Rheumatology News

Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).

But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.

Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”

Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)

Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.

Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.

On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.

“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”

Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
 

Forward thinking?

While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.

At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.

“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.

At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.

To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”

Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”

Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.

There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.

“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
 

After the pandemic

Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.

Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.

Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”

*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System. 

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

Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).

But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.

Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”

Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)

Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.

Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.

On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.

“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”

Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
 

Forward thinking?

While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.

At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.

“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.

At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.

To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”

Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”

Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.

There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.

“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
 

After the pandemic

Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.

Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.

Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”

*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System. 

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

Doctors at a Boston-area hospital learned via video conferencing that they would be receiving a 20% pay cut – a slap in the face at the precise moment that those on the front lines of the COVID-19 pandemic need a pat on the back (and more N95 respirators).

But Steward Health Care System*, which runs the hospital and dozens of others around the country, did the math and decided that the pay cuts were necessary to survive what they called “a seismic shock to our system.” They also announced furloughs for a large number of their nonclinical staff.

Spirits sank after the announcement. “It was devastating,” said one Boston doctor, who works for Steward and asked not to be identified for fear of retribution. “I didn’t say much during the call because I was so panicked, and I didn’t want to be crying on the call.”

Someone else did speak up, a senior colleague who warned that such a cut would kill morale at a time when physicians were already feeling vulnerable because of other shortages, including personal protective equipment. (Requests for interviews with Steward Health Care System executives were declined.)

Furloughs, layoffs, and even firings are happening elsewhere too. Hospitals in virus hotspots have already come up short on beds and face masks. Now a shortage of cash is prompting many to fire some of their health care workers, furlough them temporarily, or – like Steward Health Care System – slash their pay checks.

Despite almost $200 billion earmarked for hospital systems in the recently passed federal stimulus package, many hospitals are still in dire financial straits. Most make the majority of their money through so-called elective procedures, such as knee replacements and cataract surgeries, almost all of which have been postponed in order to conserve personal protective equipment and minimize spread of the virus. Those cancellations translate to a significant financial hit.

On top of that, hospitals will lose an average of $1,800 on every COVID-19 case, according to projections by Strata Decision Technology, a health care financial planning and analytic company. Some, they estimate, may lose much more, between $6,000 and $8,000 per patient. And hospitals were already hurting. According to a report from Bloomberg, at least 30 hospitals entered bankruptcy in 2019.

“This pressure on institutions to control costs has been around for several years,” said Steve Lefar, executive director of the data science division of Strata Decision Technology and lead author of the study. “This is just making it incredibly acute for them.”

Many hospital executives are bracing for months of hardship, leading to wrenching decisions to furlough or lay off staff, suspend bonuses, or cut pay – even as some short-staffed hospitals in COVID-19 hotspots are issuing pleas for doctors to come out of retirement.
 

Forward thinking?

While most furloughs and layoffs so far have affected people who don’t work directly with patients, many on the front lines have been hit with pay cuts or withheld bonuses or retirement contributions. In Massachusetts, the state’s medical society has asked Governor Charlie Baker for financial relief for health care workers in the form of grants, no-interest or forgivable small-business loans for physician practices, and deferment of medical student loan payments.

At St. Alexius Hospital in St. Louis, Sonny Saggar, MD, was fired as CEO after he clashed with a bankruptcy trustee. Dr. Saggar had proposed offering open beds to other hospital systems during the pandemic – an idea that, he said, was turned down out of concern for the bottom line.

“This is one of those times where we need to put down our search for profit and money and just look after people’s lives. We’re supposed to have that calling in health care,” said Dr. Saggar, who has since been reinstated as chief strategy officer and director of the COVID task force and ED. He noted that he and the trustee have resolved differences over funding.

At St. Claire HealthCare in Morehead, Ky., 300 employees who were not involved in direct patient care – a quarter of the hospital’s staff – have been furloughed, something Donald Lloyd II, St. Claire HealthCare’s CEO as of May 1, described as forward thinking.

