia, hypertension, emergency surgery, trauma, APACHE score of II, need for mechanical ventilation, metabolic acidosis, delirium on prior day, coma, and dexmedetomidine use. Risk factors for ICU delirium among COVID-19 patients, however, “are far different,” Dr. Greenberg said. “Why? First and foremost, we are restricting visitation of family,” he said. “That family connection largely can be lost. Second, there are limitations of nonpharmacologic interventions. There is less mobility and physical therapy employed because of the risk of health care workers’ exposure to the virus. There’s also uncertainty about the global pandemic. Anxiety and depression come with that, as well as disruptions to spiritual and religious services.”

Strategies for preventing delirium remain the same as before the pandemic and in accord with recent clinical practice guidelines: Reduce the use of certain drugs such as benzodiazepines and narcotics, reorient the patients, treat dehydration, use hearing aids and eyeglasses in patients who have them, use ear plugs to cancel noise, mobilize patients, maintain sleep/awake cycles, and encourage sedation holidays (Crit Care Med. 2018;46[9]:e825-73).

A recent study from France found that among 58 patients with COVID-19, 65% had positive Confusion Assessment Method (CAM)–ICU findings and 69% had agitation (N Engl J Med 2020;382:2268-70). Most of the patients (86%) received midazolam, 47% received propofol, and all received sufentanil. “In the pre-COVID days, we would use midazolam as a second-line agent for many of these patients,” Dr. Greenberg said. “So, times really have changed.”

The fate of COVID-19 patients following discharge from the ICU remains a concern, continued Dr. Greenberg, clinical professor of anesthesiology at the University of Chicago. A recent journal article by Michelle Biehl, MD, and Denise Sese, MD, noted that post–intensive care syndrome (PICS) or new or worsening impairment in any physical, cognitive, or mental domain is of significant concern among COVID-19 patients following their ICU stay (Cleveland Clin J Med 2020 Aug doi: 10.3949/ccjm.87a.ccc055). The authors stated that COVID-19 patients may face a higher risk of PICS because of restricted family visitation, prolonged mechanical ventilation, exposure to higher amounts of sedatives, and limited physical therapy during hospital stay.

No ideal sedative agent

The 2018 PADIS Guidelines on the use of ICU sedation suggested strong evidence for modifiable risk factors producing delirium in the context of benzodiazepines and blood transfusion. They recommend a light level of sedation and the use of propofol or dexmedetomidine over benzodiazepines. They also recommend routine delirium testing such as using the CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC) and nonpharmacologic therapies such as reorientation, cognitive stimulation, sleep improvement, and mobilization.

Several sedation-related factors may be related to an increased risk of delirium. “The type, dose, duration, and mode of delivery are very important,” Dr. Greenberg said. “The ideal sedative agent has a rapid, predictable onset; is short-acting; has anxiolytic, amnestic, and analgesic properties; is soluble; has a high therapeutic index; and no toxicity. The ideal sedative is also easy to administrate, contains no active metabolites, has minimal actions with other drugs, is reversible, and is cost effective. The problem is, there really is no ideal sedative agent. There is inadequate knowledge about the drugs [used to treat COVID-19 in the ICU] available to us, the dosage, and importantly, the pharmacokinetics and dynamics of these medications.”

The classic types of sedation being used in the ICU, he said, include the benzodiazepines midazolam, lorazepam, and diazepam, as well as propofol. Alternatives include dexmedetomidine, clonidine, ketamine, and the neuroleptics – haloperidol, quetiapine, olanzapine, ziprasidone, and risperidone. “The advantages of benzos are that they are anxiolytics, amnestics, and they are good sedatives with minimal hemodynamic effects,” Dr. Greenberg said.

Advantages of propofol include its sedative, hypnotic, and anxiolytic properties, he said. It reduces the cerebral metabolic rate and can relieve bronchospasm. “However, small studies have found that its use may be associated with an increased risk of delirium,” he said. “It is a respiratory depressant, and it can cause hypotension and decreased contractility. It has no analgesic properties, and two of the big concerns of its use in COVID-19 are the potential for hypertriglyceridemia and propofol infusion syndrome, particularly at doses of greater than 5 mg/kg per hour for greater than 48 hours. It is being given in high doses because patients are requiring higher doses to maintain ventilator synchrony.”
 

