Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

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

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

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

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

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

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com

Given the unpredictability and wide range of patients and conditions physicians see in a hospital setting, keeping current with the latest trends and methods is essential. Until now, options for maintaining certification in Hospital Medicine were limited to ABIM’s 10-year, traditional Maintenance of Certification (MOC) exam taken at a testing center. Beginning this year hospitalists will have a choice for how they maintain their certification with the introduction of the Knowledge Check-In (KCI) in Focused Practice in Hospital Medicine (FPHM). Physicians who are currently certified in Internal Medicine can also use the KCI to earn their FPHM certificate once they have been admitted into the FPHM program.
 

KCI for hospitalists

The KCI is a shorter, lower stakes assessment option that takes about three hours to complete. Similar to the traditional 10-year MOC exam, it includes access to UpToDate® without the need for a personal subscription. Physicians can choose to take the KCI at a test center or online, such as from their home or workplace. The test center experience resembles that of the traditional 10-year MOC exam, with the main difference being the shorter testing format.

Since this is the first year the KCI is offered in FPHM, it is considered to be “no consequences,” meaning that if a physician is unsuccessful they will continue to be publicly reported as certified as long as they are meeting all other MOC requirements, and their next assessment will be due two years later. However, the “no consequences” feature does not apply to physicians who are already in a grace period. Please refer to ABIM’s policy on Traditional 10-Year MOC Exam Grace Period.

The longitudinal assessment option

Responding to feedback from the community for an MOC program that is lower-stakes and more closely aligned with how physicians practice, in August 2019 ABIM announced it would develop a longitudinal assessment pathway for physicians to acquire and demonstrate current knowledge. Longitudinal assessment is a process that involves the administration of shorter assessments of specific content, such as medical knowledge, repeatedly over a period of time. A critical component of longitudinal is that it integrates education into the assessment experience.
 

What features can you expect with longitudinal assessment?

The new assessment pathway is anticipated to launch in 2022 in as many specialties as possible. As the program is being developed ABIM is engaging with the community to ensure it will meet their needs, and physicians are encouraged to join its Community Insights Network by visiting abim.org. With the new longitudinal assessment option physicians will be able to:

• Answer a question at any place or time
• Receive immediate feedback 
• See references and rationales for each answer
• Access all the resources they use in practice, such as journals or websites

The traditional MOC Exam that is taken every 10 years will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

What should you do now?

All current ABIM MOC program requirements and policies remain in effect while the new longitudinal assessment is being developed and ABIM will communicate any program changes as well as more details on the program in advance of implementation. If you have an assessment due in 2020 or 2021, you can choose from the assessment options currently available in your discipline.

Registration for all 2020 MOC assessments opened December 1, 2019. Be sure to check ABIM’s website to see exam dates – and registration dates – for FPHM and any other certificates you are maintaining.

You can also find all of your MOC program requirements and deadlines by signing into your Physician Portal at abim.org.
 

Dr. Gupta is a member of ABIM’s Internal Medicine Board and a full-time hospitalist with Apogee Physicians. As a medical director, he currently runs the Hospitalist Program at Texas Health Arlington Memorial Hospital. He is also president of the SHM North Central Texas Chapter.

Given the unpredictability and wide range of patients and conditions physicians see in a hospital setting, keeping current with the latest trends and methods is essential. Until now, options for maintaining certification in Hospital Medicine were limited to ABIM’s 10-year, traditional Maintenance of Certification (MOC) exam taken at a testing center. Beginning this year hospitalists will have a choice for how they maintain their certification with the introduction of the Knowledge Check-In (KCI) in Focused Practice in Hospital Medicine (FPHM). Physicians who are currently certified in Internal Medicine can also use the KCI to earn their FPHM certificate once they have been admitted into the FPHM program.
 

KCI for hospitalists

The KCI is a shorter, lower stakes assessment option that takes about three hours to complete. Similar to the traditional 10-year MOC exam, it includes access to UpToDate® without the need for a personal subscription. Physicians can choose to take the KCI at a test center or online, such as from their home or workplace. The test center experience resembles that of the traditional 10-year MOC exam, with the main difference being the shorter testing format.

Since this is the first year the KCI is offered in FPHM, it is considered to be “no consequences,” meaning that if a physician is unsuccessful they will continue to be publicly reported as certified as long as they are meeting all other MOC requirements, and their next assessment will be due two years later. However, the “no consequences” feature does not apply to physicians who are already in a grace period. Please refer to ABIM’s policy on Traditional 10-Year MOC Exam Grace Period.

The longitudinal assessment option

Responding to feedback from the community for an MOC program that is lower-stakes and more closely aligned with how physicians practice, in August 2019 ABIM announced it would develop a longitudinal assessment pathway for physicians to acquire and demonstrate current knowledge. Longitudinal assessment is a process that involves the administration of shorter assessments of specific content, such as medical knowledge, repeatedly over a period of time. A critical component of longitudinal is that it integrates education into the assessment experience.
 

What features can you expect with longitudinal assessment?

The new assessment pathway is anticipated to launch in 2022 in as many specialties as possible. As the program is being developed ABIM is engaging with the community to ensure it will meet their needs, and physicians are encouraged to join its Community Insights Network by visiting abim.org. With the new longitudinal assessment option physicians will be able to:

• Answer a question at any place or time
• Receive immediate feedback 
• See references and rationales for each answer
• Access all the resources they use in practice, such as journals or websites

The traditional MOC Exam that is taken every 10 years will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

What should you do now?

All current ABIM MOC program requirements and policies remain in effect while the new longitudinal assessment is being developed and ABIM will communicate any program changes as well as more details on the program in advance of implementation. If you have an assessment due in 2020 or 2021, you can choose from the assessment options currently available in your discipline.

Registration for all 2020 MOC assessments opened December 1, 2019. Be sure to check ABIM’s website to see exam dates – and registration dates – for FPHM and any other certificates you are maintaining.

You can also find all of your MOC program requirements and deadlines by signing into your Physician Portal at abim.org.
 

