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FDA authorizes Pfizer COVID vaccine for teens 12-15
The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.
The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.
Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The Pfizer adolescent vaccine is not yet a done deal, though.
Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.
The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.
The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.
Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.
American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”
President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.”
Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.
Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.
Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.
“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said.
“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.
The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.
Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The Pfizer adolescent vaccine is not yet a done deal, though.
Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.
The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.
The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.
Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.
American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”
President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.”
Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.
Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.
Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.
“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said.
“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.
The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.
Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The Pfizer adolescent vaccine is not yet a done deal, though.
Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.
The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.
The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.
Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.
American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”
President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.
In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.”
Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.
Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.
Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.
“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said.
“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”
A version of this article first appeared on Medscape.com.
NSAIDs don’t make COVID-19 worse in hospitalized patients
NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.
“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”
The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.
For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.
For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.
The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.
In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).
The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.
The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.
The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.
Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.
In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.
The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.
NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.
“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”
The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.
For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.
For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.
The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.
In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).
The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.
The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.
The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.
Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.
In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.
The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.
NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.
“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”
The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.
For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.
For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.
The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.
In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).
The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.
The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.
The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.
Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.
In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.
The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.
FROM THE LANCET RHEUMATOLOGY
A tumultuous and unforgettable year
SHM president bids farewell
As my SHM presidency wraps up, it is a good time to reflect on the past year in hospital medicine. Dominated by COVID-19 preparedness, mitigation, and (now) recovery efforts, the impacts of COVID-19 throughout the medical industry have been profound. For hospital medicine, although we have endured work and home stress unlike anything in recent memory, fortunately a few notably good changes have come about as a result of COVID-19.
Hospitalists have proven that we are extremely capable of adapting to rapidly changing evidence-based practice. The old adage of evidence taking 7 years to become mainstream clinical practice certainly has not been the paradigm during COVID-19. In many cases, clinical care pathways were changing by the week, or even by the day. Usage of SHM’s website, HMX, and educational platforms rose exponentially to keep pace with the changing landscape. Information exchange between and among hospital medicine groups was efficient and effective. This is exactly how it should be, with SHM serving as the catalyst for such information exchange.
Hospitalists were able to shift to telehealth care as the need arose. The use of telehealth is now becoming a core competency for hospitalists around the country, and we are leading the way for other specialists in adoption. COVID-19 enabled not only rapid transformation, but also better payer coverage for the use of all types of telehealth services. SHM will remain a source of training and education in telehealth best practices going forward.
Related, hospitalists also found their programs were being asked to become purveyors for remote monitoring and hospital-at-home programs. Because CMS has allowed some reimbursement for these programs, at least during the public health emergency, hospital medicine programs can more feasibly pursue building and sustaining such programs, and SHM can serve as the hub for best practice exchanges in the field.
The pandemic also created a sizable shift in the mindset of the need and enthusiasm for mainstream maintenance of certification. Although there were already questions about the value of high-stakes exams before the pandemic, both within and outside the medical industry, the pandemic created an immediate need to shift away from such exams. Now, the entire pipeline is questioning the value of these high-stakes exams, such as SATs and ACTs for college admissions, Step 1 exams for medical students, and certification exams for physicians. The pandemic has made us question these milestone exams with more scrutiny and has created a sense of urgency for a change to more adult-learner–focused alternatives. SHM will continue to be at the centerpiece of the discussion, as well as the leader in cultivating educational venues for continuous learning.
So where do we go from here?
I am confident that SHM will continue to pay deep attention to the activities that bring value to hospitalists and support changing practice patterns such as telehealth and hospital-at-home work. Not only will SHM serve as a center for best practices and a conduit for networking and information sharing at the national level – there will be significantly more focus on the support and growth of local chapters. SHM realizes that local chapters are a vital source of networking, education, and pipeline development and will continue to increase the resources to make the chapter programs dynamic and inviting for everyone interested in hospital medicine.
While this presidency year was far different than expected, I have continuously been amazed and delighted with the resiliency and endurance of our hospitalists around the country. We stood out at the front lines of the pandemic, with a mission toward service and a relentless commitment to our patients. Although we still have a long way to go before the pandemic is behind us, I firmly believe we are emerging from the haze stronger and more agile than ever. Thank you for allowing me to serve this incredible organization during such a tumultuous and unforgettable year.
Yours in service.
Dr. Scheurer is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston. She is the outgoing president of SHM.
SHM president bids farewell
SHM president bids farewell
As my SHM presidency wraps up, it is a good time to reflect on the past year in hospital medicine. Dominated by COVID-19 preparedness, mitigation, and (now) recovery efforts, the impacts of COVID-19 throughout the medical industry have been profound. For hospital medicine, although we have endured work and home stress unlike anything in recent memory, fortunately a few notably good changes have come about as a result of COVID-19.
Hospitalists have proven that we are extremely capable of adapting to rapidly changing evidence-based practice. The old adage of evidence taking 7 years to become mainstream clinical practice certainly has not been the paradigm during COVID-19. In many cases, clinical care pathways were changing by the week, or even by the day. Usage of SHM’s website, HMX, and educational platforms rose exponentially to keep pace with the changing landscape. Information exchange between and among hospital medicine groups was efficient and effective. This is exactly how it should be, with SHM serving as the catalyst for such information exchange.
Hospitalists were able to shift to telehealth care as the need arose. The use of telehealth is now becoming a core competency for hospitalists around the country, and we are leading the way for other specialists in adoption. COVID-19 enabled not only rapid transformation, but also better payer coverage for the use of all types of telehealth services. SHM will remain a source of training and education in telehealth best practices going forward.
Related, hospitalists also found their programs were being asked to become purveyors for remote monitoring and hospital-at-home programs. Because CMS has allowed some reimbursement for these programs, at least during the public health emergency, hospital medicine programs can more feasibly pursue building and sustaining such programs, and SHM can serve as the hub for best practice exchanges in the field.