Choosing the right drug

The keys to success for sedation of ICU patients are choosing the right drug at the right dose for the right duration and the right mode of delivery, and applying them to the right population. However, as noted in a recent study, the pandemic poses unique challenges to clinicians in how they care for critically ill COVID-19 patients who require sedation (Anesth Analg. 2020 Apr 22. doi: 10.1213/ANE.0000000000004887). The use of provisional work areas “has escalated because of the amount of patients we’ve had to care for over the past nine months,” Dr. Greenberg said. “We’ve used alternate providers who are not necessarily familiar with the sedation and analgesic protocols and how to use these specific medications. Drug shortages have been on the rise, so there’s a need to understand alternative agents that can be used.”

COVID-19 patients face the potential risk for an increase in drug-drug interactions and side effects due to the polypharmacy that is often required to provide adequate sedation during mechanical ventilation. He noted that these patients may have “unusually high” analgesia and sedation requirements, particularly when they’re mechanically ventilated. A hypothesis as to why patients with COVID-19 require so much sedation and analgesia is that they often have a high respiratory drive and ventilator dyssynchrony, which requires increased neuromuscular blockade. “They also have an intense inflammatory response, which may be linked to tolerance of specific opioids and other medications,” Dr. Greenberg said. “Many ventilated COVID-19 patients are of younger age and previously in good health, and therefore, have an excellent metabolism. Health care providers are concerned about self-extubation. This prompts bedside providers to administer more sedatives to prevent this unwanted complication. There may also be a reduction of drip modifications by health care workers because of the potential risk of contracting COVID-19 when going into the room multiple times and for long periods of time” (Anesth Analg. 2020;131[1]:e34-e35).

According to a sedation resource on the SCCM website, about 5% of COVID-19 patients require mechanical ventilation. “There has been a massive shortage of the usual drugs that we use,” Dr. Greenberg said. “The demand for sedatives has increased by approximately 91%, while the demand for analgesics has increased by 79%, and neuromuscular blocker demand has increased by 105%.”

A retrospective study of 24 COVID-19 patients who required ventilation in the ICU found that the median daily dose of benzodiazepines was significantly higher, compared with the median daily dose used in the OSCILLATE trial (a median of 270 mg vs. 199 mg, respectively; Anesth Analg. 2020;131[4]e198-e200. doi: 10.1213/ane.0000000000005131). In addition, their median daily dose of opioid was approximately three times higher, compared with patients in the OSCILLATE trial (a median of 775 mg vs. 289 mg). Other agents used included propofol (84%), dexmedetomidine (53%), and ketamine (11%).

“A potential strategy for COVID-19 ICU patient sedation should be analgesia first, as indicated in the 2018 PADIS guidelines,” Dr. Greenberg advised. “We should also apply nonpharmacologic measures to reduce delirium. In nonintubated patients, we should use light to moderate sedation, targeting a RASS of –2 to +1, using hydromorphone or fentanyl boluses for analgesia and midazolam boluses or dexmedetomidine for sedation,.”

For intubated patients, he continued, target a RASS of –3 to –4, or –4 to –5 in those who require neuromuscular blockade. “Use propofol first then intermittent boluses of benzodiazepines,” said Dr. Greenberg, editor-in-chief of the Anesthesia Patient Safety Foundation newsletter. “For heavy sedation, use midazolam and supplement with ketamine and other analgesics and sedatives such as barbiturates, methadone, and even inhalation anesthetics in some cases.”

For analgesia in intubated patients, use fentanyl boluses then infusion. “Patients can easily become tachyphylactic to fentanyl, and it has a long context-sensitive half time,” he said. “Hydromorphone may be least affected by organ dysfunction.”

Dr. Greenberg concluded his presentation by stating that more studies are required “to delineate the best analgesia/sedation strategies and monitoring modalities for COVID-19 ICU patients.”

In commenting on the presentation, Mangala Narasimhan, DO, FCCP, senior vice president and director of critical care services at Northwell Health, said that the recommendations regarding sedation highlight a struggle that ICU providers have been dealing with during the COVID-19 epidemic.