Dr. Gupta is a member of ABIM’s Internal Medicine Board and a full-time hospitalist with Apogee Physicians. As a medical director, he currently runs the Hospitalist Program at Texas Health Arlington Memorial Hospital. He is also president of the SHM North Central Texas Chapter.

Given the unpredictability and wide range of patients and conditions physicians see in a hospital setting, keeping current with the latest trends and methods is essential. Until now, options for maintaining certification in Hospital Medicine were limited to ABIM’s 10-year, traditional Maintenance of Certification (MOC) exam taken at a testing center. Beginning this year hospitalists will have a choice for how they maintain their certification with the introduction of the Knowledge Check-In (KCI) in Focused Practice in Hospital Medicine (FPHM). Physicians who are currently certified in Internal Medicine can also use the KCI to earn their FPHM certificate once they have been admitted into the FPHM program.
 

KCI for hospitalists

The KCI is a shorter, lower stakes assessment option that takes about three hours to complete. Similar to the traditional 10-year MOC exam, it includes access to UpToDate® without the need for a personal subscription. Physicians can choose to take the KCI at a test center or online, such as from their home or workplace. The test center experience resembles that of the traditional 10-year MOC exam, with the main difference being the shorter testing format.

Since this is the first year the KCI is offered in FPHM, it is considered to be “no consequences,” meaning that if a physician is unsuccessful they will continue to be publicly reported as certified as long as they are meeting all other MOC requirements, and their next assessment will be due two years later. However, the “no consequences” feature does not apply to physicians who are already in a grace period. Please refer to ABIM’s policy on Traditional 10-Year MOC Exam Grace Period.

The longitudinal assessment option

Responding to feedback from the community for an MOC program that is lower-stakes and more closely aligned with how physicians practice, in August 2019 ABIM announced it would develop a longitudinal assessment pathway for physicians to acquire and demonstrate current knowledge. Longitudinal assessment is a process that involves the administration of shorter assessments of specific content, such as medical knowledge, repeatedly over a period of time. A critical component of longitudinal is that it integrates education into the assessment experience.
 

What features can you expect with longitudinal assessment?

The new assessment pathway is anticipated to launch in 2022 in as many specialties as possible. As the program is being developed ABIM is engaging with the community to ensure it will meet their needs, and physicians are encouraged to join its Community Insights Network by visiting abim.org. With the new longitudinal assessment option physicians will be able to:

• Answer a question at any place or time
• Receive immediate feedback 
• See references and rationales for each answer
• Access all the resources they use in practice, such as journals or websites

The traditional MOC Exam that is taken every 10 years will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

What should you do now?

All current ABIM MOC program requirements and policies remain in effect while the new longitudinal assessment is being developed and ABIM will communicate any program changes as well as more details on the program in advance of implementation. If you have an assessment due in 2020 or 2021, you can choose from the assessment options currently available in your discipline.

Registration for all 2020 MOC assessments opened December 1, 2019. Be sure to check ABIM’s website to see exam dates – and registration dates – for FPHM and any other certificates you are maintaining.

You can also find all of your MOC program requirements and deadlines by signing into your Physician Portal at abim.org.
 

Dr. Gupta is a member of ABIM’s Internal Medicine Board and a full-time hospitalist with Apogee Physicians. As a medical director, he currently runs the Hospitalist Program at Texas Health Arlington Memorial Hospital. He is also president of the SHM North Central Texas Chapter.

The European Society for Medical Oncology (ESMO) has issued guidelines that provide a practical road map for managing lung cancer patients during the COVID-19 pandemic, but the guidelines don’t address some issues that may affect U.S. physicians.

ESMO’s lung cancer guidelines provide specific details on when to prioritize and when to delay care. However, the guidelines don’t provide recommendations for managing patients who cannot participate in telemedicine or patients who have seen their clinical trial halted because of the pandemic, two situations that may be familiar to U.S. physicians.
 

Prioritization

As with ESMO’s other disease-focused COVID-19 guidelines, the lung cancer guidelines are organized into three priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening. Medium-priority recommendations apply to patients in noncritical situations for whom delaying care beyond 6 weeks would likely lower the chance of a significant benefit from the intervention. Low-priority recommendations apply to patients whose condition is stable enough that services can be delayed for the duration of the COVID-19 pandemic.

ESMO applied the high-, medium-, and low-prioritization schema to clinically distinct domains of lung cancer management, including outpatient visits; imaging; surgical treatment and diagnostic intervention; radiation therapy; and medical oncology treatment of early, locally advanced, or metastatic lung cancer.

As an example, a high-priority outpatient visit would be a visit for a patient with a new diagnosis of lung cancer and disease-related symptoms, suspicion of advanced disease or small cell cancer, or a visit for treatment administration. Low-priority visits would be survivorship visits, follow-up for a patient with low or intermediate relapse risk, or a visit for psychological support alone. For each diagnostic and therapeutic domain, there are similarly explicit examples.
 

Strengths of the guidelines

Because of small cell lung cancer’s usually aggressive behavior, ESMO’s recommendations appropriately give high priority to the diagnosis and treatment of small cell lung cancer.

Regarding imaging of pulmonary nodules, ESMO’s guidelines are fairly faithful to the Fleischner Society’s 2017 recommendations (Radiographics. 2018 Sep-Oct;38[5]:1337-50).

Most importantly, ESMO urges oncologists to adjust their routines by amplifying telemedicine services, reducing clinic visits, delaying adjuvant radiation therapy, switching to oral therapies when possible, and taking minor liberties with the schedule and duration of immune-targeted therapy.

The guidelines contain advice on supportive therapies, particularly regarding more liberal use of myeloid growth factors for patients on cytotoxic chemotherapy and postponement of antiresorptive therapy when it is not needed urgently.
 

Unaddressed issues

ESMO’s guidelines do not suggest more liberal use of immune-targeted therapy alone for specific patient profiles, nor do the guidelines provide tips for enhancing mental and physical health of patients during this stressful time.