The pandemic also created a sizable shift in the mindset of the need and enthusiasm for mainstream maintenance of certification. Although there were already questions about the value of high-stakes exams before the pandemic, both within and outside the medical industry, the pandemic created an immediate need to shift away from such exams. Now, the entire pipeline is questioning the value of these high-stakes exams, such as SATs and ACTs for college admissions, Step 1 exams for medical students, and certification exams for physicians. The pandemic has made us question these milestone exams with more scrutiny and has created a sense of urgency for a change to more adult-learner–focused alternatives. SHM will continue to be at the centerpiece of the discussion, as well as the leader in cultivating educational venues for continuous learning.
So where do we go from here?
I am confident that SHM will continue to pay deep attention to the activities that bring value to hospitalists and support changing practice patterns such as telehealth and hospital-at-home work. Not only will SHM serve as a center for best practices and a conduit for networking and information sharing at the national level – there will be significantly more focus on the support and growth of local chapters. SHM realizes that local chapters are a vital source of networking, education, and pipeline development and will continue to increase the resources to make the chapter programs dynamic and inviting for everyone interested in hospital medicine.
While this presidency year was far different than expected, I have continuously been amazed and delighted with the resiliency and endurance of our hospitalists around the country. We stood out at the front lines of the pandemic, with a mission toward service and a relentless commitment to our patients. Although we still have a long way to go before the pandemic is behind us, I firmly believe we are emerging from the haze stronger and more agile than ever. Thank you for allowing me to serve this incredible organization during such a tumultuous and unforgettable year.
Yours in service.
Dr. Scheurer is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston. She is the outgoing president of SHM.
As my SHM presidency wraps up, it is a good time to reflect on the past year in hospital medicine. Dominated by COVID-19 preparedness, mitigation, and (now) recovery efforts, the impacts of COVID-19 throughout the medical industry have been profound. For hospital medicine, although we have endured work and home stress unlike anything in recent memory, fortunately a few notably good changes have come about as a result of COVID-19.
Hospitalists have proven that we are extremely capable of adapting to rapidly changing evidence-based practice. The old adage of evidence taking 7 years to become mainstream clinical practice certainly has not been the paradigm during COVID-19. In many cases, clinical care pathways were changing by the week, or even by the day. Usage of SHM’s website, HMX, and educational platforms rose exponentially to keep pace with the changing landscape. Information exchange between and among hospital medicine groups was efficient and effective. This is exactly how it should be, with SHM serving as the catalyst for such information exchange.
Hospitalists were able to shift to telehealth care as the need arose. The use of telehealth is now becoming a core competency for hospitalists around the country, and we are leading the way for other specialists in adoption. COVID-19 enabled not only rapid transformation, but also better payer coverage for the use of all types of telehealth services. SHM will remain a source of training and education in telehealth best practices going forward.
Related, hospitalists also found their programs were being asked to become purveyors for remote monitoring and hospital-at-home programs. Because CMS has allowed some reimbursement for these programs, at least during the public health emergency, hospital medicine programs can more feasibly pursue building and sustaining such programs, and SHM can serve as the hub for best practice exchanges in the field.
The pandemic also created a sizable shift in the mindset of the need and enthusiasm for mainstream maintenance of certification. Although there were already questions about the value of high-stakes exams before the pandemic, both within and outside the medical industry, the pandemic created an immediate need to shift away from such exams. Now, the entire pipeline is questioning the value of these high-stakes exams, such as SATs and ACTs for college admissions, Step 1 exams for medical students, and certification exams for physicians. The pandemic has made us question these milestone exams with more scrutiny and has created a sense of urgency for a change to more adult-learner–focused alternatives. SHM will continue to be at the centerpiece of the discussion, as well as the leader in cultivating educational venues for continuous learning.
So where do we go from here?
I am confident that SHM will continue to pay deep attention to the activities that bring value to hospitalists and support changing practice patterns such as telehealth and hospital-at-home work. Not only will SHM serve as a center for best practices and a conduit for networking and information sharing at the national level – there will be significantly more focus on the support and growth of local chapters. SHM realizes that local chapters are a vital source of networking, education, and pipeline development and will continue to increase the resources to make the chapter programs dynamic and inviting for everyone interested in hospital medicine.
While this presidency year was far different than expected, I have continuously been amazed and delighted with the resiliency and endurance of our hospitalists around the country. We stood out at the front lines of the pandemic, with a mission toward service and a relentless commitment to our patients. Although we still have a long way to go before the pandemic is behind us, I firmly believe we are emerging from the haze stronger and more agile than ever. Thank you for allowing me to serve this incredible organization during such a tumultuous and unforgettable year.
Yours in service.
Dr. Scheurer is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston. She is the outgoing president of SHM.
In-hospital glucose management program gives dramatic savings
Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.
The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.
In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.
Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.
About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.
“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.
Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.
“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.
Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”
Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.
“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.
Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
‘The nurses were so afraid of hypoglycemia’
Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.
“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.
In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”
So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
Inpatient hypoglycemia rate was cut nearly in half
This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:
1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.
According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.
2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.
3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.
4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.
Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.
The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).
Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).
On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
Reducing insulin pen waste by minimizing duplicate prescriptions
Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.
The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.
After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.
“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”
When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.
The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.
Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.
From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).
The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.
Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.
Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.
The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”
Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.
The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.
In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.
Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.
About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.
“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.
Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.
“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.
Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”
Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.
“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.
Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
‘The nurses were so afraid of hypoglycemia’
Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.
“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.
In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”
So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
Inpatient hypoglycemia rate was cut nearly in half
This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:
1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.
According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.
2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.
3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.
4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.
Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.
The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).
Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).
On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
Reducing insulin pen waste by minimizing duplicate prescriptions
Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.
The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.
After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.
“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”
When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.
The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.
Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.
From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).
The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.
Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.
Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.
The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”
Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest.
The two projects are part of a dedicated inpatient glucose management service led by Mihail (“Misha”) Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital.
In 2019, Dr. Zilbermint and colleagues reported that their inpatient glucose management program resulted in a 27% reduction in length of stay and a 10.7% lower 30-day readmission rate. The projected cost savings for the period January 2016 to May 2017 was $953,578.