To prepare for the influx of COVID-19 patients, the hospital shut down elective procedures early. “Prudence dictates the need to be extremely proactive,” Mr. Lloyd said. “We need to devote our limited resources to frontline clinical teams.”

Other hospitals are making similar moves, although many are not doing so publicly. Mr. Lloyd decided to put out a press release because he found it offensive that the federal government was “bailing out airlines and cruise lines before our frontline men and women caring for patients.”

Massachusetts-based Atrius Health, for instance, placed many staffers on a 1-month furlough, while simultaneously withholding a percentage of working physicians’ paychecks, saying that they plan to pay them back at a later date. TriHealth, in Cincinnati, looked elsewhere for ways to save money. Instead of cutting physician salaries, 11 executives took a 20% pay cut.

There are both better and worse ways to go about such staff reductions, according to Mr. Lefar. If reductions have to be made, it would be best if CEOs keep cuts as far away as possible from the front lines of patient care.

“My bias is to start with pay reductions for high-paid executives, then furloughs, and beyond that layoffs,” he said. (Furloughs allow employees to be brought back and receive unemployment benefits while not working.) “Anyone related to patient care – these are the people who are getting the country through this, these are the heroes.”
 

After the pandemic

Large hospital systems that can designate separate buildings for COVID-19 care may fare best financially, Mr. Lefar said. By retaining a clean, noninfectious facility, such setups could allow for an earlier return to regular procedures – as long as rapid COVID-19 testing becomes available.

Smaller hospitals, nearly half of which run at a financial loss, according to the Chartis Center for Rural Health, face the additional burdens of both limited capacity and a limited ability to separate COVID-19 care.

Mostly, Mr. Lefar said, it’s a matter of doing whatever is necessary to get through the worst of it. “A lot of what is deemed elective or scheduled will come back,” he said. “Right now it’s crisis mode. ... I think it’s going to be a rough 6-9 months, but we will get back to it.”

*Correction, 4/7/20: An earlier version of this article misstated the name of a hospital in the Boston area run by Steward Health Care System. 

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

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

gtwachtman@mdedge.com

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

gtwachtman@mdedge.com

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

gtwachtman@mdedge.com

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

Combination therapy with leflunomide and hydroxychloroquine is safe in patients with primary Sjögren’s syndrome and may elicit clinical improvement, according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.

The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.

The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.

“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.

Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.

At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.

Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.

No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).

In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.

Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”

The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.

egreb@mdedge.com

SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.

Combination therapy with leflunomide and hydroxychloroquine is safe in patients with primary Sjögren’s syndrome and may elicit clinical improvement, according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.

The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.

The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.

“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.

Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.

At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.

Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.

No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).

In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.

Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”

The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.

egreb@mdedge.com

SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.

Combination therapy with leflunomide and hydroxychloroquine is safe in patients with primary Sjögren’s syndrome and may elicit clinical improvement, according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.

The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.

The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.

“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.

Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.

At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.

Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.

No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).

In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.

Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”

The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.

egreb@mdedge.com

SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

New information from the US State Department indicates that it is lifting the suspension on visas for foreign-trained medical professionals, a move that has promise for boosting the US physician workforce battling COVID-19.

The move may also help physicians extend their visas.

The communication late last week follows a March 18 announcement that, because of COVID-19, the United States was suspending routine processing of immigrant and nonimmigrant visas, including the J and H visas, at embassies and consulates worldwide.

As reported by Medscape Medical News, the Educational Commission for Foreign Medical Graduates (ECFMG) appealed to the State Department to lift the suspension, noting that 4222 graduates of medical schools outside the United States who had matched into residencies in the United States and were ready to start on July 1 would not get the visas most of them need to begin training.