The guidelines put primacy on “patient safety.” However, Narjust Duma, MD, of the University of Wisconsin–Madison, noted that there may be other equally important considerations. The patient’s comfort level about management recommendations and the safety of family members are vital, especially those who are older or immunocompromised.

Dr. Duma also noted that access to care is an issue specific to the United States that is not specifically addressed in the ESMO guidelines.

Dr. Duma estimated that as many as 30%-40% of patients with lung cancer may have no access to the Internet, a smartphone, or the ability to set up a telemedicine encounter. A patient’s lack of health insurance, transportation, and shelter will also have a direct impact on a provider’s ability to implement the ESMO guidance.

In addition, ESMO’s lung cancer guidelines do not specifically address accrual of patients to research studies during the pandemic. In the United States, many institutions have decided to suspend recruitment of patients to clinical trials, and many developing studies have been put on hold.
 

Lung cancer management today

The COVID-19 pandemic poses unique challenges to cancer patient care, since cancer patients are at high risk of COVID-19-related mortality, but they also have a high risk of cancer progression and its associated morbidity and mortality. In an analysis of 355 Italian patients who died from COVID-19, 20% had active cancer (JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4683).

Patients with lung cancer may be particularly vulnerable to death from coronavirus infection caused by older age, comorbid conditions, and the frequent requirement for multiple modalities of treatment, including cytotoxic therapy. In China, among 18 patients with cancer and coronavirus infection, 28% had lung cancer, and those patients had a high risk of requiring ICU-level care (Lancet Oncol. 2020 Mar;21[3]:335-7).

Bearing these data in mind, even the most mundane aspects of lung cancer diagnosis, treatment, and follow-up require careful risk-benefit analysis before application to individual patients.

There are always gray areas, particularly in quantifying the risk of relapse or infection for individual patients. However, the articulation of the ESMO guidelines into the chosen domains should make them easy to apply in routine practice for many patients.

The holistic approach the ESMO guidelines promote has never been more critical than during the pandemic, nor more aptly applied than to patients with lung cancer.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest. Dr. Duma disclosed relationships with AstraZeneca and Inivata.

The European Society for Medical Oncology (ESMO) has issued guidelines that provide a practical road map for managing lung cancer patients during the COVID-19 pandemic, but the guidelines don’t address some issues that may affect U.S. physicians.

ESMO’s lung cancer guidelines provide specific details on when to prioritize and when to delay care. However, the guidelines don’t provide recommendations for managing patients who cannot participate in telemedicine or patients who have seen their clinical trial halted because of the pandemic, two situations that may be familiar to U.S. physicians.
 

Prioritization

As with ESMO’s other disease-focused COVID-19 guidelines, the lung cancer guidelines are organized into three priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening. Medium-priority recommendations apply to patients in noncritical situations for whom delaying care beyond 6 weeks would likely lower the chance of a significant benefit from the intervention. Low-priority recommendations apply to patients whose condition is stable enough that services can be delayed for the duration of the COVID-19 pandemic.

ESMO applied the high-, medium-, and low-prioritization schema to clinically distinct domains of lung cancer management, including outpatient visits; imaging; surgical treatment and diagnostic intervention; radiation therapy; and medical oncology treatment of early, locally advanced, or metastatic lung cancer.

As an example, a high-priority outpatient visit would be a visit for a patient with a new diagnosis of lung cancer and disease-related symptoms, suspicion of advanced disease or small cell cancer, or a visit for treatment administration. Low-priority visits would be survivorship visits, follow-up for a patient with low or intermediate relapse risk, or a visit for psychological support alone. For each diagnostic and therapeutic domain, there are similarly explicit examples.
 

Strengths of the guidelines

Because of small cell lung cancer’s usually aggressive behavior, ESMO’s recommendations appropriately give high priority to the diagnosis and treatment of small cell lung cancer.

Regarding imaging of pulmonary nodules, ESMO’s guidelines are fairly faithful to the Fleischner Society’s 2017 recommendations (Radiographics. 2018 Sep-Oct;38[5]:1337-50).

Most importantly, ESMO urges oncologists to adjust their routines by amplifying telemedicine services, reducing clinic visits, delaying adjuvant radiation therapy, switching to oral therapies when possible, and taking minor liberties with the schedule and duration of immune-targeted therapy.

The guidelines contain advice on supportive therapies, particularly regarding more liberal use of myeloid growth factors for patients on cytotoxic chemotherapy and postponement of antiresorptive therapy when it is not needed urgently.
 

Unaddressed issues

ESMO’s guidelines do not suggest more liberal use of immune-targeted therapy alone for specific patient profiles, nor do the guidelines provide tips for enhancing mental and physical health of patients during this stressful time.

The guidelines put primacy on “patient safety.” However, Narjust Duma, MD, of the University of Wisconsin–Madison, noted that there may be other equally important considerations. The patient’s comfort level about management recommendations and the safety of family members are vital, especially those who are older or immunocompromised.

Dr. Duma also noted that access to care is an issue specific to the United States that is not specifically addressed in the ESMO guidelines.

Dr. Duma estimated that as many as 30%-40% of patients with lung cancer may have no access to the Internet, a smartphone, or the ability to set up a telemedicine encounter. A patient’s lack of health insurance, transportation, and shelter will also have a direct impact on a provider’s ability to implement the ESMO guidance.

In addition, ESMO’s lung cancer guidelines do not specifically address accrual of patients to research studies during the pandemic. In the United States, many institutions have decided to suspend recruitment of patients to clinical trials, and many developing studies have been put on hold.
 

Lung cancer management today

The COVID-19 pandemic poses unique challenges to cancer patient care, since cancer patients are at high risk of COVID-19-related mortality, but they also have a high risk of cancer progression and its associated morbidity and mortality. In an analysis of 355 Italian patients who died from COVID-19, 20% had active cancer (JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4683).