Dr. Zilbermint’s team has written two new articles that document cost savings for specific elements of the program; namely, a set of hospital-wide hypoglycemia prevention measures, and an initiative that reduced duplicate inpatient insulin pen dispensing.
About 1 in 4 people in U.S. hospitals have diabetes or hyperglycemia. Large academic hospitals have endocrine divisions and training programs, but 85% of people receive care at small community hospitals.
“There are management guidelines, but they’re not always followed ... That’s why I’ve been advocating for endocrine hospitalists to be deployed nationally,” Dr. Zilbermint said. He is chief and director of endocrinology, diabetes, and metabolism at Johns Hopkins Community Physicians at Suburban Hospital, Bethesda, Maryland.
Asked to comment on behalf of the Society of Hospital Medicine (SHM), Greg Maynard, MD, program lead for SHM’s Electronic Quality Improvement Programs, said that Suburban’s overall program goals align with those of the SHM.
“Dedicated inpatient glycemic control teams are very important and desirable to improve the quality and safety of care for inpatients with hyperglycemia and diabetes,” he said.
Regarding specific initiatives, such as those aimed at reducing hypoglycemia and insulin pen wastage, Dr. Maynard said, “All of these are feasible in a wide variety of institutions. The main barrier is getting the institutional support for people to work on these interventions. This series of studies can help spread the word about the positive return on investment.”
Another barrier – the current lack of publicly reported measures or pay-for-performance programs for hypoglycemia prevention and glycemic control – may soon change, added Dr. Maynard, who is also chief quality officer at the University of California, Davis, Medical Center.
“The National Quality Forum has endorsed new measures, and the CDC’s National Healthcare Safety Network is working on ways to augment those measures and embed them into their infrastructure,” he said.
Although SHM doesn’t specifically endorse full-time glycemic control hospitalists over endocrinology-trained glycemic control experts, “certainly hospitalists who accrue added training are very well positioned to be an important part of these interdisciplinary teams,” Dr. Maynard said.
‘The nurses were so afraid of hypoglycemia’
Tackling hypoglycemia was Dr. Zilbermint’s first priority when he started the glycemic management program at Suburban in late 2015.
“One of the most common complaints from the nurses was that a lot of their patients had hypoglycemia, especially in the ICU, when patients were placed on insulin infusion protocols ... Every time, the nurse would have to call the attending and ask what to do,” he explains.
In addition, Dr. Zilbermint says, there was no standard for treating hypoglycemia. A nurse in one unit would give two cups of juice, another a 50% dextrose infusion, or another, milk. Even more concerning, “the nurses were so afraid of hypoglycemia they would reflexively discontinue all insulin, including basal.”
So one of the new initiatives, led by Carter Shelton, MSHCM, an administrative fellow at the Medical University of South Carolina, Charleston, was to implement a set of hospital-wide hypoglycemia prevention measures, as described in an article published online April 21 in the Journal of Diabetes Science and Technology.
Inpatient hypoglycemia rate was cut nearly in half
This began in 2016, when the multidisciplinary Suburban Hospital Glucose Steering Committee identified four main causes of insulin-induced hypoglycemia (defined as a blood glucose level of ≤70 mg/dL in a patient who had received at least one dose of insulin in the past 24 hours) and devised solutions for each:
1. Lack of a unified hypoglycemia protocol. A formal, evidence-based, nurse-driven treatment protocol with clinical decision support in the electronic medical record was developed. The Suburban team adapted much of the protocol from one that had been recently implemented at the flagship Johns Hopkins Hospital, in Baltimore, Maryland.
According to that protocol, if patients are able to swallow, they are given 15 g or 30 g of carbohydrates in order to achieve a blood glucose level of 50 to 70 mg/dL and <50 mg/dL, respectively. Levels are checked 15 minutes later. Intravenous D50 or glucagon is reserved for patients who can’t swallow.
2. For patients in critical care, the insulin infusion protocol that had been in use set blood glucose targets of 80 to 110 mg/dL, which resulted in hypoglycemia in nearly every patient who received an insulin infusion. This protocol was changed to the currently recommended 140 to 180 mg/dL.
3. Most patients were managed with sliding-scale insulin, an outdated yet still widely used regimen whereby insulin is given based only on current blood glucose without accounting for carbohydrates consumed with meals and not corrected until the subsequent meal. This was changed so that nurses give insulin after the patient has consumed at least 50% of their meal carbohydrates.
4. Lack of hypoglycemia reporting. A glucometrics dashboard – now used throughout the Johns Hopkins system – was adopted to produce daily hypoglycemia reports in the EMR system that could be reviewed by the inpatient glucose management service to track quality metrics and plan further interventions.
Between Jan. 1, 2016, and Sept. 30, 2019, out of a total 49,315 patient-days, there were 2,682 days on which any hypoglycemia occurred and 874 days on which moderate hypoglycemia occurred (≤54 mg/dL). Type 2 diabetes accounted for 84.4% of the total patient-days; type 1 accounted for 4.4%.
The overall frequency of any hypoglycemia patient-days per month decreased from 7.5% to 3.9% during the study period (P = .001). This was significant for the patients with type 2 diabetes (7.4% to 3.8%; P < .0001) but not for those with type 1 diabetes (18.5% to 18.0%; P = .08).
Rates of moderate hypoglycemia also decreased significantly among the patients with type 2 diabetes (1.9% to 1.0%; P = .03) but not for those with type 1 diabetes (7.4% to 6.0%; P = .14).
On the basis of these rates in reducing hypoglycemia, in which the inpatient hypoglycemia rate was cut nearly in half, the estimated savings in cost of care to the hospital was $98,635 during the period of January 2016 to September 2019.
Reducing insulin pen waste by minimizing duplicate prescriptions
Suburban Hospital had been using insulin vials and syringes when Dr. Zilbermint first arrived there. He lobbied the administration to allow use of pens, because they’re easier to use and they reduce the risk for needlestick injuries. Nurses were educated and retrained monthly in their use.
