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Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.

Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.

Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.

Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
 

Many forms for boxes

The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.

The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”

Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.

Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.

Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.

Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).

Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.

The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
 

More evidence passive boxes are ineffective

Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.

He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”

A desperate need to stop the virus is leading to unacceptable practices, he said.

His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.

He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.

Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.

The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”

He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.

One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.

David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”

He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.

The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.

“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”

He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.

That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”

He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.

That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”

The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.

Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.

On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.

Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.

Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.

Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.

Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
 

Many forms for boxes

The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.

The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”

Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.

Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.

Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.

Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).

Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.

The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
 

More evidence passive boxes are ineffective

Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.

He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”

A desperate need to stop the virus is leading to unacceptable practices, he said.

His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.

He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.

Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.

The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”

He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.

One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.

David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”

He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.

The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.

“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”

He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.

That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”

He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.

That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”

The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.

Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.

On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.

Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Clear aerosol boxes designed to keep COVID-19 patients’ airborne droplets from infecting health care workers during intubation may actually increase providers’ exposure to the virus, a small study suggests.

Joanna P. Simpson, MbChB, an intensivist in the department of anaesthesia and perioperative medicine at Eastern Health in Melbourne, and colleagues tested five models of barriers used for protection while intubating simulated “patients” with COVID-19 and compared the interventions with a control of having no protection. They published their findings online in Anaesthesia.

Coauthor Peter Chan, MBBS, also an intensivist at Eastern Health, said in an interview that the virus essentially concentrates inside the box and because the box has holes on the sides to allow providers’ arms in, the gaps “act as nozzles, so when a patient coughs, it creates a sudden wave of air that pushes all these particles out the path of least resistance” and into the face of the intubator.

Their institution stopped using any such aerosol-containment devices during intubation until safety can be proven.
 

Many forms for boxes

The boxes take different forms and are made by various designers and manufacturers around the world, including in the United States, but they generally cover the head and upper body of patients and allow providers to reach through holes to intubate.

The U.S. Food and Drug Administration on May 1 issued an emergency use authorization (EUA) for “protective barrier enclosures ... to prevent [health care provider] exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment [PPE].”

Others refer to them as “intubation boxes.” A search of GoFundMe campaigns showed hundreds of campaigns for intubation boxes.

Dr. Simpson and colleagues used an in-situ simulation model to evaluate laryngoscopist exposure to airborne particles sized 0.3-5.0 mcm using five aerosol containment devices (aerosol box, sealed box with suction, sealed box without suction, vertical drapes, and horizontal drapes) compared with no aerosol containment device.

Nebulized saline was used in an aerosol-generating model for 300 seconds, at which point the devices were removed to gauge particle spread for another 60 seconds.

Compared with no device use, the sealed intubation box with suction resulted in a decreased exposure for particle sizes of 0.3, 0.5, 1.0, and 2.5 mcm – but not 5.0 mcm – over all time periods (P = .003 for all time periods, which ranged from 30 to 360 seconds).

Conversely, the aerosol box, compared with no device use, showed an increase in 1.0, 2.5, and 5.0 mcm airborne-particle exposure at 300 seconds (P = .002, 0.008, and .002, respectively). Compared with no device use, neither horizontal nor vertical drapes showed any difference in any particle size exposure at any time.

The researchers used seven volunteers who took turns acting as the patient or the intubator. As each of the seven volunteers did all six trials (the five interventions plus no intervention), the study generated 42 sets of results.
 

More evidence passive boxes are ineffective

Plastic surgeon Dave Turer, MD, MS, who is also an electrical and biomedical engineer, and some emergency physician colleagues had doubts about these boxes early on and wrote about the need for thorough testing.

He told this news organization, “I find it kind of infuriating that if you search for ‘intubation box’ there are all these companies making claims that are totally unsubstantiated.”

A desperate need to stop the virus is leading to unacceptable practices, he said.

His team at the University of Pittsburgh Medical Center in Pennsylvania tested commercially available boxes using white vapor to simulate patients› exhaled breath and found the vapor billowed into the surrounding environment.

He said Simpson and colleagues had similar findings: The boxes didn’t contain the patients’ breaths and may even increase the stream heading toward intubators.

Dr. Turer said his team has designed a different kind of box, without armholes for the intubators, and with active airflow and filtering and have submitted their design and research to the FDA for an EUA.

The FDA’s current EUA is for boxes “that are no different from a face shield or a splash shield,” Dr. Turer said, adding that “they specifically state that they are not designed or intended to contain aerosol.”

He said while this study is a good start, his team’s findings will help demonstrate why the common passive boxes should not be used.

One of the most prevalent designs, he pointed out, was one by Taiwanese anesthesiologist Hsien Yung Lai that was widely circulated in March.

David W. Kaczka, MD, PhD, associate professor of anesthesia, biomedical engineering, and radiology at University of Iowa in Iowa City, is one of the researchers who modified that design and made prototypes. He said in an interview he thinks the study conclusion by Simpson et al is “not as dismal as the authors are making it out to be.”

He pointed to the relative success of the sealed box with suction. His team’s adapted model added a suction port to generate a negative pressure field around the patient.

The biggest critique he had of the study, Dr. Kaczka said, was a lack of a true control group.

“They tested all their conditions with nebulized saline,” he pointed out. “I think a more appropriately designed study would have also looked at a group where no saline was being nebulized and see what the particle counts were afterwards. It’s not clear how the device would distinguish between a particle coming from a saline nebulizer vs. coming from a simulated patient vs. coming from the laryngoscopist.”

He also noted that what comes out of a patient is not going to be saline and will have different density and viscosity.

That said, the study by Dr. Simpson and colleagues highlights the need to take a hard look at these boxes with more research, he said, adding, “I think there’s some hope there.”

He noted that a letter to the editor by Boston researchers, published online April 3 in the New England Journal of Medicine, describes how they used fluorescent dye forced from a balloon to simulate a patient’s cough to see whether an aerosol box protected intubators.

That letter concludes, “We suggest that our ad hoc barrier enclosure provided a modicum of additional protection and could be considered to be an adjunct to standard PPE.”

The Anaesthesia findings come as a second global wave becomes more likely as does awareness of the potential of airborne droplets to spread the virus.

Scientists from 32 countries warned the World Health Organization that the spread of COVID-19 through airborne droplets may have been severely underestimated.

On Wednesday, the World Health Organization formally acknowledged evidence regarding potential spread of the virus through these droplets and on Thursday issued an updated brief.

Intellectual property surrounding the device invented by Dr. Turer’s team is owned by UPMC. Dr. Chan and Dr. Kaczka have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

Sachin Dave, MD, an internist in Greenwood, Ind., never thought he’d tell his patients to avoid coming into the office. But these days, he must balance the need for face-to-face visits with the risk for COVID-19 transmission. Although he connects with most patients by telehealth, some patients still demand in-office care.

“My older patients actually insist on coming to see me in person,” said Dr. Dave, who is part of Indiana Internal Medicine Consultants, a large group practice near Indianapolis. “I have to tell them it’s not safe.”

It’s a minor hitch as his practice ramps up again – but one of those things you can’t overlook, he said. “We need to educate our patients and communicate the risk to them.”

As practices across the United States start reopening, physicians frequently hit bumps in the road, according to Kerin Bashaw, senior vice president of patient safety and risk management for the Doctors Company, a physician-owned malpractice insurer. “It’s about minimizing risk.”

As practices increase patient volume, physicians are juggling a desire for a return to patient care and increased revenue with a need to maximize patient and staff safety. Avoiding some of these common snags may help make the transition smoother.
 

1. Unclear or nonexistent polices and protocols

Some physicians know what general rules they want to follow, but they haven’t conveyed them in a readily available document. Although you and your staff may have a sense of what they are, patients may be less aware of how mandatory you consider them. It’s important to develop a formal framework that you will follow and to make sure patients and staff know it.

Dr. Dave and colleagues have stringent safety protocols in place for the small percentage of patients he does feel a need to be seen in person. Masks are mandatory for staff and patients. The waiting room is set up for social distancing. If it begins getting crowded, patients are asked to wait in their cars until an exam room is ready.

“I’m not going to see a patient who refuses to put a mask on, because when I put a mask on, I’m trying to protect my patients,” said Dr. Dave. He makes it clear that he expects the same from his patients; they must wear a mask to protect his staff and himself.

“I am going to let them in with the caveat that they don’t have qualms about wearing a mask. If they have qualms about wearing a mask, then I have qualms about seeing them in person,” he said.

Be sure that all patients understand and will adhere to your protocols before they come to the office. Patients should be triaged over the phone before arriving, according to Centers for Disease Control and Prevention recommendations. (Remember that refusing assessment or care could lead to issues of patient abandonment.)

When you don’t really have a framework to follow, you don’t really know what the structure is going to be and how your practice is going to provide care. The question is, how do you build a framework for right now? said Ron Holder, chief operations officer of the Medical Group Management Association. “The first step is do no harm.”
 

2. Trying to see too many patients too soon

On average, practices have reported a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis, according to the MGMA. It’s natural that many want to ramp up immediately and go back to their prior patient volume. But they need to take it slow and ensure that the correct safety protocols are in place, Mr. Holder said.

For example, telehealth is still reimbursable at parity, so physicians should keep taking advantage of that. MGMA’s practice reopening checklist has links to additional resources and considerations.

Some doctors want to see an overload of patients and want to get back to how they practiced before the pandemic, says orthopedic surgeon Charles Ruotolo, MD, president of Total Orthopedics and Sports Medicine in Massapequa, N.Y., and chairman of the department of orthopedics, Nassau University Medical Center, East Meadow, N.Y., “but at the same time, you know we still have to limit how many people are coming into the office.”

