CHEST Physician

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

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

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

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

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

There has been no ebb in the flurry of respiratory illnesses infecting America’s youngest children. More pediatric wards across the country are announcing crises as beds reach capacity, the pediatric death toll jumped significantly in the past week, and sometimes children are being infected with more than one virus at a time.

In Oregon, for example, the governor announced an official state of emergency to help hospitals deal with the surge of respiratory viruses. Doernbecher Children’s Hospital in Portland, which houses half of all pediatric ICU beds statewide, moved to “crisis mode” and said every pediatric ICU bed was full, Oregon Public Broadcasting reported.

Last month, pediatricians nationwide called for a similar emergency declaration from the federal government to help them respond to the wave of illnesses, which include influenza and respiratory syncytial virus (RSV).

“What’s concerning to us are not only the number of infections, but the severity of these infections, leading to a high number of emergency room visits and hospitalizations,” pediatric infectious disease expert Oscar G. Gómez-Duarte, MD, PhD, said in a news release.

Five more pediatric deaths due to the flu were logged by the CDC in the past week, bringing the total for pediatric flu deaths this season to 12. Nearly 21 per 100,000 children ages 4 and under are being hospitalized for the flu, which is double the rate for children ages 5-17. Last year at this time, fewer than 1 child under age 4 per 100,000 were being hospitalized for the flu.

RSV rates are also stunningly high.

“If we look at CDC data, the RSV hospitalization rate is 10 times higher than usual for this point in the season,” American Medical Association Vice President Andrea Garcia, JD, said in this week’s AMA podcast. “And 171 out of every 100,000 infants younger than 6 months were hospitalized with RSV for the week ending Nov. 12. That is more than double the RSV hospitalization rate for newborns last year and seven times the rate in 2018, which is the last complete season we saw before the pandemic.”

Dr. Gómez-Duarte said hospitals are admitting children with respiratory illnesses who had otherwise been healthy, and sometimes they are even seeing patients with more than one illness.

“Yes, some children are getting what we call coinfections, where they become infected with more than one virus at a time. In some instances, a child becomes initially infected with flu, begins to recover, and subsequently comes down with rhinovirus (a common cold virus), RSV, or any other respiratory virus,” he said. “These coinfections tend to be more severe than when the child just has one infection.”

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

Rebecca Chester, MD, an Arizona-based interventional cardiologist, recently left her position in a private practice and started employment at a hospital system.

“When I was negotiating my previous contract with the private practice, I found that navigating contracts from the standpoint of a woman still in childbearing years was a little disappointing and challenging,” Dr. Chester told this news organization.

“I wanted to have more children and hired a lawyer recommended by a male colleague to help me not only understand the contract but also negotiate time off and maternity leave, but the lawyer discouraged me from advocating for maternity leave, feeling that it might stigmatize me and prevent me from getting a job,” she says.

He also didn’t explain very much. “He just said it falls under ‘disability leave’ and left it at that.”

Fortunately, Dr. Chester had a good experience with the group. “As things turned out, I did have a child later that year, and they treated me well – I actually got time off – and they didn’t make me take extra call. But it might have turned out very differently because I didn’t know what I was getting into. If I hadn’t worked for such a conscientious group, I might have been in a much tougher situation.”

Since then, Dr. Chester has spoken to female colleagues who received “more support from their legal advisors regarding maternity leave.” She suggests turning to female physicians for recommendations to a lawyer.

Although the central components of a contract (for example, noncompete covenants, malpractice “tail” coverage, bonus structure, vacation time, disability, and call) are relevant to physicians of all genders, the needs of women and men are often different.

Dennis Hursh, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, told this news organization that women physicians have “several issues that need special attention when negotiating their physician employment agreements.”
 

It starts with the interview

“Women have to be sensitive to the interviewer’s casual ‘let’s-get-to-know-each-other’ types of questions that may seem natural but really are unlawful to bring into an employment interview,” said Mr. Hursh.

He warned women to beware of questions such as “Are you married? Do you have kids? Are you planning to start a family?” These may be friendly chit-chat for male interviewees but there may be other agendas when asked to a prospective female employee.