Patients with lung cancer may be particularly vulnerable to death from coronavirus infection caused by older age, comorbid conditions, and the frequent requirement for multiple modalities of treatment, including cytotoxic therapy. In China, among 18 patients with cancer and coronavirus infection, 28% had lung cancer, and those patients had a high risk of requiring ICU-level care (Lancet Oncol. 2020 Mar;21[3]:335-7).

Bearing these data in mind, even the most mundane aspects of lung cancer diagnosis, treatment, and follow-up require careful risk-benefit analysis before application to individual patients.

There are always gray areas, particularly in quantifying the risk of relapse or infection for individual patients. However, the articulation of the ESMO guidelines into the chosen domains should make them easy to apply in routine practice for many patients.

The holistic approach the ESMO guidelines promote has never been more critical than during the pandemic, nor more aptly applied than to patients with lung cancer.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest. Dr. Duma disclosed relationships with AstraZeneca and Inivata.

The European Society for Medical Oncology (ESMO) has issued guidelines that provide a practical road map for managing lung cancer patients during the COVID-19 pandemic, but the guidelines don’t address some issues that may affect U.S. physicians.

ESMO’s lung cancer guidelines provide specific details on when to prioritize and when to delay care. However, the guidelines don’t provide recommendations for managing patients who cannot participate in telemedicine or patients who have seen their clinical trial halted because of the pandemic, two situations that may be familiar to U.S. physicians.
 

Prioritization

As with ESMO’s other disease-focused COVID-19 guidelines, the lung cancer guidelines are organized into three priority levels – high, medium, and low – which are applied to several domains of diagnosis and treatment.

High-priority recommendations apply to patients whose condition is either clinically unstable or whose cancer burden is immediately life-threatening. Medium-priority recommendations apply to patients in noncritical situations for whom delaying care beyond 6 weeks would likely lower the chance of a significant benefit from the intervention. Low-priority recommendations apply to patients whose condition is stable enough that services can be delayed for the duration of the COVID-19 pandemic.

ESMO applied the high-, medium-, and low-prioritization schema to clinically distinct domains of lung cancer management, including outpatient visits; imaging; surgical treatment and diagnostic intervention; radiation therapy; and medical oncology treatment of early, locally advanced, or metastatic lung cancer.

As an example, a high-priority outpatient visit would be a visit for a patient with a new diagnosis of lung cancer and disease-related symptoms, suspicion of advanced disease or small cell cancer, or a visit for treatment administration. Low-priority visits would be survivorship visits, follow-up for a patient with low or intermediate relapse risk, or a visit for psychological support alone. For each diagnostic and therapeutic domain, there are similarly explicit examples.
 

Strengths of the guidelines

Because of small cell lung cancer’s usually aggressive behavior, ESMO’s recommendations appropriately give high priority to the diagnosis and treatment of small cell lung cancer.

Regarding imaging of pulmonary nodules, ESMO’s guidelines are fairly faithful to the Fleischner Society’s 2017 recommendations (Radiographics. 2018 Sep-Oct;38[5]:1337-50).

Most importantly, ESMO urges oncologists to adjust their routines by amplifying telemedicine services, reducing clinic visits, delaying adjuvant radiation therapy, switching to oral therapies when possible, and taking minor liberties with the schedule and duration of immune-targeted therapy.

The guidelines contain advice on supportive therapies, particularly regarding more liberal use of myeloid growth factors for patients on cytotoxic chemotherapy and postponement of antiresorptive therapy when it is not needed urgently.
 

Unaddressed issues

ESMO’s guidelines do not suggest more liberal use of immune-targeted therapy alone for specific patient profiles, nor do the guidelines provide tips for enhancing mental and physical health of patients during this stressful time.

The guidelines put primacy on “patient safety.” However, Narjust Duma, MD, of the University of Wisconsin–Madison, noted that there may be other equally important considerations. The patient’s comfort level about management recommendations and the safety of family members are vital, especially those who are older or immunocompromised.

Dr. Duma also noted that access to care is an issue specific to the United States that is not specifically addressed in the ESMO guidelines.

Dr. Duma estimated that as many as 30%-40% of patients with lung cancer may have no access to the Internet, a smartphone, or the ability to set up a telemedicine encounter. A patient’s lack of health insurance, transportation, and shelter will also have a direct impact on a provider’s ability to implement the ESMO guidance.

In addition, ESMO’s lung cancer guidelines do not specifically address accrual of patients to research studies during the pandemic. In the United States, many institutions have decided to suspend recruitment of patients to clinical trials, and many developing studies have been put on hold.
 

Lung cancer management today

The COVID-19 pandemic poses unique challenges to cancer patient care, since cancer patients are at high risk of COVID-19-related mortality, but they also have a high risk of cancer progression and its associated morbidity and mortality. In an analysis of 355 Italian patients who died from COVID-19, 20% had active cancer (JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4683).

Patients with lung cancer may be particularly vulnerable to death from coronavirus infection caused by older age, comorbid conditions, and the frequent requirement for multiple modalities of treatment, including cytotoxic therapy. In China, among 18 patients with cancer and coronavirus infection, 28% had lung cancer, and those patients had a high risk of requiring ICU-level care (Lancet Oncol. 2020 Mar;21[3]:335-7).

Bearing these data in mind, even the most mundane aspects of lung cancer diagnosis, treatment, and follow-up require careful risk-benefit analysis before application to individual patients.

There are always gray areas, particularly in quantifying the risk of relapse or infection for individual patients. However, the articulation of the ESMO guidelines into the chosen domains should make them easy to apply in routine practice for many patients.

The holistic approach the ESMO guidelines promote has never been more critical than during the pandemic, nor more aptly applied than to patients with lung cancer.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest. Dr. Duma disclosed relationships with AstraZeneca and Inivata.

Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.

“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.

“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”

The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.

For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).

Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.

Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.

The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.

“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.

The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
 

An important contribution

The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.

However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.

“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.

“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
 

“Unparalleled opportunity”

Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.

“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.

TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.

All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.

Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.

The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.

Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.

For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.

However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.