It’s not fair if some doctors in your practice are seeing 45 patients daily as they did previously whereas others are seeing half that many, he explained. “We must remain cognizant and constantly review schedules and remember we have to still keep the numbers down.”

“COVID is not going to be completely over in our lifetime,” says Evan Levine, MD, a cardiologist in Ridgefield, Conn. Taking advantage of technologies is one way to reduce risk.

He predicts that the demand will continue to increase as patients become more comfortable with virtual visits. Using Bluetooth and WiFi devices to assess patients is no longer futuristic and can help reduce the number of people in the waiting room, according to Dr. Levine, a solo practitioner and author of “What Your Doctor Won’t (or Can’t) Tell You.” “That’s a very good thing, especially as we look to fall and to flu season.”
 

3. Undercommunicating with patients and staff

Don’t assume patients know that you’ve opened back up and are seeing people in the office, Mr. Holder said. Update your practice website, send letters or newsletters to patients’ homes, maintain telephone and email contact, and post signs at the facility explaining your reopening process. The CDC has an excellent phone script that practices can adapt. Everyone should know what to expect and what’s expected of them.

He advised overcommunicating – more than you think is necessary – to your staff and patients. Tell them about the extra steps you’re taking. Let them know that their safety and health are the most important thing and that you are taking all these extra measures to make sure that they feel comfortable.

Keep staff appraised of policy changes. Stress what you’re doing to ensure the safety of your team members. “Even though you could be doing all those things, if you’re not communicating, then no one knows it,” said Mr. Holder.

He predicted the practices that emerge stronger from this crisis will be those with great patient education that have built up a lot of goodwill. Patients should know they can go to this practice’s patient portal as a trusted resource about COVID-19 and safety-related measures. This approach will pay dividends over the long term.
 

4. Giving inadequate staff training and holding too-high expectations

Staff members are scared, really scared, Ms. Bashaw said. Some may not return because they’re unsure what to expect; others may have to stay home to care for children or older relatives. Clear guidance on what is being done to ensure everyone’s safety, what is expected from staff, and flexibility with scheduling can help address these issues.

Most practices’ staff are not used to donning and removing personal protective equipment, and they’re not used to wearing masks when working with patients. Expect some mistakes.

“We had a scenario where a provider was in a room with an older patient, and the provider pulled his mask down so the patient could hear him better. He then kept the mask down while giving the patient an injection. When the family found out, they were very upset,” Ms. Bashaw related. “It was done with good intentions, to improve communication, but it’s a slip-up that could have found him liable if she became ill.”

Dr. Ruotolo had to implement new policies throughout his practice’s multiple locations in the New York metro area. They encompassed everything from staggering appointments and staff to establishing designated employee eating areas so front desk staff weren’t taking their masks off to snack.

Having specific guidelines for staff helps reassure patients that safety protocols are being adhered to. “Patients want to see we’re all doing the right thing,” he said.

Have those policies clearly written so everyone’s on the same page, Dr. Ruotolo advised. Also make sure staff knows what the rules are for patients.

Dr. Ruotolo’s reception staff hand every patient a disinfectant wipe when they arrive. They are asked to wipe down the check-in kiosk before and after using it. Assistants know not to cut corners when disinfecting exam rooms, equipment, or tables. “It’s the little things you have to think about, and make sure it’s reiterated with your staff so they’re doing it.”

If your practice isn’t back up to full staffing volume, it’s a good idea to cross train staff members so some jobs overlap, suggests Mr. Holder. Although smaller practices may already do this, at larger practices, staff members’ roles may be more specific. “You may be able to pull employees from other positions in the practice, but it’s a good idea to have some redundancy.”
 

5. Neglecting to document everything – even more so than before

The standard of care is changing every day, and so are the regulations, says Ms. Bashaw. Many physicians who work in larger practices or for health systems don’t take advantage of internal risk management departments, which can help them keep tabs on all of these changes.

Writing down simple protocols and having a consistent work flow are extremely important right now. What have you told staff and patients? Are they comfortable with how you’re minimizing their risk? Physicians can find a seven-page checklist that helps practitioners organize and methodically go through reopening process at the Doctors Company website.

Implementing state and local statutes or public health requirements and keeping track of when things stop and start can be complex, says Ms. Bashaw. Take a look at your pre–COVID-19 policies and procedures, and make sure you’re on top of the current standards for your office, including staff education. The most important step is connecting with your local public health authority and taking direction from them.

Ms. Bashaw strongly encouraged physicians to conduct huddles with their staff; it’s an evidence-based leadership practice that’s important from a medical malpractice perspective. Review the day’s game plan, then conduct a debriefing at the end of the day.

Discuss what worked well, what didn’t, and what tomorrow looks like. And be sure to document it all. “A standard routine and debrief gets everyone on the same page and shows due diligence,” she said.

Keep an administrative file so 2 years down the road, you remember what you did and when. That way, if there’s a problem or a breach or the standard isn’t adhered to, it’s documented in the file. Note what happened and when and what was done to mitigate it or what corrective action was taken.

All practices need to stay on top of regulatory changes. Smaller practices don’t have full-time staff dedicated to monitoring what’s happening in Washington. Associations such as the MGMA can help target what’s important and actionable.
 

6. Forgetting about your own and your staff’s physical and mental health

Physicians need to be worried about burnout and mental health problems from their team members, their colleagues, their patients, and themselves, according to Mr. Holder.

“There’s a mental exhaustion that is just pervasive in the world and the United States right now about all this COVID stuff and stress, not to mention all the other things that are going on,” he said.

That’s going to carry over, so physicians must make sure there’s a positive culture at the practice, where everyone’s taking care of and watching out for each other.

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

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

An inexpensive two-drug regimen of sofosbuvir (Sovaldi, Gilead Sciences) plus daclatasvir (Daklinza, Bristol-Myers Squibb) taken for 14 days significantly reduced time to recovery from COVID-19 and improved survival in people hospitalized with severe disease, research from an open-label Iranian study shows.

And the good news is that the treatment combination “already has a well-established safety profile in the treatment of hepatitis C,” said investigator Andrew Hill, PhD, from the University of Liverpool, United Kingdom.

But although the results look promising, they are preliminary, he cautioned. The combination could follow the path of ritonavir plus lopinavir (Kaletra, AbbVie Pharmaceuticals) or hydroxychloroquine (Plaquenil, Sanofi Pharmaceuticals), which showed promise early but did not perform as hoped in large randomized controlled trials.

“We need to remember that conducting research amidst a pandemic with overwhelmed hospitals is a clear challenge, and we cannot be sure of success,” he added.

Three Trials, 176 Patients

Data collected during a four-site trial of the combination treatment in Tehran during an early spike in cases in Iran were presented at the Virtual COVID-19 Conference 2020 by Hannah Wentzel, a masters student in public health at Imperial College London and a member of Hill’s team.

All 66 study participants were diagnosed with moderate to severe COVID-19 and were treated with standard care, which consisted of hydroxychloroquine 200 mg twice daily with or without the combination of lopinavir plus ritonavir 250 mg twice daily.

The 33 patients randomized to the treatment group also received the combination of sofosbuvir plus daclatasvir 460 mg once daily. These patients were slightly younger and more likely to be men than were those in the standard-care group, but the differences were not significant.

All participants were treated for 14 days, and then the researchers assessed fever, respiration rate, and blood oxygen saturation.

More patients in the treatment group than in the standard-care group had recovered at 14 days (88% vs 67%), but the difference was not significant.

However, median time to clinical recovery, which took into account death as a competing risk, was significantly faster in the treatment group than in the standard-care group (6 vs 11 days; P = .041).

The researchers then pooled their Tehran data with those from two other trials of the sofosbuvir plus daclatasvir combination conducted in Iran: one in the city of Sari with 48 patients and one in the city of Abadan with 62 patients.

A meta-analysis showed that clinical recovery in 14 days was 14% better in the treatment group than in the control group in the Sari study, 32% better in the Tehran study, and 82% better in the Abadan study. However, in a sensitivity analysis, because “the trial in Abadan was not properly randomized,” only the improvements in the Sari and Tehran studies were significant, Wentzel reported.

The meta-analysis also showed that patients in the treatment groups were 70% more likely than those in the standard-care groups to survive.

However, the treatment regimens in the standard-care groups of the three studies were all different, reflecting evolving national treatment guidelines in Iran at the time. And SARS-CoV-2 viral loads were not measured in any of the trials, so the effects of the different drugs on the virus itself could not be assessed.

Still, overall, “sofosbuvir and daclatasvir is associated with faster discharge from hospital and improved survival,” Wentzel said.

These findings are hopeful, “provocative, and encouraging,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and he echoed Hill’s call to “get these kinds of studies into randomized controlled trials.”

But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.

Results from three double-blind randomized controlled trials – one each in Iran, Egypt, and South Africa – with an estimated cumulative enrollment of about 2,000 patients, are expected in October, Hill reported.

“Having gone through feeling so desperate to help people and try new things, it’s really important to do these trials,” said Kristen Marks, MD, from Weill Cornell Medicine in New York City.

“You get tempted to just kind of throw anything at people. And I think we really have to have science to guide us,” she told Medscape Medical News.
 

This article first appeared on Medscape.com.

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Six medical societies from across the globe are emphasizing the importance of individuals obtaining the daily recommended dose of vitamin D, especially given the impact of the COVID-19 pandemic on outdoor time.

The statement, “Joint Guidance on Vitamin D in the Era of COVID-19,” is supported by the American Society for Bone and Mineral Research, the Endocrine Society, and the American Association of Clinical Endocrinologists, among others.

They felt the need to clarify the recommendations for clinicians. Central to the guidance is the recommendation to directly expose the skin to sunlight for 15-30 minutes per day, while taking care to avoid sunburn.