Many of Mr. Hursh’s female clients have been asked this type of question, which “should be regarded as a ‘red flag.’ Yes, it may be an innocent, well-intentioned ice-breaker, but it’s actually unlawful to bring that up in an employment setting and, according to the Equal Opportunity Commission, can be seen as a form of discrimination.” He advises female physicians not to engage with the question and simply to refocus the discussion.
 

Know your worth and go for it

Medscape’s Physician Compensation surveys have consistently found discrepancies in earnings between male and female physicians, both in primary care and in specialties. In 2022, male primary care physicians earned 23% more than their female counterparts, whereas male specialists earned 31% more.

One reason may be that women tend to be more timid about negotiating for better compensation packages. Amanda Hill of Hill Health Law, a health care practice based in Austin, Tex., told this news organization that in her experience one of the most “overarching” features of female physicians is “that they either don’t know what they’re worth or they undersell themselves.”

In contrast to men, “many women are afraid of coming across as greedy or crass, or even demanding or bossy. But it’s a misperception that if you ask for more money, your future employer will hate you or won’t hire you,” said Ms. Hill.

Ms. Hill and Mr. Hursh encourage physicians to find out what they’re worth, which varies by region and specialty, by consulting benchmarks provided by companies such as Medical Group Management Association.

Jon Appino, MBA, principal and founder of Contract Diagnostics, a Kansas City–based consulting company that specializes in physician employment contract reviews, told this news organization that it’s important to look beyond the salary at other aspects of the position. For example, some figures “don’t take into account how much call a physician is taking. You may know what the average ob.gyn. is making, but an ob.gyn. may be working 3 days a week, while another one is working 6 days a week, one may be on call 15 times per month and another may be on call 15 times a quarter.” Other components of compensation include relative value unit (RVU) thresholds and bonuses.

Once you have that information, “don’t be intimidated, even if you’re sitting in front of several executives who are savvy about negotiations, and don’t worry about coming across as ‘high-maintenance’ or ‘all about money,’ ” Mr. Appino says. Proceed with confidence, knowing your worth and pursuing it.
 

Part-time vs. full-time

Mr. Appino has seen “more female than male physicians who want to work less than full-time. So it’s important to clarify whether that’s a possibility now or in the future and to understand the implications of working part-time.”

He explained that a full-time employee typically puts in a 40-hour work week, which translates into 1.0 Full-Time Equivalent (FTE), or one unit of work. “For example, if a person wants to work 0.8 FTEs – 4 days a week – is vacation time pro-rated? At what point is there a medical insurance fall-off or a higher monthly premium?”

In medical settings, FTEs may be tied to different metrics rather than the number of weekly hours – for example, for a hospitalist, it might be a certain number of shifts and might also vary by specialty. And it affects the call schedule too. “Call is hard to pro-rate. Many hospital bylaws mandate that call be divided equally, but if one surgeon is working 1.0 FTEs and another is working 0.8 FTEs, how does that call schedule get divided?”
 

Maternity leave: A tricky question

Many attorneys counsel against raising the question out of fear of scaring away potential employers.

“On the one hand, it is and should be absolutely reasonable to ask about the maternity leave policy or even negotiate for paid leave or additional leave, but it also highlights that you’re planning to have a baby and be out for months,” said Ms. Hill.

“And as much as we want people to be fair and reasonable, on the side of the employer, bias still very much exists, especially in a situation where revenue is based on group numbers. So suddenly, the employer thinks up some ‘nondiscriminatory’ reason why that person isn’t a great fit for the organization.”

Andrew Knoll, MD, JD, a former hospitalist who is now a partner with Cohen Compagni Beckman Appler & Knoll PLLC in Syracuse, N.Y., said that maternity leave is “rare” in an employment agreement, except sometimes in small private practice groups, because it often falls under the purview of “disability leave,” and “from a legal perspective, it’s no different than any other type of disability leave.”

The Family and Medical Leave Act (FMLA), which applies if a group is large enough, allows employees 12 weeks of unpaid leave, during which time their job is protected and their benefits maintained. And some states require employers to offer paid family leave.

“During this time, the woman can take time off – albeit without pay sometimes – to bond with the baby,” Dr. Knoll says. “Since there are statutory laws that protect the employee’s job, offering specific paid maternity leave is very unlikely.”

Ms. Hill advises carefully examining the employer’s comprehensive benefits plan to ascertain if paid maternity leave is included in the benefits. “But unless you’re currently pregnant and want to start off the relationship with true transparency – ‘I’m due in April and curious how we can handle that if you hire me now’ – I would keep the family planning questions to yourself before you get the job.”