The switch to pens – aspart (Novolog Flexpen) for bolus insulin and glargine (Lantus SoloSTAR) – took place in 2018. The cost of the aspart pen was $16.19, and the cost of glargine was $25.08. Each holds 300 units of insulin.
After the first month, the team noticed a large increase in expenses. A quality improvement project was devised to address the issue.
“We were dispensing sometimes three or four pens per person. That’s a lot. Each pen holds 300 units, so one pen should last the entire hospital stay of an average 4- or 5-day stay,” Dr. Zilbermint explained. “We had to figure out where we were bleeding the money and where the pens were going.”
When pens disappeared, the pharmacy would have to dispense new ones. One problem was that when patients were transferred from one unit to another, the pen would be left behind and the room would be cleaned. Sometimes the pens weren’t stored properly or were misplaced. Often, they’d end up in a nurse’s pocket.
The second intervention was led by Urooj Najmi, MD, of the American International School of Medicine, Atlanta, Georgia. A program was instituted to reduce duplicate inpatient insulin pen dispensing, as detailed in an article published in the same issue of the Journal of Diabetes Science and Technology.
Solutions to reduce duplicate pen dispensing included having pharmacy track daily insulin pen reports and monitor duplicate orders, with “do not dispense” instructions conveyed via the EMR system. All multidose medications, including insulin pens, were to be placed in patients’ bins at the nursing station, and nurses were instructed to look for patients’ insulin pens prior to their being transferred to another unit, rather than ask for a replacement pen.
From July 2018 to July 2019, 3,121 patients received insulin, of whom 95% received aspart and 47% received glargine. Of the 9,516 pens dispensed, 68% were for aspart and 32% were for glargine. During the study period, the number of pens dispensed per patient dropped from 2.2 to 1.2 for aspart and from 2.1 to 1.3 for glargine; differences were highly significant (P = .0002 and P = .0005, respectively).
The total amount of unnecessary dispensing during the first 4 months after initiating the pen implementation program was 58%. The average monthly cost was $11,820.68; the projected cost per year was $141,848.
Six months after the waste reduction strategies were implemented, monthly waste had dropped to 42%, translating to an estimated potential cost savings of $66,261 over 12 months.
Because Suburban Hospital doesn’t have an outpatient dispensing license, there is still wastage when patients are discharged, because they can’t take their pens home with them. That remains a challenge, Dr. Zilbermint noted.
The team is working on implementing automatic A1c testing for patients admitted with hyperglycemia who either have a history of diabetes or whose blood glucose level is >140 mg/dL. Dr. Zilbermint said, “it’s in the guidelines, but it’s not always done.”
Dr. Zilbermint is a consultant for Guidepoint. Dr. Maynard, Mr. Shelton, and Dr. Najmi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dr. Topol talks: COVID-19 variants are innocent until proven guilty
Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”
You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?
The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.
The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.
The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.
But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.
As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.
At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.
We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.
The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.
The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.
With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.
We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.
Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?
First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.
The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.
I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?
As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.
In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.
I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.
That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.
All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.
Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.
In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.
There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
What do you think it will take to achieve herd immunity?
I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.
It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.
We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.
People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.
Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.
That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.
A version of this article first appeared on Medscape.com.
Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”
You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?
The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.
The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.
The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.
But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.
As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.
At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.
We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.
The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.
The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.
With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.
We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.
Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?
First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.
The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.
I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?
As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.
In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.
I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.
That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.
All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.
Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.
In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.
There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
What do you think it will take to achieve herd immunity?
I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.
It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.
We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.
People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.
Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.
That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.
A version of this article first appeared on Medscape.com.
Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”
You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?
The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.
The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.
The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.
But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.
As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.
At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.
We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.
The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.
The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.
With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.
We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.
Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?
First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.
The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.
I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?
As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.
In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.
I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.
That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.
All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.
Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.
In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.
There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
What do you think it will take to achieve herd immunity?
I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.
It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.
We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.
People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.
Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.
That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.
A version of this article first appeared on Medscape.com.
Infective endocarditis with stroke after TAVR has ‘dismal’ prognosis
Patients who suffer a stroke during hospitalization for infective endocarditis (IE) after transcatheter aortic valve replacement (TAVR) have a dismal prognosis, with more than half dying during the index hospitalization and two-thirds within the first year, a new study shows.
The study – the first to evaluate stroke as an IE-related complication following TAVR in a large multicenter cohort – is published in the May 11 issue of the Journal of the American College of Cardiology.
The authors, led by David del Val, MD, Quebec Heart & Lung Institute, Quebec City, explain that IE after TAVR is a rare but serious complication associated with a high mortality rate. Neurologic events, especially stroke, remain one of the most common and potentially disabling IE-related complications, but until now, no study has attempted to evaluate the predictors of stroke and outcomes in patients with IE following TAVR.
For the current study, the authors analyzed data from the Infectious Endocarditis after TAVR International Registry, including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries.
Patients who experienced a stroke during IE admission were compared with patients who did not have a stroke.
Results showed that 57 patients (10%) had a stroke during IE hospitalization, with no differences in the causative microorganism between groups. Stroke patients had higher rates of acute renal failure, systemic embolization, and persistent bacteremia.
Factors associated with a higher risk for stroke during the index IE hospitalization included stroke before IE, moderate or higher residual aortic regurgitation after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size greater than 8 mm.
The stroke rate was 3.1% in patients with none of these risk factors; 6.1% with one risk factor; 13.1% with two risk factors; 28.9% with three risk factors, and 60% with four risk factors.
“The presence of such factors (particularly in combination) may be considered for determining an earlier and more aggressive (medical or surgical) treatment in these patients,” the researchers say.
IE patients with stroke had higher rates of in-hospital mortality (54.4% vs. 28.7%) and overall mortality at 1 year (66.3% vs. 45.6%).
