Journal of Clinical Outcomes Management

Two years into the COVID-19 pandemic, the United States is still breaking records in hospital overcrowding and new cases.

The United States is logging nearly 800,000 cases a day, hospitals are starting to fray, and deaths have topped 850,000. Schools oscillate from remote to in-person learning, polarizing communities.

The vaccines are lifesaving for many, yet frustration mounts as the numbers of unvaccinated people in this country stays relatively stagnant (63% in the United States are fully vaccinated) and other parts of the world have seen hardly a single dose. Africa has the slowest vaccination rate among continents, with only 14% of the population receiving one shot, according to the New York Times tracker.

Yet there is good reason for optimism among leading U.S. experts because of how far science and medicine have come since the World Health Organization first acknowledged person-to-person transmission of the virus in January 2020.

Effective vaccines and treatments that can keep people out of the hospital were developed at an astounding pace, and advances in tracking and testing – in both access and effectiveness – are starting to pay off.

Some experts say it’s possible that the raging Omicron surge will slow by late spring, providing some relief and maybe shifting the pandemic to a slower-burning endemic.

But other experts caution to keep our guard up, saying it’s time to settle into a “new normal” and upend the strategy for fighting COVID-19.
 

Time to change COVID thinking

Three former members of the Biden-Harris Transition COVID-19 Advisory Board wrote recently in JAMA that COVID-19 has now become one of the many viral respiratory diseases that health care providers and patients will manage each year.

The group of experts from the University of Pennsylvania, University of Minnesota, and New York University write that “many of the measures to reduce transmission of SARS-CoV-2 (for example, ventilation) will also reduce transmission of other respiratory viruses. Thus, policy makers should retire previous public health categorizations, including deaths from pneumonia and influenza or pneumonia, influenza, and COVID-19, and focus on a new category: the aggregate risk of all respiratory virus infections.”

Other experts, including Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, have said it’s been clear since the early days of SARS-CoV-2 that we must learn to live with the virus because it “will be ever present for the remaining history of our species.”

But that doesn’t mean the virus will always have the upper hand. Although the United States has been reaching record numbers of hospitalizations in January, these hospitalizations differ from those of last year – marked by fewer extreme lifesaving measures, fewer deaths, and shorter hospital stays – caused in part by medical and therapeutic advances and in part to the nature of the Omicron variant itself.

One sign of progress, Dr. Adalja said, will be the widespread decoupling of cases from hospitalizations, something that has already happened in countries such as the United Kingdom.

“That’s a reflection of how well they have vaccinated their high-risk population and how poorly we have vaccinated our high-risk population,” he said.
 

Omicron will bump up natural immunity

Dr. Adalja said though the numbers of unvaccinated in the United States appear to be stuck, Omicron’s sweep will make the difference, leaving behind more natural immunity in the population.

Currently, hospitals are struggling with staffing concerns as a “direct result” of too many unvaccinated people, he said.

Andrew Badley, MD, an infectious diseases specialist at Mayo Clinic in Rochester, Minn., and director of the clinic’s COVID-19 Task Force, said the good news with Omicron is that nearly all people it infects will recover.

Over time, when the body sees foreign antigens repeatedly, the quantity and quality of the antibodies the immune system produces increase and the body becomes better at fighting disease.

So “a large amount of the population will have recovered and have a degree of immunity,” Dr. Badley said.

His optimism is tempered by his belief that “it’s going to get worse before it gets better.”

But Dr. Badley still predicts a turnaround. “We’ll see a downturn in COVID in late spring or early summer,” and well into the second quarter of 2022, “we’ll see a reemergence of control.”

Right now, with Omicron, one infected person is infecting three to five others, he said. The hope is that it will eventually reach one-to-one endemic levels.

As for the threat of new variants, Badley said, “it’s not predictable whether they will be stronger or weaker.”
 

Masks may be around for years

Many experts predict that masks will continue to be part of the national wardrobe for the foreseeable future.

“We will continue to see new cases for years and years to come. Some will respond to that with masks in public places for a very long time. I personally will do so,” Dr. Badley said.
 

Two mindsets: Inside/outside the hospital

Emily Landon, MD, an infectious disease doctor and the executive medical director of infection prevention and control at University of Chicago Medicine, told this news organization she views the pandemic from two different vantage points.

As a health care provider, she sees her hospital, like others worldwide, overwhelmed. Supplies of a major weapon to help prevent hospitalization, the monoclonal antibody sotrovimab, are running out. Dr. Landon said she has been calling other hospitals to see if they have supplies and, if so, whether Omicron patients can transfer there.

Bottom line: The things they relied on a month ago to keep people out of the hospital are no longer there, she said.

Meanwhile, “We have more COVID patients than we have ever had,” Dr. Landon said.

Last year, UChicago hit a high of 170 people hospitalized with COVID. This year, so far, the peak was 270.

Dr. Landon said she is frustrated when she leaves that overburdened world inside the hospital for the outside world, where people wear no masks or ineffective face coverings and gather unsafely. Although some of that behavior reflects an intention to flout the advice of medical experts, some is caused in part, she said, by the lack of a clear national health strategy and garbled communication from those in charge of public safety.

Americans are deciding for themselves, on an a la carte basis, whether to wear a mask or get tested or travel, and school districts decide individually when it’s time to go virtual.

“People are exhausted from having to do a risk-benefit analysis for every single activity they, their friends, their kids want to participate in,” she said.
 

U.S. behind in several areas

Despite our self-image as the global leader in science and medicine, the United States stumbled badly in its response to the pandemic, with grave consequences both at home and abroad, experts say.

In a recent commentary in JAMA, Lawrence Gostin, JD, from Georgetown University, Washington, and Jennifer Nuzzo, DrPH, at Johns Hopkins University, Baltimore, pointed to several critical shortfalls in the nation’s efforts to control the disease.

One such shortfall is public trust.

This news organization reported in June 2021 that a poll of its readers found that 44% said their trust in the CDC had waned during the pandemic, and 33% said their trust in the FDA had eroded as well.

Health care providers who responded to the poll lost trust as well. About half of the doctors and nurses who responded said they disagreed with the FDA’s decision-making during the pandemic. Nearly 60% of doctors and 65% of nurses said they disagreed with the CDC’s overall pandemic guidance.

Lack of trust can make people resist vaccines and efforts to fight the virus, the authors wrote.

“This will become really relevant when we have ample supply of Pfizer’s antiviral medication,” Mr. Gostin, who directs the O’Neill Institute for National and Global Health Law at Georgetown, told this news organization. “The next phase of the pandemic is not to link testing to contact tracing, because we’re way past that, but to link testing to treatment.”

Lack of regional manufacturing of products is also thwarting global progress.

“It is extraordinarily important that our pharmaceutical industry transfer technology in a pandemic,” Mr. Gostin said. “The most glaring failure to do that is the mRNA vaccines. We’ve got this enormously effective vaccine and the two manufacturers – Pfizer and Moderna – are refusing to share the technology with producers in other countries. That keeps coming back to haunt us.”

Another problem: When the vaccines are shared with other countries, they are being delivered close to the date they expire or arriving at a shipyards without warning, so even some of the doses that get delivered are going to waste, Mr. Gostin said.

“It’s one of the greatest moral failures of my lifetime,” he said.

Also a failure is the “jaw-dropping” state of testing 2 years into the pandemic, he said, as people continue to pay high prices for tests or endure long lines.

The U.S. government updated its calculations and ordered 1 billion tests for the general public. The COVIDtests.gov website to order the free tests is now live.

It’s a step in the right direction. Mr. Gostin and Dr. Nuzzo wrote that there is every reason to expect future epidemics that are as serious or more serious than COVID.

“Failure to address clearly observed weaknesses in the COVID-19 response will have preventable adverse health, social, and economic consequences when the next novel outbreak occurs,” they wrote.

WebMD.com

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

Two years into the COVID-19 pandemic, the United States is still breaking records in hospital overcrowding and new cases.

The United States is logging nearly 800,000 cases a day, hospitals are starting to fray, and deaths have topped 850,000. Schools oscillate from remote to in-person learning, polarizing communities.

The vaccines are lifesaving for many, yet frustration mounts as the numbers of unvaccinated people in this country stays relatively stagnant (63% in the United States are fully vaccinated) and other parts of the world have seen hardly a single dose. Africa has the slowest vaccination rate among continents, with only 14% of the population receiving one shot, according to the New York Times tracker.

Yet there is good reason for optimism among leading U.S. experts because of how far science and medicine have come since the World Health Organization first acknowledged person-to-person transmission of the virus in January 2020.

Effective vaccines and treatments that can keep people out of the hospital were developed at an astounding pace, and advances in tracking and testing – in both access and effectiveness – are starting to pay off.

Some experts say it’s possible that the raging Omicron surge will slow by late spring, providing some relief and maybe shifting the pandemic to a slower-burning endemic.

But other experts caution to keep our guard up, saying it’s time to settle into a “new normal” and upend the strategy for fighting COVID-19.
 

Time to change COVID thinking

Three former members of the Biden-Harris Transition COVID-19 Advisory Board wrote recently in JAMA that COVID-19 has now become one of the many viral respiratory diseases that health care providers and patients will manage each year.

The group of experts from the University of Pennsylvania, University of Minnesota, and New York University write that “many of the measures to reduce transmission of SARS-CoV-2 (for example, ventilation) will also reduce transmission of other respiratory viruses. Thus, policy makers should retire previous public health categorizations, including deaths from pneumonia and influenza or pneumonia, influenza, and COVID-19, and focus on a new category: the aggregate risk of all respiratory virus infections.”

Other experts, including Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, have said it’s been clear since the early days of SARS-CoV-2 that we must learn to live with the virus because it “will be ever present for the remaining history of our species.”

But that doesn’t mean the virus will always have the upper hand. Although the United States has been reaching record numbers of hospitalizations in January, these hospitalizations differ from those of last year – marked by fewer extreme lifesaving measures, fewer deaths, and shorter hospital stays – caused in part by medical and therapeutic advances and in part to the nature of the Omicron variant itself.