PCI scores were comparable in both treatment arms at 12, 24, and 36 months.

“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
 

TAILORx results highlight need for effective interventions

“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.

“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.

“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.

“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.

The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.

“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.

“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”

The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.

For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).

Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.

Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.

The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.

“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.

The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
 

An important contribution

The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.

However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.

“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.

“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
 

“Unparalleled opportunity”

Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.

“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.

TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.

All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.

Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.

The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.

Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.

For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.

However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.

PCI scores were comparable in both treatment arms at 12, 24, and 36 months.

“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
 

TAILORx results highlight need for effective interventions

“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.

“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.

“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.

“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.

The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Cognitive impairment seen in women with early breast cancer who undergo chemotherapy – so-called chemobrain – has now been reported in patients who are treated with endocrine therapy alone.

“The cognitive decline that we observed with endocrine therapy alone was really surprising and very eye-opening, because I think we have generally assumed that hormone therapy is very well tolerated,” lead author Lynne I. Wagner, PhD, professor of social science and health policy at Wake Forest School of Medicine, Winston-Salem, North Carolina, told Medscape Medical News.

“I think this is very important,” she added. “If you have a patient who has been on endocrine therapy for 3 years, don’t just assume that she’s fine and her cognitive function isn’t a concern, because for many women, it is very much a lingering and persistent concern.”

The findings come from a substudy analysis of 218 women who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone.

For most women in the study (58%), endocrine therapy initially consisted of an aromatase inhibitor; 37% of patients received tamoxifen, the researchers report. For chemotherapy, the most common regimens were docetaxel plus cyclophosphamide (70%) and anthracycline-based therapy (20%).

Women who received both chemotherapy and endocrine therapy experienced early and abrupt cognitive decline at 3 and 6 months following treatment; the decline leveled off at 12 and 36 months.

Women who were randomly assigned to receive endocrine therapy alone also experienced loss of cognition, but the loss was more gradual, and, by 36 months, it was the same as occurred in women who had received both chemotherapy and endocrine therapy.

The researchers also found that cognitive function did not return to pretreatment levels, regardless of the treatment the women received.

“We were surprised by the finding that women’s cognitive function did not return to pretreatment levels after finishing chemotherapy, but neither did the group receiving endocrine therapy alone. This highlights the importance of continuing to ask women who are receiving hormonal treatment for breast cancer about their cognitive function, even if they have been on treatment for a few years,” she said.

The findings come from a substudy of the Trial Assigning Individualized Treatment Options (TAILORx) and were published on April 9 in the Journal of Clinical Oncology.
 

An important contribution

The results of this study make an important contribution toward understanding the potential adverse cognitive effects of chemotherapy in combination with endocrine therapy and endocrine therapy alone, write Patricia A. Ganz, MD, and Kathleen Van Dyk, PhD, of the University of California, Los Angeles, in an accompanying editorial.

However, there was a difference in the effects on cognition with respect to menopausal status, and this should be a covariate or stratification variable, Ganz told Medscape Medical News.

“Clearly, this study shows that endocrine therapy is problematic. Certainly for younger women, the decrement is much worse. It may be that the brain of a young woman who has not yet gone through menopause is ill prepared, if you will, for these hormonal changes, whereas, in older women, even though they may be ill prepared for the toxicity of chemotherapy, endocrine therapy may not be as disruptive, because they have already adjusted to a low-estrogen state,” Ganz said.

“As a clinician, I can say that most of the complaints I hear are from younger women. Older women don’t really complain that much, and this may be because they are at a time in life when they don’t have to multitask, they can sleep late in the morning, and they do not have the same kind of management pressures that a younger woman would have,” she said.
 

“Unparalleled opportunity”

Before TAILORx, it was impossible to quantify the extent to which chemotherapy contributed to cognitive impairment, because all women received chemotherapy, Wagner told Medscape Medical News.

“We had been unable to isolate how much chemotherapy contributed versus all of the other aspects of having cancer, such as surgery, radiation therapy, and endocrine therapy. The design of TAILORx gave us an unparalleled opportunity to uniquely isolate the extent to which chemotherapy contributes to cognitive impairment,” she explained.

TAILORx enrolled 10,273 patients with breast cancer from April 2006 through October 2010. It was amended in January 2010 to include a patient-reported outcome substudy, which assessed cognitive impairment and other symptoms, such as fatigue, endocrine symptoms, and overall health-related quality of life.

All patients had hormone receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative early breast cancer and a midrange 21-gene recurrence score of 11 to 25.

Cognitive impairment was assessed in a subgroup of women using the 37-item Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) questionnaire, which was administered at baseline and at 3, 6, 12, 24, and 36 months.

The primary endpoint was the score on the 20-item FACT-Cog Perceived Cognitive Impairment (PCI) scale, which is part of the FACT-Cog questionnaire, at 3 months after randomization. The scale scores of the PCI range from 0 to 80, with a higher score indicating better cognitive status.

Of the 734 women who were enrolled in TAILORx after the start of the substudy, 218 women in the group who received chemotherapy plus endocrine therapy and 236 women who received endocrine therapy alone had evaluable FACT-Cog PCI data at baseline and at 3 months.

For both treatment groups, FACT-Cog PCI scores were significantly lower, indicating more impairment, at 3, 6, 12, 24, and 36 months, compared to baseline scores.

However, the pattern of cognitive decline differed between the treatment groups. Among women in the chemotherapy group, impairment was more significant at 3 months (mean PCI score, –3.82; P < .001) and at 6 months (mean PCI score, –2.62; P = .02), compared with the women who received endocrine therapy alone.

PCI scores were comparable in both treatment arms at 12, 24, and 36 months.

“This was not because the women who had chemotherapy improved but because women on endocrine therapy were also reporting a gradual increase in cognitive impairment at 12 months that persisted at 24 and 36 months. So the pace of their cognitive decline was slower and more gradual,” Wagner said.
 

