Residents

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

One of every 10 pregnant or recently pregnant women in hospital was diagnosed with COVID-19, yet up to three-quarters were asymptomatic at the time of diagnosis, according to a living systematic review from the PregCOV-19 Living Systematic Review Consortium.

dimarik/iStock/Getty Images

The study, published in BMJ, shows an increased risk of preterm delivery, as well as the need for invasive ventilation in these women, wrote John Allotey, PhD, of the University of Birmingham (England) and colleagues. The findings “will produce a strong evidence base for living guidelines on COVID-19 and pregnancy,” they noted.

The systematic review included 77 studies, one-third each from the United States and China, with the remaining studies from Belgium, Brazil, Denmark, France, Israel, Italy, Japan, Mexico, the Netherlands Portugal, Spain, and the United Kingdom.

The studies included women with COVID-19, of whom 13,118 were either pregnant or in the postpartum or postabortion period and 83,486 were of reproductive age but not pregnant. Some studies also included healthy pregnant women for comparison.

In the pregnant and recently pregnant women, the most common COVID-19 symptoms were fever (40%) and cough (39%), with lymphopenia (35%) and raised C reactive protein levels (49%) being the most common laboratory findings. Pregnant and recently pregnant women with COVID-19 were less likely to have fever (odds ratio, 0.43) and myalgia (OR, 0.48), compared with nonpregnant women of reproductive age with COVID-19, reported the authors.

The overall preterm and spontaneous preterm birth rates in the COVID-19–positive women were 17% and 6% respectively. Dr. Allotey and authors noted that “these preterm births could be medically indicated, as the overall rates of spontaneous preterm births in pregnant women with COVID-19 was broadly similar to those observed in the pre-pandemic period.” There were 18 stillbirths and 6 neonatal deaths in the COVID-19 cohort.

Overall, 73 (0.1%) of pregnant women with confirmed COVID-19 died from any cause, and severe COVID-19 infection was diagnosed in 13%. Maternal risk factors associated with severe infection included older age (OR, 1.78), high body mass index (OR, 2.3), chronic hypertension (OR, 2.0), and preexisting diabetes (OR, 2.51). Compared with nonpregnant women with COVID-19, pregnant or recently pregnant women with the infection were at increased risk of admission to intensive care (OR, 1.62) and needing invasive ventilation (OR, 1.88).

The report included studies published between December 1, 2019, and June 26, 2020, but the living systematic review will involve weekly search updates, with analysis performed every 2-4 weeks and reported through a dedicated website.
 

The value of a living meta-analysis

Asked to comment on the findings, Torri Metz, MD, a maternal-fetal medicine subspecialist at the University of Utah, Salt Lake City, expressed surprise at the 10% rate of infection in the pregnant or recently pregnant population. “This is higher than currently observed at many hospitals in the United States,” she said in an interview. “This may overestimate the actual risk as many of these studies were published early in the pandemic and did not universally sample women who were pregnant for SARS-CoV-2.”

She noted the value of a living meta-analysis in that it will be updated on a regular basis as new evidence emerges. “During this time of rapidly accumulating publications about COVID-19 infection, clinicians will find it useful to have a resource in which the available data can be combined in one source.”

And there are still some outstanding questions that new studies hopefully will shed light on, she added. “The authors found that many of the risk factors for severe disease, like diabetes, obesity and high blood pressure, in nonpregnant adults are the same in the pregnant population. What remains unknown is if pregnant patients with COVID-19 infection are at higher risk than those who are not pregnant. The authors note that this information is still limited and largely influenced in this published analysis by a CDC [Centers for Disease Control and Prevention] study in which the majority of patients had unknown pregnancy status. We also do not know if COVID-19 infection is associated with any birth defects since the majority of women with COVID-19 infection in the first trimester have not yet delivered.”

Malavika Prabhu, MD, an obstetetrician/gyneologist at Weill Cornell Medicine in New York City added that “this systematic review and meta analysis, which is a compilation of other studies done around the globe, confirms that pregnant women with preexisting medical conditions such as diabetes, hypertension, and obesity, are at increased risk of severe COVID-19 and that pregnant women with COVID-19 are at increased risk of invasive ventilation, compared to nonpregnant women with COVID-19, particularly if they have a preexisting medical condition.”

She said the preterm delivery rate of COVID-positive women is “challenging to interpret given that the total preterm birth rate potentially included many medically indicated preterm deliveries – which is to be expected – and there is no comparison group for spontaneous preterm birth presented”.

Other outstanding questions about COVID-19 pregnancies include whether they are associated with preeclampsia or smaller/growth restricted infants and why the cesarean delivery rate is high, she said. “But some of these questions are tough to answer with this data because it primarily reflects a COVID infection close to the delivery, not one that occurred several months prior to a delivery.”

Deborah Money, MD, professor of obstetrics and gynecology, medicine, and the school of population and public health, University of British Columbia, Vancouver, commented that “this is a group that have been doing ongoing living systematic reviews of the literature scanning for pregnancy outcomes. They post their information in real time on their website, so many of us in this area follow these postings as their methodology is robust and they work hard to only include high-quality literature and avoid duplication of cases in multiple papers. There has been a problem of re-reporting the same severe cases of COVID-19 in the literature.”

This “amplifies the importance of collecting Canadian-specific data to ensure that we understand if these kind of outcomes will also be found in Canada. The data presented in this paper represent outcomes from a broad range of countries with different methods of collecting information on pregnancy and highly variable prenatal care systems. This makes our pan-Canadian study of outcomes of COVID-19 for pregnant women and their infants, CANCOVID-Preg, even more important,” she said.

“Globally, we all must continue to monitor outcomes of COVID-19 in pregnancy to minimize adverse impact on women and their infants,” said Dr. Money, who was not involved in the study.

The study was partially funded by the World Health Organization and supported by Katie’s Team, a dedicated patient and public involvement group in Women’s Health. Dr. Metz is principal investigator for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network COVID-19 study; the study is funded by NICHD and enrollment is ongoing. Dr. Prabhu had no relevant financial disclosures. Dr. Money received funding from the Canadian Institutes for Health Research and the Public Health Agency of Canada and received a small grant from theBC Women’s Foundation for COVID-19 in pregnancy research.

SOURCE: Allotey J et al. BMJ. 2020;370:m3320.

One of every 10 pregnant or recently pregnant women in hospital was diagnosed with COVID-19, yet up to three-quarters were asymptomatic at the time of diagnosis, according to a living systematic review from the PregCOV-19 Living Systematic Review Consortium.

dimarik/iStock/Getty Images

The study, published in BMJ, shows an increased risk of preterm delivery, as well as the need for invasive ventilation in these women, wrote John Allotey, PhD, of the University of Birmingham (England) and colleagues. The findings “will produce a strong evidence base for living guidelines on COVID-19 and pregnancy,” they noted.

The systematic review included 77 studies, one-third each from the United States and China, with the remaining studies from Belgium, Brazil, Denmark, France, Israel, Italy, Japan, Mexico, the Netherlands Portugal, Spain, and the United Kingdom.