The State Department lifted the suspensions and issued this update:

“We encourage medical professionals with an approved US non-immigrant or immigrant visa petition (I-129, I-140, or similar) or a certificate of eligibility in an approved exchange visitor program (DS-2019), particularly those working to treat or mitigate the effects of COVID-19, to review the website of their nearest embassy or consulate for procedures to request a visa appointment.”

The State Department also issued guidance for foreign medical professionals already in the United States:

“J-1 Alien Physicians (medical residents) may consult with their program sponsor, ECFMG, to extend their programs in the United States. Generally, a J-1 program for a foreign medical resident can be extended one year at a time for up to seven years.

“Note that the expiration date on a US visa does not determine how long one can be in the United States. The way to confirm one’s required departure date is here : https://i94.cbp.dhs.gov/I94/#/home.

“Those who need to extend their stay or adjust their visa status  must apply with USCIS  (US Citizenship and Immigration Services).”

Complications Still Exist

ECFMG’s CEO, William W. Pinsky, MD, told Medscape Medical News that, although they welcomed the news from the State Department, there are still unanswered questions.

ECFMG explained that J-1 visas are currently granted only 30 days before the residency program begins.

However, travel to the United States may still be difficult in June, Pinsky said, and physicians may need to be quarantined for 2 weeks upon arrival.

“We’re still having some discussion with the Department of State on whether that regulation could be relaxed and they could come in earlier,” he said.

He cautioned that even after a J-1 visa application is made, the physician’s home country has to endorse the application.

Pinsky said he did not yet know whether that would be a problem.

He also said that, in response to New York’s plea for more healthcare workers, ECFMG is offering to verify education and licensing credentials for physicians educated outside the United States at no cost.

Individual hospitals and regulatory authorities can decide whether there may be roles in some capacity for physicians who have graduated from medical school, even if they have not completed residency or have not been licensed, he said.
 

This article first appeared on Medscape.com.

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

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

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

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

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.

Diagnosing CVD and COVID-19 simultaneously

In patients with emergent cardiovascular needs in whom COVID-19 has not been ruled out, quarantine in a single-bed room is needed, they wrote. The patient should be monitored for clinical manifestations of the disease, and undergo COVID-19 nucleic acid testing as soon as possible.

After infection control is considered, including limiting risk for infection to health care workers, risk assessment that weighs the relative advantages and disadvantages of treating the cardiovascular disease while preventing transmission can be considered, the investigators wrote.

At all times, transfers to different areas of the hospital and between hospitals should be minimized to reduce the risk for infection transmission.

The authors also recommended the use of “select laboratory tests with definitive sensitivity and specificity for disease diagnosis or assessment.”

For patients with acute aortic syndrome or acute pulmonary embolism, this means CT angiography. When acute pulmonary embolism is suspected, D-dimer testing and deep vein ultrasound can be employed, and for patients with acute coronary syndrome, ordinary electrocardiography and standard biomarkers for cardiac injury are preferred.

In addition, “all patients should undergo lung CT examination to evaluate for imaging features typical of COVID-19. ... Chest x-ray is not recommended because of a high rate of false negative diagnosis,” the authors wrote.

Intervene with caution

Medical therapy should be optimized in patients with emergent cardiovascular issues, with invasive strategies for diagnosis and therapy used “with caution,” according to the Chinese experts.

Conditions for which conservative medical treatment is recommended during COVID-19 pandemic include ST-segment elevation MI (STEMI) where thrombolytic therapy is indicated, STEMI when the optimal window for revascularization has passed, high-risk non-STEMI (NSTEMI), patients with uncomplicated Stanford type B aortic dissection, acute pulmonary embolism, acute exacerbation of heart failure, and hypertensive emergency.

“Vigilance should be paid to avoid misdiagnosing patients with pulmonary infarction as COVID-19 pneumonia,” they noted.

Diagnoses warranting invasive intervention are limited to STEMI with hemodynamic instability, life-threatening NSTEMI, Stanford type A or complex type B acute aortic dissection, bradyarrhythmia complicated by syncope or unstable hemodynamics mandating implantation of a device, and pulmonary embolism with hemodynamic instability for whom intravenous thrombolytics are too risky.

