Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Women facing issues related to perimenopause and menopause can consult their primary care physicians or ob.gyns. through telemedicine visits, but a new online portal, the Cusp, offers an alternative model with a focus on menopause and access to experts for a monthly membership fee.

The Cusp doesn’t claim to replace routine gynecologic care. Rather, it focuses on perimenopause and menopause symptoms specifically, and states that its physicians, some of whom are certified by the North American Menopause Society, provide expertise in menopause beyond what patients might receive as part of a typical ob.gyn. visit.

The Cusp is a for-profit organization, a group of physicians, nurse practitioners, and technologists who focus on integrated care for women in perimenopause and beyond. The aim is to leverage technology as a way to connect women to the care platform to book physician and nurse practitioner visits virtually and to have all of the information about their care centralized in one place.

According to the website, most patients who sign up for a care plan check in with their providers at least once a month to monitor their symptoms and tweak treatment strategies. Patients who sign up are prompted to download an app, which then becomes the main tool for scheduling future visits, tracking symptoms, and communicating with providers.

The Cusp launched in early 2019, before the advent of the COVID-19 pandemic, but the pandemic has accelerated the acceptance across medical specialties, suggesting that telemedicine is here to stay, according to Mindy Goldman, MD, professor of gynecology and gynecologic surgery at the University of California, San Francisco, and director of the Gynecology Center for Cancer Survivors and At-Risk Women at UCSF, who also serves as a medical adviser to the Cusp.

Partnering with technology companies allows opportunities to provide care in areas where there are gaps, such as menopause management, she said. Many clinicians in primary care and ob.gyn. care don’t have the time or training to discuss menopause management in depth with patients, and patient interviews conducted by the Cusp before launching the site showed that this was an area of need.

“One thing that is really unique about the Cusp is that we brought together experts to provide care in both in an evidence-based and holistic fashion,” Dr. Goldman emphasized.

The Cusp’s medical team includes physician and nurse practitioner menopause experts with backgrounds including not only ob.gyn. but also psychiatry, integrative medicine, and naturopathic medicine, with plans to add endocrinology and dermatology as well. This holistic approach allows the Cusp to tailor care based on what each woman is looking for, with evidence-based expertise to support treatment decisions, said Dr. Goldman, whose advisory role includes helping to develop patient treatment protocols and services.

If a woman wants to begin treating symptoms with a naturopathic approach, the team will provide protocols that take current guidelines into account. Regular visits, approximately once a month or as needed, allow for collaboration with the Cusp’s specialists to provide consistent care that is very comprehensive, she said.

One of the benefits of the Cusp is the opportunity for “frequent touchpoints” in which providers reach out to patients via text, email, or video. Although a traditional medical visit may include some initial discussion of menopause and treatment plans, the Cusp offers “a more seamless way to address needs on an ongoing basis,” to provide more complete patient care, Dr. Goldman said.

“We are constantly asking women what they are looking for in menopause care,” and a recurring question was about hormone testing, she said. Nontraditional practitioners may offer hormone testing as a way of individualizing care that also involves compounded formulations, and other treatments that are not standard of care. “In all of our protocols we follow what is recommended by standard organizations such as ACOG [American College of Obstetricians and Gynecologists] and NAMS.”

The Cusp’s newest service is an at-home hormone test currently for women in New York and California, but the company plans to expand this service. The hormone test, while not essential, is another tool to guide menopause management, and having a sense of when menopause will occur “gives us a chance to talk to people about behavioral changes and time to personalize a treatment protocol,” Dr. Goldman said.

The test is based in part on the anti-Müllerian hormone, which recent studies have shown is useful in predicting time to menopause. This, in combination with other hormone tests and other clinical information, will allow the Cusp’s menopause specialists to help women in perimenopause gain perspective on their symptoms and design a treatment plan that can evolve as their needs change, she explained.

“The more information you know about when menopause is going to be happening, you can tailor your treatment plan,” Dr. Goldman said. For example, a woman who may be 2 years away from menopause might consider a naturopathic approach at first, and switch to a different therapy as menopause occurs. “We know that the risks of cardiovascular disease and bone loss increase after menopause, and knowing the time to menopause gives us more guidance when educating patients about healthy lifestyle habits such as exercise and dietary changes that can help reduce these risks.”

The Cusp allows patients to use money in flexible spending accounts or health savings accounts to pay for the program. If doctors require lab tests or other procedures, these are covered through the patients’ regular health insurance as they would be if requested by a primary care physician or other health care professional.

Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn., commented that part of the value in a telehealth site such as the Cusp is to serve as “a resource for reproductively aging women to understand what is happening to them.”

Any way to improve education on the topic of menopause is empowering to women, said Dr. Pal, professor of obstetrics, gynecology, and reproductive sciences at Yale. “This is an opportunity for patients to have access to a directed evaluation” of menopause-related symptoms. Then, when women visit their regular health care provider in person, they are well-equipped with knowledge to ask more informed questions and discuss a wide range of treatment options.

Dr. Pal noted that the hormone test is less valuable than the interaction between physicians and patients, whether online or in person.

“Menopause is a Monday morning quarterback diagnosis,” she said, emphasizing that, not only is a year without menses part of the diagnosis of menopause, many women in perimenopause can have wide fluctuations in hormone levels, so a test is more of a snapshot than a diagnostic tool, and that the results might cause unnecessary angst and concerns for patients.

However, part of the value of a telehealth site that focuses on menopause is that it gives women a place to learn more about their biology and to clarify their questions about symptoms and become aware of a range of treatment options. Telehealth consultations also can help women recognize how other factors such as lifestyle modifications can play a role in menopause symptoms, and how modifying these factors may provide some relief, she said.

Dr. Pal said she would be cautious about the idea of prescribing without seeing the patient in person, but noted that telehealth sites such as the Cusp can be a win-win to enhance women’s health when used in combination with regular in-person visits to an ob.gyn. The added value in patients’ being able to discuss their concerns and to learn more about their symptoms means that they will be better informed to develop a menopause management strategy in partnership with their providers, said Dr. Pal, who is not associated with the Cusp.

Dr. Goldman disclosed receiving compensation from the Cusp for her advisory work. She also holds stock options in the company. Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board, had no financial conflicts to disclose.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

Information about COVID has evolved so quickly that it can be difficult for clinicians to feel confident that they are staying current. These summaries include links to our reference article on diagnosis of COVID-19, which is constantly updated to make sure you have the latest information.