The studies included women with COVID-19, of whom 13,118 were either pregnant or in the postpartum or postabortion period and 83,486 were of reproductive age but not pregnant. Some studies also included healthy pregnant women for comparison.

In the pregnant and recently pregnant women, the most common COVID-19 symptoms were fever (40%) and cough (39%), with lymphopenia (35%) and raised C reactive protein levels (49%) being the most common laboratory findings. Pregnant and recently pregnant women with COVID-19 were less likely to have fever (odds ratio, 0.43) and myalgia (OR, 0.48), compared with nonpregnant women of reproductive age with COVID-19, reported the authors.

The overall preterm and spontaneous preterm birth rates in the COVID-19–positive women were 17% and 6% respectively. Dr. Allotey and authors noted that “these preterm births could be medically indicated, as the overall rates of spontaneous preterm births in pregnant women with COVID-19 was broadly similar to those observed in the pre-pandemic period.” There were 18 stillbirths and 6 neonatal deaths in the COVID-19 cohort.

Overall, 73 (0.1%) of pregnant women with confirmed COVID-19 died from any cause, and severe COVID-19 infection was diagnosed in 13%. Maternal risk factors associated with severe infection included older age (OR, 1.78), high body mass index (OR, 2.3), chronic hypertension (OR, 2.0), and preexisting diabetes (OR, 2.51). Compared with nonpregnant women with COVID-19, pregnant or recently pregnant women with the infection were at increased risk of admission to intensive care (OR, 1.62) and needing invasive ventilation (OR, 1.88).

The report included studies published between December 1, 2019, and June 26, 2020, but the living systematic review will involve weekly search updates, with analysis performed every 2-4 weeks and reported through a dedicated website.
 

The value of a living meta-analysis

Asked to comment on the findings, Torri Metz, MD, a maternal-fetal medicine subspecialist at the University of Utah, Salt Lake City, expressed surprise at the 10% rate of infection in the pregnant or recently pregnant population. “This is higher than currently observed at many hospitals in the United States,” she said in an interview. “This may overestimate the actual risk as many of these studies were published early in the pandemic and did not universally sample women who were pregnant for SARS-CoV-2.”

She noted the value of a living meta-analysis in that it will be updated on a regular basis as new evidence emerges. “During this time of rapidly accumulating publications about COVID-19 infection, clinicians will find it useful to have a resource in which the available data can be combined in one source.”

And there are still some outstanding questions that new studies hopefully will shed light on, she added. “The authors found that many of the risk factors for severe disease, like diabetes, obesity and high blood pressure, in nonpregnant adults are the same in the pregnant population. What remains unknown is if pregnant patients with COVID-19 infection are at higher risk than those who are not pregnant. The authors note that this information is still limited and largely influenced in this published analysis by a CDC [Centers for Disease Control and Prevention] study in which the majority of patients had unknown pregnancy status. We also do not know if COVID-19 infection is associated with any birth defects since the majority of women with COVID-19 infection in the first trimester have not yet delivered.”

Malavika Prabhu, MD, an obstetetrician/gyneologist at Weill Cornell Medicine in New York City added that “this systematic review and meta analysis, which is a compilation of other studies done around the globe, confirms that pregnant women with preexisting medical conditions such as diabetes, hypertension, and obesity, are at increased risk of severe COVID-19 and that pregnant women with COVID-19 are at increased risk of invasive ventilation, compared to nonpregnant women with COVID-19, particularly if they have a preexisting medical condition.”

She said the preterm delivery rate of COVID-positive women is “challenging to interpret given that the total preterm birth rate potentially included many medically indicated preterm deliveries – which is to be expected – and there is no comparison group for spontaneous preterm birth presented”.

Other outstanding questions about COVID-19 pregnancies include whether they are associated with preeclampsia or smaller/growth restricted infants and why the cesarean delivery rate is high, she said. “But some of these questions are tough to answer with this data because it primarily reflects a COVID infection close to the delivery, not one that occurred several months prior to a delivery.”

Deborah Money, MD, professor of obstetrics and gynecology, medicine, and the school of population and public health, University of British Columbia, Vancouver, commented that “this is a group that have been doing ongoing living systematic reviews of the literature scanning for pregnancy outcomes. They post their information in real time on their website, so many of us in this area follow these postings as their methodology is robust and they work hard to only include high-quality literature and avoid duplication of cases in multiple papers. There has been a problem of re-reporting the same severe cases of COVID-19 in the literature.”

This “amplifies the importance of collecting Canadian-specific data to ensure that we understand if these kind of outcomes will also be found in Canada. The data presented in this paper represent outcomes from a broad range of countries with different methods of collecting information on pregnancy and highly variable prenatal care systems. This makes our pan-Canadian study of outcomes of COVID-19 for pregnant women and their infants, CANCOVID-Preg, even more important,” she said.

“Globally, we all must continue to monitor outcomes of COVID-19 in pregnancy to minimize adverse impact on women and their infants,” said Dr. Money, who was not involved in the study.

The study was partially funded by the World Health Organization and supported by Katie’s Team, a dedicated patient and public involvement group in Women’s Health. Dr. Metz is principal investigator for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network COVID-19 study; the study is funded by NICHD and enrollment is ongoing. Dr. Prabhu had no relevant financial disclosures. Dr. Money received funding from the Canadian Institutes for Health Research and the Public Health Agency of Canada and received a small grant from theBC Women’s Foundation for COVID-19 in pregnancy research.

SOURCE: Allotey J et al. BMJ. 2020;370:m3320.

One of every 10 pregnant or recently pregnant women in hospital was diagnosed with COVID-19, yet up to three-quarters were asymptomatic at the time of diagnosis, according to a living systematic review from the PregCOV-19 Living Systematic Review Consortium.

dimarik/iStock/Getty Images

The study, published in BMJ, shows an increased risk of preterm delivery, as well as the need for invasive ventilation in these women, wrote John Allotey, PhD, of the University of Birmingham (England) and colleagues. The findings “will produce a strong evidence base for living guidelines on COVID-19 and pregnancy,” they noted.

The systematic review included 77 studies, one-third each from the United States and China, with the remaining studies from Belgium, Brazil, Denmark, France, Israel, Italy, Japan, Mexico, the Netherlands Portugal, Spain, and the United Kingdom.

The studies included women with COVID-19, of whom 13,118 were either pregnant or in the postpartum or postabortion period and 83,486 were of reproductive age but not pregnant. Some studies also included healthy pregnant women for comparison.

In the pregnant and recently pregnant women, the most common COVID-19 symptoms were fever (40%) and cough (39%), with lymphopenia (35%) and raised C reactive protein levels (49%) being the most common laboratory findings. Pregnant and recently pregnant women with COVID-19 were less likely to have fever (odds ratio, 0.43) and myalgia (OR, 0.48), compared with nonpregnant women of reproductive age with COVID-19, reported the authors.