“There have been unique challenges with COVID-19 and intubated patients. We have seen severe ventilator dyssynchrony and prolonged duration of mechanical ventilation. I think we can all agree that these patients have extremely high metabolic rates, have required high levels of sedation, have an increased need for neuromuscular blockade, and have high levels of delirium for extended periods of time. The recommendations provided here are reasonable. Strategies to prevent delirium should be employed, pain management should be prioritized, analgesics can help reduce the need for opioids. Alternatives to sedation are useful in this patient population and are well tolerated. Drug shortages have provided additional challenges to these strategies and have required us to think about the use of alternative agents. The recommendations echo the experience we have had with large numbers of intubated COVID-19 patients.”

Dr. Greenberg disclosed that he receives a stipend from the Anesthesia Patient Safety Foundation for serving as editor-in-chief of the foundation’s newsletter.

[email protected]

According to the best available evidence, analagosedation remains the focus for managing COVID-19 ICU patients, according to Steven B. Greenberg, MD, FCCP, FCCM.

“The choice of sedation and analgesia is important,” Dr. Greenberg, vice chair of education in the department of anesthesiology at Evanston Hospital, part of NorthShore University Health System, Chicago, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. “We know that the right choice of these two components may increase liberation from ventilators, earlier ICU discharge, and return to normal brain function and independent functional status.”
 

Analgesia first

Prior to the current pandemic, the approach to sedation of patients in the ICU was based on the PADIS Guidelines of 2018, which call for an assessment-driven, protocol-based stepwise approach to pain and sedation management in critically ill adults (Crit Care Med. 2018;46:e825-73). “[A strategy for COVID-19 in the ICU] should focus on analagosedation defined as analgesia-first sedation rather than jumping to sedation first,” Dr. Greenberg said. “We know that pain management should be a priority of sedation, because pain may increase the risk of delirium, anxiety, and endocrine suppression, and may increase the risk of release of endogenous catecholamines, ischemia, and hypermetabolic states.”

Fentanyl appears to be the most common opioid analgesic used for patients in the ICU, “but fentanyl is a very lipophilic drug and has a long context-sensitive half-life,” he said. “There are components to fentanyl that allow it to become a very long-acting drug upon days and days of infusion. Another opioid used is remifentanil, which is typically short-acting because it is broken down in the blood by esterases, but may cause rigidity at higher doses. Dilaudid seems to be the least affected by organ dysfunction. In our very critically ill, prolonged mechanically ventilated COVID-19 patients, we’ve been using methadone for its NMDA [N-methyl-D-aspartate] antagonistic effect and its opioid-sparing effects.”

As for nonopioid analgesics, Dr. Greenberg said that clinicians have shied away from using NSAIDs because of their side effects. “Tramadol indirectly inhibits reuptake of norepinephrine and serotonin, and ketamine is being used a lot more because of its NMDA antagonist effect,” he said. “Lidocaine and gabapentin have also been used.”

In a recent systematic review and meta-analysis, researchers assessed 34 trials that examined adjuvant analgesic use with an opioid in critically ill patients versus an opioid alone (Crit Care Expl. 2020;2:e0157). They found that when using an adjuvant such as acetaminophen, clonidine, dexmedetomidine, gabapentin, ketamine, magnesium, nefopam, NSAIDs, pregabalin, and tramadol, there was a reduction in pain scores as well as a reduction in opioid consumption. “So, clinicians should consider using adjuvant agents to limit opioid exposure and improve pain scores in the critically ill,” Dr. Greenberg said.
 

ICU delirium: Risk factors, prevention

Delirium in COVID-19 patients treated in the ICU of particular concern. According to a systematic review of 33 studies, 11 risk factors for delirium in the ICU were supported by strong or moderate levels of evidence (Crit Care Med. 2015;43:40-7). These include age, dementia, hypertension, emergency surgery, trauma, APACHE score of II, need for mechanical ventilation, metabolic acidosis, delirium on prior day, coma, and dexmedetomidine use. Risk factors for ICU delirium among COVID-19 patients, however, “are far different,” Dr. Greenberg said. “Why? First and foremost, we are restricting visitation of family,” he said. “That family connection largely can be lost. Second, there are limitations of nonpharmacologic interventions. There is less mobility and physical therapy employed because of the risk of health care workers’ exposure to the virus. There’s also uncertainty about the global pandemic. Anxiety and depression come with that, as well as disruptions to spiritual and religious services.”

Strategies for preventing delirium remain the same as before the pandemic and in accord with recent clinical practice guidelines: Reduce the use of certain drugs such as benzodiazepines and narcotics, reorient the patients, treat dehydration, use hearing aids and eyeglasses in patients who have them, use ear plugs to cancel noise, mobilize patients, maintain sleep/awake cycles, and encourage sedation holidays (Crit Care Med. 2018;46[9]:e825-73).