Diagnostic testing for COVID-19 is critical. No one disputes that. But what is in dispute is whom to test, when to test, how to test, what to do while waiting for results, and how accurate those results are when you finally get them.

Here are the answers to those questions, based on the current information.

Whom to test. This is the (relatively) easy part. The ideal answer is that everyone should be tested. The Infectious Diseases Society of America issued tier-based recommendations way back in March, and they still apply. First priority continues to be patients who are ill, healthcare workers, and those with known exposure. But to truly figure out the amount of community spread in a given area, we need to test people who do not have a clear indication for testing. That is particularly true as more people return to work and the Centers for Disease Control and Prevention (CDC) has issued guidelines for workplaces to establish testing programs. Universal testing is recommended for some high-risk settings, such as nursing homes.

One key change: CDC no longer recommends testing to determine whether someone with a known infection is still infectious.

When to test. People with any symptoms suggestive of COVID should be tested, ideally as soon as feasible. But given the ongoing shortages of tests, that may not be possible, particularly for those requiring only symptomatic care. Rather, these patients should be treated as probable cases, with appropriate instructions regarding quarantine. Testing of those with known exposures ideally should be done about 5 days after exposure.

How to test. Only viral nucleic acid or antigen tests should be used to diagnose acute illness. CDC does not currently recommend using serologic assays, now broadly available, for diagnosis of acute infection, though they obviously play an important role in understanding the transmission dynamic of the virus in the general population.

Testing strategies vary from state to state and even within communities in a single state. It is recommended that clinicians check with their own local or state health department for specifics on tests available, indications for testing, and processing details. While often forgotten, it is worth emphasizing that no diagnostic tests have been approved by the US Food and Drug Administration (FDA). Rather, they are available under emergency use authorization (EUA), meaning that they have not been fully vetted by the FDA.

In late July, the FDA expanded authorization for real-time reverse transcription–polymerase chain reaction (rRT-PCR) molecular assays, utilizing nasal or nasopharyngeal swabs, to permit testing of all persons, regardless of exposure history or symptoms. The FDA maintains a list of all approved diagnostic tests and corresponding labs. Current evidence suggests that no one test is better than any other — and most clinicians won›t have a choice anyway. Patients will have to get what is available via their health department or insurance plan.

Two point-of-care antigen tests using nasopharyngeal or nasal samples have been issued an EUA. These tests can be used only in settings with a valid CLIA certificate.

Several commercial laboratories have received approval to process diagnostic tests using patients’ self-collected saliva rather than swabs. One lab has now received authorization for in-home testing without any input from a clinician. These testing options can be a boon for patients who have symptoms or exposure and for whatever reason are unable to get to a diagnostic site. These samples are collected at home and mailed to a lab. Note that these tests are not yet widely available.

Waiting for results. If waiting for results meant a day or even a couple of days, the answer to this one would be easier. But if the wait extends to 1 and even sometimes 2 weeks, then the test is not able to meaningfully guide clinical decisions. The latest guidance from the CDC is that individuals with symptoms suggestive of COVID who do not require hospitalization should remain at home in self-quarantine for at least 10 days from symptom onset. Asymptomatic individuals with a known exposure to someone else with COVID, or participation in a high-risk event like an indoor gathering involving more than 10 persons, should self-quarantine either until they receive a negative test result or 14 days after the exposure.

Accuracy of results. A positive rRT-PCR antigen test is highly accurate, indicating presence of SARS-CoV-2 RNA. There appears to be no significant cross-reactivity with other respiratory viruses or even other coronaviruses. A small study conducted in Korea suggests that patients with persistent positive tests who are beyond 10 days from the initial positive test and are now symptom free are no longer infectious.

For patients with a high suspicion of COVID-19, a negative test should not rule out the infection. The number of false-negative results is not well known, though the resultant risk is “substantial.” A number of factors affect the likelihood of a false-negative test, including when the sample was collected relative to the timing of illness and the type of specimen collected; for example, nasopharyngeal swabs are more likely to be accurate vs nasal or throat specimens. Repeat or serial testing increases the sensitivity but may not always be available. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria are likely to emerge because of the concern about these false-negative results.
 

This article first appeared on Medscape.com.

A system designed for resource-limited settings provides rapid cancer profiling and requires “scant” cellular specimens, according to researchers.

The automated image cytometry system is called CytoPAN. In preclinical experiments, CytoPAN provided accurate cancer detection in 1 hour using as few as 50 cells.

In a prospective study of 68 breast cancer patients, CytoPAN detected cancer with 100% accuracy. The receptor subtyping accuracy was 96% for HER2 and 93% for estrogen and progesterone receptors.

Jouha Min, PhD, of Massachusetts General Hospital, Boston, and colleagues reported these findings in Science Translational Medicine.

The authors explained that the CytoPAN system is designed to address one of the biggest cancer challenges in low- and middle-income countries (LMICs), where more than two-thirds of cancer deaths occur: providing rapid, affordable diagnostics that enable patients to obtain locally available treatments.

Unfortunately, because of bottlenecks in specimen acquisition, complex handling logistics, a lack of pathologists, and limited laboratory infrastructure, diagnosis in many LMICs frequently takes months. Cancers typically are not diagnosed until advanced symptoms such as palpable mass lesions, weight loss, and malaise have become manifest.
 

Lesion assessment guides management

For women with suspicion of breast cancer, the authors noted, preoperative assessment of focal lesions for receptor status, presence of invasion, histologic type, and tumor grade are crucial for planning therapeutic management. For physicians to provide, for example, tamoxifen, which is commonly available at low cost in LMICs, they must know a patients’ hormone receptor status.

While core and open surgical biopsies yield abundant tissue for embedding, sectioning, and staining for subsequent histopathological analysis, they entail lengthy work flow and call for expensive instrumentation and a trained workforce, the authors noted.

Fine needle aspirations (FNAs) can be performed by nonphysicians after minimal training with very low complication rates. The much smaller–gauge needles (20-25 gauge) used in FNAs are generally well tolerated, the authors added.

This is why CytoPAN was designed for use with specimens obtained via FNA of palpable mass lesions.
 

Self-contained design

The CytoPAN system was engineered as a self-contained, integrated cytometry platform enabling same-day diagnosis and treatment of breast lesions.

The system was designed to comply with the World Health Organization’s “ASSURED” criteria (affordable, sensitive, specific, user friendly, rapid and robust, equipment free, and deliverable to end users), and to be potentially operable by nonphysicians after brief training.