Mr. Hursh, author of “The Final Hurdle: A Physician’s Guide to Negotiating a Fair Employment Agreement” (Charleston, S.C.: Advantage, 2012), has a different perspective. “I think all women, no matter how old they are, should ask about maternity leave, whether or not they’re planning a family,” he said.

“The employer may say, ‘We treat maternity leave like any other disability; our policy is such-and-such.’ If they cite an unacceptable policy, it’s a red flag about how they treat women, and should give a woman pause before accepting a position at that organization. Even if your rights are protected under the law and the organization’s policy is violating the law, no one wants to go to battle with HR or to have to go to court.”
 

Do you want partnership?

Not all female physicians entering a private practice want to advance to becoming partners. Many who are balancing family and work commitments “would prefer to just go into the office, perform their clinical responsibilities, go home, and be done” without the extra headaches, tasks, and time involved with business leadership, says Mr. Appino.

Some private practices have different contracts for those on partnership vs. nonpartnership tracks, so “you should ascertain this information and make sure it’s not automatically assumed that you would like to be on a partnership track,” says Mr. Appino.

On the other hand, you may want to become a partner. “I always suggest asking about the possibility of obtaining a leadership position in an organization or becoming an owner in a private practice,” says Mr. Hursh. “You may be told, ‘We’ve never had a woman in leadership before.’ This might be innocent if you’re the first woman hired, but it might be a red flag as to how women are regarded.” Either way, it’s important to have the information and know what your options are.
 

The impact of shift schedule

Mr. Hursh advises drilling down into the specifics of the schedule if you’re considering becoming a hospitalist. “Does a ‘week-on/week-off’ shift schedule assume you’ll be taking your vacation time or completing your CME requirements during the week off? This is important for all physicians, but especially for women who might want to use their weeks off to attend to children and family.”

Moreover, “there should be limits on shifts. You shouldn’t have a full day shift followed by a night shift. And there should be a limit on the number of shifts you work without time off. Twelve would be a brutal schedule. Seven is a reasonable amount. Make sure this is in writing and that the contract protects you. Don’t allow the employer to say, ‘We expect you to do the work we assign’ and leave it vague.”

Often, hospitalists will receive an annual salary under the assumption that a certain minimum number of shifts will be completed, but there is no maximum. “It’s important that the salary includes the minimum number of shifts, but that a compensation structure is created so that additional shifts receive additional compensation,” Mr. Hursh said.
 

Removing the ‘golden handcuffs’

Ms. Hill observes that there are some “really terrible contracts out there, which physicians – especially women – often feel pressured into signing.” They’re told, “This is our standard contract. You won’t find anything better.” Or, “Don’t worry about the small print and legalese.” The physician “gets scared or is artificially reassured, signs an overwhelmingly unfair contract, and then feels stuck.”

Being stuck in a bad contract “is debilitating and adds to burnout, feeling of depression, and the sense that there is no recourse and nowhere to go, especially if your family depends on you,” Ms. Hill said.

“More women than men feel hamstrung or are resigned to being harassed – which is not uncommon in the medical setting, especially in surgical specialties – or just accept poor treatment,” Ms. Hill added. Yes, you can “fight the system and go to HR, but fighting the system is very hard.”

She urges women “not to feel stuck or imprisoned by the ‘golden handcuffs’ but to consult a good lawyer, even if you have to break the contract.” Be aware of the reasons for your unhappiness and bring them to your lawyer – perhaps the system has engaged in fraud, perhaps there has been sexual or racial harassment, perhaps the organization hasn’t followed its own compliance policies.

Dr. Chester consulted Ms. Hill before signing the contract for her current position. “I wanted someone who could give me personalized advice, not only generic advice, and who understood my needs as a woman.”

Ms. Hill helped her to understand “what was and wasn’t fair and reasonable, what changes I could request based on my goals and whether they were realistic, and how to pick my battles. For example, I tried to negotiate tail coverage up front in my previous job but was unsuccessful. The new employer paid tail for me, both from my previous employment and for my current employment.”

Dr. Chester advises other female physicians “never to sign anything without having a lawyer review it and to make sure that the lawyer is sensitive to their specific needs.”