TAILORx results highlight need for effective interventions

“I was excited to see the publication of this work,” Jamie S. Myers, PhD, RN, of University of Kansas School of Nursing, Kansas City, told Medscape Medical News.

“Drs. Wagner and Cella have been so instrumental in the development of the FACT PROs, and we have used the FACT-Cog PCI subscale in much of our work. The TAILORx study provided a beautiful opportunity to capture PRO data for women with early breast cancer randomized to chemotherapy plus endocrine therapy versus endocrine therapy alone, and I was not surprised that endocrine therapy was associated with reports of cognitive decline,” Myers said in email correspondence.

“This study further confirms the work conducted by my mentor, Dr. Catherine Bender at the University of Pittsburgh. Women receiving endocrine therapy continue to report issues with cognitive function. What was encouraging about this study was confirmation that the contribution of chemotherapy to the cognitive decline that women experience does level out at 12 months for the majority of women. However, as the results clearly demonstrated, neither group in this study returned to baseline by 36 months, likely due to the ongoing impact of the endocrine therapy,” she said.

“I completely agree with the researchers that we must continue to vigilantly monitor and assess women for cognitive changes throughout their treatment trajectory. And these study results certainly highlight the need for effective interventions to either prevent or mitigate the cognitive effects of breast cancer treatment. I hope these researchers will continue to assess women’s report of cognitive function for a significant period of time after endocrine therapy is completed. This would give us very important information about the recovery trajectory for cognitive function once endocrine therapy is complete. I would also hope they would break down the results by category of endocrine therapy, for example, specific aromatase inhibitor versus tamoxifen, as this too could yield important information,” Myers said.

The study was supported by the National Cancer Institute. Wagner, Ganz, Van Dyk, and Myers have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.

The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.

Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”

The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.

The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.

Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”

One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.

“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.

According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
 

Results from the global and UCSF registries

As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).

The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.

The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
 

EULAR registry results

As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.

The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.

Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.

An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.

The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.

Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”

The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.

The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.

Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”

One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.

“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.

According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
 

Results from the global and UCSF registries

As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).

The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.

The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
 

EULAR registry results

As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.

The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.

Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.

An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.

The COVID-19 Global Rheumatology Alliance (GRA) has created pediatric and adult registries for health care providers to enter information on their rheumatology patients with COVID-19. The adult registry is hosted by the University of California, San Francisco, Research Electronic Data Capture system, while the Childhood Arthritis and Rheumatology Research Alliance is supporting the pediatric registry. A separate path for data entry of both adult and pediatric cases has been established through the European League Against Rheumatism for European countries and countries with EULAR member organizations.

Prior to the creation of the registries, there were no data available to guide rheumatologists in clinical decision making for their patients, noted Jinoos Yazdany, MD, MPH, COVID-19 GRA steering committee member and chief of the division of rheumatology at Zuckerberg San Francisco General Hospital. “COVID-19 has potential to severely affect those with rheumatologic diseases or those taking immunosuppressive drugs,” she said in an interview. “The GRA registries were designed to answer critical questions that will inform the medical care of this population.”

The GRA began on Twitter, with conversations between Leonard H. Calabrese, DO, of the Cleveland Clinic; Paul Sufka, MD, of HealthPartners in St. Paul, Minn.; Philip Robinson, MBChB, PhD, of the Royal Brisbane (Australia) Hospital; and herself, Dr. Yazdany said. Dr. Robinson started work on the governance of the GRA, Dr. Yazdany designed the data infrastructure, and Dr. Sufka approached his professional networks and social media followings to promote the effort and ask for support. The COVID-19 GRA steering committee representatives include patients, private practice rheumatologists, and international investigators. Listed among official supporters of the alliance are the American College of Rheumatology and EULAR along with more than 290 medical societies, institutions, journals, and other organizations in rheumatology.

The goal of the registries is to examine the health outcomes of patients with rheumatic diseases and COVID-19 based on sociodemographic factors, comorbidities, and clinical presentations of COVID-19 as well as what role taking immunosuppressive drugs prior to a COVID-19 infection play in helping or hindering outcomes. Hydroxychloroquine, used to treat lupus and arthritis, is a potential treatment candidate for COVID-19. Biologics such as tocilizumab (Actemra) and sarilumab (Kevzara), which target interleukin-6, and anakinra (Kineret), which targets IL-1, are treatment candidates for patients who have experienced COVID-related cytokine storm syndrome, which researchers believe may contribute to worsening or fatal cases.

Dr. Yazdany, who is also vice chair of real-world data infrastructure, registry, and institutional review board/ethics for the GRA, said that there are some important high-level trends in the data thus far. “People with lupus and those taking hydroxychloroquine are becoming infected with SARS-CoV-2, which is counter to misinformation on social media. Most people with rheumatic diseases on immunosuppression are recovering, which is great news for our patients.”

One of the major strengths of the registries is that each case is entered by the rheumatologist treating the patient and contains detailed clinical information, Dr. Yazdany said. However, the registry has no control group, it is not a population surveillance study, and it may contain selection bias through rheumatologists omitting milder, undiagnosed cases.

“The Global Alliance case reporting registry represents the collective effort of hundreds of rheumatologists across the world. I have never been more inspired by the strength and collaboration of the rheumatology community,” Dr. Yazdany said.

According to a paper published in the Lancet Rheumatology, which references data on 110 cases from the combined databases up to April 1, about three-fourths of cases presented with fever (79%) and cough (77%), and about half presented with shortness of breath (50%) and myalgia (45%).
 

Results from the global and UCSF registries

As of April 18, 334 cases were in the global and UCSF registries, with 121 patients (36%) in the database having both COVID-19 and RA, 33 patients (10%) with psoriatic arthritis, 58 patients (17%) with systemic lupus erythematosus, 28 patients (8%) with axial spondyloarthritis, 27 patients (8%) with vasculitis, and 19 patients (6%) with Sjögren’s syndrome. There were less than five cases reported for patients with the following rheumatic diseases: inflammatory myopathy, ocular inflammation, other inflammatory arthritis, polymyalgia rheumatica, sarcoidosis, systemic sclerosis, osteoporosis, psoriasis, isolated pulmonary capillaritis, gout, and autoinflammatory disease. A majority of the patients in the registries are women (74%) aged younger than 65 years (78%) and are white (52%).