The statement noted that “vitamin D is very safe when taken at reasonable dosages and is important for musculoskeletal health. Levels are likely to decline as individuals reduce outside activity (sun exposure) during the pandemic.”

It added that “most older and younger adults can safely take 400-1000 IU daily to keep vitamin D levels within the optimal range as recommended by [the US] Institute of Medicine guidelines.”

The statement also noted that the scientific evidence clearly supports the benefits that vitamin D (in combination with calcium intake) plays in building a strong skeleton and preventing bone loss.

Other societies supporting the statement are the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

What role for vitamin D in COVID-19?

Over recent months, the role of vitamin D in relation to prevention of COVID-19 has been the subject of intense debate. Now, these societies have joined forces and endorsed evidence-based guidance to clarify the issue around obtaining the daily recommended dosage of vitamin D.

During the pandemic, orders to stay at home meant individuals were likely to spend less time outdoors and have less opportunity to draw their vitamin D directly from sunlight, which is its main source, other than a limited number of foods or as a dietary supplement, the societies explained.

However, they acknowledged that the role of vitamin D in COVID-19 remains unclear.

“The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection; however, our guidance does not preclude further study of the potential effects of vitamin D on COVID-19,” the joint statement said.

Research to date suggests that vitamin D may play a role in enhancing the immune response, and given prior work demonstrating a role for the activated form of vitamin D – 1,25(OH)2D – in immune responses, “further research into vitamin D supplementation in COVID-19 disease is warranted,” it added. “Trials to date have been observational and there have been no randomized, controlled trials from which firm conclusions about causal relationships can be drawn. Observational studies suggest associations between low vitamin D concentrations and higher rates of COVID-19 infection.”

Medscape Medical News previously reported on the existing observational data regarding vitamin D in COVID-19. A recent rapid evidence review by the National Institute for Health and Care Excellence failed to find any evidence that vitamin D supplementation reduces the risk or severity of COVID-19.

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

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Nearly half of hospitalized COVID-19 patients without a prior diabetes diagnosis have hyperglycemia, and the latter is an independent predictor of mortality at 28 days, new research indicates.

The findings, from a retrospective analysis of 605 patients with COVID-19 seen at two hospitals in Wuhan, China, were published online July 10 in Diabetologia by Sufei Wang, of the department of respiratory and critical care medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and colleagues.

Several previous studies have demonstrated a link between hyperglycemia and worse outcomes in COVID-19, and at least one diabetes diagnosis, but this is the first to focus specifically on that group of patients.

Wang and colleagues found that a fasting blood glucose of 7.0 mmol/L (126 mg/dL) or greater on admission – present in 45.6% of those without a prior diabetes diagnosis – was an independent predictor of 28-day mortality.

Although A1c data weren’t analyzed, the population is believed to include both individuals with preexisting but undiagnosed diabetes and those without diabetes who have acute stress hyperglycemia.

“Glycemic testing and control should be recommended for all COVID-19 patients even if they do not have preexisting diabetes, as most COVID-19 patients are prone to glucose metabolic disorders,” they emphasized.

“Addressing elevated fasting blood glucose at an early stage can help clinicians better manage the condition and lower the mortality risk of COVID-19 patients,” Wang and colleagues noted.
 

Hyperglycemia predicts COVID-19 death, complications

The study involved consecutive patients with COVID-19 and definitive 28-day outcome and fasting blood glucose measurement on admission to two Wuhan-area hospitals between Jan. 24 to Feb. 10, 2020. A total of 605 patients did not have a previous diabetes diagnosis. They were a median age of 59 years and 53.2% were men.

Just over half, 54.4%, had a fasting blood glucose below 6.1 mmol/L (110.0 mg/dL). The rest had dysglycemia: 16.5% had a fasting blood glucose of 6.1-6.9 mmol/L (110-125 mg/dL), considered the prediabetes range, and 29.1% had a fasting blood glucose of 7 mmol/L (126 mg/dL) or above, the cutoff for diabetes.

“These results indicate that our study included both undiagnosed diabetic patients and nondiabetic patients with hyperglycemia caused by an acute blood glucose disorder,” the authors noted.

Over 28 days of hospitalization, 18.8% (114) of the patients died and 39.2% developed one or more in-hospital complications. 

The authors used the CRB-65 score, which assigns 1 point for each of four indicators – confusion, respiratory rate >30 breaths/min, systolic blood pressure ≤90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years – to assess pneumonia severity.

Just over half, 55.2%, had a CRB-65 score of 0, 43.1% had a score of 1-2, and 1.7% had a score of 3-4.

In multivariable analysis, significant independent predictors of 28-day mortality were age (hazard ratio, 1.02), male sex (HR, 1.75), CRB-65 score 1-2 (HR, 2.68), CRB-65 score 3-4 (HR, 5.25), and fasting blood glucose ≥7.0 mmol/L (HR, 2.30).

Compared with patients with normal glucose (<6.1 mmol/L), 28-day mortality was twice as high (HR, 2.06) for those with a fasting blood glucose of 6.1-6.9 mmol/L and more than threefold higher for ≥7.0 mmol/L (HR, 3.54).

Pneumonia severity also predicted 28-day mortality, with hazard ratios of 4.35 and 13.80 for patients with CRB-65 scores of 1-2 and 3-4, respectively, compared with 0.

Inhospital complications, including acute respiratory distress syndrome or acute cardiac, kidney, or liver injury or cerebrovascular accident, occurred in 14.2%, 7.9%, and 17.0% of those in the lowest to highest fasting blood glucose groups.

Complications were more than twice as common in patients with a fasting blood glucose of 6.1-6.9 mmol/L (HR, 2.61) and four times more common (HR, 3.99) among those with a fasting blood glucose ≥7.0 mmol/L, compared with those with normoglycemia.

The study was supported by the National Natural Science Foundation of China and Major Projects of the National Science and Technology. The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

bjancin@mdedge.com

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

bjancin@mdedge.com

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

bjancin@mdedge.com

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

What do you do now?

Your waiting room is filled with mask-wearing individuals, except for one person. Your staff offers a mask to this person, citing your office policy of requiring masks for all persons in order to prevent asymptomatic COVID-19 spread, and the patient refuses to put it on.

What can you/should you/must you do? Are you required to see a patient who refuses to wear a mask? If you ask the patient to leave without being seen, can you be accused of patient abandonment? If you allow the patient to stay, could you be liable for negligence for exposing others to a deadly illness?

The rules on mask-wearing, while initially downright confusing, have inexorably come to a rough consensus. By governors’ orders, masks are now mandatory in most states, though when and where they are required varies. For example, effective July 7, the governor of Washington has ordered that a business not allow a customer to enter without a face covering.

So far, there are no cases or court decisions to guide us about whether it is negligence to allow an unmasked patient to commingle in a medical practice. Nor do we have case law to help us determine whether patient abandonment would apply if a patient is sent home without being seen.

We can apply the legal principles and cases from other situations to this one, however, to tell us what constitutes negligence or patient abandonment. The practical questions, legally, are who might sue and on what basis?

Who might sue?

Someone who is injured in a public place may sue the owner for negligence if the owner knew or should have known of a danger and didn’t do anything about it. For example, individuals have sued grocery stores successfully after they slipped on a banana peel and fell. If, say, the banana peel was black, that indicates that it had been there for a while, and judges have found that the store management should have known about it and removed it.

Compare the banana peel scenario with the scenario where most news outlets and health departments are telling people, every day, to wear masks while in indoor public spaces, yet owners of a medical practice or facility allow individuals who are not wearing masks to sit in their waiting room. If an individual who was also in the waiting room with the unmasked individual develops COVID-19 2 days later, the ill individual may sue the medical practice for negligence for not removing the unmasked individual.

What about the individual’s responsibility to move away from the person not wearing a mask? That is the aspect of this scenario that attorneys and experts could argue about, for days, in a court case. But to go back to the banana peel case, one could argue that a customer in a grocery store should be looking out for banana peels on the floor and avoid them, yet courts have assigned liability to grocery stores when customers slip and fall.

Let’s review the four elements of negligence which a plaintiff would need to prove:

• Duty: Obligation of one person to another
• Breach: Improper act or omission, in the context of proper behavior to avoid imposing undue risks of harm to other persons and their property
• Damage
• Causation: That the act or omission caused the harm

Those who run medical offices and facilities have a duty to provide reasonably safe public spaces. Unmasked individuals are a risk to others nearby, so the “breach” element is satisfied if a practice fails to impose safety measures. Causation could be proven, or at least inferred, if contact tracing of an individual with COVID-19 showed that the only contact likely to have exposed the ill individual to the virus was an unmasked individual in a medical practice’s waiting room, especially if the unmasked individual was COVID-19 positive before, during, or shortly after the visit to the practice.

What about patient abandonment?

“Patient abandonment” is the legal term for terminating the physician-patient relationship in such a manner that the patient is denied necessary medical care. It is a form of negligence.

Refusing to see a patient unless the patient wears a mask is not denying care, in this attorney’s view, but rather establishing reasonable conditions for getting care. The patient simply needs to put on a mask.

What about the patient who refuses to wear a mask for medical reasons? There are exceptions in most of the governors’ orders for individuals with medical conditions that preclude covering nose and mouth with a mask. A medical office is the perfect place to test an individual’s ability or inability to breathe well while wearing a mask. “Put the mask on and we’ll see how you do” is a reasonable response. Monitor the patient visually and apply a pulse oximeter with mask off and mask on.

One physician recently wrote about measuring her own oxygen levels while wearing four different masks for 5 minutes each, with no change in breathing.

Editor’s note: Read more about mask exemptions in a Medscape interview with pulmonologist Albert Rizzo, MD, chief medical officer of the American Lung Association.