A recent study from France found that among 58 patients with COVID-19, 65% had positive Confusion Assessment Method (CAM)–ICU findings and 69% had agitation (N Engl J Med 2020;382:2268-70). Most of the patients (86%) received midazolam, 47% received propofol, and all received sufentanil. “In the pre-COVID days, we would use midazolam as a second-line agent for many of these patients,” Dr. Greenberg said. “So, times really have changed.”

The fate of COVID-19 patients following discharge from the ICU remains a concern, continued Dr. Greenberg, clinical professor of anesthesiology at the University of Chicago. A recent journal article by Michelle Biehl, MD, and Denise Sese, MD, noted that post–intensive care syndrome (PICS) or new or worsening impairment in any physical, cognitive, or mental domain is of significant concern among COVID-19 patients following their ICU stay (Cleveland Clin J Med 2020 Aug doi: 10.3949/ccjm.87a.ccc055). The authors stated that COVID-19 patients may face a higher risk of PICS because of restricted family visitation, prolonged mechanical ventilation, exposure to higher amounts of sedatives, and limited physical therapy during hospital stay.

No ideal sedative agent

The 2018 PADIS Guidelines on the use of ICU sedation suggested strong evidence for modifiable risk factors producing delirium in the context of benzodiazepines and blood transfusion. They recommend a light level of sedation and the use of propofol or dexmedetomidine over benzodiazepines. They also recommend routine delirium testing such as using the CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC) and nonpharmacologic therapies such as reorientation, cognitive stimulation, sleep improvement, and mobilization.

Several sedation-related factors may be related to an increased risk of delirium. “The type, dose, duration, and mode of delivery are very important,” Dr. Greenberg said. “The ideal sedative agent has a rapid, predictable onset; is short-acting; has anxiolytic, amnestic, and analgesic properties; is soluble; has a high therapeutic index; and no toxicity. The ideal sedative is also easy to administrate, contains no active metabolites, has minimal actions with other drugs, is reversible, and is cost effective. The problem is, there really is no ideal sedative agent. There is inadequate knowledge about the drugs [used to treat COVID-19 in the ICU] available to us, the dosage, and importantly, the pharmacokinetics and dynamics of these medications.”

The classic types of sedation being used in the ICU, he said, include the benzodiazepines midazolam, lorazepam, and diazepam, as well as propofol. Alternatives include dexmedetomidine, clonidine, ketamine, and the neuroleptics – haloperidol, quetiapine, olanzapine, ziprasidone, and risperidone. “The advantages of benzos are that they are anxiolytics, amnestics, and they are good sedatives with minimal hemodynamic effects,” Dr. Greenberg said.

Advantages of propofol include its sedative, hypnotic, and anxiolytic properties, he said. It reduces the cerebral metabolic rate and can relieve bronchospasm. “However, small studies have found that its use may be associated with an increased risk of delirium,” he said. “It is a respiratory depressant, and it can cause hypotension and decreased contractility. It has no analgesic properties, and two of the big concerns of its use in COVID-19 are the potential for hypertriglyceridemia and propofol infusion syndrome, particularly at doses of greater than 5 mg/kg per hour for greater than 48 hours. It is being given in high doses because patients are requiring higher doses to maintain ventilator synchrony.”
 

Choosing the right drug

The keys to success for sedation of ICU patients are choosing the right drug at the right dose for the right duration and the right mode of delivery, and applying them to the right population. However, as noted in a recent study, the pandemic poses unique challenges to clinicians in how they care for critically ill COVID-19 patients who require sedation (Anesth Analg. 2020 Apr 22. doi: 10.1213/ANE.0000000000004887). The use of provisional work areas “has escalated because of the amount of patients we’ve had to care for over the past nine months,” Dr. Greenberg said. “We’ve used alternate providers who are not necessarily familiar with the sedation and analgesic protocols and how to use these specific medications. Drug shortages have been on the rise, so there’s a need to understand alternative agents that can be used.”