The overall preterm and spontaneous preterm birth rates in the COVID-19–positive women were 17% and 6% respectively. Dr. Allotey and authors noted that “these preterm births could be medically indicated, as the overall rates of spontaneous preterm births in pregnant women with COVID-19 was broadly similar to those observed in the pre-pandemic period.” There were 18 stillbirths and 6 neonatal deaths in the COVID-19 cohort.

Overall, 73 (0.1%) of pregnant women with confirmed COVID-19 died from any cause, and severe COVID-19 infection was diagnosed in 13%. Maternal risk factors associated with severe infection included older age (OR, 1.78), high body mass index (OR, 2.3), chronic hypertension (OR, 2.0), and preexisting diabetes (OR, 2.51). Compared with nonpregnant women with COVID-19, pregnant or recently pregnant women with the infection were at increased risk of admission to intensive care (OR, 1.62) and needing invasive ventilation (OR, 1.88).

The report included studies published between December 1, 2019, and June 26, 2020, but the living systematic review will involve weekly search updates, with analysis performed every 2-4 weeks and reported through a dedicated website.
 

The value of a living meta-analysis

Asked to comment on the findings, Torri Metz, MD, a maternal-fetal medicine subspecialist at the University of Utah, Salt Lake City, expressed surprise at the 10% rate of infection in the pregnant or recently pregnant population. “This is higher than currently observed at many hospitals in the United States,” she said in an interview. “This may overestimate the actual risk as many of these studies were published early in the pandemic and did not universally sample women who were pregnant for SARS-CoV-2.”

She noted the value of a living meta-analysis in that it will be updated on a regular basis as new evidence emerges. “During this time of rapidly accumulating publications about COVID-19 infection, clinicians will find it useful to have a resource in which the available data can be combined in one source.”

And there are still some outstanding questions that new studies hopefully will shed light on, she added. “The authors found that many of the risk factors for severe disease, like diabetes, obesity and high blood pressure, in nonpregnant adults are the same in the pregnant population. What remains unknown is if pregnant patients with COVID-19 infection are at higher risk than those who are not pregnant. The authors note that this information is still limited and largely influenced in this published analysis by a CDC [Centers for Disease Control and Prevention] study in which the majority of patients had unknown pregnancy status. We also do not know if COVID-19 infection is associated with any birth defects since the majority of women with COVID-19 infection in the first trimester have not yet delivered.”

Malavika Prabhu, MD, an obstetetrician/gyneologist at Weill Cornell Medicine in New York City added that “this systematic review and meta analysis, which is a compilation of other studies done around the globe, confirms that pregnant women with preexisting medical conditions such as diabetes, hypertension, and obesity, are at increased risk of severe COVID-19 and that pregnant women with COVID-19 are at increased risk of invasive ventilation, compared to nonpregnant women with COVID-19, particularly if they have a preexisting medical condition.”

She said the preterm delivery rate of COVID-positive women is “challenging to interpret given that the total preterm birth rate potentially included many medically indicated preterm deliveries – which is to be expected – and there is no comparison group for spontaneous preterm birth presented”.

Other outstanding questions about COVID-19 pregnancies include whether they are associated with preeclampsia or smaller/growth restricted infants and why the cesarean delivery rate is high, she said. “But some of these questions are tough to answer with this data because it primarily reflects a COVID infection close to the delivery, not one that occurred several months prior to a delivery.”

Deborah Money, MD, professor of obstetrics and gynecology, medicine, and the school of population and public health, University of British Columbia, Vancouver, commented that “this is a group that have been doing ongoing living systematic reviews of the literature scanning for pregnancy outcomes. They post their information in real time on their website, so many of us in this area follow these postings as their methodology is robust and they work hard to only include high-quality literature and avoid duplication of cases in multiple papers. There has been a problem of re-reporting the same severe cases of COVID-19 in the literature.”

This “amplifies the importance of collecting Canadian-specific data to ensure that we understand if these kind of outcomes will also be found in Canada. The data presented in this paper represent outcomes from a broad range of countries with different methods of collecting information on pregnancy and highly variable prenatal care systems. This makes our pan-Canadian study of outcomes of COVID-19 for pregnant women and their infants, CANCOVID-Preg, even more important,” she said.

“Globally, we all must continue to monitor outcomes of COVID-19 in pregnancy to minimize adverse impact on women and their infants,” said Dr. Money, who was not involved in the study.

The study was partially funded by the World Health Organization and supported by Katie’s Team, a dedicated patient and public involvement group in Women’s Health. Dr. Metz is principal investigator for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network COVID-19 study; the study is funded by NICHD and enrollment is ongoing. Dr. Prabhu had no relevant financial disclosures. Dr. Money received funding from the Canadian Institutes for Health Research and the Public Health Agency of Canada and received a small grant from theBC Women’s Foundation for COVID-19 in pregnancy research.

SOURCE: Allotey J et al. BMJ. 2020;370:m3320.

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

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

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

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

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

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

The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.

European Society of Cardiology

The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.

“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.

The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.

Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.

One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.

The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.

The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.

The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.

Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.

Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.

Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.

The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).

The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.

A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.

Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).

“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.

Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.

“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
 

Protective for older patients?

The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.

He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.

He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.

Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”

“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.

Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.

Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”

But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.

Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.

The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.

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

The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.

European Society of Cardiology

The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.

“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.

The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.

Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.

One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.

The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.

The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.

The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.

Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.

Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.

Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.

The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).

The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.

A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.

Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).

“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.

Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.

“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
 

Protective for older patients?

The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.

He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.

He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.

Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”

“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.

Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.

Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”

But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.

Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.

The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.

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

The first randomized study to compare continuing versus stopping ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with COVID-19 has shown no difference in key outcomes between the two approaches.

European Society of Cardiology

The BRACE CORONA trial – conducted in patients had been taking an ACE inhibitor or an ARB on a long-term basis and who were subsequently hospitalized with COVID-19 – showed no difference in the primary endpoint of number of days alive and out of hospital among those whose medication was suspended for 30 days and those who continued undergoing treatment with these agents.

“Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalized patients with mild to moderate COVID-19, they should generally be continued for those with an indication,” principal investigator Renato Lopes, MD, of Duke Clinical Research Institute, Durham, N.C., concluded.

The BRACE CORONA trial was presented at the European Society of Cardiology Congress 2020 on Sept. 1.

Dr. Lopes explained that there are two conflicting hypotheses about the role of ACE inhibitors and ARBs in COVID-19.

One hypothesis suggests that use of these drugs could be harmful by increasing the expression of ACE2 receptors (which the SARS-CoV-2 virus uses to gain entry into cells), thus potentially enhancing viral binding and viral entry. The other suggests that ACE inhibitors and ARBs could be protective by reducing production of angiotensin II and enhancing the generation of angiotensin 1-7, which attenuates inflammation and fibrosis and therefore could attenuate lung injury.

The BRACE CORONA trial was an academic-led randomized study that tested two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days or continuing these drugs for patients who had been taking these medications on a long-term basis and were hospitalized with a confirmed diagnosis of COVID-19.