One sign of progress, Dr. Adalja said, will be the widespread decoupling of cases from hospitalizations, something that has already happened in countries such as the United Kingdom.

“That’s a reflection of how well they have vaccinated their high-risk population and how poorly we have vaccinated our high-risk population,” he said.
 

Omicron will bump up natural immunity

Dr. Adalja said though the numbers of unvaccinated in the United States appear to be stuck, Omicron’s sweep will make the difference, leaving behind more natural immunity in the population.

Currently, hospitals are struggling with staffing concerns as a “direct result” of too many unvaccinated people, he said.

Andrew Badley, MD, an infectious diseases specialist at Mayo Clinic in Rochester, Minn., and director of the clinic’s COVID-19 Task Force, said the good news with Omicron is that nearly all people it infects will recover.

Over time, when the body sees foreign antigens repeatedly, the quantity and quality of the antibodies the immune system produces increase and the body becomes better at fighting disease.

So “a large amount of the population will have recovered and have a degree of immunity,” Dr. Badley said.

His optimism is tempered by his belief that “it’s going to get worse before it gets better.”

But Dr. Badley still predicts a turnaround. “We’ll see a downturn in COVID in late spring or early summer,” and well into the second quarter of 2022, “we’ll see a reemergence of control.”

Right now, with Omicron, one infected person is infecting three to five others, he said. The hope is that it will eventually reach one-to-one endemic levels.

As for the threat of new variants, Badley said, “it’s not predictable whether they will be stronger or weaker.”
 

Masks may be around for years

Many experts predict that masks will continue to be part of the national wardrobe for the foreseeable future.

“We will continue to see new cases for years and years to come. Some will respond to that with masks in public places for a very long time. I personally will do so,” Dr. Badley said.
 

Two mindsets: Inside/outside the hospital

Emily Landon, MD, an infectious disease doctor and the executive medical director of infection prevention and control at University of Chicago Medicine, told this news organization she views the pandemic from two different vantage points.

As a health care provider, she sees her hospital, like others worldwide, overwhelmed. Supplies of a major weapon to help prevent hospitalization, the monoclonal antibody sotrovimab, are running out. Dr. Landon said she has been calling other hospitals to see if they have supplies and, if so, whether Omicron patients can transfer there.

Bottom line: The things they relied on a month ago to keep people out of the hospital are no longer there, she said.

Meanwhile, “We have more COVID patients than we have ever had,” Dr. Landon said.

Last year, UChicago hit a high of 170 people hospitalized with COVID. This year, so far, the peak was 270.

Dr. Landon said she is frustrated when she leaves that overburdened world inside the hospital for the outside world, where people wear no masks or ineffective face coverings and gather unsafely. Although some of that behavior reflects an intention to flout the advice of medical experts, some is caused in part, she said, by the lack of a clear national health strategy and garbled communication from those in charge of public safety.

Americans are deciding for themselves, on an a la carte basis, whether to wear a mask or get tested or travel, and school districts decide individually when it’s time to go virtual.

“People are exhausted from having to do a risk-benefit analysis for every single activity they, their friends, their kids want to participate in,” she said.
 

U.S. behind in several areas

Despite our self-image as the global leader in science and medicine, the United States stumbled badly in its response to the pandemic, with grave consequences both at home and abroad, experts say.

In a recent commentary in JAMA, Lawrence Gostin, JD, from Georgetown University, Washington, and Jennifer Nuzzo, DrPH, at Johns Hopkins University, Baltimore, pointed to several critical shortfalls in the nation’s efforts to control the disease.

One such shortfall is public trust.

This news organization reported in June 2021 that a poll of its readers found that 44% said their trust in the CDC had waned during the pandemic, and 33% said their trust in the FDA had eroded as well.

Health care providers who responded to the poll lost trust as well. About half of the doctors and nurses who responded said they disagreed with the FDA’s decision-making during the pandemic. Nearly 60% of doctors and 65% of nurses said they disagreed with the CDC’s overall pandemic guidance.

Lack of trust can make people resist vaccines and efforts to fight the virus, the authors wrote.

“This will become really relevant when we have ample supply of Pfizer’s antiviral medication,” Mr. Gostin, who directs the O’Neill Institute for National and Global Health Law at Georgetown, told this news organization. “The next phase of the pandemic is not to link testing to contact tracing, because we’re way past that, but to link testing to treatment.”

Lack of regional manufacturing of products is also thwarting global progress.

“It is extraordinarily important that our pharmaceutical industry transfer technology in a pandemic,” Mr. Gostin said. “The most glaring failure to do that is the mRNA vaccines. We’ve got this enormously effective vaccine and the two manufacturers – Pfizer and Moderna – are refusing to share the technology with producers in other countries. That keeps coming back to haunt us.”

Another problem: When the vaccines are shared with other countries, they are being delivered close to the date they expire or arriving at a shipyards without warning, so even some of the doses that get delivered are going to waste, Mr. Gostin said.

“It’s one of the greatest moral failures of my lifetime,” he said.

Also a failure is the “jaw-dropping” state of testing 2 years into the pandemic, he said, as people continue to pay high prices for tests or endure long lines.

The U.S. government updated its calculations and ordered 1 billion tests for the general public. The COVIDtests.gov website to order the free tests is now live.

It’s a step in the right direction. Mr. Gostin and Dr. Nuzzo wrote that there is every reason to expect future epidemics that are as serious or more serious than COVID.

“Failure to address clearly observed weaknesses in the COVID-19 response will have preventable adverse health, social, and economic consequences when the next novel outbreak occurs,” they wrote.

WebMD.com

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

Two years into the COVID-19 pandemic, the United States is still breaking records in hospital overcrowding and new cases.

The United States is logging nearly 800,000 cases a day, hospitals are starting to fray, and deaths have topped 850,000. Schools oscillate from remote to in-person learning, polarizing communities.

The vaccines are lifesaving for many, yet frustration mounts as the numbers of unvaccinated people in this country stays relatively stagnant (63% in the United States are fully vaccinated) and other parts of the world have seen hardly a single dose. Africa has the slowest vaccination rate among continents, with only 14% of the population receiving one shot, according to the New York Times tracker.

Yet there is good reason for optimism among leading U.S. experts because of how far science and medicine have come since the World Health Organization first acknowledged person-to-person transmission of the virus in January 2020.

Effective vaccines and treatments that can keep people out of the hospital were developed at an astounding pace, and advances in tracking and testing – in both access and effectiveness – are starting to pay off.

Some experts say it’s possible that the raging Omicron surge will slow by late spring, providing some relief and maybe shifting the pandemic to a slower-burning endemic.

But other experts caution to keep our guard up, saying it’s time to settle into a “new normal” and upend the strategy for fighting COVID-19.
 

Time to change COVID thinking

Three former members of the Biden-Harris Transition COVID-19 Advisory Board wrote recently in JAMA that COVID-19 has now become one of the many viral respiratory diseases that health care providers and patients will manage each year.

The group of experts from the University of Pennsylvania, University of Minnesota, and New York University write that “many of the measures to reduce transmission of SARS-CoV-2 (for example, ventilation) will also reduce transmission of other respiratory viruses. Thus, policy makers should retire previous public health categorizations, including deaths from pneumonia and influenza or pneumonia, influenza, and COVID-19, and focus on a new category: the aggregate risk of all respiratory virus infections.”

Other experts, including Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, have said it’s been clear since the early days of SARS-CoV-2 that we must learn to live with the virus because it “will be ever present for the remaining history of our species.”

But that doesn’t mean the virus will always have the upper hand. Although the United States has been reaching record numbers of hospitalizations in January, these hospitalizations differ from those of last year – marked by fewer extreme lifesaving measures, fewer deaths, and shorter hospital stays – caused in part by medical and therapeutic advances and in part to the nature of the Omicron variant itself.

One sign of progress, Dr. Adalja said, will be the widespread decoupling of cases from hospitalizations, something that has already happened in countries such as the United Kingdom.

“That’s a reflection of how well they have vaccinated their high-risk population and how poorly we have vaccinated our high-risk population,” he said.
 

Omicron will bump up natural immunity

Dr. Adalja said though the numbers of unvaccinated in the United States appear to be stuck, Omicron’s sweep will make the difference, leaving behind more natural immunity in the population.

Currently, hospitals are struggling with staffing concerns as a “direct result” of too many unvaccinated people, he said.

Andrew Badley, MD, an infectious diseases specialist at Mayo Clinic in Rochester, Minn., and director of the clinic’s COVID-19 Task Force, said the good news with Omicron is that nearly all people it infects will recover.

Over time, when the body sees foreign antigens repeatedly, the quantity and quality of the antibodies the immune system produces increase and the body becomes better at fighting disease.

So “a large amount of the population will have recovered and have a degree of immunity,” Dr. Badley said.

His optimism is tempered by his belief that “it’s going to get worse before it gets better.”

But Dr. Badley still predicts a turnaround. “We’ll see a downturn in COVID in late spring or early summer,” and well into the second quarter of 2022, “we’ll see a reemergence of control.”

Right now, with Omicron, one infected person is infecting three to five others, he said. The hope is that it will eventually reach one-to-one endemic levels.

As for the threat of new variants, Badley said, “it’s not predictable whether they will be stronger or weaker.”
 

Masks may be around for years

Many experts predict that masks will continue to be part of the national wardrobe for the foreseeable future.

“We will continue to see new cases for years and years to come. Some will respond to that with masks in public places for a very long time. I personally will do so,” Dr. Badley said.
 

Two mindsets: Inside/outside the hospital

Emily Landon, MD, an infectious disease doctor and the executive medical director of infection prevention and control at University of Chicago Medicine, told this news organization she views the pandemic from two different vantage points.