COVID-19 patients face the potential risk for an increase in drug-drug interactions and side effects due to the polypharmacy that is often required to provide adequate sedation during mechanical ventilation. He noted that these patients may have “unusually high” analgesia and sedation requirements, particularly when they’re mechanically ventilated. A hypothesis as to why patients with COVID-19 require so much sedation and analgesia is that they often have a high respiratory drive and ventilator dyssynchrony, which requires increased neuromuscular blockade. “They also have an intense inflammatory response, which may be linked to tolerance of specific opioids and other medications,” Dr. Greenberg said. “Many ventilated COVID-19 patients are of younger age and previously in good health, and therefore, have an excellent metabolism. Health care providers are concerned about self-extubation. This prompts bedside providers to administer more sedatives to prevent this unwanted complication. There may also be a reduction of drip modifications by health care workers because of the potential risk of contracting COVID-19 when going into the room multiple times and for long periods of time” (Anesth Analg. 2020;131[1]:e34-e35).

According to a sedation resource on the SCCM website, about 5% of COVID-19 patients require mechanical ventilation. “There has been a massive shortage of the usual drugs that we use,” Dr. Greenberg said. “The demand for sedatives has increased by approximately 91%, while the demand for analgesics has increased by 79%, and neuromuscular blocker demand has increased by 105%.”

A retrospective study of 24 COVID-19 patients who required ventilation in the ICU found that the median daily dose of benzodiazepines was significantly higher, compared with the median daily dose used in the OSCILLATE trial (a median of 270 mg vs. 199 mg, respectively; Anesth Analg. 2020;131[4]e198-e200. doi: 10.1213/ane.0000000000005131). In addition, their median daily dose of opioid was approximately three times higher, compared with patients in the OSCILLATE trial (a median of 775 mg vs. 289 mg). Other agents used included propofol (84%), dexmedetomidine (53%), and ketamine (11%).

“A potential strategy for COVID-19 ICU patient sedation should be analgesia first, as indicated in the 2018 PADIS guidelines,” Dr. Greenberg advised. “We should also apply nonpharmacologic measures to reduce delirium. In nonintubated patients, we should use light to moderate sedation, targeting a RASS of –2 to +1, using hydromorphone or fentanyl boluses for analgesia and midazolam boluses or dexmedetomidine for sedation,.”

For intubated patients, he continued, target a RASS of –3 to –4, or –4 to –5 in those who require neuromuscular blockade. “Use propofol first then intermittent boluses of benzodiazepines,” said Dr. Greenberg, editor-in-chief of the Anesthesia Patient Safety Foundation newsletter. “For heavy sedation, use midazolam and supplement with ketamine and other analgesics and sedatives such as barbiturates, methadone, and even inhalation anesthetics in some cases.”

For analgesia in intubated patients, use fentanyl boluses then infusion. “Patients can easily become tachyphylactic to fentanyl, and it has a long context-sensitive half time,” he said. “Hydromorphone may be least affected by organ dysfunction.”

Dr. Greenberg concluded his presentation by stating that more studies are required “to delineate the best analgesia/sedation strategies and monitoring modalities for COVID-19 ICU patients.”

In commenting on the presentation, Mangala Narasimhan, DO, FCCP, senior vice president and director of critical care services at Northwell Health, said that the recommendations regarding sedation highlight a struggle that ICU providers have been dealing with during the COVID-19 epidemic.

“There have been unique challenges with COVID-19 and intubated patients. We have seen severe ventilator dyssynchrony and prolonged duration of mechanical ventilation. I think we can all agree that these patients have extremely high metabolic rates, have required high levels of sedation, have an increased need for neuromuscular blockade, and have high levels of delirium for extended periods of time. The recommendations provided here are reasonable. Strategies to prevent delirium should be employed, pain management should be prioritized, analgesics can help reduce the need for opioids. Alternatives to sedation are useful in this patient population and are well tolerated. Drug shortages have provided additional challenges to these strategies and have required us to think about the use of alternative agents. The recommendations echo the experience we have had with large numbers of intubated COVID-19 patients.”

Dr. Greenberg disclosed that he receives a stipend from the Anesthesia Patient Safety Foundation for serving as editor-in-chief of the foundation’s newsletter.

[email protected]

I remember New Year’s Day 2020, full of hope and wonderment of what the year would bring. I was coming into the Society of Hospital Medicine as the incoming President, taking the 2020 reins in the organization’s 20th year. It would be a year of transitioning to a new CEO, reinvigorating our membership engagement efforts, and renewing a strategic plan for forward progress into the next decade. It would be a year chock full of travel, speaking engagements, and meetings with thousands of hospitalists around the globe.