The primary outcome was the number of days alive and out of hospital at 30 days. Patients who were using more than three antihypertensive drugs or sacubitril/valsartan or who were hemodynamically unstable at presentation were excluded from the study.

The trial enrolled 659 patients from 29 sites in Brazil. The mean age of patients was 56 years, 40% were women, and 52% were obese. ACE inhibitors were being taken by 15% of the trial participants; ARBs were being taken by 85%. The median duration of ACE inhibitor/ARB treatment was 5 years.

Patients were a median of 6 days from COVID-19 symptom onset. For 30% of the patients, oxygen saturation was below 94% at entry. In terms of COVID-19 symptoms, 57% were classified as mild, and 43% as moderate.

Those with severe COVID-19 symptoms who needed intubation or vasoactive drugs were excluded. Antihypertensive therapy would generally be discontinued in these patients anyway, Dr. Lopes said.

Results showed that the average number of days alive and out of hospital was 21.9 days for patients who stopped taking ACE inhibitors/ARBs and 22.9 days for patients who continued taking these medications. The average difference between groups was –1.1 days.

The average ratio of days alive and out of hospital between the suspending and continuing groups was 0.95 (95% CI, 0.90-1.01; P = .09).

The proportion of patients alive and out of hospital by the end of 30 days in the suspending ACE inhibitor/ARB group was 91.8% versus 95% in the continuing group.

A similar 30-day mortality rate was seen for patients who continued and those who suspended ACE inhibitor/ARB therapy, at 2.8% and 2.7%, respectively (hazard ratio, 0.97). The median number of days that patients were alive and out of hospital was 25 in both groups.

Dr. Lopes said that there was no difference between the two groups with regard to many other secondary outcomes. These included COVID-19 disease progression (need for intubation, ventilation, need for vasoactive drugs, or imaging results) and cardiovascular endpoints (MI, stroke, thromboembolic events, worsening heart failure, myocarditis, or hypertensive crisis).

“Our results endorse with reliable and more definitive data what most medical and cardiovascular societies are recommending – that patients do not stop ACE inhibitor or ARB medication. This has been based on observational data so far, but BRACE CORONA now provides randomized data to support this recommendation,” Dr. Lopes concluded.

Dr. Lopes noted that several subgroups had been prespecified for analysis. Factors included age, obesity, difference between ACE inhibitors/ARBs, difference in oxygen saturation at presentation, time since COVID-19 symptom onset, degree of lung involvement on CT, and symptom severity on presentation.

“We saw very consistent effects of our main findings across all these subgroups, and we plan to report more details of these in the near future,” he said.
 

Protective for older patients?

The discussant of the study at the ESC Hotline session, Gianfranco Parati, MD, University of Milan-Bicocca and San Luca Hospital, Milan, congratulated Lopes and his team for conducting this important trial at such a difficult time.

He pointed out that patients in the BRACE CORONA trial were quite young (average age, 56 years) and that observational data so far suggest that ACE inhibitors and ARBs have a stronger protective effect in older COVID-19 patients.

He also noted that the percentage of patients alive and out of hospital at 30 days was higher for the patients who continued on treatment in this study (95% vs. 91.8%), which suggested an advantage in maintaining the medication.

Dr. Lopes replied that one-quarter of the population in the BRACE CORONA trial was older than 65 years, which he said was a “reasonable number.”

“Subgroup analysis by age did not show a significant interaction, but the effect of continuing treatment does seem to be more favorable in older patients and also in those who were sicker and had more comorbidities,” he added.

Dr. Parati also suggested that it would have been difficult to discern differences between ACE inhibitors and ARBs in the BRACE CORONA trial, because so few patents were taking ACE inhibitors; the follow-up period of 30 days was relatively short, inasmuch as these drugs may have long-term effects; and it would have been difficult to show differences in the main outcomes used in the study – mortality and time out of hospital – in these patients with mild to moderate disease.

Franz H. Messerli, MD, and Christoph Gräni, MD, University of Bern (Switzerland), said in a joint statement: “The BRACE CORONA trial provides answers to what we know from retrospective studies: if you have already COVID, don’t stop renin-angiotensin system blocker medication.”

But they added that the study does not answer the question about the risk/benefit of ACE inhibitors or ARBs with regard to possible enhanced viral entry through the ACE2 receptor. “What about all those on these drugs who are not infected with COVID? Do they need to stop them? We simply don’t know yet,” they said.

Dr. Messerli and Dr. Gräni added that they would like to see a study that compared patients before SARS-CoV-2 infection who were without hypertension, patients with hypertension who were taking ACE inhibitors or ARBs, and patients with hypertension taking other antihypertensive drugs.

The BRACE CORONA trial was sponsored by D’Or Institute for Research and Education and the Brazilian Clinical Research Institute. Dr. Lopes has disclosed no relevant financial relationships.

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

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

During a telemedicine visit with his physician, a 62-year-old obese patient with an ankle injury reported new swelling of his leg. Three weeks had passed since the man visited an emergency department, where he underwent surgery and had a cast applied to the wound. The physician, during the telemedicine visit, advised the patient to elevate his leg and see an orthopedist within 24 hours. A Doppler ultrasound was ordered for 12:30 p.m. that same day.

The patient never made it to the appointment. He became unresponsive and went into full arrest hours later. His death fueled a lawsuit by his family that claimed failure to diagnose and treat deep venous thrombosis. The family contended the providers involved should have referred the patient to care immediately during the video visit.  

The case, which comes from the claims database of national medical liability insurer The Doctors Company, illustrates the legal risks that can stem from video visits with patients, says Richard Cahill, JD, vice president and associate general counsel for The Doctors Company.

“By evaluating the patient remotely, the physician failed to appreciate the often subtle nuances of the clinical presentation, which undoubtedly could have been more accurately assessed in the office setting, and would probably have led to more urgent evaluation and intervention, thereby likely preventing the unfortunate and otherwise avoidable result,” said Mr. Cahill.

According to a Harris poll, 42% of Americans reported using video visits during the pandemic, a trend that is likely to continue as practices reopen and virtual care becomes the norm. But as physicians conduct more video visits, so grows their risk for lawsuits associated with the technology. 

“We probably will see more malpractice suits filed the more telehealth is used,” said Mei Wa Kwong, JD, executive director of the Center for Connected Health Policy. “It’s a numbers game. The more it’s used, the higher likelihood that lawsuits occur.”
 

Three problems in not being able to touch the patient

1. The primary challenge with video visits “is the inability to directly observe and lay hands on the patient,” says Jonathan Einbinder, MD, assistant vice president of analytics for CRICO, a medical liability insurer based in Boston.

“While you can see them via video, it can be hard to get a full sense of how sick the patient is and whether other things might be going on than what they are reporting,” said Dr. Einbinder, a practicing internist. 

Such incomplete pictures can lead to diagnostic errors and the potential for lawsuits, as demonstrated by a recent CRICO analysis. Of 106 telemedicine-related claims from 2014 to 2018, 66% were diagnosis related, according to the analysis of claims from CRICO’s national database. Twelve percent of the telemedicine-related claims were associated with surgical treatment, 11% were related to medical treatment, and 5% were associated with medication issues. A smaller number of claims resulted from patient monitoring, ob.gyn. care, and safety and security.