Surgery rates were low (25%) even in the presence of stroke and failed to improve outcomes in this population.
Noting that consensus guidelines for managing patients with IE recommend surgery along with antibiotic treatment for patients developing systemic embolism, particularly stroke, the researchers say their findings suggest that such surgery recommendations may not be extrapolated to TAVR-IE patients, and specific guidelines are warranted for this particular population.
Furthermore, the possibility of early surgery in those patients with factors increasing the risk for stroke should be evaluated in future studies.
The authors note that TAVR has revolutionized the treatment of aortic stenosis and is currently moving toward less complex and younger patients with lower surgical risk. Despite the relatively low incidence of IE after TAVR, the number of procedures is expected to grow exponentially, increasing the number of patients at risk of developing this life-threatening complication. Therefore, detailed knowledge of this disease and its complications is essential to improve outcomes.
They point out that the 10% rate of stroke found in this study is substantially lower, compared with the largest surgical prosthetic-valve infective endocarditis registries, but they suggest that the unique clinical profile of TAVR patients may lead to an underdiagnosis of stroke, with a high proportion of elderly patients who more frequently present with nonspecific symptoms.
They conclude that “IE post-TAVR is associated with a poor prognosis with high in-hospital and late mortality rates. Our study reveals that patients with IE after TAVR complicated by stroke showed an even worse prognosis.”
“The progressive implementation of advanced imaging modalities for early IE diagnosis, especially nuclear imaging, may translate into a better prognosis in coming years. Close attention should be paid to early recognition of stroke-associated factors to improve clinical outcomes,” they add.
In an accompanying editorial, Vuyisile Nkomo, MD, Daniel DeSimone, MD, and William Miranda, MD, Mayo Clinic, Rochester, Minn., say the current study “highlights the devastating consequences of IE after TAVR and the even worse consequences when IE was associated with stroke.”
This points to the critical importance of efforts to prevent IE with appropriate antibiotic prophylaxis and addressing potential sources of infection (for example, dental screening) before invasive cardiac procedures.
“Patient education is critical in regard to recognizing early signs and symptoms of IE. In particular, patients must be informed to obtain blood cultures with any episode of fever, as identification of bacteremia is critical in the diagnosis of IE,” the editorialists comment.
Endocarditis should also be suspected in afebrile patients with increasing transcatheter heart valve gradients or new or worsening regurgitation, they state.
Multimodality imaging is important for the early diagnosis of IE to facilitate prompt antibiotic treatment and potentially decrease the risk for IE complications, especially systemic embolization, they add.
“Despite the unequivocal advances in the safety and periprocedural complications of TAVR, IE with and without stroke in this TAVR population remains a dreadful complication,” they conclude.
Dr. Del Val was supported by a research grant from the Fundación Alfonso Martin Escudero. The editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who suffer a stroke during hospitalization for infective endocarditis (IE) after transcatheter aortic valve replacement (TAVR) have a dismal prognosis, with more than half dying during the index hospitalization and two-thirds within the first year, a new study shows.
The study – the first to evaluate stroke as an IE-related complication following TAVR in a large multicenter cohort – is published in the May 11 issue of the Journal of the American College of Cardiology.
The authors, led by David del Val, MD, Quebec Heart & Lung Institute, Quebec City, explain that IE after TAVR is a rare but serious complication associated with a high mortality rate. Neurologic events, especially stroke, remain one of the most common and potentially disabling IE-related complications, but until now, no study has attempted to evaluate the predictors of stroke and outcomes in patients with IE following TAVR.
For the current study, the authors analyzed data from the Infectious Endocarditis after TAVR International Registry, including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries.
Patients who experienced a stroke during IE admission were compared with patients who did not have a stroke.
Results showed that 57 patients (10%) had a stroke during IE hospitalization, with no differences in the causative microorganism between groups. Stroke patients had higher rates of acute renal failure, systemic embolization, and persistent bacteremia.
Factors associated with a higher risk for stroke during the index IE hospitalization included stroke before IE, moderate or higher residual aortic regurgitation after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size greater than 8 mm.
The stroke rate was 3.1% in patients with none of these risk factors; 6.1% with one risk factor; 13.1% with two risk factors; 28.9% with three risk factors, and 60% with four risk factors.
“The presence of such factors (particularly in combination) may be considered for determining an earlier and more aggressive (medical or surgical) treatment in these patients,” the researchers say.
IE patients with stroke had higher rates of in-hospital mortality (54.4% vs. 28.7%) and overall mortality at 1 year (66.3% vs. 45.6%).
Surgery rates were low (25%) even in the presence of stroke and failed to improve outcomes in this population.
Noting that consensus guidelines for managing patients with IE recommend surgery along with antibiotic treatment for patients developing systemic embolism, particularly stroke, the researchers say their findings suggest that such surgery recommendations may not be extrapolated to TAVR-IE patients, and specific guidelines are warranted for this particular population.
Furthermore, the possibility of early surgery in those patients with factors increasing the risk for stroke should be evaluated in future studies.
The authors note that TAVR has revolutionized the treatment of aortic stenosis and is currently moving toward less complex and younger patients with lower surgical risk. Despite the relatively low incidence of IE after TAVR, the number of procedures is expected to grow exponentially, increasing the number of patients at risk of developing this life-threatening complication. Therefore, detailed knowledge of this disease and its complications is essential to improve outcomes.
They point out that the 10% rate of stroke found in this study is substantially lower, compared with the largest surgical prosthetic-valve infective endocarditis registries, but they suggest that the unique clinical profile of TAVR patients may lead to an underdiagnosis of stroke, with a high proportion of elderly patients who more frequently present with nonspecific symptoms.
They conclude that “IE post-TAVR is associated with a poor prognosis with high in-hospital and late mortality rates. Our study reveals that patients with IE after TAVR complicated by stroke showed an even worse prognosis.”
“The progressive implementation of advanced imaging modalities for early IE diagnosis, especially nuclear imaging, may translate into a better prognosis in coming years. Close attention should be paid to early recognition of stroke-associated factors to improve clinical outcomes,” they add.