What are some practical tips?

Assuming that a patient is not in acute distress, options in this scenario include:

• Send the patient home and offer a return visit if masked or when the pandemic is over.
• Offer a telehealth visit, with the patient at home.

What if the unmasked person is not a patient but the companion of a patient? What if the individual refusing to wear a mask is an employee? In neither of these two hypotheticals is there a basis for legal action against a practice whose policy requires that everyone wear masks on the premises.

A companion who arrives without a mask should leave the office. An employee who refuses to mask up could be sent home. If the employee has a disability covered by the Americans with Disabilities Act, then the practice may need to make reasonable accommodations so that the employee works in a room alone if unable to work from home.

Those who manage medical practices should check the websites of the state health department and medical societies at least weekly, to see whether the agencies have issued guidance. For example, the Texas Medical Association has issued limited guidance.

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

The COVID-19 literature has been peppered with reports about myocarditis accompanying the disease. If true, this could, in part, explain some of the observed cardiac injury and arrhythmias in seriously ill patients, but also have implications for prognosis.

But endomyocardial biopsies and autopsies, the gold-standard confirmation tests, have been few and far between. That has led some cardiologists to question the true rate of myocarditis with SARS-CoV-2, or even if there is definitive proof the virus causes myocarditis.

Predictors of death in COVID-19 are older age, cardiovascular comorbidities, and elevated troponin or NT-proBNP – none of which actually fit well with the epidemiology of myocarditis due to other causes, Alida L.P. Caforio, MD, of Padua (Italy) University said in an interview. Myocarditis is traditionally a disease of the young, and most cases are immune-mediated and do not release troponin.

Moreover, myocarditis is a diagnosis of exclusion. For it to be made with any certainty requires proof, by biopsy or autopsy, of inflammatory infiltrates within the myocardium with myocyte necrosis not typical of myocardial infarction, said Dr. Caforio, who chaired the European Society of Cardiology’s writing committee for its 2013 position statement on myocardial and pericardial diseases.

“We have one biopsy-proven case, and in this case there were no viruses in the myocardium, including COVID-19,” she said. “There’s no proof that we have COVID-19 causing myocarditis because it has not been found in the cardiomyocytes.”
 

Emerging evidence

The virus-negative case from Lombardy, Italy, followed an early case series suggesting fulminant myocarditis was involved in 7% of COVID-related deaths in Wuhan, China.

Other case reports include cardiac magnetic resonance (CMR) findings typical of acute myocarditis in a man with no lung involvement or fever but a massive troponin spike, and myocarditis presenting as reverse takotsubo syndrome in a woman undergoing CMR and endomyocardial biopsy.

A CMR analysis in May said acute myocarditis, by 2018 Lake Louise Criteria, was present in eight of 10 patients with “myocarditis-like syndrome,” and a study just out June 30 said the coronavirus can infect heart cells in a lab dish.

Among the few autopsy series, a preprint on 12 patients with COVID-19 in the Seattle area showed coronavirus in the heart tissue of 1 patient.

“It was a low level, so there’s the possibility that it could be viremia, but the fact we do see actual cardiomyocyte injury associated with inflammation, that’s a myocarditis pattern. So it could be related to the SARS-CoV-2 virus,” said Desiree Marshall, MD, director of autopsy and after-death services, University of Washington Medical Center, Seattle.

The “waters are a little bit muddy,” however, because the patient had a coinfection clinically with influenza and methicillin-susceptible Staphylococcus aureus, which raises the specter that influenza could also have contributed, she said.

Data pending publication from two additional patients show no coronavirus in the heart. Acute respiratory distress syndrome pathology was common in all patients, but there was no evidence of vascular inflammation, such as endotheliitis, Dr. Marshall said.

SARS-CoV-2 cell entry depends on the angiotensin-converting enzyme 2 (ACE2) receptor, which is widely expressed in the heart and on endothelial cells and is linked to inflammatory activation. Autopsy data from three COVID-19 patients showed endothelial cell infection in the heart and diffuse endothelial inflammation, but no sign of lymphocytic myocarditis.
 

Defining myocarditis

“There are some experts who believe we’re likely still dealing with myocarditis but with atypical features, while others suggest there is no myocarditis by strict classic criteria,” said Peter Liu, MD, chief scientific officer/vice president of research, University of Ottawa Heart Institute.

“I don’t think either extreme is accurate,” he said. “The truth is likely somewhere in between, with evidence of both cardiac injury and inflammation. But nothing in COVID-19, as we know today, is classic; it’s a new disease, so we need to be more open minded as new data emerge.”

Part of the divide may indeed stem from the way myocarditis is defined. “Based on traditional Dallas criteria, classic myocarditis requires evidence of myocyte necrosis, which we have, but also inflammatory cell infiltrate, which we don’t consistently have,” he said. “But on the other hand, there is evidence of inflammation-induced cardiac damage, often aggregated around blood vessels.”

The situation is evolving in recent days, and new data under review demonstrated inflammatory infiltrates, which fits the traditional myocarditis criteria, Dr. Liu noted. Yet the viral etiology for the inflammation is still elusive in definitive proof.

In traditional myocarditis, there is an abundance of lymphocytes and foci of inflammation in the myocardium, but COVID-19 is very unusual, in that these lymphocytes are not as exuberant, he said. Lymphopenia or low lymphocyte counts occur in up to 80% of patients. Also, older patients, who initially made up the bulk of the severe COVID-19 cases, are less T-lymphocyte responsive.

“So the lower your lymphocyte count, the worse your outcome is going to be and the more likely you’re going to get cytokine storm,” Dr. Liu said. “And that may be the reason the suspected myocarditis in COVID-19 is atypical because the lymphocytes, in fact, are being suppressed and there is instead more vasculitis.”

Recent data from myocardial gene expression analysis showed that the viral receptor ACE2 is present in the myocardium, and can be upregulated in conditions such as heart failure, he said. However, the highest ACE2 expression is found in pericytes around blood vessels, not myocytes. “This may explain the preferential vascular involvement often observed.”
 

Cardiac damage in the young

Evidence started evolving in early April that young COVID-19 patients without lung disease, generally in their 20s and 30s, can have very high troponin peaks and a form of cardiac damage that does not appear to be related to sepsis, systemic shock, or cytokine storm.

“That’s the group that I do think has some myocarditis, but it’s different. It’s not lymphocytic myocarditis, like enteroviral myocarditis,” Leslie T. Cooper Jr., MD, a myocarditis expert at Mayo Clinic, Jacksonville, Florida, said in an interview.

“The data to date suggest that most SARS cardiac injury is related to stress or high circulating cytokine levels. However, myocarditis probably does affect some patients, he added. “The few published cases suggest a role for macrophages or endothelial cells, which could affect cardiac myocyte function. This type of injury could cause the ST-segment elevation MI-like patterns we have seen in young people with normal epicardial coronary arteries.”

Dr. Cooper, who coauthored a report on the management of COVID-19 cardiovascular syndrome, pointed out that it’s been hard for researchers to isolate genome from autopsy samples because of RNA degradation prior to autopsy and the use of formalin fixation for tissues prior to RNA extraction.

“Most labs are not doing next-generation sequencing, and even with that, RNA protection and fresh tissue may be required to detect viral genome,” he said.
 

No proven therapy

Although up to 50% of acute myocarditis cases undergo spontaneous healing, recognition and multidisciplinary management of clinically suspected myocarditis is important. The optimal treatment remains unclear.

An early case report suggested use of methylprednisolone and intravenous immunoglobulin helped spare the life of a 37-year-old with clinically suspected fulminant myocarditis with cardiogenic shock.

In a related commentary, Dr. Caforio and colleagues pointed out that the World Health Organization considers the use of IV corticosteroids controversial, even in pneumonia due to COVID-19, because it may reduce viral clearance and increase sepsis risk. Intravenous immunoglobulin is also questionable because there is no IgG response to COVID-19 in the plasma donors’ pool.

“Immunosuppression should be reserved for only virus-negative non-COVID myocarditis,” Dr. Caforio said in an interview. “There is no appropriate treatment nowadays for clinically suspected COVID-19 myocarditis. There is no proven therapy for COVID-19, even less for COVID-19 myocarditis.”

Although definitive publication of the RECOVERY trial is still pending, the benefits of dexamethasone – a steroid that works predominantly through its anti-inflammatory effects – appear to be in the sickest patients, such as those requiring ICU admission or respiratory support.

“Many of the same patients would have systemic inflammation and would have also shown elevated cardiac biomarkers,” Dr. Liu observed. “Therefore, it is conceivable that a subset who had cardiac inflammation also benefited from the treatment. Further data, possibly through subgroup analysis and eventually meta-analysis, may help us to understand if dexamethasone also benefited patients with dominant cardiac injury.”

Dr. Caforio, Dr. Marshall, Dr. Liu, and Dr. Cooper reported having no relevant conflicts of interest.

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

The COVID-19 literature has been peppered with reports about myocarditis accompanying the disease. If true, this could, in part, explain some of the observed cardiac injury and arrhythmias in seriously ill patients, but also have implications for prognosis.

But endomyocardial biopsies and autopsies, the gold-standard confirmation tests, have been few and far between. That has led some cardiologists to question the true rate of myocarditis with SARS-CoV-2, or even if there is definitive proof the virus causes myocarditis.

Predictors of death in COVID-19 are older age, cardiovascular comorbidities, and elevated troponin or NT-proBNP – none of which actually fit well with the epidemiology of myocarditis due to other causes, Alida L.P. Caforio, MD, of Padua (Italy) University said in an interview. Myocarditis is traditionally a disease of the young, and most cases are immune-mediated and do not release troponin.