CytoPAN operators collect cells through minimally invasive FNAs and use lyophilized immunostaining kits with relevant antibodies (not requiring refrigeration). Operators perform imaging using the CytoPAN device, which is then subjected to an automated analysis algorithm with results displayed on a user interface.

CytoPAN classifies detected malignant cells according to four subtypes reflecting estrogen receptor (ER), progesterone receptor (PR), and HER2 status – luminal HER2-negative, luminal HER2-positive, HER2-positive, and triple-negative breast cancer. This is intended to facilitate informed treatment choices (e.g., a selective ER modulator, antiestrogen or aromatase inhibitor for ER/PR-positive patients; an anti-HER2 agent for HER2-positive patients).

The final diagnostic report from a given patient sample includes cancer cell population and molecular subtype distribution. The entire diagnostic procedure takes less than an hour. A repeat biopsy, should the sample be nondiagnostic, can be taken within an hour.
 

Murine, then human testing

A test of CytoPAN on FNA samples from mouse xenografts representing the spectrum of human breast cancer subtypes showed correct and reproducible molecular subtyping that matched well with flow cytometry reports derived from the same tumors.

To determine the clinical utility of CytoPAN, investigators enrolled 68 treatment-naive breast cancer patients who were referred for primary surgery at the Kyungpook National University Chilgok Hospital in Daegu, South Korea. FNA samples were obtained after visualization of breast masses by ultrasound or CT.

Surgical specimens and/or core biopsies were processed by routine pathology for “gold-standard” comparison. FNA samples had sufficient numbers of cells in 63 (93%) patients, with a mean number of cells among them of 1,308 (range, 93-11,985).

CytoPAN analysis correctly identified malignant breast cancer in 55 patients and benign lesions in 5 patients. Three cases were inconclusive because of low numbers of Quad-positive cells for further analysis. The authors pointed out that roughly 20% of biopsy samples in developed countries are deemed “nondiagnostic” because of insufficient cellular contents.

The authors’ summary underscored CytoPAN’s affordable system using cellular rather than tissue specimens, actionable results in an hour, lack of moving parts, multiplexed analysis, and user-friendly interface.

Cancer detection accuracy was 100% (no false negatives or false positives), and receptor subtyping accuracy was 97% for HER2 and 93% for ER/PR.

“Based on these results, we envision prospective clinical trials in remote, decentralized locations,” the authors wrote. The system is being tested further in Botswana.

“I find the data in this paper compelling – particularly for those patients presenting with a palpable mass on clinical exam. ... Certainly in resource-limited settings, this would have significant appeal,” William J. Gradishar, MD, of Northwestern University, Chicago, said in an interview.

Dr. Gradishar explained that, while palpable masses that lead to a diagnosis of noninvasive disease alone are uncommon in the United States because of routine screening mammography, they may still be an issue in other parts of the world.

The authors received funding from the National Institutes of Health, the MGH Scholar Fund, and Robert Wood Johnson Foundation. Some authors disclosed relationships with Akili, Accure Health, ModeRNA, Tarveda, Lumicell, and Noul. Dr. Gradishar reported having no disclosures.

SOURCE: Min J et al. Sci Transl Med. 2020 Aug 5. doi: 10.1126/scitranslmed.aaz9746.

A system designed for resource-limited settings provides rapid cancer profiling and requires “scant” cellular specimens, according to researchers.

The automated image cytometry system is called CytoPAN. In preclinical experiments, CytoPAN provided accurate cancer detection in 1 hour using as few as 50 cells.

In a prospective study of 68 breast cancer patients, CytoPAN detected cancer with 100% accuracy. The receptor subtyping accuracy was 96% for HER2 and 93% for estrogen and progesterone receptors.

Jouha Min, PhD, of Massachusetts General Hospital, Boston, and colleagues reported these findings in Science Translational Medicine.

The authors explained that the CytoPAN system is designed to address one of the biggest cancer challenges in low- and middle-income countries (LMICs), where more than two-thirds of cancer deaths occur: providing rapid, affordable diagnostics that enable patients to obtain locally available treatments.

Unfortunately, because of bottlenecks in specimen acquisition, complex handling logistics, a lack of pathologists, and limited laboratory infrastructure, diagnosis in many LMICs frequently takes months. Cancers typically are not diagnosed until advanced symptoms such as palpable mass lesions, weight loss, and malaise have become manifest.
 

Lesion assessment guides management

For women with suspicion of breast cancer, the authors noted, preoperative assessment of focal lesions for receptor status, presence of invasion, histologic type, and tumor grade are crucial for planning therapeutic management. For physicians to provide, for example, tamoxifen, which is commonly available at low cost in LMICs, they must know a patients’ hormone receptor status.

While core and open surgical biopsies yield abundant tissue for embedding, sectioning, and staining for subsequent histopathological analysis, they entail lengthy work flow and call for expensive instrumentation and a trained workforce, the authors noted.

Fine needle aspirations (FNAs) can be performed by nonphysicians after minimal training with very low complication rates. The much smaller–gauge needles (20-25 gauge) used in FNAs are generally well tolerated, the authors added.

This is why CytoPAN was designed for use with specimens obtained via FNA of palpable mass lesions.
 

Self-contained design

The CytoPAN system was engineered as a self-contained, integrated cytometry platform enabling same-day diagnosis and treatment of breast lesions.

The system was designed to comply with the World Health Organization’s “ASSURED” criteria (affordable, sensitive, specific, user friendly, rapid and robust, equipment free, and deliverable to end users), and to be potentially operable by nonphysicians after brief training.

CytoPAN operators collect cells through minimally invasive FNAs and use lyophilized immunostaining kits with relevant antibodies (not requiring refrigeration). Operators perform imaging using the CytoPAN device, which is then subjected to an automated analysis algorithm with results displayed on a user interface.

CytoPAN classifies detected malignant cells according to four subtypes reflecting estrogen receptor (ER), progesterone receptor (PR), and HER2 status – luminal HER2-negative, luminal HER2-positive, HER2-positive, and triple-negative breast cancer. This is intended to facilitate informed treatment choices (e.g., a selective ER modulator, antiestrogen or aromatase inhibitor for ER/PR-positive patients; an anti-HER2 agent for HER2-positive patients).

The final diagnostic report from a given patient sample includes cancer cell population and molecular subtype distribution. The entire diagnostic procedure takes less than an hour. A repeat biopsy, should the sample be nondiagnostic, can be taken within an hour.
 