Interventions should be done in a cath lab or operating room with negative-pressure ventilation, with strict periprocedural disinfection. Personal protective equipment should also be of the strictest level.

In patients for whom COVID-19 cannot be ruled out presenting in a region with low incidence of COVID-19, interventions should only be considered for more severe cases and undertaken in a cath lab, electrophysiology lab, or operating room “with more than standard disinfection procedures that fulfill regulatory mandates for infection control.”

If negative-pressure ventilation is not available, air conditioning (for example, laminar flow and ventilation) should be stopped.

Establish plans now

“We operationalized all of these strategies at Beth Israel Deaconess Medical Center several weeks ago, since Boston had that early outbreak with the Biogen conference, but I suspect many institutions nationally are still formulating plans,” said Dhruv Kazi, MD, MSc, in an interview.

Although COVID-19 is “primarily a single-organ disease – it destroys the lungs” – transmission of infection to cardiology providers was an early problem that needed to be addressed, said Dr. Kazi. “We now know that a cardiologist seeing a patient who reports shortness of breath and then leans in to carefully auscultate the lungs and heart can get exposed if not provided adequate personal protective equipment; hence the cancellation of elective procedures, conversion of most elective visits to telemedicine, if possible, and the use of surgical/N95 masks in clinic and on rounds.”

Regarding the CSC recommendation to consider medical over invasive management, Dr. Kazi noteed that this works better in a setting where rapid testing is available. “Where that is not the case – as in the U.S. – resorting to conservative therapy for all COVID suspect cases will result in suboptimal care, particularly when nine out of every 10 COVID suspects will eventually rule out.”

One of his biggest worries now is that patients simply won’t come. Afraid of being exposed to COVID-19, patients with MIs and strokes may avoid or delay coming to the hospital.

“There is some evidence that this occurred in Wuhan, and I’m starting to see anecdotal evidence of this in Boston,” said Dr. Kazi. “We need to remind our patients that, if they experience symptoms of a heart attack or stroke, they deserve the same lifesaving treatment we offered before this pandemic set in. They should not try and sit it out.”

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

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

lfranki@mdedge.com

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

lfranki@mdedge.com

The Food and Drug Administration issued an Emergency Use Authorization on March 28, 2020, allowing for the usage of hydroxychloroquine sulfate and chloroquine phosphate products in certain hospitalized patients with COVID-19.

The products, currently stored by the Strategic National Stockpile, will be distributed by the SNS to states so that doctors may prescribe the drugs to adolescent and adult patients hospitalized with COVID-19 in the absence of appropriate or feasible clinical trials. The SNS will work with the Federal Emergency Management Agency to ship the products to states.

According to the Emergency Use Authorization, fact sheets will be provided to health care providers and patients with important information about hydroxychloroquine sulfate and chloroquine phosphate, including the risks of using them to treat COVID-19.

lfranki@mdedge.com

Adalimumab biosimilars are years away from entering the marketplace in the United States because of patent disputes, but they already have led to substantial discounts in Denmark, researchers wrote in JAMA Internal Medicine.

The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired there in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication, wrote Thomas Bo Jensen, MD, and colleagues in a research letter.

Denmark did not automatically substitute biosimilars, but the Danish Medicines Council recommended adalimumab biosimilars for all indications following Humira’s patent expiration. The recommendations “included switching patients to a biosimilar who were already well treated with the originator,” the researchers wrote.

To study the shift to adalimumab biosimilars across all indications in Denmark and calculate cost reductions, Dr. Jensen, of the department of clinical pharmacology at Copenhagen University Hospital Bispebjerg, and coinvestigators examined monthly data on drug sales from Amgros, which purchases all hospital drugs in the country.