Another analysis by The Doctors Company similarly determined that diagnostic errors are the most common allegation in telemedicine-related claims. In the study of 28 telemedicine-related claims from The Doctors’ database, 71% were diagnosis related, 11% were associated with mismanagement of treatment, and 7% were related to improper management of a surgical patient. Other allegations included improper performance of treatment or procedure and improper performance of surgery.

“Because a ‘typical’ exam can’t be done, there is the potential to miss things,” said David L. Feldman, MD, chief medical officer for The Doctors Company Group. “A subtlety, perhaps a lump that can’t be seen but only felt, and only by an experienced examiner, for example, may be missed.” 

2. Documentation dangers also loom, said William Sullivan, DO, JD, an emergency physician and an attorney who specializes in health care. The legal risk lies in documenting a video visit in the same way the doctor would document an in-person visit, he explained.

“Investigation into a potential lawsuit begins when there is some type of bad outcome related to medical care,” Dr. Sullivan explained. “To determine whether the lawsuit has merit, patients/attorneys review the medical records to retrospectively determine the potential cause of the bad outcome. If the documentation reflects an examination that could not have been performed, a lawyer might be more likely to pursue a case, and it would be more difficult to defend the care provided.”

Dr. Sullivan provided this example: During a video visit, a patient complains of acute onset weakness. The physician documents that the patient’s heart has a “regular rate and rhythm,” and “muscle strength is equal bilaterally.” The following day, the patient’s weakness continues, and the patient goes to the emergency department where he is diagnosed with stroke. An EKG in the ED shows that the patient is in atrial fibrillation.

“The telehealth provider would have a difficult time explaining how it was determined that the patient had normal muscle strength and a normal heart rhythm over a video visit the day before,” Dr. Sullivan said. “A lawyer in a subsequent malpractice case would present the provider as careless and would argue that if the provider had only sent the patient to the emergency department after the telehealth visit instead of documenting exam findings that couldn’t have been performed, the patient could have been successfully treated for the stroke.”

3. Poorly executed informed consent can also give rise to a lawsuit. This includes informed consent regarding the use of telehealth as the accepted modality for the visit rather than traditional on-site evaluations, as well as preprocedure informed consent.

“Inadequate and/or poorly documented informed consent can result in a claim for medical battery,” Mr. Cahill said.

A medical battery allegation refers to the alleged treatment or touching of a patient’s body without that person’s consent. As the AMA Journal of Ethics explains, a patient’s consent must be given, either expressly or implicitly, before a physician may legally “interfere” with the physical body of the patient.

Ideally, the informed consent process is undertaken during a first in-person visit, before virtual visits begin, Dr. Feldman said.

“There is a lot that a patient has to understand when a visit is done virtually, which is part of the informed consent process,” Dr. Feldman said. “The pandemic has forced some physicians to do their first visit virtually, and this makes the process of informing patients more onerous. It is not a simple matter of converting an in-person office practice to a remote office practice. The work flows are different, so there are definitely legal concerns as it relates to privacy and cybersecurity to name a few.”
 

Waivers may be weak protection

Since the pandemic started, a number of states have enacted emergency malpractice protections to shield health professionals from lawsuits. Some protections, such as those in Massachusetts, offer immunity to health professionals who provide general care to patients during the COVID-19 emergency, in addition to treatment of COVID-19 patients. Other protections, like those in Connecticut, apply specifically to care provided in support of the state’s pandemic response.

Whether that immunity applies both to in-person visits and video visits during the pandemic is not certain, said J. Richard Moore, JD, a medical liability defense attorney based in Indianapolis. Indiana’s immunity statute for example, does not make a specific provision for telehealth, he said.

“My best prediction is that if considered by the courts, the immunity would be applied to telehealth services, so long as they are being provided ‘in response to the emergency,’ which is the scope of the immunity,” he said. “I would not consider telehealth physicians to be either more or less protected than in-person providers.”

Regulatory scrutiny for telehealth providers has also been relaxed in response to COVID-19, but experts warn not to rely on the temporary shields for ultimate protection.

In March, the U.S. Department of Health and Human Service’s Office of Civil Rights (OCR) eased enforcement actions for noncompliance with Health Insurance Portability and Accountability Act requirements in connection with the good faith provision of telehealth during the COVID-19 health crisis. Under the notice, health providers can use popular applications such as Apple FaceTime, Facebook Messenger, Zoom, or Google Hangouts, to offer telehealth care without risk that OCR will impose fines or penalties for HIPAA violations.

But once the current health care emergency is mitigated, the waivers will likely be withdrawn, and enforcement actions will probably resume, Mr. Cahill said.

“It is recommended that, to avoid potential problems going forward, practitioners use due diligence and undertake best efforts to obey existing privacy and security requirements, including the use of technology that satisfies compliance regulations, despite the waiver by OCR,” he said.

In addition, a majority of states have relaxed state-specific rules for practicing telehealth and loosened licensure requirements during the pandemic. At least 47 states have issued waivers to alter in-state licensure requirements for telemedicine in response to COVID-19, according to the Federation of State Medical Boards. Most of the waivers allow physicians licensed in other states to provide care in states where they do not hold licenses, and some enable doctors to treat patients without first having had an in-person evaluation.

But at least for now, these are temporary changes, reminds Amy Lerman, JD, a health care attorney based in Washington, who specializes in telehealth and corporate compliance. Given the current pandemic environment, a significant concern is that physicians new to the telemedicine space are reacting only to the most recent rules established in the context of the pandemic, Ms. Lerman said.

“As previously noted, the recent developments are temporary in nature – states and various federal agencies have been pretty clear in setting this temporal boundary,” she said. “It is not advisable for providers to build telepractice models around temporary sets of rules. 

“Furthermore, the recent developments are not necessarily comprehensive relative to all of the state-specific and other requirements that telemedicine providers are otherwise expected to follow, so relying only on the most recent guidance may cause providers to create telepractice models that have key gaps with respect to regulatory compliance.”
 

How you can avoid a lawsuit

As businesses reopen and practices resume treatments, physicians should weigh the choice between in-person care and video visits very carefully, said Joseph Kvedar, MD, president of the American Telemedicine Association and a dermatology professor at Harvard Medical School, Boston.

“We have to be very thoughtful about quality in this current phase, where we are doing what I call a hybrid model,” he said. “Some services are offered by telehealth and some require patients to come into the doctor’s office. We have to be very thoughtful about what types of care we determine to be appropriate for telehealth, and that has to be based on clinical quality. And if it is, it should follow that we’ll have low incidence of liability claims.”

Data should be at the center of that conclusion, Dr. Kvedar advises.

“Think about what data is needed to make a therapeutic or diagnostic decision,” he said. “If a health care provider can gather the information needed without touching the patient, then the provider is probably on safe, solid ground making that decision via a telehealth interaction. If the patient can come into the doctor’s office, and the provider deems it necessary to see the patient in person and touch the patient in order to make that clinical decision, then the patient should come in.”