Moreover, myocarditis is a diagnosis of exclusion. For it to be made with any certainty requires proof, by biopsy or autopsy, of inflammatory infiltrates within the myocardium with myocyte necrosis not typical of myocardial infarction, said Dr. Caforio, who chaired the European Society of Cardiology’s writing committee for its 2013 position statement on myocardial and pericardial diseases.

“We have one biopsy-proven case, and in this case there were no viruses in the myocardium, including COVID-19,” she said. “There’s no proof that we have COVID-19 causing myocarditis because it has not been found in the cardiomyocytes.”
 

Emerging evidence

The virus-negative case from Lombardy, Italy, followed an early case series suggesting fulminant myocarditis was involved in 7% of COVID-related deaths in Wuhan, China.

Other case reports include cardiac magnetic resonance (CMR) findings typical of acute myocarditis in a man with no lung involvement or fever but a massive troponin spike, and myocarditis presenting as reverse takotsubo syndrome in a woman undergoing CMR and endomyocardial biopsy.

A CMR analysis in May said acute myocarditis, by 2018 Lake Louise Criteria, was present in eight of 10 patients with “myocarditis-like syndrome,” and a study just out June 30 said the coronavirus can infect heart cells in a lab dish.

Among the few autopsy series, a preprint on 12 patients with COVID-19 in the Seattle area showed coronavirus in the heart tissue of 1 patient.

“It was a low level, so there’s the possibility that it could be viremia, but the fact we do see actual cardiomyocyte injury associated with inflammation, that’s a myocarditis pattern. So it could be related to the SARS-CoV-2 virus,” said Desiree Marshall, MD, director of autopsy and after-death services, University of Washington Medical Center, Seattle.

The “waters are a little bit muddy,” however, because the patient had a coinfection clinically with influenza and methicillin-susceptible Staphylococcus aureus, which raises the specter that influenza could also have contributed, she said.

Data pending publication from two additional patients show no coronavirus in the heart. Acute respiratory distress syndrome pathology was common in all patients, but there was no evidence of vascular inflammation, such as endotheliitis, Dr. Marshall said.

SARS-CoV-2 cell entry depends on the angiotensin-converting enzyme 2 (ACE2) receptor, which is widely expressed in the heart and on endothelial cells and is linked to inflammatory activation. Autopsy data from three COVID-19 patients showed endothelial cell infection in the heart and diffuse endothelial inflammation, but no sign of lymphocytic myocarditis.
 

Defining myocarditis

“There are some experts who believe we’re likely still dealing with myocarditis but with atypical features, while others suggest there is no myocarditis by strict classic criteria,” said Peter Liu, MD, chief scientific officer/vice president of research, University of Ottawa Heart Institute.

“I don’t think either extreme is accurate,” he said. “The truth is likely somewhere in between, with evidence of both cardiac injury and inflammation. But nothing in COVID-19, as we know today, is classic; it’s a new disease, so we need to be more open minded as new data emerge.”

Part of the divide may indeed stem from the way myocarditis is defined. “Based on traditional Dallas criteria, classic myocarditis requires evidence of myocyte necrosis, which we have, but also inflammatory cell infiltrate, which we don’t consistently have,” he said. “But on the other hand, there is evidence of inflammation-induced cardiac damage, often aggregated around blood vessels.”

The situation is evolving in recent days, and new data under review demonstrated inflammatory infiltrates, which fits the traditional myocarditis criteria, Dr. Liu noted. Yet the viral etiology for the inflammation is still elusive in definitive proof.

In traditional myocarditis, there is an abundance of lymphocytes and foci of inflammation in the myocardium, but COVID-19 is very unusual, in that these lymphocytes are not as exuberant, he said. Lymphopenia or low lymphocyte counts occur in up to 80% of patients. Also, older patients, who initially made up the bulk of the severe COVID-19 cases, are less T-lymphocyte responsive.

“So the lower your lymphocyte count, the worse your outcome is going to be and the more likely you’re going to get cytokine storm,” Dr. Liu said. “And that may be the reason the suspected myocarditis in COVID-19 is atypical because the lymphocytes, in fact, are being suppressed and there is instead more vasculitis.”

Recent data from myocardial gene expression analysis showed that the viral receptor ACE2 is present in the myocardium, and can be upregulated in conditions such as heart failure, he said. However, the highest ACE2 expression is found in pericytes around blood vessels, not myocytes. “This may explain the preferential vascular involvement often observed.”
 

Cardiac damage in the young

Evidence started evolving in early April that young COVID-19 patients without lung disease, generally in their 20s and 30s, can have very high troponin peaks and a form of cardiac damage that does not appear to be related to sepsis, systemic shock, or cytokine storm.

“That’s the group that I do think has some myocarditis, but it’s different. It’s not lymphocytic myocarditis, like enteroviral myocarditis,” Leslie T. Cooper Jr., MD, a myocarditis expert at Mayo Clinic, Jacksonville, Florida, said in an interview.

“The data to date suggest that most SARS cardiac injury is related to stress or high circulating cytokine levels. However, myocarditis probably does affect some patients, he added. “The few published cases suggest a role for macrophages or endothelial cells, which could affect cardiac myocyte function. This type of injury could cause the ST-segment elevation MI-like patterns we have seen in young people with normal epicardial coronary arteries.”

Dr. Cooper, who coauthored a report on the management of COVID-19 cardiovascular syndrome, pointed out that it’s been hard for researchers to isolate genome from autopsy samples because of RNA degradation prior to autopsy and the use of formalin fixation for tissues prior to RNA extraction.

“Most labs are not doing next-generation sequencing, and even with that, RNA protection and fresh tissue may be required to detect viral genome,” he said.
 

No proven therapy

Although up to 50% of acute myocarditis cases undergo spontaneous healing, recognition and multidisciplinary management of clinically suspected myocarditis is important. The optimal treatment remains unclear.

An early case report suggested use of methylprednisolone and intravenous immunoglobulin helped spare the life of a 37-year-old with clinically suspected fulminant myocarditis with cardiogenic shock.

In a related commentary, Dr. Caforio and colleagues pointed out that the World Health Organization considers the use of IV corticosteroids controversial, even in pneumonia due to COVID-19, because it may reduce viral clearance and increase sepsis risk. Intravenous immunoglobulin is also questionable because there is no IgG response to COVID-19 in the plasma donors’ pool.

“Immunosuppression should be reserved for only virus-negative non-COVID myocarditis,” Dr. Caforio said in an interview. “There is no appropriate treatment nowadays for clinically suspected COVID-19 myocarditis. There is no proven therapy for COVID-19, even less for COVID-19 myocarditis.”

Although definitive publication of the RECOVERY trial is still pending, the benefits of dexamethasone – a steroid that works predominantly through its anti-inflammatory effects – appear to be in the sickest patients, such as those requiring ICU admission or respiratory support.

“Many of the same patients would have systemic inflammation and would have also shown elevated cardiac biomarkers,” Dr. Liu observed. “Therefore, it is conceivable that a subset who had cardiac inflammation also benefited from the treatment. Further data, possibly through subgroup analysis and eventually meta-analysis, may help us to understand if dexamethasone also benefited patients with dominant cardiac injury.”

Dr. Caforio, Dr. Marshall, Dr. Liu, and Dr. Cooper reported having no relevant conflicts of interest.

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

The COVID-19 literature has been peppered with reports about myocarditis accompanying the disease. If true, this could, in part, explain some of the observed cardiac injury and arrhythmias in seriously ill patients, but also have implications for prognosis.

But endomyocardial biopsies and autopsies, the gold-standard confirmation tests, have been few and far between. That has led some cardiologists to question the true rate of myocarditis with SARS-CoV-2, or even if there is definitive proof the virus causes myocarditis.

Predictors of death in COVID-19 are older age, cardiovascular comorbidities, and elevated troponin or NT-proBNP – none of which actually fit well with the epidemiology of myocarditis due to other causes, Alida L.P. Caforio, MD, of Padua (Italy) University said in an interview. Myocarditis is traditionally a disease of the young, and most cases are immune-mediated and do not release troponin.

Moreover, myocarditis is a diagnosis of exclusion. For it to be made with any certainty requires proof, by biopsy or autopsy, of inflammatory infiltrates within the myocardium with myocyte necrosis not typical of myocardial infarction, said Dr. Caforio, who chaired the European Society of Cardiology’s writing committee for its 2013 position statement on myocardial and pericardial diseases.

“We have one biopsy-proven case, and in this case there were no viruses in the myocardium, including COVID-19,” she said. “There’s no proof that we have COVID-19 causing myocarditis because it has not been found in the cardiomyocytes.”
 

Emerging evidence

The virus-negative case from Lombardy, Italy, followed an early case series suggesting fulminant myocarditis was involved in 7% of COVID-related deaths in Wuhan, China.

Other case reports include cardiac magnetic resonance (CMR) findings typical of acute myocarditis in a man with no lung involvement or fever but a massive troponin spike, and myocarditis presenting as reverse takotsubo syndrome in a woman undergoing CMR and endomyocardial biopsy.

A CMR analysis in May said acute myocarditis, by 2018 Lake Louise Criteria, was present in eight of 10 patients with “myocarditis-like syndrome,” and a study just out June 30 said the coronavirus can infect heart cells in a lab dish.

Among the few autopsy series, a preprint on 12 patients with COVID-19 in the Seattle area showed coronavirus in the heart tissue of 1 patient.

“It was a low level, so there’s the possibility that it could be viremia, but the fact we do see actual cardiomyocyte injury associated with inflammation, that’s a myocarditis pattern. So it could be related to the SARS-CoV-2 virus,” said Desiree Marshall, MD, director of autopsy and after-death services, University of Washington Medical Center, Seattle.