Murine, then human testing

A test of CytoPAN on FNA samples from mouse xenografts representing the spectrum of human breast cancer subtypes showed correct and reproducible molecular subtyping that matched well with flow cytometry reports derived from the same tumors.

To determine the clinical utility of CytoPAN, investigators enrolled 68 treatment-naive breast cancer patients who were referred for primary surgery at the Kyungpook National University Chilgok Hospital in Daegu, South Korea. FNA samples were obtained after visualization of breast masses by ultrasound or CT.

Surgical specimens and/or core biopsies were processed by routine pathology for “gold-standard” comparison. FNA samples had sufficient numbers of cells in 63 (93%) patients, with a mean number of cells among them of 1,308 (range, 93-11,985).

CytoPAN analysis correctly identified malignant breast cancer in 55 patients and benign lesions in 5 patients. Three cases were inconclusive because of low numbers of Quad-positive cells for further analysis. The authors pointed out that roughly 20% of biopsy samples in developed countries are deemed “nondiagnostic” because of insufficient cellular contents.

The authors’ summary underscored CytoPAN’s affordable system using cellular rather than tissue specimens, actionable results in an hour, lack of moving parts, multiplexed analysis, and user-friendly interface.

Cancer detection accuracy was 100% (no false negatives or false positives), and receptor subtyping accuracy was 97% for HER2 and 93% for ER/PR.

“Based on these results, we envision prospective clinical trials in remote, decentralized locations,” the authors wrote. The system is being tested further in Botswana.

“I find the data in this paper compelling – particularly for those patients presenting with a palpable mass on clinical exam. ... Certainly in resource-limited settings, this would have significant appeal,” William J. Gradishar, MD, of Northwestern University, Chicago, said in an interview.

Dr. Gradishar explained that, while palpable masses that lead to a diagnosis of noninvasive disease alone are uncommon in the United States because of routine screening mammography, they may still be an issue in other parts of the world.

The authors received funding from the National Institutes of Health, the MGH Scholar Fund, and Robert Wood Johnson Foundation. Some authors disclosed relationships with Akili, Accure Health, ModeRNA, Tarveda, Lumicell, and Noul. Dr. Gradishar reported having no disclosures.

SOURCE: Min J et al. Sci Transl Med. 2020 Aug 5. doi: 10.1126/scitranslmed.aaz9746.

A system designed for resource-limited settings provides rapid cancer profiling and requires “scant” cellular specimens, according to researchers.

The automated image cytometry system is called CytoPAN. In preclinical experiments, CytoPAN provided accurate cancer detection in 1 hour using as few as 50 cells.

In a prospective study of 68 breast cancer patients, CytoPAN detected cancer with 100% accuracy. The receptor subtyping accuracy was 96% for HER2 and 93% for estrogen and progesterone receptors.

Jouha Min, PhD, of Massachusetts General Hospital, Boston, and colleagues reported these findings in Science Translational Medicine.

The authors explained that the CytoPAN system is designed to address one of the biggest cancer challenges in low- and middle-income countries (LMICs), where more than two-thirds of cancer deaths occur: providing rapid, affordable diagnostics that enable patients to obtain locally available treatments.

Unfortunately, because of bottlenecks in specimen acquisition, complex handling logistics, a lack of pathologists, and limited laboratory infrastructure, diagnosis in many LMICs frequently takes months. Cancers typically are not diagnosed until advanced symptoms such as palpable mass lesions, weight loss, and malaise have become manifest.
 

Lesion assessment guides management

For women with suspicion of breast cancer, the authors noted, preoperative assessment of focal lesions for receptor status, presence of invasion, histologic type, and tumor grade are crucial for planning therapeutic management. For physicians to provide, for example, tamoxifen, which is commonly available at low cost in LMICs, they must know a patients’ hormone receptor status.

While core and open surgical biopsies yield abundant tissue for embedding, sectioning, and staining for subsequent histopathological analysis, they entail lengthy work flow and call for expensive instrumentation and a trained workforce, the authors noted.

Fine needle aspirations (FNAs) can be performed by nonphysicians after minimal training with very low complication rates. The much smaller–gauge needles (20-25 gauge) used in FNAs are generally well tolerated, the authors added.

This is why CytoPAN was designed for use with specimens obtained via FNA of palpable mass lesions.
 

Self-contained design

The CytoPAN system was engineered as a self-contained, integrated cytometry platform enabling same-day diagnosis and treatment of breast lesions.

The system was designed to comply with the World Health Organization’s “ASSURED” criteria (affordable, sensitive, specific, user friendly, rapid and robust, equipment free, and deliverable to end users), and to be potentially operable by nonphysicians after brief training.

CytoPAN operators collect cells through minimally invasive FNAs and use lyophilized immunostaining kits with relevant antibodies (not requiring refrigeration). Operators perform imaging using the CytoPAN device, which is then subjected to an automated analysis algorithm with results displayed on a user interface.

CytoPAN classifies detected malignant cells according to four subtypes reflecting estrogen receptor (ER), progesterone receptor (PR), and HER2 status – luminal HER2-negative, luminal HER2-positive, HER2-positive, and triple-negative breast cancer. This is intended to facilitate informed treatment choices (e.g., a selective ER modulator, antiestrogen or aromatase inhibitor for ER/PR-positive patients; an anti-HER2 agent for HER2-positive patients).

The final diagnostic report from a given patient sample includes cancer cell population and molecular subtype distribution. The entire diagnostic procedure takes less than an hour. A repeat biopsy, should the sample be nondiagnostic, can be taken within an hour.
 

Murine, then human testing

A test of CytoPAN on FNA samples from mouse xenografts representing the spectrum of human breast cancer subtypes showed correct and reproducible molecular subtyping that matched well with flow cytometry reports derived from the same tumors.

To determine the clinical utility of CytoPAN, investigators enrolled 68 treatment-naive breast cancer patients who were referred for primary surgery at the Kyungpook National University Chilgok Hospital in Daegu, South Korea. FNA samples were obtained after visualization of breast masses by ultrasound or CT.

Surgical specimens and/or core biopsies were processed by routine pathology for “gold-standard” comparison. FNA samples had sufficient numbers of cells in 63 (93%) patients, with a mean number of cells among them of 1,308 (range, 93-11,985).