What I didn’t know is that we would soon face the grim reality that the long-voiced concern of infectious disease experts and epidemiologists would come true. That our colleagues and friends and families would be infected, hospitalized, and die from this new disease, for which there were no good, effective treatments. That our ability to come together as a nation to implement basic infection control and epidemiologic practices would be fractured, uncoordinated, and ineffective. That within 6 months of the first case on U.S. soil, we would witness 5,270,000 people being infected from the disease, and 167,000 dying from it. And that the stunning toll of the disease would ripple into every nook and cranny of our society, from the economy to the fabric of our families and to the mental and physical health of all of our citizens.

However, what I couldn’t have known on this past New Year’s Day is how incredibly resilient and innovative our hospital medicine society and community would be to not only endure this new way of working and living, but also to find ways to improve upon how we care for all patients, despite COVID-19. What I couldn’t have known is how hospitalists would pivot to new arenas of care settings, including the EDs, ICUs, “COVID units,” and telehealth – flawlessly and seamlessly filling care gaps that would otherwise be catastrophically unfilled.

What I couldn’t have known is how we would be willing to come back into work, day after day, to care for our patients, despite the risks to ourselves and our families. What I couldn’t have known is how hospitalists would come together as a community to network and share knowledge in unprecedented ways, both humbly and proactively – knowing that we would not have all the answers but that we probably had better answers than most. What I couldn’t have known is that the SHM staff would pivot our entire SHM team away from previous “staple” offerings (e.g., live meetings) to virtual learning and network opportunities, which would be attended at rates higher than ever seen before, including live webinars, HMX exchanges, and e-learnings. What I couldn’t have known is that we would figure out, in a matter of weeks, what treatments were and were not effective for our patients and get those treatments to them despite the difficulties. And what I couldn’t have known is how much prouder I would be, more than ever before, to tell people: “I am a hospitalist.”

I took my son to the dentist recently, and when we were just about to leave, the dentist asked: “What do you do for a living?” and I stated: “I am a hospitalist.” He slowly breathed in and replied: “Oh … wow … you have really seen things …” Yes, we have.

So, is 2020 shaping up as expected? Absolutely not! But I am more inspired, humbled, and motivated than ever to proudly serve SHM with more energy and enthusiasm than I would have dreamed on New Year’s Day. And even if we can’t see each other in person (as we so naively planned), through virtual meetings (national, regional, and chapter), webinars, social media, and other listening modes, we will still be able to connect as a community and share ideas and issues as we muddle through the remainder of 2020 and beyond. We need each other more than ever before, and I am so proud to be a part of this SHM family.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.

I remember New Year’s Day 2020, full of hope and wonderment of what the year would bring. I was coming into the Society of Hospital Medicine as the incoming President, taking the 2020 reins in the organization’s 20th year. It would be a year of transitioning to a new CEO, reinvigorating our membership engagement efforts, and renewing a strategic plan for forward progress into the next decade. It would be a year chock full of travel, speaking engagements, and meetings with thousands of hospitalists around the globe.

What I didn’t know is that we would soon face the grim reality that the long-voiced concern of infectious disease experts and epidemiologists would come true. That our colleagues and friends and families would be infected, hospitalized, and die from this new disease, for which there were no good, effective treatments. That our ability to come together as a nation to implement basic infection control and epidemiologic practices would be fractured, uncoordinated, and ineffective. That within 6 months of the first case on U.S. soil, we would witness 5,270,000 people being infected from the disease, and 167,000 dying from it. And that the stunning toll of the disease would ripple into every nook and cranny of our society, from the economy to the fabric of our families and to the mental and physical health of all of our citizens.

However, what I couldn’t have known on this past New Year’s Day is how incredibly resilient and innovative our hospital medicine society and community would be to not only endure this new way of working and living, but also to find ways to improve upon how we care for all patients, despite COVID-19. What I couldn’t have known is how hospitalists would pivot to new arenas of care settings, including the EDs, ICUs, “COVID units,” and telehealth – flawlessly and seamlessly filling care gaps that would otherwise be catastrophically unfilled.