The most common comorbid conditions among patients in the registry are hypertension (33%), lung disease (18%), diabetes (11%), cardiovascular disease (10%), chronic renal insufficiency or end-stage renal disease (7%), morbid obesity (7%), and cancer (4%). Before being diagnosed with COVID-19, 219 patients (66%) in the registry were taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), which included antimalarials, azathioprine, cyclophosphamide, cyclosporine, leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, and tacrolimus. A total of 122 patients (37%) were taking biologic DMARDs, 101 patients were taking glucocorticoids (30%), 86 patients (26%) were taking hydroxychloroquine, 41 patients (12%) were taking NSAIDs, and 18 patients (5%) were taking a Janus kinase inhibitor.

The most recent data from the registry show that 128 patients (38%) have been hospitalized for COVID-19, and 19 patients (6%) have died. Although 104 patients (31%) resolved their infections, 177 patients (53%) have a COVID-19 infection status of “unresolved,” and 53 patients (16%) have an unknown infection status.
 

EULAR registry results

As of April 21, 249 cases were in the EULAR registry, including 110 hospitalizations (44%) and 37 deaths (15%). Overall, 64% of these patients were women, and they had a median age of 60 years.

The top five diagnoses of these patients were RA (39%), psoriatic arthritis (15%), spondyloarthritis (9%), systemic lupus erythematosus (9%), and gout (5%). A total of 27% had no reported comorbidities, while lung disease occurred in 26%, hypertension in 34%, diabetes in 11%, and cardiovascular disease on 11%. The registry also reported use of any DMARD in 80%, including 62% on csDMARDs, 31% on biologics, and 2% on targeted synthetic DMARDs.

Ten authors in the Lancet Rheumatology paper reported personal and institutional relationships in the form of grants, corporate sponsorships, advisory board memberships, investigator appointments, speaker’s bureau positions, personal fees, and consultancies for a variety of pharmaceutical companies, agencies, societies, and other organizations. The other authors reported no relevant conflicts of interest.

Join us on Thursday, April 23, at 8:30 p.m. EST as we discuss how the COVID-19 pandemic is affecting the mental health of psychiatry patients and providers around the world.

Our special guests include two psychiatry educators with expertise in therapeutic psychotherapy and solutions on how to help our most vulnerable populations being affected by COVID-19, Dinah Miller, MD (@shrinkraphdinah), and Elizabeth Ryznar, MD (@RyznarMD). We hope you will participate in our Twitter chat this evening, at 8:30 p.m. EST on #MDedgeChats.

Public health emergencies can affect the well-being of individuals and communities causing possible feelings of insecurity, confusion, and emotional isolation. These effects may translate into a range of emotional reactions affecting current psychiatric conditions and creating new ones, according to the New England Journal of Medicine.

According to the Kaiser Family Foundation, “nearly 45% of adults across the country say that worry and stress related to the coronavirus pandemic are hurting their mental health.”

In this chat, we will discuss this topic and how COVID-19 is affecting your patients and practice. Join us tonight and feel free to share what you have experienced during this pandemic at 8:30 pm EST on #MDedgeChats.

Topics of Conversation

Question 1: How are pre-pandemic patients doing during the crisis?
Question 2: How has COVID-19 affected inpatient and outpatient care for you?
Question 3: How are our most vulnerable populations being affected by COVID-19?
Question 4: How are you doing personally and professionally as a medical professional and psychiatrist amidst this pandemic?
Question 5: What psychiatric manifestations are you seeing in your patients who have had COVID-19?

About Dr. Dinah Miller

Dr. Dinah Miller (@shrinkrapdinah) a psychiatrist with a private practice and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller is also a columnist for and a member of the Editorial Advisory Board of Clinical Psychiatry News. She is the co-author of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016) and “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University, 2011).

About Dr. Elizabeth Ryznar

Dr. Elizabeth Ryznar (@RyznarMD) is a psychiatry clinician-educator research fellow and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. She completed her medical training at Harvard Medical School in Boston and her residency training at Northwestern University in Chicago. Dr. Ryznar is co-editor of the new book “Landmark Papers in Psychiatry,” published by Oxford University Press, and has several peer-reviewed articles.

Resources

• Mental health and the COVID-19 pandemic
• Brief examines the COVID-19 crisis’ implications for Americans’ mental health
• COVID-19: Helping health care workers on the front lines
• Overcoming COVID-related stress
• Confessions of an outpatient psychiatrist during the pandemic
• Psychiatric patients may be among the hardest hit
• Experts hasten to head off mental health crisis

Kclark@mdedge.com

Join us on Thursday, April 23, at 8:30 p.m. EST as we discuss how the COVID-19 pandemic is affecting the mental health of psychiatry patients and providers around the world.

Our special guests include two psychiatry educators with expertise in therapeutic psychotherapy and solutions on how to help our most vulnerable populations being affected by COVID-19, Dinah Miller, MD (@shrinkraphdinah), and Elizabeth Ryznar, MD (@RyznarMD). We hope you will participate in our Twitter chat this evening, at 8:30 p.m. EST on #MDedgeChats.

Public health emergencies can affect the well-being of individuals and communities causing possible feelings of insecurity, confusion, and emotional isolation. These effects may translate into a range of emotional reactions affecting current psychiatric conditions and creating new ones, according to the New England Journal of Medicine.

According to the Kaiser Family Foundation, “nearly 45% of adults across the country say that worry and stress related to the coronavirus pandemic are hurting their mental health.”

In this chat, we will discuss this topic and how COVID-19 is affecting your patients and practice. Join us tonight and feel free to share what you have experienced during this pandemic at 8:30 pm EST on #MDedgeChats.