In an accompanying editorial, Vuyisile Nkomo, MD, Daniel DeSimone, MD, and William Miranda, MD, Mayo Clinic, Rochester, Minn., say the current study “highlights the devastating consequences of IE after TAVR and the even worse consequences when IE was associated with stroke.”
This points to the critical importance of efforts to prevent IE with appropriate antibiotic prophylaxis and addressing potential sources of infection (for example, dental screening) before invasive cardiac procedures.
“Patient education is critical in regard to recognizing early signs and symptoms of IE. In particular, patients must be informed to obtain blood cultures with any episode of fever, as identification of bacteremia is critical in the diagnosis of IE,” the editorialists comment.
Endocarditis should also be suspected in afebrile patients with increasing transcatheter heart valve gradients or new or worsening regurgitation, they state.
Multimodality imaging is important for the early diagnosis of IE to facilitate prompt antibiotic treatment and potentially decrease the risk for IE complications, especially systemic embolization, they add.
“Despite the unequivocal advances in the safety and periprocedural complications of TAVR, IE with and without stroke in this TAVR population remains a dreadful complication,” they conclude.
Dr. Del Val was supported by a research grant from the Fundación Alfonso Martin Escudero. The editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who suffer a stroke during hospitalization for infective endocarditis (IE) after transcatheter aortic valve replacement (TAVR) have a dismal prognosis, with more than half dying during the index hospitalization and two-thirds within the first year, a new study shows.
The study – the first to evaluate stroke as an IE-related complication following TAVR in a large multicenter cohort – is published in the May 11 issue of the Journal of the American College of Cardiology.
The authors, led by David del Val, MD, Quebec Heart & Lung Institute, Quebec City, explain that IE after TAVR is a rare but serious complication associated with a high mortality rate. Neurologic events, especially stroke, remain one of the most common and potentially disabling IE-related complications, but until now, no study has attempted to evaluate the predictors of stroke and outcomes in patients with IE following TAVR.
For the current study, the authors analyzed data from the Infectious Endocarditis after TAVR International Registry, including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries.
Patients who experienced a stroke during IE admission were compared with patients who did not have a stroke.
Results showed that 57 patients (10%) had a stroke during IE hospitalization, with no differences in the causative microorganism between groups. Stroke patients had higher rates of acute renal failure, systemic embolization, and persistent bacteremia.
Factors associated with a higher risk for stroke during the index IE hospitalization included stroke before IE, moderate or higher residual aortic regurgitation after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size greater than 8 mm.
The stroke rate was 3.1% in patients with none of these risk factors; 6.1% with one risk factor; 13.1% with two risk factors; 28.9% with three risk factors, and 60% with four risk factors.
“The presence of such factors (particularly in combination) may be considered for determining an earlier and more aggressive (medical or surgical) treatment in these patients,” the researchers say.
IE patients with stroke had higher rates of in-hospital mortality (54.4% vs. 28.7%) and overall mortality at 1 year (66.3% vs. 45.6%).
Surgery rates were low (25%) even in the presence of stroke and failed to improve outcomes in this population.
Noting that consensus guidelines for managing patients with IE recommend surgery along with antibiotic treatment for patients developing systemic embolism, particularly stroke, the researchers say their findings suggest that such surgery recommendations may not be extrapolated to TAVR-IE patients, and specific guidelines are warranted for this particular population.
Furthermore, the possibility of early surgery in those patients with factors increasing the risk for stroke should be evaluated in future studies.
The authors note that TAVR has revolutionized the treatment of aortic stenosis and is currently moving toward less complex and younger patients with lower surgical risk. Despite the relatively low incidence of IE after TAVR, the number of procedures is expected to grow exponentially, increasing the number of patients at risk of developing this life-threatening complication. Therefore, detailed knowledge of this disease and its complications is essential to improve outcomes.
They point out that the 10% rate of stroke found in this study is substantially lower, compared with the largest surgical prosthetic-valve infective endocarditis registries, but they suggest that the unique clinical profile of TAVR patients may lead to an underdiagnosis of stroke, with a high proportion of elderly patients who more frequently present with nonspecific symptoms.
They conclude that “IE post-TAVR is associated with a poor prognosis with high in-hospital and late mortality rates. Our study reveals that patients with IE after TAVR complicated by stroke showed an even worse prognosis.”
“The progressive implementation of advanced imaging modalities for early IE diagnosis, especially nuclear imaging, may translate into a better prognosis in coming years. Close attention should be paid to early recognition of stroke-associated factors to improve clinical outcomes,” they add.
In an accompanying editorial, Vuyisile Nkomo, MD, Daniel DeSimone, MD, and William Miranda, MD, Mayo Clinic, Rochester, Minn., say the current study “highlights the devastating consequences of IE after TAVR and the even worse consequences when IE was associated with stroke.”
This points to the critical importance of efforts to prevent IE with appropriate antibiotic prophylaxis and addressing potential sources of infection (for example, dental screening) before invasive cardiac procedures.
“Patient education is critical in regard to recognizing early signs and symptoms of IE. In particular, patients must be informed to obtain blood cultures with any episode of fever, as identification of bacteremia is critical in the diagnosis of IE,” the editorialists comment.
Endocarditis should also be suspected in afebrile patients with increasing transcatheter heart valve gradients or new or worsening regurgitation, they state.
Multimodality imaging is important for the early diagnosis of IE to facilitate prompt antibiotic treatment and potentially decrease the risk for IE complications, especially systemic embolization, they add.
“Despite the unequivocal advances in the safety and periprocedural complications of TAVR, IE with and without stroke in this TAVR population remains a dreadful complication,” they conclude.