An important step to preventing liability is also having strong telehealth systems and protocols in place and the necessary support to carry them out, said Dr. Einbinder of medical liability insurer CRICO.

For example, Dr. Einbinder, who practices in a 12-doctor internal medicine group, said when he finishes a virtual visit, he enters any orders into the electronic health record. Some of the orders will result in notifications to Dr. Einbinder if they are not executed, such as a referral appointment or a procedure that was not completed. 

“I also can forward my orders to a front desk pool that is responsible for making sure things get done,” he said. “And, in our hospital system, we have good case management for complex patients and population management for a variety of chronic conditions. These represent additional safety nets.” 

Another liability safeguard is sending patients a “visit summary” after each virtual visit, Dr. Sullivan said. This could be in the form of an email or a text that includes a brief template including items such as diagnosis, recommendations, follow-up, and a reminder to contact the doctor or go to the emergency department if symptoms worsen or new problems develop.

“Patients tend to remember about half of what physicians tell them and half of the information patients do remember is incorrect,” he said. “Consider a few sentences in an e-mail or text message as a substitute for the after-visit instructions from an office visit to enhance patient understanding. There are several inexpensive programs/services that allow text messages to be sent from a computer using a separate dedicated phone number and pretty much every patient has a cell phone to receive the instructions.”

Dr. Sullivan suggests having a documentation template specifically for telehealth visits. He also recommends the inclusion an “informed refusal of care” in the record when necessary. Dr. Sullivan’s wife, a family physician, has encountered several patients who fear contracting COVID-19 and who have refused her recommendations for in-person visits, he said. In such cases, he said it’s a good idea to document that the patient decided to forgo the recommendations given.

“If a patient suffers a bad outcome because of a failure to seek an in-person exam, a short note in the patient’s chart would help to establish that the lack of a follow-up physical exam was the patient’s informed decision, not due to some alleged negligence of the medical provider,” he said.

Concerning informed consent, Dr. Feldman says at a minimum physicians should discuss the following with patients:

• Names and credentials of staff participating.
• The right to stop or refuse treatment by telemedicine.
• Technology that will be used.
• Privacy and security risks.
• Technology-specific risks and permission to bill.
• Alternative care in case of an emergency or technology malfunction.
• Any state-specific requirements.

“Physicians can ensure they have a strong informed consent process during video visits by taking the time to cover these points at the beginning of the first visit, and being sure the patient understands and agrees to these,” Dr. Sullivan explained. “Ideally, this conversation can be recorded for future reference if necessary or at a minimum documented in the medical record.”
 

Consider these extra precautions

Mr. Cahill advises that practitioners be especially mindful of their “web-side manner” and the setting in which they are communicating with virtual patients to promote confidentiality, professionalism, and uninterrupted interactions.

“Use of a headset in a quiet home office is advisable,” he said. “Physicians must also be cognizant of their physical appearance and the background behind them when the visit includes both audio and visual capability. For ‘face-to-face’ telehealth encounters, it is recommended that a white lab jacket be worn as the appropriate attire; coat and tie are unnecessary.”

Some patients may need to be reminded of the need for confidentiality during a video visit, Mr. Moore added. Physicians are typically in a position to ensure confidentiality, but some patients may not understand how to protect their privacy on their end. 

“If the physician sees on the screen or hears from an audio connection that there are other people around who may be able to overhear what is communicated, the physician probably has some responsibility to remind the patient that she or he may want to go to a more private place, close the door, etc.,” he said. “While I think a claim against a physician on this basis would be pretty weak, it is still a good practice for the physician to be cognizant of those kinds of concerns even if the patient is not.”

Finally, for physicians who set up telehealth operability during the pandemic – possibly in a hurry – consider using your actual case data to take a look backward, said Ms. Lerman, the Washington-based health care attorney. Reviewing the data can help determine whether you’re in compliance with relevant state laws, she said. 

“If, for example, a provider set up telehealth operations during the pandemic and can see that most of [the] patients are based in a single state, or a small group of states, it is worthwhile to take [the] time and become familiar with the telemedicine laws in those states,” she said. “If there are modifications that need to be made, it may be easier to make them incrementally before the telehealth operations grow any larger in scope.” 

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

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

A new analysis of existing research confirms a stark link between excess weight and COVID-19: People with obesity are much more likely to be diagnosed with the novel coronavirus, undergo hospitalization and ICU admission, and die.

Obese patients faced the greatest bump in risk on the hospitalization front, with their odds of being admitted listed as 113% higher. The odds of diagnosis, ICU admission, and death were 46% higher (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.30-1.65; P < .0001); 74% higher (OR, 1.74, CI, 1.46-2.08, P < .0001); 48% (OR, 1.48, CI, 1.22–1.80, P < .001, all pooled analyses and 95% CI), respectively. All differences were highly significantly different, investigators reported in a systematic review and meta-analysis published online Aug. 26 in Obesity Reviews.

“Essentially, these are pretty scary statistics,” nutrition researcher and study lead author Barry M. Popkin, PhD, of the University of North Carolina at Chapel Hill School of Public Health, said in an interview. “Other studies have talked about an increase in mortality, and we were thinking there’d be a little increase like 10% – nothing like 48%.”

According to the Johns Hopkins University of Medicine tracker, nearly 6 million people in the United States had been diagnosed with COVID-19 as of Aug. 30. The number of deaths had surpassed 183,000.

The authors of the new review launched their project to better understand the link between obesity and COVID-19 “all the way from being diagnosed to death,” Dr. Popkin said, adding that the meta-analysis is the largest of its kind to examine the link.

Dr. Popkin and colleagues analyzed 75 studies during January to June 2020 that tracked 399,461 patients (55% of whom were male) diagnosed with COVID-19. They found that 18 of 20 studies linked obesity with a 46% higher risk of diagnosis, but Dr. Popkin cautioned that this may be misleading. “I suspect it’s because they’re sicker and getting tested more for COVID,” he said. “I don’t think obesity enhances your likelihood of getting COVID. We don’t have a biological rationale for that.”

The researchers examined 19 studies that explored a link between obesity and hospitalization; all 19 found a higher risk of hospitalization in patients with obesity (pooled OR, 2.13). Twenty-one of 22 studies that looked at ICU admissions discovered a higher risk for patients with obesity (pooled OR, 1.74). And 27 of 35 studies that examined COVID-19 mortality found a higher death rate in patients with obesity (pooled OR, 1.48).

The review also looked at 14 studies that examined links between obesity and administration of invasive mechanical ventilation. All the studies found a higher risk for patients with obesity (pooled OR, 1.66; 95% CI, 1.38-1.99; P < .0001).

Could socioeconomic factors explain the difference in risk for people with obesity? It’s not clear. According to Dr. Popkin, most of the studies don’t examine factors such as income. While he believes physical factors are the key to the higher risk, he said “there’s clearly a social side to this.”