Topics of Conversation

Question 1: How are pre-pandemic patients doing during the crisis?
Question 2: How has COVID-19 affected inpatient and outpatient care for you?
Question 3: How are our most vulnerable populations being affected by COVID-19?
Question 4: How are you doing personally and professionally as a medical professional and psychiatrist amidst this pandemic?
Question 5: What psychiatric manifestations are you seeing in your patients who have had COVID-19?

About Dr. Dinah Miller

Dr. Dinah Miller (@shrinkrapdinah) a psychiatrist with a private practice and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller is also a columnist for and a member of the Editorial Advisory Board of Clinical Psychiatry News. She is the co-author of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016) and “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University, 2011).

About Dr. Elizabeth Ryznar

Dr. Elizabeth Ryznar (@RyznarMD) is a psychiatry clinician-educator research fellow and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. She completed her medical training at Harvard Medical School in Boston and her residency training at Northwestern University in Chicago. Dr. Ryznar is co-editor of the new book “Landmark Papers in Psychiatry,” published by Oxford University Press, and has several peer-reviewed articles.

Resources

• Mental health and the COVID-19 pandemic
• Brief examines the COVID-19 crisis’ implications for Americans’ mental health
• COVID-19: Helping health care workers on the front lines
• Overcoming COVID-related stress
• Confessions of an outpatient psychiatrist during the pandemic
• Psychiatric patients may be among the hardest hit
• Experts hasten to head off mental health crisis

Kclark@mdedge.com

Join us on Thursday, April 23, at 8:30 p.m. EST as we discuss how the COVID-19 pandemic is affecting the mental health of psychiatry patients and providers around the world.

Our special guests include two psychiatry educators with expertise in therapeutic psychotherapy and solutions on how to help our most vulnerable populations being affected by COVID-19, Dinah Miller, MD (@shrinkraphdinah), and Elizabeth Ryznar, MD (@RyznarMD). We hope you will participate in our Twitter chat this evening, at 8:30 p.m. EST on #MDedgeChats.

Public health emergencies can affect the well-being of individuals and communities causing possible feelings of insecurity, confusion, and emotional isolation. These effects may translate into a range of emotional reactions affecting current psychiatric conditions and creating new ones, according to the New England Journal of Medicine.

According to the Kaiser Family Foundation, “nearly 45% of adults across the country say that worry and stress related to the coronavirus pandemic are hurting their mental health.”

In this chat, we will discuss this topic and how COVID-19 is affecting your patients and practice. Join us tonight and feel free to share what you have experienced during this pandemic at 8:30 pm EST on #MDedgeChats.

Topics of Conversation

Question 1: How are pre-pandemic patients doing during the crisis?
Question 2: How has COVID-19 affected inpatient and outpatient care for you?
Question 3: How are our most vulnerable populations being affected by COVID-19?
Question 4: How are you doing personally and professionally as a medical professional and psychiatrist amidst this pandemic?
Question 5: What psychiatric manifestations are you seeing in your patients who have had COVID-19?

About Dr. Dinah Miller

Dr. Dinah Miller (@shrinkrapdinah) a psychiatrist with a private practice and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore. Dr. Miller is also a columnist for and a member of the Editorial Advisory Board of Clinical Psychiatry News. She is the co-author of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016) and “Shrink Rap: Three Psychiatrists Explain Their Work” (Baltimore: Johns Hopkins University, 2011).

About Dr. Elizabeth Ryznar

Dr. Elizabeth Ryznar (@RyznarMD) is a psychiatry clinician-educator research fellow and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore. She completed her medical training at Harvard Medical School in Boston and her residency training at Northwestern University in Chicago. Dr. Ryznar is co-editor of the new book “Landmark Papers in Psychiatry,” published by Oxford University Press, and has several peer-reviewed articles.

Resources

• Mental health and the COVID-19 pandemic
• Brief examines the COVID-19 crisis’ implications for Americans’ mental health
• COVID-19: Helping health care workers on the front lines
• Overcoming COVID-related stress
• Confessions of an outpatient psychiatrist during the pandemic
• Psychiatric patients may be among the hardest hit
• Experts hasten to head off mental health crisis

Kclark@mdedge.com

This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.

Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.

Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.

Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.

Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.

This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.

Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.

Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.

Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.

Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.

This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This patient had prurigo nodularis (PN). The diagnosis usually is made clinically by the appearance of the lesions and the cycle of severe pruritus and scratching. In this case, the patient had acutely excoriated lesions in addition to more chronic lesions that had become hyperpigmented nodules. The distribution pattern on his back was typical and highlighted the clinical course of PN. There were no lesions present where the patient was unable to scratch; however, lesions were present where he could reach, hence the term Picker’s nodules. Often, these patients have a history of atopic dermatitis, and anxiety may play a role in patients nervously scratching the lesions.

Biopsy is indicated if there is suspicion of bullous pemphigoid or cutaneous T-cell lymphoma. Pathology of PN shows increased density of nerve fibers in the dermis along with an increased number of T cells, mast cells, and eosinophilic granulocytes. Most patients do not require biopsy unless the diagnosis is in doubt.

Treatment can be difficult due to the severe pruritis and subsequent scratching that appears to prolong the chronic cycle of inflammation. Daily use of nonsedating antihistamines (eg, loratadine, cetirizine) may help reduce pruritus and break the cycle. Sedating antihistamines (eg, diphenhydramine, hydroxyzine) can be used cautiously at bedtime; cotton gloves worn while sleeping may reduce nocturnal scratching and excoriations.

Topical steroids (eg, triamcinolone, betamethasone) can reduce the itching and local inflammation. Emollients can help with associated dyshidrosis and eczema, if present.

Second line therapies include topical calcineurin inhibitors (eg, tacrolimus, pimecrolimus), calcipotriene, and narrow beam UVB therapy.

This patient had done reasonably well with cetirizine and triamcinolone in the past, so treatment was restarted. He was counseled regarding the nature and chronicity of his PN and told that if he could achieve symptom control and stop scratching the lesions, his condition might resolve.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.