The “waters are a little bit muddy,” however, because the patient had a coinfection clinically with influenza and methicillin-susceptible Staphylococcus aureus, which raises the specter that influenza could also have contributed, she said.

Data pending publication from two additional patients show no coronavirus in the heart. Acute respiratory distress syndrome pathology was common in all patients, but there was no evidence of vascular inflammation, such as endotheliitis, Dr. Marshall said.

SARS-CoV-2 cell entry depends on the angiotensin-converting enzyme 2 (ACE2) receptor, which is widely expressed in the heart and on endothelial cells and is linked to inflammatory activation. Autopsy data from three COVID-19 patients showed endothelial cell infection in the heart and diffuse endothelial inflammation, but no sign of lymphocytic myocarditis.
 

Defining myocarditis

“There are some experts who believe we’re likely still dealing with myocarditis but with atypical features, while others suggest there is no myocarditis by strict classic criteria,” said Peter Liu, MD, chief scientific officer/vice president of research, University of Ottawa Heart Institute.

“I don’t think either extreme is accurate,” he said. “The truth is likely somewhere in between, with evidence of both cardiac injury and inflammation. But nothing in COVID-19, as we know today, is classic; it’s a new disease, so we need to be more open minded as new data emerge.”

Part of the divide may indeed stem from the way myocarditis is defined. “Based on traditional Dallas criteria, classic myocarditis requires evidence of myocyte necrosis, which we have, but also inflammatory cell infiltrate, which we don’t consistently have,” he said. “But on the other hand, there is evidence of inflammation-induced cardiac damage, often aggregated around blood vessels.”

The situation is evolving in recent days, and new data under review demonstrated inflammatory infiltrates, which fits the traditional myocarditis criteria, Dr. Liu noted. Yet the viral etiology for the inflammation is still elusive in definitive proof.

In traditional myocarditis, there is an abundance of lymphocytes and foci of inflammation in the myocardium, but COVID-19 is very unusual, in that these lymphocytes are not as exuberant, he said. Lymphopenia or low lymphocyte counts occur in up to 80% of patients. Also, older patients, who initially made up the bulk of the severe COVID-19 cases, are less T-lymphocyte responsive.

“So the lower your lymphocyte count, the worse your outcome is going to be and the more likely you’re going to get cytokine storm,” Dr. Liu said. “And that may be the reason the suspected myocarditis in COVID-19 is atypical because the lymphocytes, in fact, are being suppressed and there is instead more vasculitis.”

Recent data from myocardial gene expression analysis showed that the viral receptor ACE2 is present in the myocardium, and can be upregulated in conditions such as heart failure, he said. However, the highest ACE2 expression is found in pericytes around blood vessels, not myocytes. “This may explain the preferential vascular involvement often observed.”
 

Cardiac damage in the young

Evidence started evolving in early April that young COVID-19 patients without lung disease, generally in their 20s and 30s, can have very high troponin peaks and a form of cardiac damage that does not appear to be related to sepsis, systemic shock, or cytokine storm.

“That’s the group that I do think has some myocarditis, but it’s different. It’s not lymphocytic myocarditis, like enteroviral myocarditis,” Leslie T. Cooper Jr., MD, a myocarditis expert at Mayo Clinic, Jacksonville, Florida, said in an interview.

“The data to date suggest that most SARS cardiac injury is related to stress or high circulating cytokine levels. However, myocarditis probably does affect some patients, he added. “The few published cases suggest a role for macrophages or endothelial cells, which could affect cardiac myocyte function. This type of injury could cause the ST-segment elevation MI-like patterns we have seen in young people with normal epicardial coronary arteries.”

Dr. Cooper, who coauthored a report on the management of COVID-19 cardiovascular syndrome, pointed out that it’s been hard for researchers to isolate genome from autopsy samples because of RNA degradation prior to autopsy and the use of formalin fixation for tissues prior to RNA extraction.

“Most labs are not doing next-generation sequencing, and even with that, RNA protection and fresh tissue may be required to detect viral genome,” he said.
 

No proven therapy

Although up to 50% of acute myocarditis cases undergo spontaneous healing, recognition and multidisciplinary management of clinically suspected myocarditis is important. The optimal treatment remains unclear.

An early case report suggested use of methylprednisolone and intravenous immunoglobulin helped spare the life of a 37-year-old with clinically suspected fulminant myocarditis with cardiogenic shock.

In a related commentary, Dr. Caforio and colleagues pointed out that the World Health Organization considers the use of IV corticosteroids controversial, even in pneumonia due to COVID-19, because it may reduce viral clearance and increase sepsis risk. Intravenous immunoglobulin is also questionable because there is no IgG response to COVID-19 in the plasma donors’ pool.

“Immunosuppression should be reserved for only virus-negative non-COVID myocarditis,” Dr. Caforio said in an interview. “There is no appropriate treatment nowadays for clinically suspected COVID-19 myocarditis. There is no proven therapy for COVID-19, even less for COVID-19 myocarditis.”

Although definitive publication of the RECOVERY trial is still pending, the benefits of dexamethasone – a steroid that works predominantly through its anti-inflammatory effects – appear to be in the sickest patients, such as those requiring ICU admission or respiratory support.

“Many of the same patients would have systemic inflammation and would have also shown elevated cardiac biomarkers,” Dr. Liu observed. “Therefore, it is conceivable that a subset who had cardiac inflammation also benefited from the treatment. Further data, possibly through subgroup analysis and eventually meta-analysis, may help us to understand if dexamethasone also benefited patients with dominant cardiac injury.”

Dr. Caforio, Dr. Marshall, Dr. Liu, and Dr. Cooper reported having no relevant conflicts of interest.

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

As more jurisdictions mandate facial coverings in public, questions have arisen about whether it’s safe for everyone – including those with lung disease – to wear masks. Stories about people who claim to be unable to wear masks because of breathing problems are appearing in the news with increasing frequency, and patients are starting to call their doctors to request medical exemptions to public mask requirements.

David Fuentes Prieto/Shutterstock

To address these issues, Medscape spoke with the chief medical officer of the American Lung Association, Dr. Albert Rizzo.
 

The CDC recommendations on mask wearing say, “Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated, or otherwise unable to remove the mask without assistance.” Does this language suggest that there indeed is a subset of the adult population with lung disease who shouldn’t wear masks?

It makes sense to say that if it makes you uncomfortable to wear a mask because it affects your breathing, you should think twice about getting in a situation where you would have to wear a mask.

I’ve told many of my high-risk patients, “The best way to avoid getting COVID-19 is to stay home and stay away from sick people, especially if you feel that you are not going to be able to wear a mask or facial covering of some sort.”

The reason that some people have trouble with a mask is that they haven’t tried the right style of mask – by that I mean how tightly it fits and the material it’s made out of. Sometimes it really is just that people with lung disease don’t like to have anything covering their faces. Many of these patients feel better where there is air blowing across their faces – they will have a fan blowing even in the middle of winter because they feel more comfortable.

I won’t say it’s all in their heads, but sometimes it’s a matter of desensitizing themselves to wearing a mask. I liken it to people who have sleep apnea. We often have to desensitize them to wearing a mask for sleeping. We tell them to put it on while they are watching TV — don’t hook it up to anything yet, just get used to having something on your face.

I’ve told my patients the same thing about masks for COVID-19. Put on the mask, see how it feels. If you become uncomfortable breathing with it on, take it off, but maybe you can handle it for a half hour or 45 minutes. Find out how much time you have for a trip to the grocery store based on how comfortable you are wearing it at home.

It’s a matter of training the patient, giving them options of how to get comfortable with it, and then making them realize that they have to weigh the benefits and risks of wearing the mask and feeling out of breath versus going out in public and being potentially exposed to coronavirus. And the bottom line is, anybody who is wearing a mask and starts to feel uncomfortable, they can take the mask off.
 

You mentioned different types of masks. Is there a type of mask that is typically more breathable that clinicians can recommend to patients with lung disease?

First, I remind patients who think they will have trouble breathing with a mask on that they are choosing a mask not so much to protect themselves – that would take an N95 mask to filter out the virus. The mask is worn so that when they cough or drink or speak, they aren’t sending respiratory droplets out into the environment. Even when we speak, respiratory droplets can easily go out as far as 6 feet, or further with coughing or sneezing. With facial coverings, we try to keep those respiratory droplets from getting out and infecting others.

So when choosing a mask, you don’t have to worry as much about a tight-fitting mask. I recommend a loose-fitting mask that covers the nose and mouth and isn’t going to fall off but isn’t so tight around the ears and neck to make them feel uncomfortable. Even though it doesn’t really protect the wearer, it is cutting down on the ability to breathe in droplets – maybe not microscopic particles, but it’s better than nothing.
 

Is a face shield a reasonable alternative for someone who feels they can’t breathe with a mask on?

Yes. I’m surprised that face shields don’t get more attention. I’ve tried them out, and they are actually more comfortable than masks. They do impede the spilling out of droplets into the public, but they are not as close fitting to the face as a mask. If you want to protect others, the face shield should be adequate. It is not as good at preventing you from breathing in viral particles.

Some people have claimed that wearing a mask makes them hyperventilate and feel like they are going to pass out, or the mask causes them to become hypoxic. Are these valid concerns?

We get two questions about masks from patients who feel that they are short of breath or are worried about wearing a mask. One is whether their oxygen level is dropping. It’s usually not that. It’s usually because they feel that the mask is an impediment to getting air in. Their oxygen levels are stable.

The other question is whether the mask causes CO₂ retention. For the mask to trap enough exhaled CO₂ and for us to breathe enough of that CO₂ back in to raise our CO₂ level, it has to be a pretty tight-fitting mask. With the type of masks we are suggesting that people wear, that’s very unlikely to occur.
 