What I couldn’t have known is how we would be willing to come back into work, day after day, to care for our patients, despite the risks to ourselves and our families. What I couldn’t have known is how hospitalists would come together as a community to network and share knowledge in unprecedented ways, both humbly and proactively – knowing that we would not have all the answers but that we probably had better answers than most. What I couldn’t have known is that the SHM staff would pivot our entire SHM team away from previous “staple” offerings (e.g., live meetings) to virtual learning and network opportunities, which would be attended at rates higher than ever seen before, including live webinars, HMX exchanges, and e-learnings. What I couldn’t have known is that we would figure out, in a matter of weeks, what treatments were and were not effective for our patients and get those treatments to them despite the difficulties. And what I couldn’t have known is how much prouder I would be, more than ever before, to tell people: “I am a hospitalist.”

I took my son to the dentist recently, and when we were just about to leave, the dentist asked: “What do you do for a living?” and I stated: “I am a hospitalist.” He slowly breathed in and replied: “Oh … wow … you have really seen things …” Yes, we have.

So, is 2020 shaping up as expected? Absolutely not! But I am more inspired, humbled, and motivated than ever to proudly serve SHM with more energy and enthusiasm than I would have dreamed on New Year’s Day. And even if we can’t see each other in person (as we so naively planned), through virtual meetings (national, regional, and chapter), webinars, social media, and other listening modes, we will still be able to connect as a community and share ideas and issues as we muddle through the remainder of 2020 and beyond. We need each other more than ever before, and I am so proud to be a part of this SHM family.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.

I remember New Year’s Day 2020, full of hope and wonderment of what the year would bring. I was coming into the Society of Hospital Medicine as the incoming President, taking the 2020 reins in the organization’s 20th year. It would be a year of transitioning to a new CEO, reinvigorating our membership engagement efforts, and renewing a strategic plan for forward progress into the next decade. It would be a year chock full of travel, speaking engagements, and meetings with thousands of hospitalists around the globe.

What I didn’t know is that we would soon face the grim reality that the long-voiced concern of infectious disease experts and epidemiologists would come true. That our colleagues and friends and families would be infected, hospitalized, and die from this new disease, for which there were no good, effective treatments. That our ability to come together as a nation to implement basic infection control and epidemiologic practices would be fractured, uncoordinated, and ineffective. That within 6 months of the first case on U.S. soil, we would witness 5,270,000 people being infected from the disease, and 167,000 dying from it. And that the stunning toll of the disease would ripple into every nook and cranny of our society, from the economy to the fabric of our families and to the mental and physical health of all of our citizens.

However, what I couldn’t have known on this past New Year’s Day is how incredibly resilient and innovative our hospital medicine society and community would be to not only endure this new way of working and living, but also to find ways to improve upon how we care for all patients, despite COVID-19. What I couldn’t have known is how hospitalists would pivot to new arenas of care settings, including the EDs, ICUs, “COVID units,” and telehealth – flawlessly and seamlessly filling care gaps that would otherwise be catastrophically unfilled.

What I couldn’t have known is how we would be willing to come back into work, day after day, to care for our patients, despite the risks to ourselves and our families. What I couldn’t have known is how hospitalists would come together as a community to network and share knowledge in unprecedented ways, both humbly and proactively – knowing that we would not have all the answers but that we probably had better answers than most. What I couldn’t have known is that the SHM staff would pivot our entire SHM team away from previous “staple” offerings (e.g., live meetings) to virtual learning and network opportunities, which would be attended at rates higher than ever seen before, including live webinars, HMX exchanges, and e-learnings. What I couldn’t have known is that we would figure out, in a matter of weeks, what treatments were and were not effective for our patients and get those treatments to them despite the difficulties. And what I couldn’t have known is how much prouder I would be, more than ever before, to tell people: “I am a hospitalist.”

I took my son to the dentist recently, and when we were just about to leave, the dentist asked: “What do you do for a living?” and I stated: “I am a hospitalist.” He slowly breathed in and replied: “Oh … wow … you have really seen things …” Yes, we have.

So, is 2020 shaping up as expected? Absolutely not! But I am more inspired, humbled, and motivated than ever to proudly serve SHM with more energy and enthusiasm than I would have dreamed on New Year’s Day. And even if we can’t see each other in person (as we so naively planned), through virtual meetings (national, regional, and chapter), webinars, social media, and other listening modes, we will still be able to connect as a community and share ideas and issues as we muddle through the remainder of 2020 and beyond. We need each other more than ever before, and I am so proud to be a part of this SHM family.

Dr. Scheurer is chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is president of SHM.

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.