As a health care provider, she sees her hospital, like others worldwide, overwhelmed. Supplies of a major weapon to help prevent hospitalization, the monoclonal antibody sotrovimab, are running out. Dr. Landon said she has been calling other hospitals to see if they have supplies and, if so, whether Omicron patients can transfer there.

Bottom line: The things they relied on a month ago to keep people out of the hospital are no longer there, she said.

Meanwhile, “We have more COVID patients than we have ever had,” Dr. Landon said.

Last year, UChicago hit a high of 170 people hospitalized with COVID. This year, so far, the peak was 270.

Dr. Landon said she is frustrated when she leaves that overburdened world inside the hospital for the outside world, where people wear no masks or ineffective face coverings and gather unsafely. Although some of that behavior reflects an intention to flout the advice of medical experts, some is caused in part, she said, by the lack of a clear national health strategy and garbled communication from those in charge of public safety.

Americans are deciding for themselves, on an a la carte basis, whether to wear a mask or get tested or travel, and school districts decide individually when it’s time to go virtual.

“People are exhausted from having to do a risk-benefit analysis for every single activity they, their friends, their kids want to participate in,” she said.
 

U.S. behind in several areas

Despite our self-image as the global leader in science and medicine, the United States stumbled badly in its response to the pandemic, with grave consequences both at home and abroad, experts say.

In a recent commentary in JAMA, Lawrence Gostin, JD, from Georgetown University, Washington, and Jennifer Nuzzo, DrPH, at Johns Hopkins University, Baltimore, pointed to several critical shortfalls in the nation’s efforts to control the disease.

One such shortfall is public trust.

This news organization reported in June 2021 that a poll of its readers found that 44% said their trust in the CDC had waned during the pandemic, and 33% said their trust in the FDA had eroded as well.

Health care providers who responded to the poll lost trust as well. About half of the doctors and nurses who responded said they disagreed with the FDA’s decision-making during the pandemic. Nearly 60% of doctors and 65% of nurses said they disagreed with the CDC’s overall pandemic guidance.

Lack of trust can make people resist vaccines and efforts to fight the virus, the authors wrote.

“This will become really relevant when we have ample supply of Pfizer’s antiviral medication,” Mr. Gostin, who directs the O’Neill Institute for National and Global Health Law at Georgetown, told this news organization. “The next phase of the pandemic is not to link testing to contact tracing, because we’re way past that, but to link testing to treatment.”

Lack of regional manufacturing of products is also thwarting global progress.

“It is extraordinarily important that our pharmaceutical industry transfer technology in a pandemic,” Mr. Gostin said. “The most glaring failure to do that is the mRNA vaccines. We’ve got this enormously effective vaccine and the two manufacturers – Pfizer and Moderna – are refusing to share the technology with producers in other countries. That keeps coming back to haunt us.”

Another problem: When the vaccines are shared with other countries, they are being delivered close to the date they expire or arriving at a shipyards without warning, so even some of the doses that get delivered are going to waste, Mr. Gostin said.

“It’s one of the greatest moral failures of my lifetime,” he said.

Also a failure is the “jaw-dropping” state of testing 2 years into the pandemic, he said, as people continue to pay high prices for tests or endure long lines.

The U.S. government updated its calculations and ordered 1 billion tests for the general public. The COVIDtests.gov website to order the free tests is now live.

It’s a step in the right direction. Mr. Gostin and Dr. Nuzzo wrote that there is every reason to expect future epidemics that are as serious or more serious than COVID.

“Failure to address clearly observed weaknesses in the COVID-19 response will have preventable adverse health, social, and economic consequences when the next novel outbreak occurs,” they wrote.

WebMD.com

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

Black patients hospitalized with skin and soft-tissue infections were more likely to receive clindamycin and less likely to receive cefazolin – the latter of which is considered a first-line SSTI treatment – in a national cross-sectional study involving over 1,000 patients in 91 hospitals.

The potential racial disparity in management of SSTI was detected after data were adjusted for penicillin allergy history and for MRSA colonization/infection. The data were also adjusted for hospital day (since admission) in order to control for the administration of more empiric therapy early on.

Massachusetts General Hospital

Clindamycin, a beta-lactam alternative, is not recommended as an SSTI treatment given its frequent dosing requirements and high potential for adverse events including Clostridioides difficile infection (DCI). “Clindamycin is an option but it’s considered inferior. ... It covers MRSA but it shouldn’t be a go-to for skin and soft-tissue infections,” said senior author Kimberly Blumenthal, MD, MSc, assistant professor of medicine at Harvard University, and an allergist, immunologist, and drug allergy and epidemiology researcher at Massachusetts General Hospital, both in Boston.

Cefazolin, on the other hand, does not cover MRSA but is “a guideline-recommended first-line antibiotic for cellulitis SSTI in the hospital,” she said in an interview.

The findings, recently published in JAMA Network Open, offer a valuable portrait of the antibiotics being prescribed in the inpatient setting for SSTIs. Vancomycin, which typically is reserved for MRSA, was the most commonly prescribed antibiotic, regardless of race. Piperacillin-tazobactam, a beta-lactam, was the second most commonly prescribed antibiotic, again regardless of race.

Intravenously administered cefazolin was used in 13% of White inpatients versus 5% of Black inpatients. After controlling for kidney disease, diabetes, and ICU location (in addition to hospital day, penicillin allergy history, and MRSA), White inpatients had an increased likelihood of being prescribed cefazolin (adjusted odds ratio, 2.82; 95% confidence interval, 1.41-5.63) and a decreased likelihood of clindamycin use (aOR, 0.54; 95% CI, 0.30-0.96), compared with Black inpatients.

The investigators utilized the Acute Care Hospital Groups network within Vizient, a member-driven health care performance improvement company, to collect data for the study. Most of the hospitals (91%) that submitted data on adult inpatients with cellulitis or SSTIs (without other infections) were in urban settings and 9% were in rural settings; 60% were community hospitals and 40% were academic medical centers. The researchers accounted for “clustering by hospital” – such as the use of internal guidelines – in their methodology.

Black patients hospitalized with skin and soft-tissue infections were more likely to receive clindamycin and less likely to receive cefazolin – the latter of which is considered a first-line SSTI treatment – in a national cross-sectional study involving over 1,000 patients in 91 hospitals.

The potential racial disparity in management of SSTI was detected after data were adjusted for penicillin allergy history and for MRSA colonization/infection. The data were also adjusted for hospital day (since admission) in order to control for the administration of more empiric therapy early on.

Massachusetts General Hospital

Clindamycin, a beta-lactam alternative, is not recommended as an SSTI treatment given its frequent dosing requirements and high potential for adverse events including Clostridioides difficile infection (DCI). “Clindamycin is an option but it’s considered inferior. ... It covers MRSA but it shouldn’t be a go-to for skin and soft-tissue infections,” said senior author Kimberly Blumenthal, MD, MSc, assistant professor of medicine at Harvard University, and an allergist, immunologist, and drug allergy and epidemiology researcher at Massachusetts General Hospital, both in Boston.

Cefazolin, on the other hand, does not cover MRSA but is “a guideline-recommended first-line antibiotic for cellulitis SSTI in the hospital,” she said in an interview.

The findings, recently published in JAMA Network Open, offer a valuable portrait of the antibiotics being prescribed in the inpatient setting for SSTIs. Vancomycin, which typically is reserved for MRSA, was the most commonly prescribed antibiotic, regardless of race. Piperacillin-tazobactam, a beta-lactam, was the second most commonly prescribed antibiotic, again regardless of race.

Intravenously administered cefazolin was used in 13% of White inpatients versus 5% of Black inpatients. After controlling for kidney disease, diabetes, and ICU location (in addition to hospital day, penicillin allergy history, and MRSA), White inpatients had an increased likelihood of being prescribed cefazolin (adjusted odds ratio, 2.82; 95% confidence interval, 1.41-5.63) and a decreased likelihood of clindamycin use (aOR, 0.54; 95% CI, 0.30-0.96), compared with Black inpatients.

The investigators utilized the Acute Care Hospital Groups network within Vizient, a member-driven health care performance improvement company, to collect data for the study. Most of the hospitals (91%) that submitted data on adult inpatients with cellulitis or SSTIs (without other infections) were in urban settings and 9% were in rural settings; 60% were community hospitals and 40% were academic medical centers. The researchers accounted for “clustering by hospital” – such as the use of internal guidelines – in their methodology.

Black patients hospitalized with skin and soft-tissue infections were more likely to receive clindamycin and less likely to receive cefazolin – the latter of which is considered a first-line SSTI treatment – in a national cross-sectional study involving over 1,000 patients in 91 hospitals.

The potential racial disparity in management of SSTI was detected after data were adjusted for penicillin allergy history and for MRSA colonization/infection. The data were also adjusted for hospital day (since admission) in order to control for the administration of more empiric therapy early on.

Massachusetts General Hospital

Clindamycin, a beta-lactam alternative, is not recommended as an SSTI treatment given its frequent dosing requirements and high potential for adverse events including Clostridioides difficile infection (DCI). “Clindamycin is an option but it’s considered inferior. ... It covers MRSA but it shouldn’t be a go-to for skin and soft-tissue infections,” said senior author Kimberly Blumenthal, MD, MSc, assistant professor of medicine at Harvard University, and an allergist, immunologist, and drug allergy and epidemiology researcher at Massachusetts General Hospital, both in Boston.

Cefazolin, on the other hand, does not cover MRSA but is “a guideline-recommended first-line antibiotic for cellulitis SSTI in the hospital,” she said in an interview.

The findings, recently published in JAMA Network Open, offer a valuable portrait of the antibiotics being prescribed in the inpatient setting for SSTIs. Vancomycin, which typically is reserved for MRSA, was the most commonly prescribed antibiotic, regardless of race. Piperacillin-tazobactam, a beta-lactam, was the second most commonly prescribed antibiotic, again regardless of race.