CytoPAN analysis correctly identified malignant breast cancer in 55 patients and benign lesions in 5 patients. Three cases were inconclusive because of low numbers of Quad-positive cells for further analysis. The authors pointed out that roughly 20% of biopsy samples in developed countries are deemed “nondiagnostic” because of insufficient cellular contents.

The authors’ summary underscored CytoPAN’s affordable system using cellular rather than tissue specimens, actionable results in an hour, lack of moving parts, multiplexed analysis, and user-friendly interface.

Cancer detection accuracy was 100% (no false negatives or false positives), and receptor subtyping accuracy was 97% for HER2 and 93% for ER/PR.

“Based on these results, we envision prospective clinical trials in remote, decentralized locations,” the authors wrote. The system is being tested further in Botswana.

“I find the data in this paper compelling – particularly for those patients presenting with a palpable mass on clinical exam. ... Certainly in resource-limited settings, this would have significant appeal,” William J. Gradishar, MD, of Northwestern University, Chicago, said in an interview.

Dr. Gradishar explained that, while palpable masses that lead to a diagnosis of noninvasive disease alone are uncommon in the United States because of routine screening mammography, they may still be an issue in other parts of the world.

The authors received funding from the National Institutes of Health, the MGH Scholar Fund, and Robert Wood Johnson Foundation. Some authors disclosed relationships with Akili, Accure Health, ModeRNA, Tarveda, Lumicell, and Noul. Dr. Gradishar reported having no disclosures.

SOURCE: Min J et al. Sci Transl Med. 2020 Aug 5. doi: 10.1126/scitranslmed.aaz9746.

Manpreet Malik, MD, a hospitalist at Emory University, takes care of patients with COVID-19 at Grady Memorial Hospital in downtown Atlanta. Born in India but living in the United States for more than 10 years, he is awaiting permanent resident status. At the current pace of U.S. Citizenship and Immigration Services, that may be decades away.

Dr. Malik lives and works in the United States on an H-1B visa, which is based on employment in a specialty occupation. Although he has a job that he loves, his immigrant status, social life, and geographic location in the United States is, technically, entirely dependent on doing that job.

“For single-income families with doctors on visas, the pandemic brings anxiety and uncertainty about legal status in the U.S. in case the breadwinner gets sick, disabled or unemployed,” he said.

In a presentation to be given at the HM20 Virtual, hosted by the Society of Hospital Medicine, Dr. Malik will offer perspective on the current challenges facing immigrant hospitalists and health care workers, especially in a U.S. health care system stretched thin and one in which many health professionals born outside the United States are working on the front lines. These challenges should be motivation to make legislative changes to give these health care workers more stability, flexibility, and peace of mind, he said.

The talk – to be given along with HM20 course director Benji Mathews, MD, SFHM, and called “The Immigrant Hospitalist: Navigating the Uncertain Terrain During COVID-19” – will describe a long-standing issue and outline a path forward, the two physicians said.

“The objective of this talk is to really highlight the contributions of these physicians and health care workers and also to provide a call for action for our hospitalist colleagues. This talk paints a picture of what my family and thousands of the other immigrant health care worker families are going through,” Dr. Malik said.

Dr. Mathews said that many physicians do not have benefits they can fall back on should they fall ill. And without the jobs their visas are based on, they could face deportation.

“That’s extreme – but the pathway towards that is very much there,” said Dr. Mathews, who was born in the Middle East and immigrated to the United States, received a green card, and later his citizenship. He now advocates for immigrant health and immigrant health care workers.

Dr. Malik and Dr. Mathews recently published a perspective piece in the Journal of Hospital Medicine. In it, they pointed out that 16.4% of health care workers are immigrants, and 29% of physicians are immigrants. Among practicing hospitalists, 32% are international medical graduates. They called for reform to visa regulations to allow physicians who are immigrants to travel to areas where they are most needed during the pandemic, for extensions of visa deadlines, and exemption from future immigration bans or limitations. These measures would only bolster the health care workforce that is under such strain during the pandemic, they write. (J Hosp Med. 2020 Aug;15[8]:505-506)

Dr. Malik said that, even while under added personal strain caused by the uncertainty of the past several months, he has never questioned his decision to be a physician in the United States.

“Now, more than ever, there is a sense of purpose and a passion to make a difference for our patients,” he said.

“I think most of us get into medicine and become hospitalists because we want to care for people, because we want to serve, because we want to be able to take care of sick, hospitalized patients, and that can be anywhere in the world, whether you’re in India serving a population that you grew up with or whether you’re in the U.S. serving the population that are your neighbors, your friends, your community, or people that are vulnerable. You’re serving humanity, and that is the ultimate goal.”
 

SHM advocacy on immigration issues

SHM has been advocating for more equitable skilled-immigration system, recognizing that from visa-backlogs to per-country caps, unfair visa restrictions have limited the United States’ ability to adequately expand its health care workforce.

The Society has consistently advocated on Capitol Hill for visa and skilled-immigration reform and has championed several significant immigration bills, including the following:

The Fairness for High Skilled Immigrants Act

• This legislation will eliminate per-country caps on green cards and convert the system into a “first-come, first-serve” system. This will help ensure certain nationalize are not disproportionally impacted by excessive green card backlogs.
• This legislation has passed the House of Representatives. Send a message to your Senator asking them to cosponsor this legislation.

The Conrad State 30 Physician Reauthorization Act

• This legislation will renew the Conrad State 30 program, which allows physicians on a J-1 visa to remain in the United States if they work in an underserved region for a minimum of three years. This legislation also included additional employment protection claims.
•  

The Healthcare Workforce Resilience Act

• This legislation will recapture 40,000 unused immigrant visas for foreign doctors (15,000) and nurses (25,000), as well as provide visas for their spouse and children.
• This legislation will only be in effect for the duration of the COVID-19 public health emergency.

To join SHM in supporting our immigrant clinicians, you can send a message to your representatives in support of these bills by visiting hospitalmedicine.org/takeaction.
 

Manpreet Malik, MD, a hospitalist at Emory University, takes care of patients with COVID-19 at Grady Memorial Hospital in downtown Atlanta. Born in India but living in the United States for more than 10 years, he is awaiting permanent resident status. At the current pace of U.S. Citizenship and Immigration Services, that may be decades away.

Dr. Malik lives and works in the United States on an H-1B visa, which is based on employment in a specialty occupation. Although he has a job that he loves, his immigrant status, social life, and geographic location in the United States is, technically, entirely dependent on doing that job.