“The proportion of adalimumab biosimilars increased from 71.6% (7,040 of 9,829 pens) in November 2018 to 95.1% (8,974 of 9,438 pens) in December 2018,” the researchers wrote. “Costs of adalimumab decreased by 82.8% from September 2018 to December 2018 (September: 8,197 pens at $5.13 million; December: 9,438 pens at $1.01 million).” The results were similar in rheumatology, dermatology, and gastroenterology.

The Food and Drug Administration has approved five adalimumab biosimilars in the United States, but “they will not enter the market until 2023 owing to patent disputes with AbbVie, the manufacturer of Humira,” wrote Jennifer D. Claytor, MD, of the department of internal medicine at University of California, San Francisco, and Walid Gellad, MD, of the division of general internal medicine at University of Pittsburgh, in an accompanying editorial.

The annual postrebate price of Humira doubled between 2013 and 2018, from $19,000 to $38,000, and these price increases may influence the price of biosimilars, “which will be priced using Humira’s price as an anchor,” Dr. Claytor and Dr. Gellad wrote.

A rapid shift to adalimumab biosimilars across the United States when they become available is “unlikely,” they wrote. Nonetheless, “some health care systems of comparable size to Denmark (e.g., the Veterans Affairs system) and others that are larger (e.g., Kaiser Permanente) ... have the ability to switch products quickly through use of formularies and a prescriber workforce. For example, Kaiser Permanente has successfully replaced Remicade (infliximab) with biosimilars in 80% of patients.”

Given the many biologics in development and increasing health care spending, “we need to take seriously the substantial savings offered by biosimilars and the feasibility, as evidenced by Denmark, of switching to biosimilars quickly once they are available on the market,” Dr. Claytor and Dr. Gellad concluded.

The research was supported by an unrestricted grant from Helsefonden. One author disclosed receiving grants from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb outside the current study. The editorial authors had no disclosures.

jremaly@mdedge.com

SOURCE: Jensen TB et al. JAMA Intern Med. 2020 Mar 30. doi: 10.1001/jamainternmed.2020.0338.

Adalimumab biosimilars are years away from entering the marketplace in the United States because of patent disputes, but they already have led to substantial discounts in Denmark, researchers wrote in JAMA Internal Medicine.

The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired there in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication, wrote Thomas Bo Jensen, MD, and colleagues in a research letter.

Denmark did not automatically substitute biosimilars, but the Danish Medicines Council recommended adalimumab biosimilars for all indications following Humira’s patent expiration. The recommendations “included switching patients to a biosimilar who were already well treated with the originator,” the researchers wrote.

To study the shift to adalimumab biosimilars across all indications in Denmark and calculate cost reductions, Dr. Jensen, of the department of clinical pharmacology at Copenhagen University Hospital Bispebjerg, and coinvestigators examined monthly data on drug sales from Amgros, which purchases all hospital drugs in the country.

“The proportion of adalimumab biosimilars increased from 71.6% (7,040 of 9,829 pens) in November 2018 to 95.1% (8,974 of 9,438 pens) in December 2018,” the researchers wrote. “Costs of adalimumab decreased by 82.8% from September 2018 to December 2018 (September: 8,197 pens at $5.13 million; December: 9,438 pens at $1.01 million).” The results were similar in rheumatology, dermatology, and gastroenterology.

The Food and Drug Administration has approved five adalimumab biosimilars in the United States, but “they will not enter the market until 2023 owing to patent disputes with AbbVie, the manufacturer of Humira,” wrote Jennifer D. Claytor, MD, of the department of internal medicine at University of California, San Francisco, and Walid Gellad, MD, of the division of general internal medicine at University of Pittsburgh, in an accompanying editorial.

The annual postrebate price of Humira doubled between 2013 and 2018, from $19,000 to $38,000, and these price increases may influence the price of biosimilars, “which will be priced using Humira’s price as an anchor,” Dr. Claytor and Dr. Gellad wrote.