Intravenously administered cefazolin was used in 13% of White inpatients versus 5% of Black inpatients. After controlling for kidney disease, diabetes, and ICU location (in addition to hospital day, penicillin allergy history, and MRSA), White inpatients had an increased likelihood of being prescribed cefazolin (adjusted odds ratio, 2.82; 95% confidence interval, 1.41-5.63) and a decreased likelihood of clindamycin use (aOR, 0.54; 95% CI, 0.30-0.96), compared with Black inpatients.

The investigators utilized the Acute Care Hospital Groups network within Vizient, a member-driven health care performance improvement company, to collect data for the study. Most of the hospitals (91%) that submitted data on adult inpatients with cellulitis or SSTIs (without other infections) were in urban settings and 9% were in rural settings; 60% were community hospitals and 40% were academic medical centers. The researchers accounted for “clustering by hospital” – such as the use of internal guidelines – in their methodology.

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

One of the unexpected consequences of the pandemic is that many people are rethinking their priorities and lifestyles, and physicians are no exception.

This year’s Medscape Physician Lifestyle and Happiness Report surveyed more than 10,000 physicians in 29 specialties about how they are prioritizing wellness, work-life balance, and their family lives during this challenging time.

Pets, prayer, and partners

The pandemic has taken a toll on physicians outside of work as well as on the job. Eight in 10 physicians (82% of men and 80% of women) said they were “somewhat” or “very” happy outside of work before the pandemic. This is almost exactly the same result as in last year’s survey.

However, when asked how happy they are outside of work currently, only 6 in 10 (59%) reported being “somewhat” or “very” happy. While the pandemic has made life difficult for everyone, health care professionals face particular stresses even outside of work. Wayne M. Sotile, PhD, founder of the Center for Physician Resilience, says he has counseled doctors who witnessed COVID-related suffering and death at work, then came home to a partner who didn’t believe that the pandemic was real.

Still, physicians reported that spending time with people they love and engaging in favorite activities helps them stay happy. “Spending time with pets” and “religious practice/prayer” were frequent “other” responses to the question, “What do you do to maintain happiness and mental health?” Seven in 10 physicians reported having some kind of religious or spiritual beliefs.

The majority of physicians (83%) are either married or living with a partner, with male physicians edging out their female peers (89% vs. 75%). Among married physicians, 8 in 10 physicians reported that their union is “good” or “very good.” The pandemic may have helped in this respect. Dr. Sotile says he’s heard physicians say that they’ve connected more with their families in the past 18 months. Specialists with the highest rates of happy marriages were otolaryngologists and immunologists (both 91%), followed closely by dermatologists, rheumatologists, and nephrologists (all 90%).

Among physicians balancing a medical career and parenthood, female physicians reported feeling conflicted more often than males (48% vs. 29%). Nicole A. Sparks, MD, an ob.gyn. and a health and lifestyle blogger, cites not being there for her kids as a source of stress. She notes that her two young children notice when she’s not there to help with homework, read bedtime stories, or make their dinner. “Mom guilt can definitely set in if I have to miss important events,” she says.

Work-life balance is an important, if elusive, goal for physicians, and not just females. Sixty percent of female doctors and 53% of male doctors said they would be willing to take a cut in pay if it meant more free time and a better work-life balance. Many doctors do manage to get away from work occasionally, with one-fifth of all physicians taking 5 or more weeks of vacation each year.

Seeking a ‘balanced life’

Alexis Polles, MD, medical director for the Professionals Resource Network, points out the importance of taking time for personal health and wellness. “When we work with professionals who have problems with mental health or substance abuse, they often don’t have a balanced life,” she says. “They are usually in a workaholic mindset and disregard their own needs.”

Few physicians seem to prioritize self-care, with a third indicating they “always” or “most of the time” spend enough time on their own health and wellness. But of those who do, males (38%) are more likely than females (27%) to spend enough time on their own health and wellness. Dr. Polles adds that exercising after a shift can help physicians better make the transition from professional to personal life. Though they did not report when they exercised, about a third of physicians reported doing so four or more times per week. Controlling weight is an issue as well, with 49% of male and 55% of female physicians saying they are currently trying to lose weight.

Of physicians who drink alcohol, about a third have three or more drinks per week. (The CDC defines “heavy drinking” as consuming 15 drinks or more per week for men and eight drinks or more per week for women.)

Of those surveyed, 92% say they do not regularly use cannabidiol or cannabis, and a mere 4% of respondents said they would use at least one of these substances if they were to become legal in their state.

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

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

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

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

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

A new investigation has found that rates of physical trauma following operative vaginal delivery (OVD) in Canada are higher than previously reported.

The cohort study of more than 1.3 million deliveries in the country found trauma rates were highest with forceps delivery, with more than 1 in 4 pregnancies resulting in maternal trauma and 1 in 105 infants experiencing neonatal trauma. Maternal and neonatal trauma following vacuum deliveries was less common, occurring in 1 in 8 pregnancies and 1 in 104 infants, according to the researchers, who reported their findings in the Canadian Medical Association Journal .

“The rates of trauma following OVD in Canada are higher than previously reported, irrespective of region, level of obstetric care, and volume of instrument use among hospitals,” lead author Giulia Muraca, PhD, MPH, assistant professor of obstetrics and gynecology at McMaster University, Hamilton, Ont., said in an interview. “While OVDs may be associated with low rates of morbidity in carefully selected circumstances, the uniformly high rates of trauma among forceps and vacuum deliveries documented across regions, levels of obstetric care, and hospitals show that such conditions do not apply to routine obstetric practice in Canada.”

The American College of Obstetricians and Gynecologists considers OVD a way to reduce the rate of cesarean deliveries. However, the group has also pointed to a decline in familiarity with the procedures among clinicians new to the field.

Current reports also show that while OVD accounts for up to 15% of deliveries in Canada, Australia, and the United Kingdom, the risks associated with the approach are heavily dependent on the expertise of the provider. Declining use of OVD in favor of cesarean delivery has reduced opportunities for clinicians to acquire proficiency in performing these deliveries, according to the researchers.

Given these various factors, the investigators said the consensus on the safety of OVD is under scrutiny.

“An examination of maternal and neonatal trauma among OVD in contemporary practice is necessary to ensure that health care providers, policy makers, and pregnant individuals are informed regarding the risks of OVD typically experienced in routine obstetric practice, rather than those encountered under ideal conditions,” Dr. Muraca said.
 

Over 1 million deliveries studied

Dr. Muraca and colleagues looked at 1,326,191 deliveries occurring across Canada (except Quebec) between April 2013 and March 2019. The researchers included all singleton, term (≥37 weeks), in-hospital deliveries to women who had not undergone a previous cesarean delivery.

The study’s primary outcome measures were composite maternal trauma and composite neonatal trauma. Maternal trauma included obstetric anal sphincter injury (OASI); cervical or high vaginal laceration; pelvic hematoma; obstetric injury to the pelvic organs, pelvic joints, or ligaments; injury to the bladder or urethra; and other pelvic trauma. Neonatal trauma comprised intracranial hemorrhage and laceration, skull fracture, severe injury to the central or peripheral nervous system, fracture of the long bones, injury to the liver or spleen, seizures, and neonatal death.

The analysis found that 38,500 (2.9%) of the cases involved attempted forceps deliveries while 110,987 (8.4%) were attempted vacuum deliveries. Of the attempted forceps deliveries, 1,606 (4.2%) failed, while 8,791 (7.9%) of attempted vacuum deliveries failed.

Maternal trauma was observed in 25.3% of all forceps deliveries (n = 9,728) and 13.2% of all vacuum deliveries (n = 14,614), the researchers reported. The most common form of maternal trauma was OASI, which was observed in 21.52% of women undergoing forceps delivery and 11.67% of those undergoing vacuum delivery. The rates of all other forms of maternal trauma were higher among patients undergoing attempted forceps delivery than among their counterparts undergoing attempted vacuum delivery.

After adjusting for possible confounders, rates of maternal trauma remained higher with forceps than with vacuum deliveries (adjusted rate ratio, 1.70).

The rate of neonatal trauma was comparable for forceps (9.56/1,000 live births) and vacuum deliveries (9.58/1,000 live births). In these cases, damage to the peripheral nervous system was the most common form of neonatal trauma, occurring in 4.85/1,000 live births with forceps delivery and 3.41/1,000 live births for vacuum delivery, the researchers found.
 

Consider morbidity following OVD against potential alternatives, authors say

According to Dr. Muraca, the rates of maternal trauma in her study – along with accumulating evidence of the severe long-term consequences of these injuries – demonstrates the importance of reporting timely, empirically derived risk measures that accurately reflect those that pregnant individuals may encounter in typical obstetric practice.

“Although there is merit in understanding the estimates of risk that can be achieved when conditions are optimal, the interpretation of these estimates can be misleading, especially given secular shifts in patterns of practice,” she said. “The failure to do so compromises women’s autonomy in making evidence-informed decisions regarding childbirth interventions, such as evaluating the short- and long-term risks of OVD and cesarean delivery.

Her group recommended that morbidity following OVD be weighed against potential alternatives to such procedures, which carry their own risks. “This includes an extended second stage of labor and a spontaneous vaginal delivery, or a second-stage cesarean delivery, both of which are associated with significant morbidity,” Dr. Muraca said. “However, a comprehensive consideration of high population rates of OVD morbidity also prompts questions about choice of instrument, obstetrician training in OVD use, and for recognizing cases that would benefit from a cesarean delivery earlier in labor.”

Alan Peaceman, MD, professor of obstetrics and gynecology at Northwestern University, Chicago, said he was not surprised by the rates of sphincter injury, but that the rate of severe neonatal injury rate was higher than he expected. However, he added, “I don’t think clinicians should change their approach based on a single study. They should continue with the approach that they are most skilled at and is appropriate for the clinical circumstances.”

The study was funded by a grant from the Canadian Institutes of Health Research. Dr. Muraca and Dr. Peaceman have disclosed no relevant financial relationships.