Dr. Del Val was supported by a research grant from the Fundación Alfonso Martin Escudero. The editorialists have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Trends in the management of pulmonary embolism
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
One of the newest trends in pulmonary embolism management is treatment of cancer associated venous thromboembolism (VTE) which encompasses deep vein thrombosis (DVT) and PE. Following the clinical management of cancer-associated venous thromboembolism in the hospital, direct oral anticoagulant therapy at discharge is your starting point, except in cases of intact luminal cancers, Scott Kaatz, DO, MSc, FACP, SFHM, said during SHM Converge, the annual conference of the Society of Hospital Medicine.
Dr. Kaatz, of the division of hospital medicine at Henry Ford Hospital, Detroit, based his remarks on emerging recommendations from leading medical societies on the topic, as well as a one-page algorithm from the Anticoagulation Forum that can be accessed at https://acforum-excellence.org/Resource-Center/resource_files/1638-2020-11-30-121425.pdf.
For the short-term treatment of VTE (3-6 months) for patients with active cancer, the American Society of Hematology guideline panel suggests direct oral anticoagulants, such as apixaban, edoxaban, or rivaroxaban, over low-molecular-weight heparin (LMWH) – a conditional recommendation based on low certainty in the evidence of effects.
Dr. Kaatz also discussed the latest recommendations regarding length of VTE treatment. After completion of primary treatment for patients with DVT and/or PE provoked by a chronic risk factor such as a surgery, pregnancy, or having a leg in a cast, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “On the other hand, patients with DVT and/or PE provoked by a transient factor typically do not require antithrombotic therapy after completion of primary treatment,” said Dr. Kaatz, who is also a clinical professor of medicine at Wayne State University, Detroit.
After completion of primary treatment for patients with unprovoked DVT and/or PE, the ASH guideline panel suggests indefinite antithrombotic therapy over stopping anticoagulation. “The recommendation does not apply to patients who have a high risk for bleeding complications,” he noted.
Transient or reversible risk factors should be also considered in length of VTE treatment. For example, according to guidelines from the European Society of Cardiology, the estimated risk for long-term VTE recurrence is high (defined as greater than 8% per year) for patients with active cancer, for patients with one or more previous episodes of VTE in the absence of a major transient or reversible factor, and for those with antiphospholipid antibody syndrome.
Dr. Kaatz also highlighted recommendations for the acute treatment of intermediate risk, or submassive PE. The ESC guidelines state that if anticoagulation is initiated parenterally, LMWH or fondaparinux is recommended over unfractionated heparin (UFH) for most patients. “The reason for that is, one drug-use evaluation study found that, after 24 hours using UFH, only about 24% of patients had reached their therapeutic goal,” Dr. Kaatz said. Guidelines for intermediate risk patients from ASH recommend anticoagulation as your starting point, while thrombolysis is reasonable to consider for submassive PE and low risk for bleeding in selected younger patients or for patients at high risk for decompensation because of concomitant cardiopulmonary disease. “The bleeding rates get much higher in patients over age 65,” he said.
Another resource Dr. Kaatz mentioned is the Pulmonary Embolism Response Team (PERT) Consortium, which was developed after initial efforts of a multidisciplinary team of physicians at Massachusetts General Hospital. The first PERT sought to coordinate and expedite the treatment of pulmonary embolus with a team of physicians from a variety of specialties. In 2019 the PERT Consortium published guidelines on the diagnosis, treatment, and follow-up of acute PE. “It includes detailed algorithms that are a little different from the ASH and ESC guidelines,” Dr. Kaatz said.
Dr. Kaatz disclosed that he is a consultant for Janssen, Pfizer, Portola/Alexion, Bristol-Myers Squibb, Novartis, and CSL Behring. He has also received research funding from Janssen, Bristol-Myers Squibb, and Osmosis. He also holds board positions with the AC Forum and the National Blood Clot Alliance Medical and Scientific Advisory Board.
FROM SHM CONVERGE 2021
Clinician well-being a top priority, Surgeon General says
Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.
“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.
Dr. Scheurer said that this was “welcome news and wonderful to hear.”
“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”
Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.
He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.
“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.
The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.
One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.
“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”
Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.
“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”
On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.
“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”
Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”
Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.
“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”
Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.
“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.
Dr. Scheurer said that this was “welcome news and wonderful to hear.”
“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”
Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.
He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.
“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.
The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.
One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.
“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”
Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.
“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”
On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.
“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”
Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”
Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.
“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”
Clinicians’ well-being is a “crisis” of grave import to the public health and a top issue that he hopes to get more squarely on the public radar screen, Surgeon General Vivek Murthy, MD, MBA, said May 6 in a “fireside chat” with SHM president Danielle Scheurer, MD, MSRC, SFHM, at SHM Converge, the annual conference of the Society of Hospital Medicine.
“This is a crisis that I don’t know that the country recognizes is fully important,” Dr. Murthy said. “I don’t think that most people in the public recognize just how extraordinarily difficult it is, for many clinicians, to come to practice. And if the clinicians continue to burn out at the rate that they are – in addition to the humanitarian crisis of people who are struggling that we should all feel concern about – it will impact care in a profound way.” He said part of his plan is a “national agenda” for clinician well-being, with a clear pathway for creating an environment more conducive to providing quality patient care.
Dr. Scheurer said that this was “welcome news and wonderful to hear.”
“Fortunately or unfortunately, now I do think it’s more in the front seat,” she said, adding that “this notion of ‘heal thyself,’ we know doesn’t work and these are really systemic ailments that we all have to tackle together.”
Dr. Murthy, a hospitalist by training, recently began his second term as Surgeon General, having served under President Obama and appointed to the post again by President Biden. This second appointment is different in the knowledge he has about the job from the start, in the enormity of the public health challenges posed by the COVID-19 pandemic, and in the political tenor of the country.
He said one of his main priorities is to “recenter our public health response” with scientists and public health leaders regaining their proper role.
“Have them be the voices that are actually speaking directly to the public, not in a way that’s biased by the politics or by politicians, but it’s really guided again by the science and substance of what we know needs to happen,” he said.