“For single-income families with doctors on visas, the pandemic brings anxiety and uncertainty about legal status in the U.S. in case the breadwinner gets sick, disabled or unemployed,” he said.

In a presentation to be given at the HM20 Virtual, hosted by the Society of Hospital Medicine, Dr. Malik will offer perspective on the current challenges facing immigrant hospitalists and health care workers, especially in a U.S. health care system stretched thin and one in which many health professionals born outside the United States are working on the front lines. These challenges should be motivation to make legislative changes to give these health care workers more stability, flexibility, and peace of mind, he said.

The talk – to be given along with HM20 course director Benji Mathews, MD, SFHM, and called “The Immigrant Hospitalist: Navigating the Uncertain Terrain During COVID-19” – will describe a long-standing issue and outline a path forward, the two physicians said.

“The objective of this talk is to really highlight the contributions of these physicians and health care workers and also to provide a call for action for our hospitalist colleagues. This talk paints a picture of what my family and thousands of the other immigrant health care worker families are going through,” Dr. Malik said.

Dr. Mathews said that many physicians do not have benefits they can fall back on should they fall ill. And without the jobs their visas are based on, they could face deportation.

“That’s extreme – but the pathway towards that is very much there,” said Dr. Mathews, who was born in the Middle East and immigrated to the United States, received a green card, and later his citizenship. He now advocates for immigrant health and immigrant health care workers.

Dr. Malik and Dr. Mathews recently published a perspective piece in the Journal of Hospital Medicine. In it, they pointed out that 16.4% of health care workers are immigrants, and 29% of physicians are immigrants. Among practicing hospitalists, 32% are international medical graduates. They called for reform to visa regulations to allow physicians who are immigrants to travel to areas where they are most needed during the pandemic, for extensions of visa deadlines, and exemption from future immigration bans or limitations. These measures would only bolster the health care workforce that is under such strain during the pandemic, they write. (J Hosp Med. 2020 Aug;15[8]:505-506)

Dr. Malik said that, even while under added personal strain caused by the uncertainty of the past several months, he has never questioned his decision to be a physician in the United States.

“Now, more than ever, there is a sense of purpose and a passion to make a difference for our patients,” he said.

“I think most of us get into medicine and become hospitalists because we want to care for people, because we want to serve, because we want to be able to take care of sick, hospitalized patients, and that can be anywhere in the world, whether you’re in India serving a population that you grew up with or whether you’re in the U.S. serving the population that are your neighbors, your friends, your community, or people that are vulnerable. You’re serving humanity, and that is the ultimate goal.”
 

SHM advocacy on immigration issues

SHM has been advocating for more equitable skilled-immigration system, recognizing that from visa-backlogs to per-country caps, unfair visa restrictions have limited the United States’ ability to adequately expand its health care workforce.

The Society has consistently advocated on Capitol Hill for visa and skilled-immigration reform and has championed several significant immigration bills, including the following:

The Fairness for High Skilled Immigrants Act

• This legislation will eliminate per-country caps on green cards and convert the system into a “first-come, first-serve” system. This will help ensure certain nationalize are not disproportionally impacted by excessive green card backlogs.
• This legislation has passed the House of Representatives. Send a message to your Senator asking them to cosponsor this legislation.

The Conrad State 30 Physician Reauthorization Act

• This legislation will renew the Conrad State 30 program, which allows physicians on a J-1 visa to remain in the United States if they work in an underserved region for a minimum of three years. This legislation also included additional employment protection claims.
•  

The Healthcare Workforce Resilience Act

• This legislation will recapture 40,000 unused immigrant visas for foreign doctors (15,000) and nurses (25,000), as well as provide visas for their spouse and children.
• This legislation will only be in effect for the duration of the COVID-19 public health emergency.

To join SHM in supporting our immigrant clinicians, you can send a message to your representatives in support of these bills by visiting hospitalmedicine.org/takeaction.
 

Manpreet Malik, MD, a hospitalist at Emory University, takes care of patients with COVID-19 at Grady Memorial Hospital in downtown Atlanta. Born in India but living in the United States for more than 10 years, he is awaiting permanent resident status. At the current pace of U.S. Citizenship and Immigration Services, that may be decades away.

Dr. Malik lives and works in the United States on an H-1B visa, which is based on employment in a specialty occupation. Although he has a job that he loves, his immigrant status, social life, and geographic location in the United States is, technically, entirely dependent on doing that job.

“For single-income families with doctors on visas, the pandemic brings anxiety and uncertainty about legal status in the U.S. in case the breadwinner gets sick, disabled or unemployed,” he said.

In a presentation to be given at the HM20 Virtual, hosted by the Society of Hospital Medicine, Dr. Malik will offer perspective on the current challenges facing immigrant hospitalists and health care workers, especially in a U.S. health care system stretched thin and one in which many health professionals born outside the United States are working on the front lines. These challenges should be motivation to make legislative changes to give these health care workers more stability, flexibility, and peace of mind, he said.

The talk – to be given along with HM20 course director Benji Mathews, MD, SFHM, and called “The Immigrant Hospitalist: Navigating the Uncertain Terrain During COVID-19” – will describe a long-standing issue and outline a path forward, the two physicians said.

“The objective of this talk is to really highlight the contributions of these physicians and health care workers and also to provide a call for action for our hospitalist colleagues. This talk paints a picture of what my family and thousands of the other immigrant health care worker families are going through,” Dr. Malik said.

Dr. Mathews said that many physicians do not have benefits they can fall back on should they fall ill. And without the jobs their visas are based on, they could face deportation.

“That’s extreme – but the pathway towards that is very much there,” said Dr. Mathews, who was born in the Middle East and immigrated to the United States, received a green card, and later his citizenship. He now advocates for immigrant health and immigrant health care workers.

Dr. Malik and Dr. Mathews recently published a perspective piece in the Journal of Hospital Medicine. In it, they pointed out that 16.4% of health care workers are immigrants, and 29% of physicians are immigrants. Among practicing hospitalists, 32% are international medical graduates. They called for reform to visa regulations to allow physicians who are immigrants to travel to areas where they are most needed during the pandemic, for extensions of visa deadlines, and exemption from future immigration bans or limitations. These measures would only bolster the health care workforce that is under such strain during the pandemic, they write. (J Hosp Med. 2020 Aug;15[8]:505-506)

Dr. Malik said that, even while under added personal strain caused by the uncertainty of the past several months, he has never questioned his decision to be a physician in the United States.