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

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Approximately 3% of youth who tested positive for COVID-19 in an emergency department setting had severe outcomes after 2 weeks, but this risk was 0.5% among those not admitted to the hospital, based on data from more than 3,000 individuals aged 18 and younger.

In the early stages of the COVID-19 pandemic, youth younger than 18 years accounted for fewer than 5% of reported cases, but now account for approximately 25% of positive cases, wrote Anna L. Funk, PhD, of the University of Calgary, Alberta, Canada, and colleagues.

However, the risk of severe outcomes of youth with COVID-19 remains poorly understood and data from large studies are lacking, they noted.

In a prospective cohort study published in JAMA Network Open, the researchers reviewed data from 3,221 children and adolescents who were tested for COVID-19 at one of 41 emergency departments in 10 countries including Argentina, Australia, Canada, Costa Rica, Italy, New Zealand, Paraguay, Singapore, Spain, and the United States between March 2020 and June 2021. Positive infections were confirmed by polymerase chain reaction (PCR) testing. At 14 days’ follow-up after a positive test, 735 patients (22.8%), were hospitalized, 107 (3.3%) had severe outcomes, and 4 (0.12%) had died. Severe outcomes were significantly more likely in children aged 5-10 years and 10-18 years vs. less than 1 year (odds ratios, 1.60 and 2.39, respectively), and in children with a self-reported chronic illness (OR, 2.34) or a prior episode of pneumonia (OR, 3.15).

Severe outcomes were more likely in patients who presented with symptoms that started 4-7 days before seeking care, compared with those whose symptoms started 0-3 days before seeking care (OR, 2.22).

The researchers also reviewed data from a subgroup of 2,510 individuals who were discharged home from the ED after initial testing. At 14 days’ follow-up, 50 of these patients (2.0%) were hospitalized and 12 (0.5%) had severe outcomes. In addition, the researchers found that the risk of severe outcomes among hospitalized COVID-19–positive youth was nearly four times higher, compared with hospitalized youth who tested negative for COVID-19 (risk difference, 3.9%).

Previous retrospective studies of severe outcomes in children and adolescents with COVID-19 have yielded varying results, in part because of the variation in study populations, the researchers noted in their discussion of the findings. “Our study population provides a risk estimate for youths brought for ED care.” Therefore, “Our lower estimate of severe disease likely reflects our stringent definition, which required the occurrence of complications or specific invasive interventions,” they said.

The study limitations included the potential overestimation of the risk of severe outcomes because patients were recruited in the ED, the researchers noted. Other limitations included variation in regional case definitions, screening criteria, and testing capacity among different sites and time periods. “Thus, 5% of our SARS-CoV-2–positive participants were asymptomatic – most of whom were tested as they were positive contacts of known cases or as part of routine screening procedures,” they said. The findings also are not generalizable to all community EDs and did not account for variants, they added.

However, the results were strengthened by the ability to compare outcomes for children with positive tests to similar children with negative tests, and add to the literature showing an increased risk of severe outcomes for those hospitalized with positive tests, the researchers concluded.
 

Data may inform clinical decisions

“The data [in the current study] are concerning for severe outcomes for children even prior to the Omicron strain,” said Margaret Thew, DNP, FP-BC, of Children’s Wisconsin-Milwaukee Hospital, in an interview. “Presently, the number of children infected with the Omicron strain is much higher and hospitalizations among children are at their highest since COVID-19 began,” she said. “For medical providers caring for this population, the study sheds light on pediatric patients who may be at higher risk of severe illness when they become infected with COVID-19,” she added.

“I was surprised by how high the number of pediatric patients hospitalized (22%) and the percentage (3%) with severe disease were during this time,” given that the timeline for these data preceded the spread of the Omicron strain, said Ms. Thew. “The risk of prior pneumonia was quite surprising. I do not recall seeing prior pneumonia as a risk factor for more severe COVID-19 with children or adults,” she added.

The take-home messaging for clinicians caring for children and adolescents is the added knowledge of the risk factors for severe outcomes from COVID-19, including the 10-18 age range, chronic illness, prior pneumonia, and longer symptom duration before seeking care in the ED, Ms. Thew emphasized.

However, additional research is needed on the impact of the new strains of COVID-19 on pediatric and adolescent hospitalizations, Ms. Thew said. Research also is needed on the other illnesses that have resulted from COVID-19, including illness requiring antibiotic use or medical interventions or treatments, and on the risk of combined COVID-19 and influenza viruses, she noted.

The study was supported by the Canadian Institutes of Health Research, Alberta Innovates, the Alberta Health Services University of Calgary Clinical Research Fund, the Alberta Children’s Hospital Research Institute, the COVID-19 Research Accelerator Funding Track (CRAFT) Program at the University of California, Davis, and the Cincinnati Children’s Hospital Medical Center Division of Emergency Medicine Small Grants Program. Lead author Dr. Funk was supported by the University of Calgary Eyes-High Post-Doctoral Research Fund, but had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting Jan. 1.

The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS’ commercial formulary and is being assailed as the latest example of “nonmedical switching” used by health insurers to control costs.

In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its “dangerously disruptive” decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.

PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, called the formulary change “reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best,” he said in a statement.

Craig Beavers, PharmD, vice president of Baptist Health Paducah, Kentucky, said that, as chair of the American College of Cardiology’s Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company’s perspective.

“The underlying driver is cost,” he told this news organization.

Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.

“Apixaban may be better for a patient with a history of GI bleeding because there’s less GI bleeding, but the guidelines don’t necessarily spell those things out,” Dr. Beavers said. “That’s where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines.”

Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications, Christina Peaslee, told this news organization that the formulary decision “maintains clinically appropriate, cost-effective prescription coverage” for its clients and members.

“Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred – showing that consensus clinical guidelines do not favor one over the other,” she said in an email. “Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis.”

Ms. Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.

The decision to exclude apixaban is also limited to a “subset of commercial drug lists,” she said, although specifics on which plans and the number of affected patients were not forthcoming.

The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism, as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.

Ms. Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. “This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber.”

The company will also continue to provide “robust, personalized outreach to the small number of members who will need to switch to an alternative medication,” she added.

Dr. Beavers said negotiations with CVS are still in the early stages, but, in the meantime, the ACC is providing health care providers with tools, such as drug copay cards and electronic prior authorizations, to help ensure patients don’t have gaps in coverage.

In a Jan. 14 news release addressing the formulary change, ACC notes that a patient’s pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.

During discussions with CVS Caremark, it says the ACC and the American Society of Hematology “underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications.”

The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.

“The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access,” the release says.

In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.

The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.

PACH has an online petition against nonmedical switching, which at press time had garnered 2,126 signatures.

One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. “Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch.”

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

The evidence is in: Less is more when it comes to treating uncomplicated community-acquired pneumonia (CAP) in young children. Five days of antibiotic therapy resulted in a superior clinical response compared to 10 days of treatment and had the added benefit of a lower risk of inducing antibiotic resistance, according to the randomized, controlled SCOUT-CAP trial.

“Several studies have shown shorter antibiotic courses to be non-inferior to the standard treatment strategy, but in our study, we show that a shortened 5-day course of therapy was superior to standard therapy because the short course achieved similar outcomes with fewer days of antibiotics,” Derek Williams, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn., said in an email.

“These data are immediately applicable to frontline clinicians, and we hope this study will shift the paradigm towards more judicious treatment approaches for childhood pneumonia, resulting in care that is safer and more effective,” he added.

The study was published online Jan. 18 in JAMA Pediatrics.
 

Uncomplicated CAP

The study enrolled children aged 6 months to 71 months diagnosed with uncomplicated CAP who demonstrated early clinical improvement in response to 5 days of antibiotic treatment. Participants were prescribed either amoxicillin, amoxicillin and clavulanate, or cefdinir according to standard of care and were randomized on day 6 to another 5 days of their initially prescribed antibiotic course or to placebo.

“Those assessed on day 6 were eligible only if they had not yet received a dose of antibiotic therapy on that day,” the authors write. The primary endpoint was end-of-treatment response, adjusted for the duration of antibiotic risk as assessed by RADAR. As the authors explain, RADAR is a composite endpoint that ranks each child’s clinical response, resolution of symptoms, and antibiotic-associated adverse effects (AEs) in an ordinal desirability of outcome ranking, or DOOR.

“There were no differences between strategies in the DOOR or in its individual components,” Dr. Williams and colleagues point out. A total of 380 children took part in the study. The mean age of participants was 35.7 months, and half were male.

Over 90% of children randomized to active therapy were prescribed amoxicillin. “Fewer than 10% of children in either strategy had an inadequate clinical response,” the authors report.

However, the 5-day antibiotic strategy had a 69% (95% CI, 63%-75%) probability of children achieving a more desirable RADAR outcome compared with the standard, 10-day course, as assessed either on days 6 to 10 at outcome assessment visit one (OAV1) or at OAV2 on days 19 to 25.

There were also no significant differences between the two groups in the percentage of participants with persistent symptoms at either assessment point, they note. At assessment visit one, 40% of children assigned to the short-course strategy and 37% of children assigned to the 10-day strategy reported an antibiotic-related AE, most of which were mild.
 

Resistome analysis

Some 171 children were included in a resistome analysis in which throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. The total number of resistance genes per prokaryotic cell (RGPC) was significantly lower in children treated with antibiotics for 5 days compared with children who were treated for 10 days.

Specifically, the median number of total RGPC was 1.17 (95% CI, 0.35-2.43) for the short-course strategy and 1.33 (95% CI, 0.46-11.08) for the standard-course strategy (P = .01). Similarly, the median number of β-lactamase RGPC was 0.55 (0.18-1.24) for the short-course strategy and 0.60 (0.21-2.45) for the standard-course strategy (P = .03).

“Providing the shortest duration of antibiotics necessary to effectively treat an infection is a central tenet of antimicrobial stewardship and a convenient and cost-effective strategy for caregivers,” the authors observe. For example, reducing treatment from 10 to 5 days for outpatient CAP could reduce the number of days spent on antibiotics by up to 7.5 million days in the U.S. each year.