On the biological front, it appears that “the immune system is much weaker if you’re obese,” he said, and excess weight may worsen the course of a respiratory disease such as COVID-19 because of lung disorders such as sleep apnea.

In addition to highlighting inflammation and a weakened immune system, the review offers multiple explanations for why patients with obesity face worse outcomes in COVID-19. It may be more difficult for medical professionals to care for them in the hospital because of their weight, the authors wrote, and “obesity may also impair therapeutic treatments during COVID-19 infections.” The authors noted that ACE inhibitors may worsen COVID-19 in patients with type 2 diabetes.

The researchers noted that “potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.” They pointed to research that suggests T-cell responses are weaker and antibody titers wane at a faster rate in people with obesity who are vaccinated against influenza.

SOURCE: Popkin BM et al. Obes Rev. 2020 Aug 26. doi: 10.1111/obr.13128.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration on Aug. 28 expanded its emergency use authorization (EUA) of remdesivir (Veklury) to include treatment of all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease.

An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.

“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
 

‘Further evaluation’ needed

The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.

The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.

Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.

Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].

“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.

“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.

The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.

For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
 

This article first appeared on Medscape.com.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.

New York City Health + Hospitals (NYCH+H), the country’s largest public health care system, encompasses 11 hospitals with 4,354 staffed acute beds during normal times. It serves as the safety net for 1.1 million of the 8.4 million residents of the most populous city in the United States, many of them uninsured, undocumented, covered by Medicaid, or otherwise disadvantaged.

At the very epicenter in the early days of the historic COVID-19 pandemic, NYCH+H transferred patients between its facilities, added medical and ICU beds by the hundreds, mobilized palliative care volunteers, harnessed telemedicine and a clinician hotline, and made other sweeping changes to ensure that the city’s public health system would be able to respond to demand at the peak of the surge. That peak hit in April, when an average of 9,000 new COVID-19 cases were being reported in the city every day.

Through it all, hospitalists have played critical roles in both planning for the system’s response and caring for severely ill COVID-19 patients. Their stories reflect both the unprecedented demands on the system and the dedication of frontline clinicians.

One of those, Carla Saladini-Aponte, MD, who just finished her residency in June 2019, found herself on the firing line in March 2020 as an attending physician at 457-bed NYCH+H/Jacobi Hospital in the Bronx. “I have experienced so much in my first year on the job, dealing with a disease that we’ve never seen before,” she said. “We didn’t grasp the extent of the COVID crisis in the beginning, so we were emotionally unprepared when it first hit.”

Starting on March 30, NYCH+H administration mobilized a centralized incident command structure to coordinate response systemwide to a rapidly changing situation.

Two weeks later Jacobi was a COVID-19 hospital, top to bottom, with its medical ICU beds increased from 12 to more than 100. By mid-April, Dr. Saladini-Aponte’s team, one of 11 medical teams in the hospital, had 26 patients, all of them with COVID-19. There was not a consensus in the early days on how to manage patients with severe respiratory distress. “But by the time the surge came, we had a better understanding of the scope of the situation,” she said.

Learning to be an attending

“They don’t teach you how to be an attending during residency,” Dr. Saladini-Aponte said. “At the beginning I wasn’t such a good teacher. I just wanted to prove myself and stay one step ahead of the residents. But as an academic hospitalist you have to listen to others. I learned to ask questions of the residents every morning, including how they were doing personally.”

Sometimes a visiting consultant would ask on the floor: “‘Where’s your attending?’” not recognizing Dr. Saladini-Aponte, fresh out of residency, filling that role. At times, she felt like a PGY-4 (postgraduate year 4). But she quickly grew into the attending role and was asked to be site coordinator for the mobilization of palliative medicine volunteers at Jacobi.

“We found ourselves having to make tough ethical decisions. Some patients, even if we provided a ventilator and maximum oxygen therapy, would still die. There were difficult discussions when we didn’t know if we had enough dialysis machines, or how to manage other limited resources. The hospital was saying: You decide, if there’s a high degree of certainty about the outcome. But we had never practiced medicine this way before,” she said.

“That’s why our hospital provided daily ethics meetings with our ethics council. There would be eight people sitting 6 feet apart in a conference room, all wearing masks. We’d talk about situations that were giving us trouble. Their role wasn’t to provide answers but to help us see the scope of the situation and the complexities,” she explained.

Dr. Saladini-Aponte said she has had many sleepless nights since the pandemic began. “Sometimes, I would come home from work and lie down on the floor and cry,” she said. “But we had so much support from volunteers helping our little hospitalist service of seven.” It was also important to keep up with the clinical information, and one of her coworkers created “cheat sheets” for the clinicians, regularly updated with the latest essential information on antibiotics, testing, and the like.

“At the peak, I was trying to read everything I could about the virus. I was just pulling myself in too many directions. I asked for help from my boyfriend to remind me not to log onto my computer when I came home from work,” she said. “One of my techniques for preventing burnout was just to avoid social media. I couldn’t deal with what was going on in the news. It just angered me. Even now, seeing people without masks makes me very uncomfortable.”
 

Organizing the crisis response

As chief value officer for NYCH+H, Hyung (Harry) Cho, MD, FACP, SFHM, typically focuses on issues of patient safety and overuse of medical treatments in the health system. But in the COVID-19 crisis, he found himself at the forefront of organizing its response. “We tried to provide support centrally and to standardize practice in how we test and treat,” he said.

“We were truly at the epicenter of the pandemic,” Dr. Cho said. “All of our hospitals had different experiences, and unique responses. But the system worked well.” Patients were transferred from the more overtaxed hospitals to Bellevue and other NYCH+H hospitals with spare beds. An emergency medical response structure was put in place, and every morning the system’s Tiger Team, with multidisciplinary personnel from administration, operations, logistics, and medical/technical specialists, would gather virtually to discuss needs across the system.

“It was a very open atmosphere and we asked people to report what was happening on the ground,” Dr. Cho said. “We started rapidly reviewing batches of 20 patients at a time for transfer in order to alleviate pressure in the most overtaxed ERs.”

NYCH+H also had to work through concerns about PPE, just like other U.S. hospitals. Treatment guidelines were changing by the day. Medical concerns were relayed at a rapid pace. Another priority was trying to limit unnecessary exposure for staff through a recommendation that only one clinician from a team would go into the room of an infected patient, unless another was absolutely needed.

The reality of public health

NYCH+H was created by the New York State Legislature in 1969 and rebranded in 2015. It includes a low- to no-cost health insurance plan called MetroPlus, along with outpatient centers, comprehensive case management, and social supports in the home.

“What people know about public health systems is that we typically are underresourced. That’s just the reality of public health,” Dr. Cho said. “We help the community, the underserved. The people who truly needed our help are also the ones who have been disproportionately affected by COVID-19. And that is where we really shine as a system.”

Dr. Cho lauded the performance of the health system’s frontline staff. “Watching them come together during the entire pandemic, and do their best every day, was truly inspiring,” he said. “But when they got to the peak, it really took an emotional toll on them.”