“Now, more than ever, there is a sense of purpose and a passion to make a difference for our patients,” he said.

“I think most of us get into medicine and become hospitalists because we want to care for people, because we want to serve, because we want to be able to take care of sick, hospitalized patients, and that can be anywhere in the world, whether you’re in India serving a population that you grew up with or whether you’re in the U.S. serving the population that are your neighbors, your friends, your community, or people that are vulnerable. You’re serving humanity, and that is the ultimate goal.”
 

SHM advocacy on immigration issues

SHM has been advocating for more equitable skilled-immigration system, recognizing that from visa-backlogs to per-country caps, unfair visa restrictions have limited the United States’ ability to adequately expand its health care workforce.

The Society has consistently advocated on Capitol Hill for visa and skilled-immigration reform and has championed several significant immigration bills, including the following:

The Fairness for High Skilled Immigrants Act

• This legislation will eliminate per-country caps on green cards and convert the system into a “first-come, first-serve” system. This will help ensure certain nationalize are not disproportionally impacted by excessive green card backlogs.
• This legislation has passed the House of Representatives. Send a message to your Senator asking them to cosponsor this legislation.

The Conrad State 30 Physician Reauthorization Act

• This legislation will renew the Conrad State 30 program, which allows physicians on a J-1 visa to remain in the United States if they work in an underserved region for a minimum of three years. This legislation also included additional employment protection claims.
•  

The Healthcare Workforce Resilience Act

• This legislation will recapture 40,000 unused immigrant visas for foreign doctors (15,000) and nurses (25,000), as well as provide visas for their spouse and children.
• This legislation will only be in effect for the duration of the COVID-19 public health emergency.

To join SHM in supporting our immigrant clinicians, you can send a message to your representatives in support of these bills by visiting hospitalmedicine.org/takeaction.
 

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Lindsey Criswell, MD, MPH, DSc, has been selected as the next director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Dr. Criswell, vice chancellor of research at the University of California, San Francisco, will replace acting director Robert H. Carter, MD, who has overseen NIAMS since December 2018, following the unexpected death of longtime director Stephen I. Katz, MD, PhD, who had directed the institute since 1995. She will start her new role in early 2021, according to the NIH.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator. Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well-positioned to direct NIAMS,” said NIH director Francis S. Collins, MD, PhD, said in an announcement.

Dr. Criswell, who holds the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman Distinguished Professorship in Rheumatology at UCSF, spent most of her career at the university, focusing her research on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders, according to the NIH.

NIAMS has a budget of nearly $625 million and its extramural research program supports scientific studies and research training and career development throughout the country through grants and contracts to research organizations in fields that include rheumatology, muscle biology, orthopedics, bone and mineral metabolism, and dermatology.

jevans@mdedge.com

Targeted prophylaxis with posaconazole was more effective than fluconazole in children with acute lymphoblastic leukemia who were undergoing induction chemotherapy in order to prevent invasive fungal infection, according to a study by Tian Zhang of Xidian University, Xi’an, China, and colleagues.

The researchers performed a single-center, retrospective cohort study of 155 patients with newly diagnosed acute lymphoblastic leukemia, comparing invasive fungal infections in those who received no prophylaxis (60 patients), posaconazole prophylaxis (70), or fluconazole prophylaxis (55) during induction therapy, according to a report published in the Journal of Microbiology, Immunology and Infection.

Proven and probable invasive fungal infections occurred during the induction phase in 45% in the no-prophylaxis group, in 18% of the posaconazole group and in 72% of the fluconazole group. Posaconazole prophylaxis reduced the odds of invasive fungal infections by greater than 60%, prolonged infection-free survival significantly, and did not increase the risk of hepatotoxicity.

In addition, the researchers found that the combination of age at diagnosis, clinically documented bacterial infection in the first 15 days of induction therapy, and absolute neutrophil count curve enabled significant prediction of the susceptibility to infections after receiving posaconazole prophylaxis.

“In general, these findings may serve as a basis for developing screening protocols to identify children who are at high risk for infection despite posaconazole prophylaxis so that early intervention can be initiated to mitigate fungal infections,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang T et al. J Microbiol Immunol Infect. 2020 Aug 1. doi: 10.1016/j.jmii.2020.07.008.

Targeted prophylaxis with posaconazole was more effective than fluconazole in children with acute lymphoblastic leukemia who were undergoing induction chemotherapy in order to prevent invasive fungal infection, according to a study by Tian Zhang of Xidian University, Xi’an, China, and colleagues.

The researchers performed a single-center, retrospective cohort study of 155 patients with newly diagnosed acute lymphoblastic leukemia, comparing invasive fungal infections in those who received no prophylaxis (60 patients), posaconazole prophylaxis (70), or fluconazole prophylaxis (55) during induction therapy, according to a report published in the Journal of Microbiology, Immunology and Infection.

Proven and probable invasive fungal infections occurred during the induction phase in 45% in the no-prophylaxis group, in 18% of the posaconazole group and in 72% of the fluconazole group. Posaconazole prophylaxis reduced the odds of invasive fungal infections by greater than 60%, prolonged infection-free survival significantly, and did not increase the risk of hepatotoxicity.

In addition, the researchers found that the combination of age at diagnosis, clinically documented bacterial infection in the first 15 days of induction therapy, and absolute neutrophil count curve enabled significant prediction of the susceptibility to infections after receiving posaconazole prophylaxis.

“In general, these findings may serve as a basis for developing screening protocols to identify children who are at high risk for infection despite posaconazole prophylaxis so that early intervention can be initiated to mitigate fungal infections,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang T et al. J Microbiol Immunol Infect. 2020 Aug 1. doi: 10.1016/j.jmii.2020.07.008.

Targeted prophylaxis with posaconazole was more effective than fluconazole in children with acute lymphoblastic leukemia who were undergoing induction chemotherapy in order to prevent invasive fungal infection, according to a study by Tian Zhang of Xidian University, Xi’an, China, and colleagues.

The researchers performed a single-center, retrospective cohort study of 155 patients with newly diagnosed acute lymphoblastic leukemia, comparing invasive fungal infections in those who received no prophylaxis (60 patients), posaconazole prophylaxis (70), or fluconazole prophylaxis (55) during induction therapy, according to a report published in the Journal of Microbiology, Immunology and Infection.