A rapid shift to adalimumab biosimilars across the United States when they become available is “unlikely,” they wrote. Nonetheless, “some health care systems of comparable size to Denmark (e.g., the Veterans Affairs system) and others that are larger (e.g., Kaiser Permanente) ... have the ability to switch products quickly through use of formularies and a prescriber workforce. For example, Kaiser Permanente has successfully replaced Remicade (infliximab) with biosimilars in 80% of patients.”

Given the many biologics in development and increasing health care spending, “we need to take seriously the substantial savings offered by biosimilars and the feasibility, as evidenced by Denmark, of switching to biosimilars quickly once they are available on the market,” Dr. Claytor and Dr. Gellad concluded.

The research was supported by an unrestricted grant from Helsefonden. One author disclosed receiving grants from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb outside the current study. The editorial authors had no disclosures.

jremaly@mdedge.com

SOURCE: Jensen TB et al. JAMA Intern Med. 2020 Mar 30. doi: 10.1001/jamainternmed.2020.0338.

Adalimumab biosimilars are years away from entering the marketplace in the United States because of patent disputes, but they already have led to substantial discounts in Denmark, researchers wrote in JAMA Internal Medicine.

The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired there in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication, wrote Thomas Bo Jensen, MD, and colleagues in a research letter.

Denmark did not automatically substitute biosimilars, but the Danish Medicines Council recommended adalimumab biosimilars for all indications following Humira’s patent expiration. The recommendations “included switching patients to a biosimilar who were already well treated with the originator,” the researchers wrote.

To study the shift to adalimumab biosimilars across all indications in Denmark and calculate cost reductions, Dr. Jensen, of the department of clinical pharmacology at Copenhagen University Hospital Bispebjerg, and coinvestigators examined monthly data on drug sales from Amgros, which purchases all hospital drugs in the country.

“The proportion of adalimumab biosimilars increased from 71.6% (7,040 of 9,829 pens) in November 2018 to 95.1% (8,974 of 9,438 pens) in December 2018,” the researchers wrote. “Costs of adalimumab decreased by 82.8% from September 2018 to December 2018 (September: 8,197 pens at $5.13 million; December: 9,438 pens at $1.01 million).” The results were similar in rheumatology, dermatology, and gastroenterology.

The Food and Drug Administration has approved five adalimumab biosimilars in the United States, but “they will not enter the market until 2023 owing to patent disputes with AbbVie, the manufacturer of Humira,” wrote Jennifer D. Claytor, MD, of the department of internal medicine at University of California, San Francisco, and Walid Gellad, MD, of the division of general internal medicine at University of Pittsburgh, in an accompanying editorial.

The annual postrebate price of Humira doubled between 2013 and 2018, from $19,000 to $38,000, and these price increases may influence the price of biosimilars, “which will be priced using Humira’s price as an anchor,” Dr. Claytor and Dr. Gellad wrote.

A rapid shift to adalimumab biosimilars across the United States when they become available is “unlikely,” they wrote. Nonetheless, “some health care systems of comparable size to Denmark (e.g., the Veterans Affairs system) and others that are larger (e.g., Kaiser Permanente) ... have the ability to switch products quickly through use of formularies and a prescriber workforce. For example, Kaiser Permanente has successfully replaced Remicade (infliximab) with biosimilars in 80% of patients.”

Given the many biologics in development and increasing health care spending, “we need to take seriously the substantial savings offered by biosimilars and the feasibility, as evidenced by Denmark, of switching to biosimilars quickly once they are available on the market,” Dr. Claytor and Dr. Gellad concluded.

The research was supported by an unrestricted grant from Helsefonden. One author disclosed receiving grants from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb outside the current study. The editorial authors had no disclosures.

jremaly@mdedge.com

SOURCE: Jensen TB et al. JAMA Intern Med. 2020 Mar 30. doi: 10.1001/jamainternmed.2020.0338.