NYCH+H’s in-house staff support program, called Helping Healers Heal, was mobilized with specially trained teams at each of its 11 hospitals to provide peer-to-peer support, mental health expertise, and team-debriefing sessions to staff members following traumatic events. Support is provided both over the phone and in person on the floors, Dr. Cho said. “During the surge, everything was happening so quickly, there was no time to take a pause. Now, as we are able to catch our breath, that’s when they most need support.”

The hospitalists at NYCH+H hospitals intended to have goals-of-care conversations with all patients, but everyone was very busy – so having these conversations became harder and harder, Dr. Cho said. Recognizing limited staffing for the quadrupling of patients who needed palliative care at NYCH+H hospitals, he asked the medicine chairs about their palliative care needs and then used social media outreach to ask for help. The message went viral, attracting 413 volunteers from across the country. Sixty-seven telepalliative volunteers were put to work doing goals-of-care conversations remotely with inpatients and their families.¹

Expediting transfers

For Ian Fagan, MD, a hospitalist and associate medical director for general internal medicine Inpatient Services at Bellevue Hospital in Manhattan, hospitalist shifts are a normal part of his job. But he had to give them up during the surge to focus on planning, management, and especially scheduling other doctors, with sufficient backups needed to cover last minute changes. Dr. Fagan did that by using the existing pool of hospitalist staff, physicians who were reassigned from other specialties, agency staff, military medical personnel, and volunteer doctors who flew in from around the country to help. He also worked 10- to 12-hour days for 36 consecutive days.

The impact of disparities in access to care in New York City was reflected in the greater demand for care in the hospitals in Brooklyn, Queens, and the Bronx. “With fewer patients and more hospital beds in Manhattan, we had the capacity to share our beds,” Dr. Fagan said. “It was so amazing to me how quickly we could move patients from one hospital to another. We started accepting up to 40 transfers a day. But hey, we were still really busy.”

Bellevue is the nation’s oldest public hospital. “We care for the homeless, for immigrants, and we don’t ask questions. That’s our mission. I’m so proud to work here, and so grateful,” Dr. Fagan said. “If someone is undocumented or without insurance, I will give them exactly the same care. We stepped up in a big way to care for people of New York, but we’ve always been there for them – and we were there for them during the COVID surge.”

The hospitals in the system also worked together in ways Dr. Fagan had never seen. “It helped to have a central command structure with a bird’s eye view from above the level of individual hospitals, to organize and see which hospitals could step up. It’s good to have the data to put it in perspective,” he said. The system also utilized a temporary low-acuity medical center set up by NYCH+H on Roosevelt Island, as well as field hospitals organized at the Jacob K. Javits Convention Center and the USTA Billie Jean King National Tennis Center.

“At Bellevue we tried to stay ready, with the ability to turn former hospital units that were being used as offices back to beds. We always had three units lined up that were fully ready to convert. For example, I was medical director of the preop clinic and one day they gave us 24 hours to pack everything and move out. Three days later, it was a 24-bed unit. We also built a more robust rapid response and code team,” he said.

“It was hard for me not to take hospitalist shifts, because my identity is being a doctor. I eventually came to terms with the importance of the role that I was doing every day. I felt I could protect my colleagues, and if they were having an emotional day, to give them the opportunity to talk to someone. I also did the onboarding, one-on-one, of the new doctors.”

As the crisis in New York City has ebbed, Dr. Fagan was recently able to again take a week of clinical service. “The first day back on the floor I felt that I had forgotten everything. But by the end of the day, I thought, ‘Okay, I do know how to do this, after all.’ Census is down here. It’s quiet. That’s good. We need it now,” he said.

“I think the hardest moment for me was when the head nurse on our trauma unit, Ernesto DeLeon, known to everybody here, died of COVID in our ICU in April,” Dr. Fagan said. When Mr. DeLeon died, 100 hospital personnel gathered in the halls outside the room to pay their respects. “There had been a palpable fear in our lives – and this showed us that the fear was real. Ernesto was the first person I knew well who died, who acquired COVID at work doing what we’re all doing. We haven’t lost any doctors yet, but when this nurse died, we allowed ourselves to realize that this is personal. In that moment, we needed to allow ourselves to be human.”

Joan Curcio, MD, associate director of medicine at Elmhurst Hospital, said Elmhurst was where the story started for New York City and for NYCH+H. “I trained here and have spent my entire career at this hospital. It came to feel like what a battleground must be like, with things coming at you from every direction,” she said. “It was overwhelming in ways I could not have foreseen. I had seen videos from Italy [an early COVID-19 epicenter], but until it happened here, it was just hard to process.”

Things started slowly, with a few patients with severe acute respiratory distress syndrome and a 5- to 7-day turnaround to get results of their viral infection tests. “By week 2, a greater number of patients from our clinics and testing sites were filtering through the emergency department. Then hundreds.”

The normal occupancy rate for the department of medicine at Elmhurst is 110-115%, which typically means full beds plus patients in the emergency department. “We started to grow to 160, then 180, and then a peak of 250% of occupancy. We took over a rehab surgery floor, then a 35-bed surgery and hospice floor, which went to full capacity just like that,” she said. The number of non–critical care service teams increased to 20, working with redeployed staff, volunteers, military, and agency personnel, while ICU beds increased from 20 to 105.

“We were dealing with a much higher acuity level and enduring emotional turmoil with families, trying to carve out time to call them after our shift was over,” Dr. Curcio explained. Elmhurst developed a call-in hotline and a daily call-out service for families. Technology was mobilized to provide video visits and new systems were designed for isolation and for PPE distribution and use.

“I just felt that I couldn’t get everything done. I felt continually overwhelmed, and it didn’t matter how much time I took. I never felt I was able to give enough to anybody in any area, which was hard to take,” Dr. Curcio said. “But I still felt a sense of purpose and that I was making a difference – thanks to lots of support from the central office.”

Patient volume at Elmhurst is now down, lower than Dr. Curcio has ever seen it. “One of the main issues right now, moving forward, is ‘how do we function in a post-crisis mode?’” she said. The process of transitioning back to non-COVID-19 care will be complex. “When we clear a floor and clean it to go back to being a cold [COVID-19-negative] unit, it’s a whole different level of cleaning that takes 7 days.”

One moment that was particularly jarring for Dr. Curcio occurred while she was giving a tour of the hospital to visiting military medical personnel. “We went into the emergency department and I turned around and looked into a shower room, which was full of body bags. They were all full.”

But the experience has also been inspiring. “People gave their all without complaint. We hospitalists, and all those recruited to act as hospitalists, essentially took responsibility for the COVID response,” she said. “This was, hopefully, the experience of a lifetime as a medical professional. I wouldn’t want to ever experience something as daunting as this again.”
 

Reference

1. Israilov S et al. National outreach of telepalliative medicine volunteers for a New York City safety net system COVID-19 pandemic response. J Pain Symptom Manag. 2020 May 29. doi: 10.1016/j.jpainsymman.2020.05.026.