“If we can safely reduce antibiotic exposure, we can minimize antibiotic side effects while also helping to slow antibiotic resistance,” Dr. Williams pointed out.

Fewer days of having to give their child repeated doses of antibiotics is also more convenient for families, he added.

Asked to comment on the study, David Greenberg, MD, professor of pediatrics and infectious diseases, Ben Gurion University of the Negev, Israel, explained that the length of antibiotic therapy as recommended by various guidelines is more or less arbitrary, some infections being excepted.

“There have been no studies evaluating the recommendation for a 100-day treatment course, and it’s kind of a joke because if you look at the treatment of just about any infection, it’s either for 7 days or 14 days or even 20 days because it’s easy to calculate – it’s not that anybody proved that treatment of whatever infection it is should last this long,” he told this news organization.

Moreover, adherence to a shorter antibiotic course is much better than it is to a longer course. If, for example, physicians tell a mother to take two bottles of antibiotics for a treatment course of 10 days, she’ll finish the first bottle which is good for 5 days and, because the child is fine, “she forgets about the second bottle,” Dr. Greenberg said.

In one of the first studies to compare a short versus long course of antibiotic therapy in uncomplicated CAP in young children, Dr. Greenberg and colleagues initially compared a 3-day course of high-dose amoxicillin to a 10-day course of the same treatment, but the 3-day course was associated with an unacceptable failure rate. (At the time, the World Health Organization was recommending a 3-day course of antibiotics for the treatment of uncomplicated CAP in children.)

They stopped the study and then initiated a second study in which they compared a 5-day course of the same antibiotic to a 10-day course and found the 5-day course was comparable to the 10-day course in terms of clinical cure rates. As a result of his study, Dr. Greenberg has long since prescribed a 5-day course of antibiotics for his own patients.

“Five days is good,” he affirmed. “And if patients start a 10-day course of an antibiotic for, say, a urinary tract infection and a subsequent culture comes back negative, they don’t have to finish the antibiotics either.” Dr. Greenberg said.

Dr. Williams said he has no financial ties to industry. Dr. Greenberg said he has served as a consultant for Pfizer, Merck, Johnson & Johnson, and AstraZeneca. He is also a founder of the company Beyond Air.

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

The evidence is in: Less is more when it comes to treating uncomplicated community-acquired pneumonia (CAP) in young children. Five days of antibiotic therapy resulted in a superior clinical response compared to 10 days of treatment and had the added benefit of a lower risk of inducing antibiotic resistance, according to the randomized, controlled SCOUT-CAP trial.

“Several studies have shown shorter antibiotic courses to be non-inferior to the standard treatment strategy, but in our study, we show that a shortened 5-day course of therapy was superior to standard therapy because the short course achieved similar outcomes with fewer days of antibiotics,” Derek Williams, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn., said in an email.

“These data are immediately applicable to frontline clinicians, and we hope this study will shift the paradigm towards more judicious treatment approaches for childhood pneumonia, resulting in care that is safer and more effective,” he added.

The study was published online Jan. 18 in JAMA Pediatrics.
 

Uncomplicated CAP

The study enrolled children aged 6 months to 71 months diagnosed with uncomplicated CAP who demonstrated early clinical improvement in response to 5 days of antibiotic treatment. Participants were prescribed either amoxicillin, amoxicillin and clavulanate, or cefdinir according to standard of care and were randomized on day 6 to another 5 days of their initially prescribed antibiotic course or to placebo.

“Those assessed on day 6 were eligible only if they had not yet received a dose of antibiotic therapy on that day,” the authors write. The primary endpoint was end-of-treatment response, adjusted for the duration of antibiotic risk as assessed by RADAR. As the authors explain, RADAR is a composite endpoint that ranks each child’s clinical response, resolution of symptoms, and antibiotic-associated adverse effects (AEs) in an ordinal desirability of outcome ranking, or DOOR.

“There were no differences between strategies in the DOOR or in its individual components,” Dr. Williams and colleagues point out. A total of 380 children took part in the study. The mean age of participants was 35.7 months, and half were male.

Over 90% of children randomized to active therapy were prescribed amoxicillin. “Fewer than 10% of children in either strategy had an inadequate clinical response,” the authors report.

However, the 5-day antibiotic strategy had a 69% (95% CI, 63%-75%) probability of children achieving a more desirable RADAR outcome compared with the standard, 10-day course, as assessed either on days 6 to 10 at outcome assessment visit one (OAV1) or at OAV2 on days 19 to 25.

There were also no significant differences between the two groups in the percentage of participants with persistent symptoms at either assessment point, they note. At assessment visit one, 40% of children assigned to the short-course strategy and 37% of children assigned to the 10-day strategy reported an antibiotic-related AE, most of which were mild.
 

Resistome analysis

Some 171 children were included in a resistome analysis in which throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. The total number of resistance genes per prokaryotic cell (RGPC) was significantly lower in children treated with antibiotics for 5 days compared with children who were treated for 10 days.

Specifically, the median number of total RGPC was 1.17 (95% CI, 0.35-2.43) for the short-course strategy and 1.33 (95% CI, 0.46-11.08) for the standard-course strategy (P = .01). Similarly, the median number of β-lactamase RGPC was 0.55 (0.18-1.24) for the short-course strategy and 0.60 (0.21-2.45) for the standard-course strategy (P = .03).

“Providing the shortest duration of antibiotics necessary to effectively treat an infection is a central tenet of antimicrobial stewardship and a convenient and cost-effective strategy for caregivers,” the authors observe. For example, reducing treatment from 10 to 5 days for outpatient CAP could reduce the number of days spent on antibiotics by up to 7.5 million days in the U.S. each year.

“If we can safely reduce antibiotic exposure, we can minimize antibiotic side effects while also helping to slow antibiotic resistance,” Dr. Williams pointed out.

Fewer days of having to give their child repeated doses of antibiotics is also more convenient for families, he added.

Asked to comment on the study, David Greenberg, MD, professor of pediatrics and infectious diseases, Ben Gurion University of the Negev, Israel, explained that the length of antibiotic therapy as recommended by various guidelines is more or less arbitrary, some infections being excepted.

“There have been no studies evaluating the recommendation for a 100-day treatment course, and it’s kind of a joke because if you look at the treatment of just about any infection, it’s either for 7 days or 14 days or even 20 days because it’s easy to calculate – it’s not that anybody proved that treatment of whatever infection it is should last this long,” he told this news organization.

Moreover, adherence to a shorter antibiotic course is much better than it is to a longer course. If, for example, physicians tell a mother to take two bottles of antibiotics for a treatment course of 10 days, she’ll finish the first bottle which is good for 5 days and, because the child is fine, “she forgets about the second bottle,” Dr. Greenberg said.

In one of the first studies to compare a short versus long course of antibiotic therapy in uncomplicated CAP in young children, Dr. Greenberg and colleagues initially compared a 3-day course of high-dose amoxicillin to a 10-day course of the same treatment, but the 3-day course was associated with an unacceptable failure rate. (At the time, the World Health Organization was recommending a 3-day course of antibiotics for the treatment of uncomplicated CAP in children.)

They stopped the study and then initiated a second study in which they compared a 5-day course of the same antibiotic to a 10-day course and found the 5-day course was comparable to the 10-day course in terms of clinical cure rates. As a result of his study, Dr. Greenberg has long since prescribed a 5-day course of antibiotics for his own patients.

“Five days is good,” he affirmed. “And if patients start a 10-day course of an antibiotic for, say, a urinary tract infection and a subsequent culture comes back negative, they don’t have to finish the antibiotics either.” Dr. Greenberg said.

Dr. Williams said he has no financial ties to industry. Dr. Greenberg said he has served as a consultant for Pfizer, Merck, Johnson & Johnson, and AstraZeneca. He is also a founder of the company Beyond Air.

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

The evidence is in: Less is more when it comes to treating uncomplicated community-acquired pneumonia (CAP) in young children. Five days of antibiotic therapy resulted in a superior clinical response compared to 10 days of treatment and had the added benefit of a lower risk of inducing antibiotic resistance, according to the randomized, controlled SCOUT-CAP trial.

“Several studies have shown shorter antibiotic courses to be non-inferior to the standard treatment strategy, but in our study, we show that a shortened 5-day course of therapy was superior to standard therapy because the short course achieved similar outcomes with fewer days of antibiotics,” Derek Williams, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn., said in an email.

“These data are immediately applicable to frontline clinicians, and we hope this study will shift the paradigm towards more judicious treatment approaches for childhood pneumonia, resulting in care that is safer and more effective,” he added.

The study was published online Jan. 18 in JAMA Pediatrics.
 

Uncomplicated CAP

The study enrolled children aged 6 months to 71 months diagnosed with uncomplicated CAP who demonstrated early clinical improvement in response to 5 days of antibiotic treatment. Participants were prescribed either amoxicillin, amoxicillin and clavulanate, or cefdinir according to standard of care and were randomized on day 6 to another 5 days of their initially prescribed antibiotic course or to placebo.

“Those assessed on day 6 were eligible only if they had not yet received a dose of antibiotic therapy on that day,” the authors write. The primary endpoint was end-of-treatment response, adjusted for the duration of antibiotic risk as assessed by RADAR. As the authors explain, RADAR is a composite endpoint that ranks each child’s clinical response, resolution of symptoms, and antibiotic-associated adverse effects (AEs) in an ordinal desirability of outcome ranking, or DOOR.

“There were no differences between strategies in the DOOR or in its individual components,” Dr. Williams and colleagues point out. A total of 380 children took part in the study. The mean age of participants was 35.7 months, and half were male.

Over 90% of children randomized to active therapy were prescribed amoxicillin. “Fewer than 10% of children in either strategy had an inadequate clinical response,” the authors report.