What can clinicians do to reassure patients with some type of lung disease that they can safely wear masks?

There are a few things they can do right in the office. Have them put the mask on for a few minutes and make sure they feel comfortable with it. With an oximeter, patients can see that their oxygen levels don’t change when they are breathing through the mask for a period of time.

You can’t really measure CO₂ retention that easily, but most patients with chronic obstructive pulmonary disease or pulmonary fibrosis don’t have an elevated CO₂ at baseline. A little more education is helpful in those situations. In most cases, they aren’t going to retain enough CO₂ to have problems wearing a mask.

Only a small percentage of patients with lung disease are CO₂ retainers, and many of those patients are being seen by pulmonary specialists. Those are the patients you might want to be more cautious with, to make sure they aren’t wearing anything that is tight fitting or that makes them work harder to breathe. It’s not that the mask is causing CO₂ retention, but the increased work of breathing may make it harder to exhale the CO₂.
 

Does a mask interfere with supplemental oxygen in any way?

Supplemental oxygen is typically supplied through a nasal cannula, so 100% oxygen is still getting to the nasal passages and entrained down into the airway, so it shouldn’t be a problem.

Some of the resistance to wearing masks has come from people with asthma. Is it safe for patients with asthma to wear masks, or should these patients be exempt from wearing masks?

In general, the breathing of people with mild asthma, both young and old, should not be impeded by the wearing of facial coverings. The concerns about oxygen and carbon dioxide among patients with more severe lung disease should not play a role in asthma.

Since younger adults with COVID-19 seem to have fewer or no symptoms and may actually be carrying the virus unknowingly, this should be the main population who should wear masks to prevent transmission to others.

Exemptions for mask wearing for mild asthma should be discouraged and dealt with on a case-by-case basis if there is a particular concern for that individual.
 

How do you respond if a patient asks you for a formal medical exemption to wearing a mask?

We’ve been asked to do a lot of letter writing for patients around going back to work, as well as the issue of wearing masks. The discussion usually revolves around trying to avoid going somewhere where you would have to wear a mask if it makes you feel uncomfortable.

I do not recommend automatically exempting individuals from wearing masks, even many of my pulmonary patients. There needs to be an understanding by the patient regarding the purpose of the mask and the overall advice to stay out of situations where social distancing is not being practiced. If you can take the time to discuss options as mentioned above – mask styles, desensitization, etc – the patient usually understands and will try wearing a mask.

On a case-by-case basis, some individuals may need to be exempted, but I feel this is a small number. I prefer my high-risk (older, chronic disease, etc) patients do everything they can to avoid infection – handwashing, mask wearing, and socially distancing.

They should also realize that even with a note, it is not going to help if they are in the middle of the grocery store and someone confronts them about not wearing a mask. It may help as they enter a store that says “masks required” and they can show it to someone monitoring the door. But I’m not really sure in what situations having that note is going to be helpful if confrontations occur.

Patients are also asking how safe is it for them to go back to work and be out in public. I tell them, nothing is going to be 100% safe. Until we have an effective vaccine, we are all going to have to weigh the potential risks of going to an area where social distancing isn’t maintained, people aren’t wearing face masks, and you can’t wash your hands as much as you’d like to. That’s going to be a struggle for all of us to get back out into situations where people interact socially.

Albert A. Rizzo, MD, is chief medical officer for the American Lung Association, chief of the Section of Pulmonary and Critical Care Medicine at the Christiana Care Health System in Newark, Delaware, and a member of Christiana Care Pulmonary Associates. He is board certified in internal medicine, pulmonary medicine, critical care medicine, and sleep medicine and is a clinical assistant professor of medicine at Thomas Jefferson University Medical School, Philadelphia.

This article first appeared on Medscape.com.

As more jurisdictions mandate facial coverings in public, questions have arisen about whether it’s safe for everyone – including those with lung disease – to wear masks. Stories about people who claim to be unable to wear masks because of breathing problems are appearing in the news with increasing frequency, and patients are starting to call their doctors to request medical exemptions to public mask requirements.

David Fuentes Prieto/Shutterstock

To address these issues, Medscape spoke with the chief medical officer of the American Lung Association, Dr. Albert Rizzo.
 

The CDC recommendations on mask wearing say, “Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated, or otherwise unable to remove the mask without assistance.” Does this language suggest that there indeed is a subset of the adult population with lung disease who shouldn’t wear masks?

It makes sense to say that if it makes you uncomfortable to wear a mask because it affects your breathing, you should think twice about getting in a situation where you would have to wear a mask.

I’ve told many of my high-risk patients, “The best way to avoid getting COVID-19 is to stay home and stay away from sick people, especially if you feel that you are not going to be able to wear a mask or facial covering of some sort.”

The reason that some people have trouble with a mask is that they haven’t tried the right style of mask – by that I mean how tightly it fits and the material it’s made out of. Sometimes it really is just that people with lung disease don’t like to have anything covering their faces. Many of these patients feel better where there is air blowing across their faces – they will have a fan blowing even in the middle of winter because they feel more comfortable.

I won’t say it’s all in their heads, but sometimes it’s a matter of desensitizing themselves to wearing a mask. I liken it to people who have sleep apnea. We often have to desensitize them to wearing a mask for sleeping. We tell them to put it on while they are watching TV — don’t hook it up to anything yet, just get used to having something on your face.

I’ve told my patients the same thing about masks for COVID-19. Put on the mask, see how it feels. If you become uncomfortable breathing with it on, take it off, but maybe you can handle it for a half hour or 45 minutes. Find out how much time you have for a trip to the grocery store based on how comfortable you are wearing it at home.

It’s a matter of training the patient, giving them options of how to get comfortable with it, and then making them realize that they have to weigh the benefits and risks of wearing the mask and feeling out of breath versus going out in public and being potentially exposed to coronavirus. And the bottom line is, anybody who is wearing a mask and starts to feel uncomfortable, they can take the mask off.
 

You mentioned different types of masks. Is there a type of mask that is typically more breathable that clinicians can recommend to patients with lung disease?

First, I remind patients who think they will have trouble breathing with a mask on that they are choosing a mask not so much to protect themselves – that would take an N95 mask to filter out the virus. The mask is worn so that when they cough or drink or speak, they aren’t sending respiratory droplets out into the environment. Even when we speak, respiratory droplets can easily go out as far as 6 feet, or further with coughing or sneezing. With facial coverings, we try to keep those respiratory droplets from getting out and infecting others.

So when choosing a mask, you don’t have to worry as much about a tight-fitting mask. I recommend a loose-fitting mask that covers the nose and mouth and isn’t going to fall off but isn’t so tight around the ears and neck to make them feel uncomfortable. Even though it doesn’t really protect the wearer, it is cutting down on the ability to breathe in droplets – maybe not microscopic particles, but it’s better than nothing.
 

Is a face shield a reasonable alternative for someone who feels they can’t breathe with a mask on?

Yes. I’m surprised that face shields don’t get more attention. I’ve tried them out, and they are actually more comfortable than masks. They do impede the spilling out of droplets into the public, but they are not as close fitting to the face as a mask. If you want to protect others, the face shield should be adequate. It is not as good at preventing you from breathing in viral particles.

Some people have claimed that wearing a mask makes them hyperventilate and feel like they are going to pass out, or the mask causes them to become hypoxic. Are these valid concerns?

We get two questions about masks from patients who feel that they are short of breath or are worried about wearing a mask. One is whether their oxygen level is dropping. It’s usually not that. It’s usually because they feel that the mask is an impediment to getting air in. Their oxygen levels are stable.

The other question is whether the mask causes CO₂ retention. For the mask to trap enough exhaled CO₂ and for us to breathe enough of that CO₂ back in to raise our CO₂ level, it has to be a pretty tight-fitting mask. With the type of masks we are suggesting that people wear, that’s very unlikely to occur.
 

What can clinicians do to reassure patients with some type of lung disease that they can safely wear masks?

There are a few things they can do right in the office. Have them put the mask on for a few minutes and make sure they feel comfortable with it. With an oximeter, patients can see that their oxygen levels don’t change when they are breathing through the mask for a period of time.

You can’t really measure CO₂ retention that easily, but most patients with chronic obstructive pulmonary disease or pulmonary fibrosis don’t have an elevated CO₂ at baseline. A little more education is helpful in those situations. In most cases, they aren’t going to retain enough CO₂ to have problems wearing a mask.

Only a small percentage of patients with lung disease are CO₂ retainers, and many of those patients are being seen by pulmonary specialists. Those are the patients you might want to be more cautious with, to make sure they aren’t wearing anything that is tight fitting or that makes them work harder to breathe. It’s not that the mask is causing CO₂ retention, but the increased work of breathing may make it harder to exhale the CO₂.
 

Does a mask interfere with supplemental oxygen in any way?

Supplemental oxygen is typically supplied through a nasal cannula, so 100% oxygen is still getting to the nasal passages and entrained down into the airway, so it shouldn’t be a problem.

Some of the resistance to wearing masks has come from people with asthma. Is it safe for patients with asthma to wear masks, or should these patients be exempt from wearing masks?

In general, the breathing of people with mild asthma, both young and old, should not be impeded by the wearing of facial coverings. The concerns about oxygen and carbon dioxide among patients with more severe lung disease should not play a role in asthma.

Since younger adults with COVID-19 seem to have fewer or no symptoms and may actually be carrying the virus unknowingly, this should be the main population who should wear masks to prevent transmission to others.

Exemptions for mask wearing for mild asthma should be discouraged and dealt with on a case-by-case basis if there is a particular concern for that individual.
 