The response to COVID goes beyond continuing an aggressive vaccination and testing campaign, he said. The pandemic has given rise to worse mental health issues such as depression and anxiety, substance use disorders, and delays in care for other medical conditions for fear of infection – and these are all priorities, Dr. Murthy said.
One “silver lining” of the pandemic is the expansion of telehealth, but this needs refining and persistence to make it work optimally for all patients, he said.
“We have to ensure that that expansion continues and that it’s even – meaning that there are so many parts of the country where broadband access is a challenge for patients, so they don’t have the benefits of telemedicine,” he said. “We also need to ensure that these systems are integrated across our current systems, across hospitals so that we’re not creating more work for clinicians when it comes to utilizing this technology to reach their patients.”
Clinicians – typically viewed as coming to Capitol Hill only to push for higher payment or changes to medical liability laws – need to use their trusted voices to raise the profile of preventive care and identifying and fixing social barriers related to health, such as transportation issues and unsafe neighborhoods, Dr. Murthy said.
“No one really celebrates the heart attack that was prevented or the asthma that was prevented – we celebrate the illness that took place and was cured,” he said. “We know as clinicians that if you really want to reduce human suffering that you have to focus on the prevention side of the house, and I think that unless our colleagues in medicine and in public health come together and advocate for greater investments in prevention, or a national agenda around prevention, my worry is that it won’t naturally develop.”
On vaccine hesitancy, Dr. Murthy said that the United States needs to work more in increasing confidence that the vaccines will work, and in access to vaccines, but, mostly, in motivation.
“What we’ve learned is that ultimately trusted voices are what make all the difference when it comes to vaccination,” he said. “It’s one of these large, people-powered movements that we have to build in our community.”
Dr. Scheurer noted that, with hospitalists in 90% of U.S. hospitals, they can play a big role. “If we can all do our part then we’ll at least take the ball further down the field.”
Dr. Murthy added that, since residency, when he cared for young cancer patients near his own age, he has focused on “finding meaning now” in his work and life. The pandemic has reinforced this, and he doesn’t necessarily want life to go back to exactly how it was before the pandemic.
“Many of us are thinking – ‘Is there actually a better way for us to live our lives and design our workdays and our choices other than what we were doing prepandemic? Can we center our lives more around the people we love and care about, can we design our work to accommodate our family as opposed to the other way around, to always make our families accommodate our work?’ – These are the kinds of choices that we have to make as a society.”
FROM SHM CONVERGE 2021
How to utilize the updated PHM Core Competencies
Converge 2021 session
Making The Pediatric Hospital Medicine Core Competencies Work for You
Presenters
Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP
Session summary
The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.
The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.
The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.
Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.
The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.
The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Key takeaways
- Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
- The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
- The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.
Converge 2021 session
Making The Pediatric Hospital Medicine Core Competencies Work for You
Presenters
Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP
Session summary
The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.
The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.
The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.
Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.
The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.
The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Key takeaways
- Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
- The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
- The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.
Converge 2021 session
Making The Pediatric Hospital Medicine Core Competencies Work for You
Presenters
Erin Fisher, MD, MHM, FAAP; Sandra Gage, MD, PhD, SFHM, FAAP; Jennifer Maniscalco, MD, MPH, MAcM, FAAP; Sofia Teferi, MD, SFHM, FAAP
Session summary
The Pediatric Hospital Medicine (PHM) Core Competencies were originally published in the Journal of Hospital Medicine in 2010, and created a framework for graduate and continuing medical education, reflecting the roles and expectations for all pediatric hospitalists in the United States. Since that time, the field of PHM, scope of practice, and roles of hospitalists has evolved, making a substantial update to this dossier necessary.
The 2020 PHM Core Competencies consist of four sections, including common clinical diagnoses and conditions, specialized services, core skills, and the health care system. The four topics are covered in 66 chapters, which were updated or created for the present version.
The Core Competencies have many practical applications, including teaching or curriculum development, which may be used by trainees as well as PHM providers. The speakers gave real-world examples of the competencies’ application to evaluations, and the continuum of knowledge, skills, attitudes, and system implementation in the development of a trainee from student to practicing hospitalist. Trainees’ knowledge gaps can be identified using the competencies, and utilization of the provided compendium will help identify sources that can aid in teaching.
Professional development is an excellent way to utilize the Core Competencies. Division directors may identify a needed area for improvement and the competencies can serve as a road map for establishing goals, plan development, and analysis of results of the intervention. They are also a great resource for PHM board prep. Although the competencies were not developed specifically for the PHM boards, they do contain all 13 PHM content domains set forth by the American Board of Pediatrics for PHM.
The Core Competencies can also be used to justify service line needs and resources in discussions with administration. For instance, if one is a pediatric hospitalist at a community hospital and asked to take over the newborn nursery, the competencies can be used to get buy-in from the group, as a guide for additional training, to provide a framework for development of practice pathways, and to request resources needed.
The Pediatric Core Competencies are a great resource for pediatric hospitalists and group leaders with many uses, from board preparation to education and professional development. They provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Key takeaways
- Given a change in scope of practice of pediatric hospitalists over the past 10 years, the PHM Core Competencies were updated and published in the Journal of Hospital Medicine in 2020.
- The Core Competencies have many practical applications including education, curriculum development, professional development, and PHM board preparation.
- The Core Competencies provide a framework for improvement of knowledge, skills, and attitudes within an organization.
Dr. Schwenk is a pediatric hospitalist at Norton Children’s Hospital in Louisville, Ky., where he serves as a medical director of inpatient services. He is an associate professor of pediatrics at the University of Louisville School of Medicine. He is a Senior Fellow of Hospital Medicine and has served on the executive council of the Pediatrics Special Interest Group and the Annual Meeting Committee for SHM Converge.
FROM SHM CONVERGE 2021
SHM Converge Daily News -- Day 3
Click here for the Friday issue of the SHM Converge Daily News newsletter.
Click here for the Friday issue of the SHM Converge Daily News newsletter.
Click here for the Friday issue of the SHM Converge Daily News newsletter.