However, the 5-day antibiotic strategy had a 69% (95% CI, 63%-75%) probability of children achieving a more desirable RADAR outcome compared with the standard, 10-day course, as assessed either on days 6 to 10 at outcome assessment visit one (OAV1) or at OAV2 on days 19 to 25.

There were also no significant differences between the two groups in the percentage of participants with persistent symptoms at either assessment point, they note. At assessment visit one, 40% of children assigned to the short-course strategy and 37% of children assigned to the 10-day strategy reported an antibiotic-related AE, most of which were mild.
 

Resistome analysis

Some 171 children were included in a resistome analysis in which throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. The total number of resistance genes per prokaryotic cell (RGPC) was significantly lower in children treated with antibiotics for 5 days compared with children who were treated for 10 days.

Specifically, the median number of total RGPC was 1.17 (95% CI, 0.35-2.43) for the short-course strategy and 1.33 (95% CI, 0.46-11.08) for the standard-course strategy (P = .01). Similarly, the median number of β-lactamase RGPC was 0.55 (0.18-1.24) for the short-course strategy and 0.60 (0.21-2.45) for the standard-course strategy (P = .03).

“Providing the shortest duration of antibiotics necessary to effectively treat an infection is a central tenet of antimicrobial stewardship and a convenient and cost-effective strategy for caregivers,” the authors observe. For example, reducing treatment from 10 to 5 days for outpatient CAP could reduce the number of days spent on antibiotics by up to 7.5 million days in the U.S. each year.

“If we can safely reduce antibiotic exposure, we can minimize antibiotic side effects while also helping to slow antibiotic resistance,” Dr. Williams pointed out.

Fewer days of having to give their child repeated doses of antibiotics is also more convenient for families, he added.

Asked to comment on the study, David Greenberg, MD, professor of pediatrics and infectious diseases, Ben Gurion University of the Negev, Israel, explained that the length of antibiotic therapy as recommended by various guidelines is more or less arbitrary, some infections being excepted.

“There have been no studies evaluating the recommendation for a 100-day treatment course, and it’s kind of a joke because if you look at the treatment of just about any infection, it’s either for 7 days or 14 days or even 20 days because it’s easy to calculate – it’s not that anybody proved that treatment of whatever infection it is should last this long,” he told this news organization.

Moreover, adherence to a shorter antibiotic course is much better than it is to a longer course. If, for example, physicians tell a mother to take two bottles of antibiotics for a treatment course of 10 days, she’ll finish the first bottle which is good for 5 days and, because the child is fine, “she forgets about the second bottle,” Dr. Greenberg said.

In one of the first studies to compare a short versus long course of antibiotic therapy in uncomplicated CAP in young children, Dr. Greenberg and colleagues initially compared a 3-day course of high-dose amoxicillin to a 10-day course of the same treatment, but the 3-day course was associated with an unacceptable failure rate. (At the time, the World Health Organization was recommending a 3-day course of antibiotics for the treatment of uncomplicated CAP in children.)

They stopped the study and then initiated a second study in which they compared a 5-day course of the same antibiotic to a 10-day course and found the 5-day course was comparable to the 10-day course in terms of clinical cure rates. As a result of his study, Dr. Greenberg has long since prescribed a 5-day course of antibiotics for his own patients.

“Five days is good,” he affirmed. “And if patients start a 10-day course of an antibiotic for, say, a urinary tract infection and a subsequent culture comes back negative, they don’t have to finish the antibiotics either.” Dr. Greenberg said.

Dr. Williams said he has no financial ties to industry. Dr. Greenberg said he has served as a consultant for Pfizer, Merck, Johnson & Johnson, and AstraZeneca. He is also a founder of the company Beyond Air.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

A new analysis of data from a major U.S. trial comparing antibiotics with surgery for appendicitis yielded more information that can help patients weigh options for treatment.

The presence of mineralized stool, known as appendicolith, was associated with a nearly twofold increased risk of undergoing appendectomy within 30 days of initiating antibiotics, write David Flum, MD, of the University of Washington, Seattle, and coauthors in a paper published in JAMA Surgery on Jan. 12, 2021.

But the surprise was the lack of an association between appendectomy and factors often presumed to be consistent with more severe appendicitis.

Physicians have had their own ideas about what factors make a patient more likely to need an appendectomy after an initial round of treatment with antibiotics, such as a high white blood cell count or a perforation seen on CT scan, Dr. Flum said in an interview. But the research didn’t support some of these theories.

“This is why we do the studies,” Dr. Flum said. “Sometimes we find out that our hunches were wrong.”

Dr. Flum and coauthors measured the association between different patient factors and disease severity and the need for appendectomy following a course of antibiotics. They used adjusted odds ratios to describe these relationships while accounting for other differences.

An OR of 1.0 – or when the confidence interval around an OR crosses 1 – signals that there is no association between that factor and appendectomy. Positive ORs with confidence intervals that exclude 1.0 suggest the factor was associated with appendectomy.

The OR was 1.99 for the presence of appendicolith, a finding with a 95% confidence interval of 1.28-3.10. The OR was 1.53 (95% CI, 1.01-2.31) for female sex.

But the OR was 1.14 (95% CI, 0.66-1.98) for perforation, abscess, or fat stranding.

The OR was 1.09 (95% CI, 1.00-1.18) for radiographic finding of a larger appendix, as measured by diameter.

And the OR was 1.03 (95% CI, 0.98-1.09) for having a higher white blood cell count, as measured by a 1,000-cells/mcL increase.
 

Appy or not?

This paper draws from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial (NCT02800785), for which top-line results were published in 2020 in the New England Journal of Medicine. In that paper, Dr. Flum and colleagues reported on results for 1,552 adults (414 with an appendicolith) who were evenly randomized to either antibiotics treatment or appendectomy. After 30 days, antibiotics were found to be noninferior to appendectomy, as reported by this news organization.

The federal Patient-Centered Outcomes Research Institute funded the CODA research. Dr. Flum said the National Institutes of Health had not appeared interested in funding a look at the different options available to patients experiencing appendicitis. Congress created PCORI as part of the Affordable Care Act of 2010, seeking to encourage researchers to study which treatments best serve patients through direct comparisons. Its support was critical for Dr. Flum and colleagues in seeking to help people weigh their options for treating appendicitis.

The CODA study “models what the patient’s experience is like, and this has not been the focus of NIH as much,” Dr. Flum said.

The CODA team has sought to make it easy for patients to consider what its findings and other research on appendicitis mean for them. They created an online decision-making tool, available at the aptly named http://www.appyornot.org/ website, which has videos in English and Spanish explaining patients’ options in simple terms. The website also asks questions about personal preferences, priorities, and resources to help them choose a treatment based on their individual situation.
 

Shift away from ‘paternalistic framing’

In the past, surgeons focused on the risk for patients from procedures, making the decisions for them about whether or not to proceed. There’s now a drive to shift away from this “paternalistic framing” toward shared decision-making, Dr. Flum said.

Surgeons need to have conversations with their patients about what’s happening in their lives as well as to assess their fears and concerns about treatment options, he said. These are aspects of patient care that were not covered in medical school or surgical training, but they lead to “less paternalistic” treatment. A patient’s decision about whether to choose surgery or antibiotics for appendicitis may hinge on factors such as insurance coverage, access to childcare, and the ability to miss days of work.

Dr. Flum said his fellow surgeons by and large have reacted well to the CODA team’s work.

“To their credit, the surgical community has embraced a healthy skepticism about the role of surgery,” Dr. Flum said.

The guidelines of the American College of Surgeons state that there is “high-quality evidence” that most patients with appendicitis can be managed with antibiotics instead of appendectomy (69% overall avoid appendectomy by 90 days, 75% of those without appendicolith, and 59% of those with appendicolith).

“Based on the surgeon’s judgment, patient preferences, and local resources (e.g., hospital staff, bed, and PPE supply availability) antibiotics are an acceptable first-line treatment, with appendectomy offered for those with worsening or recurrent symptoms,” the ACS guidelines say.

In an interview, Samir M. Fakhry, MD, vice president of HCA Center for Trauma and Acute Care Surgery Research in Nashville, Tenn., agreed with Dr. Flum about the shift taking place in medicine.

The CODA research, including the new paper in JAMA Surgery, makes it easier for physicians to work with patients and their families to reach decisions about how to treat appendicitis, Dr. Fakhry said.

These important discussions take time, he said, and patients must be allowed that time. Patients might feel misled, for example, if a surgeon pressed for appendectomy without explaining that a course of antibiotics may have served them well. Other patients may opt for surgery right away, especially in cases with appendicoliths, to avoid the potential for repeat episodes of medical care.

“You’ve got people who just want to get it done and over with. You’ve got people who want to avoid surgery no matter what,” Dr. Fakhry said. “It’s not just about the science and the data.”

This study was supported by a grant from PCORI. The authors reported having served as consultants or reviewers or have received fees for work outside of this paper from Stryker, Kerecis, Acera, Medline, Shriner’s Research Fund, UpToDate, and Tetraphase Pharmaceuticals Stryker.

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

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Most children with multisystem inflammatory syndrome related to COVID-19 infection show recovery of cardiac function by 3 months, but longer term follow-up is still needed, suggests a new retrospective longitudinal cohort study.

While 80%-85% of children with multisystem inflammatory syndrome have cardiovascular involvement, “lack of knowledge about the short-term consequences of MIS-C has led to uncertainty among physicians in making recommendations about follow-up,” Daisuke Matsubara, MD, PhD, and colleagues wrote in their paper, which was published in the Journal of the American Heart Association.

Dr. Matsubara, of the department of pediatrics at the Children’s Hospital of Philadelphia, and colleagues examined cardiac outcomes among 60 patients aged 18 years or under admitted to two Philadelphia hospitals with MIS-C between April 2020 and January 2021. They compared those with outcomes in 60 age-matched healthy children who had undergone echocardiography for a range of non–COVID-related conditions such as chest pain or syncope.

The study used echocardiography, MRI, biochemistry, and functional and clinical parameters to assess the degree of change and damage to the heart at 3 months after admission.