How do you respond if a patient asks you for a formal medical exemption to wearing a mask?

We’ve been asked to do a lot of letter writing for patients around going back to work, as well as the issue of wearing masks. The discussion usually revolves around trying to avoid going somewhere where you would have to wear a mask if it makes you feel uncomfortable.

I do not recommend automatically exempting individuals from wearing masks, even many of my pulmonary patients. There needs to be an understanding by the patient regarding the purpose of the mask and the overall advice to stay out of situations where social distancing is not being practiced. If you can take the time to discuss options as mentioned above – mask styles, desensitization, etc – the patient usually understands and will try wearing a mask.

On a case-by-case basis, some individuals may need to be exempted, but I feel this is a small number. I prefer my high-risk (older, chronic disease, etc) patients do everything they can to avoid infection – handwashing, mask wearing, and socially distancing.

They should also realize that even with a note, it is not going to help if they are in the middle of the grocery store and someone confronts them about not wearing a mask. It may help as they enter a store that says “masks required” and they can show it to someone monitoring the door. But I’m not really sure in what situations having that note is going to be helpful if confrontations occur.

Patients are also asking how safe is it for them to go back to work and be out in public. I tell them, nothing is going to be 100% safe. Until we have an effective vaccine, we are all going to have to weigh the potential risks of going to an area where social distancing isn’t maintained, people aren’t wearing face masks, and you can’t wash your hands as much as you’d like to. That’s going to be a struggle for all of us to get back out into situations where people interact socially.

Albert A. Rizzo, MD, is chief medical officer for the American Lung Association, chief of the Section of Pulmonary and Critical Care Medicine at the Christiana Care Health System in Newark, Delaware, and a member of Christiana Care Pulmonary Associates. He is board certified in internal medicine, pulmonary medicine, critical care medicine, and sleep medicine and is a clinical assistant professor of medicine at Thomas Jefferson University Medical School, Philadelphia.

This article first appeared on Medscape.com.

As more jurisdictions mandate facial coverings in public, questions have arisen about whether it’s safe for everyone – including those with lung disease – to wear masks. Stories about people who claim to be unable to wear masks because of breathing problems are appearing in the news with increasing frequency, and patients are starting to call their doctors to request medical exemptions to public mask requirements.

David Fuentes Prieto/Shutterstock

To address these issues, Medscape spoke with the chief medical officer of the American Lung Association, Dr. Albert Rizzo.
 

The CDC recommendations on mask wearing say, “Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, incapacitated, or otherwise unable to remove the mask without assistance.” Does this language suggest that there indeed is a subset of the adult population with lung disease who shouldn’t wear masks?

It makes sense to say that if it makes you uncomfortable to wear a mask because it affects your breathing, you should think twice about getting in a situation where you would have to wear a mask.

I’ve told many of my high-risk patients, “The best way to avoid getting COVID-19 is to stay home and stay away from sick people, especially if you feel that you are not going to be able to wear a mask or facial covering of some sort.”

The reason that some people have trouble with a mask is that they haven’t tried the right style of mask – by that I mean how tightly it fits and the material it’s made out of. Sometimes it really is just that people with lung disease don’t like to have anything covering their faces. Many of these patients feel better where there is air blowing across their faces – they will have a fan blowing even in the middle of winter because they feel more comfortable.

I won’t say it’s all in their heads, but sometimes it’s a matter of desensitizing themselves to wearing a mask. I liken it to people who have sleep apnea. We often have to desensitize them to wearing a mask for sleeping. We tell them to put it on while they are watching TV — don’t hook it up to anything yet, just get used to having something on your face.

I’ve told my patients the same thing about masks for COVID-19. Put on the mask, see how it feels. If you become uncomfortable breathing with it on, take it off, but maybe you can handle it for a half hour or 45 minutes. Find out how much time you have for a trip to the grocery store based on how comfortable you are wearing it at home.

It’s a matter of training the patient, giving them options of how to get comfortable with it, and then making them realize that they have to weigh the benefits and risks of wearing the mask and feeling out of breath versus going out in public and being potentially exposed to coronavirus. And the bottom line is, anybody who is wearing a mask and starts to feel uncomfortable, they can take the mask off.
 

You mentioned different types of masks. Is there a type of mask that is typically more breathable that clinicians can recommend to patients with lung disease?

First, I remind patients who think they will have trouble breathing with a mask on that they are choosing a mask not so much to protect themselves – that would take an N95 mask to filter out the virus. The mask is worn so that when they cough or drink or speak, they aren’t sending respiratory droplets out into the environment. Even when we speak, respiratory droplets can easily go out as far as 6 feet, or further with coughing or sneezing. With facial coverings, we try to keep those respiratory droplets from getting out and infecting others.

So when choosing a mask, you don’t have to worry as much about a tight-fitting mask. I recommend a loose-fitting mask that covers the nose and mouth and isn’t going to fall off but isn’t so tight around the ears and neck to make them feel uncomfortable. Even though it doesn’t really protect the wearer, it is cutting down on the ability to breathe in droplets – maybe not microscopic particles, but it’s better than nothing.
 

Is a face shield a reasonable alternative for someone who feels they can’t breathe with a mask on?

Yes. I’m surprised that face shields don’t get more attention. I’ve tried them out, and they are actually more comfortable than masks. They do impede the spilling out of droplets into the public, but they are not as close fitting to the face as a mask. If you want to protect others, the face shield should be adequate. It is not as good at preventing you from breathing in viral particles.

Some people have claimed that wearing a mask makes them hyperventilate and feel like they are going to pass out, or the mask causes them to become hypoxic. Are these valid concerns?

We get two questions about masks from patients who feel that they are short of breath or are worried about wearing a mask. One is whether their oxygen level is dropping. It’s usually not that. It’s usually because they feel that the mask is an impediment to getting air in. Their oxygen levels are stable.

The other question is whether the mask causes CO₂ retention. For the mask to trap enough exhaled CO₂ and for us to breathe enough of that CO₂ back in to raise our CO₂ level, it has to be a pretty tight-fitting mask. With the type of masks we are suggesting that people wear, that’s very unlikely to occur.
 

What can clinicians do to reassure patients with some type of lung disease that they can safely wear masks?

There are a few things they can do right in the office. Have them put the mask on for a few minutes and make sure they feel comfortable with it. With an oximeter, patients can see that their oxygen levels don’t change when they are breathing through the mask for a period of time.

You can’t really measure CO₂ retention that easily, but most patients with chronic obstructive pulmonary disease or pulmonary fibrosis don’t have an elevated CO₂ at baseline. A little more education is helpful in those situations. In most cases, they aren’t going to retain enough CO₂ to have problems wearing a mask.

Only a small percentage of patients with lung disease are CO₂ retainers, and many of those patients are being seen by pulmonary specialists. Those are the patients you might want to be more cautious with, to make sure they aren’t wearing anything that is tight fitting or that makes them work harder to breathe. It’s not that the mask is causing CO₂ retention, but the increased work of breathing may make it harder to exhale the CO₂.
 

Does a mask interfere with supplemental oxygen in any way?

Supplemental oxygen is typically supplied through a nasal cannula, so 100% oxygen is still getting to the nasal passages and entrained down into the airway, so it shouldn’t be a problem.

Some of the resistance to wearing masks has come from people with asthma. Is it safe for patients with asthma to wear masks, or should these patients be exempt from wearing masks?

In general, the breathing of people with mild asthma, both young and old, should not be impeded by the wearing of facial coverings. The concerns about oxygen and carbon dioxide among patients with more severe lung disease should not play a role in asthma.

Since younger adults with COVID-19 seem to have fewer or no symptoms and may actually be carrying the virus unknowingly, this should be the main population who should wear masks to prevent transmission to others.

Exemptions for mask wearing for mild asthma should be discouraged and dealt with on a case-by-case basis if there is a particular concern for that individual.
 

How do you respond if a patient asks you for a formal medical exemption to wearing a mask?

We’ve been asked to do a lot of letter writing for patients around going back to work, as well as the issue of wearing masks. The discussion usually revolves around trying to avoid going somewhere where you would have to wear a mask if it makes you feel uncomfortable.

I do not recommend automatically exempting individuals from wearing masks, even many of my pulmonary patients. There needs to be an understanding by the patient regarding the purpose of the mask and the overall advice to stay out of situations where social distancing is not being practiced. If you can take the time to discuss options as mentioned above – mask styles, desensitization, etc – the patient usually understands and will try wearing a mask.

On a case-by-case basis, some individuals may need to be exempted, but I feel this is a small number. I prefer my high-risk (older, chronic disease, etc) patients do everything they can to avoid infection – handwashing, mask wearing, and socially distancing.

They should also realize that even with a note, it is not going to help if they are in the middle of the grocery store and someone confronts them about not wearing a mask. It may help as they enter a store that says “masks required” and they can show it to someone monitoring the door. But I’m not really sure in what situations having that note is going to be helpful if confrontations occur.

Patients are also asking how safe is it for them to go back to work and be out in public. I tell them, nothing is going to be 100% safe. Until we have an effective vaccine, we are all going to have to weigh the potential risks of going to an area where social distancing isn’t maintained, people aren’t wearing face masks, and you can’t wash your hands as much as you’d like to. That’s going to be a struggle for all of us to get back out into situations where people interact socially.

Albert A. Rizzo, MD, is chief medical officer for the American Lung Association, chief of the Section of Pulmonary and Critical Care Medicine at the Christiana Care Health System in Newark, Delaware, and a member of Christiana Care Pulmonary Associates. He is board certified in internal medicine, pulmonary medicine, critical care medicine, and sleep medicine and is a clinical assistant professor of medicine at Thomas Jefferson University Medical School, Philadelphia.

This article first appeared on Medscape.com.