It can be hard to be a female physician. Having the right knowledge and ammunition and knowing how to negotiate well paves the way for success and thriving in an often male-dominated market.

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

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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

Outcomes were similar for comatose patients who received 36 versus 72 hours of device-based temperature control after out-of-hospital cardiac arrest, a randomized trial shows.

“Since 2005, active fever prevention in comatose patients has been advocated by the guidelines for 72 hours after an out-of-hospital cardiac arrest,” Christian Hassager, MD, of the University of Copenhagen, told this news organization. “Our study is the first randomized trial ever on this subject – and it challenges the guidelines.”

At 90 days, a primary endpoint – a composite of death from any cause or hospital discharge with a high Cerebral Performance Category score – occurred in 32.4% of those in the 36-hour group and 33.6% of those in the 72-hour group; mortality was 29.5% versus 30.3%, respectively.

The study was published online  in The New England Journal of Medicine. The results were also presented at the Resuscitation Science Symposium during the American Heart Association scientific sessions.
 

No significant differences

Assessment of the two device-based fever-prevention strategies for the duration was a predefined, additional randomly assigned open-label intervention in the Blood Pressure and Oxygenation Targets in Post Resuscitation Care (BOX) trial, which involved comatose adult patients who had been resuscitated after out-of-hospital cardiac arrest at two Danish cardiac arrest centers.

The main BOX analysis compared different primary strategies in these patients in a two-by-two factorial design: higher versus lower blood pressure targets and higher versus lower oxygenation targets. They found no difference between the various strategies in terms of death and discharge from hospital in a poor neurologic state. Those results were presented at the European Society of Cardiology Congress on Aug. 27, and simultaneously published in separate articles in The New England Journal of Medicine.

For this current analysis, a total of 789 comatose patients (mean age, 62; 80% men) received device-based temperature control targeting 36° C for 24 hours followed by 37° C for either 12 or 48 hours (total intervention times, 36 and 72 hours, respectively) or until the patient regained consciousness.

Patients were kept sedated and were receiving mechanical ventilation during the temperature control at 36° C, the authors note. Target core body temperature was controlled using commercially available surface cooling at one of the sites in 286 patients (Criticool and Allon, Belmont Medical Technologies) and using intravenous cooling in 503 patients at the other site (Thermogard XP, and Cool Line Catheter, Zoll).

Body temperature was maintained at 37° C with the same type of device that had been used for 36° C during the initial 24 hours. If the patient awakened, cooling was terminated.

Physicians in both groups were permitted to use non–device-based fever treatment (that is, for a body temperature > 37.5° C) with drugs such as paracetamol, by uncovering the patient’s body, or both, at the discretion of the treating physician. Ice packs or pads were not used.

The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability) within 90 days after randomization.

Secondary outcomes at 90 days included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability).

A primary endpoint event occurred in 32.3% of patients in the 36-hour group and in 33.6% of those in the 72-hour group (hazard ratio, 0.99). Mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group.

The median Montreal Cognitive Assessment scores were 26 and 27, respectively. No significant between-group differences in the incidence of adverse events were observed.

The authors concluded that “active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma.”

Dr. Hassager added, “We will continue with a new trial where we will randomize to treatment as usual or immediate wakeup call and no temperature intervention at all.”
 

Findings ‘very persuasive’

Intensivist Ken Parhar, MD, clinical associate professor, Critical Care Medicine at the University of Calgary (Alta.) and Alberta Health Services, Edmonton, and medical director, Cardiovascular Intensive Care Unit, commented on the study.

“The findings are very clear and very persuasive,” he said. “I think this should be incorporated into future guidelines, though it would be nice to see the trial repeated in another center.”

Dr. Parhar has kept comatose patients under temperature control for less than 72 hours, but mainly because those patients started to wake up. “This study provides clarity on the safety of that process – that we don’t have to unnecessarily keep somebody sedated just for an arbitrary timeline,” he said. “Beyond 36 hours, we need to continue to use our judgment.”

The study was supported by a grant from the Novo Nordisk Foundation, as was the work of one of the coauthors. Dr. Hassager’s work was funded by a grant from the Lundbeck Foundation; he also received an individual research grant from the Novo Nordisk Foundation, as well as honoraria from ABIOMED. No other disclosures were declared.

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