When the patients first presented to a hospital, 42 had biochemical signs of myocardial injury, such as elevated brain-type natriuretic peptide and troponin levels. However, most patients’ symptoms were no longer present by the time they were discharged from hospital.

The researchers found that 81% of patients who presented with myocardial injury had lost the left atrial contraction phase. This dropped to 51% during the subacute phase, then 30% at 1 month. By 3-4 months, all patients achieved normal left atrial contraction phase.

At 1 month after admission, all MIS-C patients had significant signs of cardiac strain, compared with controls, including changes to global longitudinal strain, global circumferential strain, circumferential early diastolic strain rate, and right ventricular free wall longitudinal strain.
 

Parameters of strain normalized by 3 months

All parameters of strain had normalized, compared with controls, by 3 months. In the case of global longitudinal strain and left atrial strain, the median time to normalization was 6 days. For left ventricular ejection fraction the median time to normalization was 8 days and for right ventricular free wall longitudinal strain it was 9 days.

A small difference persisted with global longitudinal strain, but the authors said the difference was within the range of normal published values and not clinically relevant. The dysfunction appeared to be spread evenly across the heart rather than varying between segments, they noted.

“Deformation analysis could detect subtle myocardial changes; therefore, our study suggests the absence of persistent subclinical myocardial dysfunction after 3-4 months,” Dr. Matsubara said in an interview.

Four patients experienced small coronary aneurysms during the acute phase of MIS-C, but all had resolved within 2 months and none experienced any further lesions.

Among the 14 patients who underwent cardiac MRI at presentation, 2 had evidence of myocardial edema and fibrosis during the subacute phase of illness, despite having normal left ventricular systolic function and conventional echocardiography.

At follow-up, only one patient had residual edema; this individual had no evidence of fibrosis and had normal systolic function.
 

Study provides reassurance, but longer follow-up needed

Commenting on the study, pediatric cardiologist Devyani Chowdhury, MD, director of Cardiology Care for Children in Lancaster, Pa., said that overall it provided reassurance that most children do recover from MIS-C – and fits with her own clinical experience of the condition – but cautioned that longer-term follow-up was still needed.

“Three months is really not long term for a child,” Dr. Chowdhury said in an interview. “I’ve had a couple of patients whose MRIs have not normalized even after 1 year.”

Dr. Chowdhury also noted that it was a relatively small sample size, and it was also not yet possible to work out what host factors might play a role in increasing the risk of longer-term effects of MIS-C.

“I think it is a disease in evolution and we have to give it time, but in the very short term at least these kids are not dying, they are recovering, going home, and returning to activity and the heart is getting better,” she said.

The study authors suggested their findings could provide an evidence base for recommendations on when children with MIS-C can return to sports and physical activity, given that current consensus statements on the issue treat MIS-C as being equivalent to myocarditis in adults.

Dr. Matsubara noted that the cardiac outcomes of MIS-C were very different from those in COVID-19–affected adults, where echocardiography and MRI show longer-term evidence of myocardial impairments.

“This finding is also different from that of adult COVID-19, where the high troponin is reported to be the prognostic factor,” he said, suggesting this could explain different mechanisms of myocardial injury between MIS-C and COVID-19 myocarditis.

One author was supported by the National Institutes of Health. No conflicts of interest were declared.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.

Behavior problems, anxiety, and depression in youths were associated with these individuals participating in remote schooling during broader social lockdowns in a new study.

The systematic review, which was published in JAMA Pediatrics on Jan. 18, 2022, was based on data from 36 studies from 11 countries on mental health, physical health, and well-being in children and adolescents aged 0-18 years. The total population included 79,781 children and 18,028 parents or caregivers. The studies reflected the first wave of pandemic school closures and lockdowns from February to July 2020, with the duration of school closure ranging from 1 week to 3 months.

“There are strong theoretical reasons to suggest that school closures may have contributed to a considerable proportion of the harms identified here, particularly mental health harms, through reduction in social contacts with peers and teachers,” Russell Viner, PhD, of UCL Great Ormond St Institute of Child Health, London, and colleagues wrote in their paper.

The researchers included 9 longitudinal pre-post studies, 5 cohort studies, 21 cross-sectional studies, and 1 modeling study in their analysis. Overall, approximately one-third of the studies (36%) were considered high quality, and approximately two-thirds (64%) of the studies were published in journals. Twenty-five of the reports analyzed focused on mental health and well-being.

Schools provide not only education, but also services including meals, health care, and health supplies. Schools also serve as a safety net and source of social support for children, the researchers noted.

The losses children may have experienced during school closures occurred during a time when more than 167,000 children younger than 18 years lost a parent or caregiver to COVID-19, according to a recent report titled “Hidden Pain” by researchers at the University of Pennsylvania, Nemours Children’s Health, and the COVID Collaborative. Although not addressed in the current study, school closures would prevent bereaved children from receiving social-emotional support from friends and teachers. This crisis of loss also prompted the American Academy of Pediatrics to issue a National State of Emergency in Children’s Mental Health in October 2021.
 

New study results

These studies identified associations between school closures during broader lockdowns and increased emotional and behavioral problems, as well as increased restlessness and inattention. Across these studies, 18%-60% of children and adolescents scored higher than the risk thresholds for diagnoses of distress, especially depressive symptoms and anxiety.

Although two studies showed no significant association with suicide in response to school closures during lockdowns, three studies suggested increased use of screen time, two studies reported increased social media use, and six studies reported lower levels of physical activity.

Three studies of child abuse showed decreases in notifications during lockdowns, likely driven by lack of referrals from schools, the authors noted. A total of 10 studies on sleep and 5 studies on diet showed inconsistent evidence of harm during the specific period of school closures and social lockdowns.

“The contrast of rises in distress with decreases in presentations suggests that there was an escalation of unmet mental health need during lockdowns in already vulnerable children and adolescents,” the researchers wrote. “More troubling still is evidence of a reduction in the ability of the health and social care systems to protect children in many countries, as shown by the large falls in child protection referrals seen in high-quality cohort studies.”
 

‘Study presents concrete assessments rather than speculation’

“Concerns have been widely expressed in the lay media and beyond that school closures could negatively impact the mental and physical health of children and adolescents,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “The authors presented a narrative synthesis summarizing available evidence for the first wave of COVID-19 on school closures during the broader social lockdown occurring during this period.”

The “importance” of this research is that “it is not a single convenience sample study, but a systematic review from 11 countries including the United States, United Kingdom, China, and Turkey, among others, and that the quality of the information was graded,” Dr. Jay said. “Although not a meta-analysis, the study presents concrete assessments rather than speculation and overviews its limitations so that the clinician can weigh this information. Importantly, the authors excluded closure of schools with transmission of infection.

“Clearly, school lockdowns as a measure of controlling infectious disease needs balance with potential of negative health behaviors in children and adolescents. Ongoing prospective longitudinal studies are needed as sequential waves of the pandemic continue,” she emphasized.

“Clinically, this study highlights the need for clinicians to consider [asking] about the impact of school closures and remote versus hybrid versus in-person education [as part of their] patients and families question inventory,” Dr. Jay said. “Also, the use of depression inventories can be offered to youth to assess their mental health state at a visit, either via telemedicine or in person, and ideally at sequential visits for a more in-depth assessment.”
 

Schools play key role in social and emotional development

“It was important to conduct this study now, because this current time is unprecedented,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “We know based on evolutionary biology, anthropology, and developmental psychology, among other disciplines, that meaningful interpersonal interactions embedded in the context of community are vital to supporting human well-being.

“In our current time, the primary framework of community for our children is the school setting; it is the predominant space where they engage in the interpersonal interactions necessary for developing resilience, their sense of purpose, belonging, and fidelity,” he emphasized.

“Rarely in the course of human existence have kids been removed from the broader context of community to this extent and for this duration,” Dr. Loper said. “This study capitalizes on this unprecedented moment to begin to further understand how compromises in our sociocultural infrastructure of community, like school closures and lockdowns, may manifest as mental health problems in children and adolescents. More importantly, it contributes to the exploration of potential unintended consequences of our current infection control measures so we can adapt to support the overall well-being of our children in this ‘new normal.’ ”

Dr. Loper added that he was not surprised by the new study’s findings.

“We were already seeing a decline in pediatric mental health and overall well-being in the years preceding COVID-19 because of the ‘isolation epidemic’ involving many of the factors that this study explored,” he said. “I think this review further illustrates the vital necessity of community to support the health and well-being of humans, and specifically children and adolescents.”

From a clinical standpoint, “we need to be intentional and consistent in balancing infection control measures with our kids’ fundamental psychosocial needs,” Dr. Loper said.

“We need to recognize that, when children and adolescents are isolated from community, their fundamental psychosocial needs go unmet,” he emphasized. “If children and adolescents cannot access the meaningful interpersonal interactions necessary for resilience, then they cannot overcome or navigate distress. They will exhibit the avoidance and withdrawal behaviors that accumulate to manifest as adverse mental health symptoms like anxiety and depression.

“Additional research is needed to further explore how compromises in the psychosocial infrastructure of community manifest as downstream symptom indicators such as anxiety and depression,” which are often manifestations of unmet needs, Dr. Loper said.
 

Limitations and strengths, according to authors

The findings were limited by several factors, including a lack of examination of school closures’ effects on mental health independent of broader social lockdowns, according to the researchers. Other limitations included the authors potentially having missed studies, inclusion of cross-sectional studies with relatively weak evidence, potential bias from studies using parent reports, and a focus on the first COVID-19 wave, during which many school closures were of limited duration. Also, the researchers said they did not include studies focused on particular groups, such as children with learning difficulties or autism.

The use of large databases from education as well as health care in studies analyzed were strengths of the new research, they said. The investigators received no outside funding for their study. The researchers, Dr. Jay, and Dr. Loper had no financial conflicts to disclose. Dr. Jay serves on the editorial advisory board of Pediatric News.