Proven and probable invasive fungal infections occurred during the induction phase in 45% in the no-prophylaxis group, in 18% of the posaconazole group and in 72% of the fluconazole group. Posaconazole prophylaxis reduced the odds of invasive fungal infections by greater than 60%, prolonged infection-free survival significantly, and did not increase the risk of hepatotoxicity.

In addition, the researchers found that the combination of age at diagnosis, clinically documented bacterial infection in the first 15 days of induction therapy, and absolute neutrophil count curve enabled significant prediction of the susceptibility to infections after receiving posaconazole prophylaxis.

“In general, these findings may serve as a basis for developing screening protocols to identify children who are at high risk for infection despite posaconazole prophylaxis so that early intervention can be initiated to mitigate fungal infections,” the researchers concluded.

The authors reported that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang T et al. J Microbiol Immunol Infect. 2020 Aug 1. doi: 10.1016/j.jmii.2020.07.008.

The rapid decline in pediatric hospital visits that came quickly after COVID-19 has emerged as a major public health threat, creating the need for adaptations among those offering hospital-based care, according to an objective look at patient numbers that was presented at the virtual Pediatric Hospital Medicine.

“Pre-COVID, operating margins had already taken a significant decline – and there are lots of different reasons for why this was happening – but a lot of hospitals in the United States were going from seeing about a 5% operating margin to closer to 2% to 3%,” said Magna Dias, MD, medical director, pediatric inpatient services, at Yale New Haven Children’s Hospital, Bridgeport, Conn.

This nearly 50% decline “was already putting pressure on us in the community hospital setting where pediatrics is not necessarily generating a ton of revenue to justify our programs, but post COVID, our operating revenue – and this is a report from May – was down 282%,” Dr. Dias reported.

Dr. Dias said that hundreds of hospitals have furloughed workers in the United States since the pandemic began. Although the job losses are not confined to pediatric care, statistics show that pediatrics is one of the hardest hit specialties.

“Looking specifically at ED [emergency department] visits under age 14, one study showed a 71% to 72% decrease post COVID,” Dr. Dias said. This included a 97% reduction in ED visits for flu and more than an 80% reduction in visits for asthma, otitis media, and nausea or vomiting.

It is not clear when children will return to the hospital in pre-COVID-19 numbers, but it might not be soon if the a second wave of infections follows the first, according to Dr. Dias. She suggested that pediatric hospitalists should be thinking about how to expand their services.

“One thing we are really good at in terms of working in the community hospital is diversification. We are used to working in more than one area and being flexible,” Dr. Dias said. Quoting Charles Darwin, who concluded that adaption to change predicts species survival, Dr. Dias advised pediatric hospitalists to look for new opportunities.

Taking on a broader range of responsibilities will not be a significant leap for many pediatric hospitalists. In a survey conducted several years ago by the American Academy of Pediatrics (AAP), hospital staff pediatricians were associated with activities ranging from work in the neonatal intensive care unit to primary ED coverage, according to Dr. Dias. Now with declining patient volumes on pediatric floors, she foresees an even greater expansion, including the care of young adults.

One organization formed in response to the COVID-19 pandemic, called the Pediatric Overflow Planning Contingency Response Network (POPCoRN) has been taking a lead in guiding the delivery of adult care in a pediatric environment. As a cochair of a community hospital special interest group within POPCoRN, Dr. Dias said she has participated in these discussions.

“At some centers, they have gone from age 18 to 21, some have gone up to age 25, some have gone up to 30 years,” she said.

Many centers are working to leverage telemedicine to reach pediatric patients no longer coming to the hospital, according to Dr. Dias.

“There are a lot of people being very creative in telemedicine,” she said. While it is considered as one way “to keep children at your institution,” Dr. Dias said others are considering how telemedicine might provide new opportunities. For one example, telemedicine might be an opportunity to deliver care in rural hospitals without pediatric services.

In an AAP survey of pediatric hospitalists conducted several years ago, justifying services was listed as the second most important concern right after access to subspecialty support. Due to COVID-19, Dr. Dias expects the order of these concerns to flip. Indeed, she predicted that many pediatric hospitalists are going to need to reassess their programs.

“We have started looking at what are our opportunities for building back revenue as well as how to recession-proof our practices should there be another surge and another decrease in pediatric volume,” Dr. Dias said.

The changes in pediatric care are not confined to the hospital setting. According to Amy H. Porter, MD, assistant professor of pediatrics at the Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., COVID-19 has “changed the way pediatric medicine is being practiced.”

Although she works in outpatient pediatric care, she said that routine care “is way down” in this setting as well. Like Dr. Dias, she has witnessed a major increase in the use of telemedicine to reach pediatric patients, but she is very concerned about the large proportion of children who are missing routine care, including vaccinations.

“We were already seeing outbreaks of whooping cough and measles pre COVID, so we are quite worried that we will see more,” Dr. Porter said.

A reduction in demand for care does not have the same immediate effect on revenue at a large health maintenance organization like Kaiser Permanente, but growing unemployment in the general population will mean fewer HMO members. In turn, this could have an impact on the entire system.

“When membership goes down, then it will have implications for how we can provide services,” Dr. Porter said.

In the meantime, social workers at Kaiser Permanente “are tirelessly working” to help parents losing benefits to obtain medicines for sick children with chronic diseases, according to Dr. Porter. She echoed the comments of Dr. Dias in predicting major changes in pediatric care if the COVID-19 pandemic and its economic consequences persist.

The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The rapid decline in pediatric hospital visits that came quickly after COVID-19 has emerged as a major public health threat, creating the need for adaptations among those offering hospital-based care, according to an objective look at patient numbers that was presented at the virtual Pediatric Hospital Medicine.

“Pre-COVID, operating margins had already taken a significant decline – and there are lots of different reasons for why this was happening – but a lot of hospitals in the United States were going from seeing about a 5% operating margin to closer to 2% to 3%,” said Magna Dias, MD, medical director, pediatric inpatient services, at Yale New Haven Children’s Hospital, Bridgeport, Conn.

This nearly 50% decline “was already putting pressure on us in the community hospital setting where pediatrics is not necessarily generating a ton of revenue to justify our programs, but post COVID, our operating revenue – and this is a report from May – was down 282%,” Dr. Dias reported.

Dr. Dias said that hundreds of hospitals have furloughed workers in the United States since the pandemic began. Although the job losses are not confined to pediatric care, statistics show that pediatrics is one of the hardest hit specialties.

“Looking specifically at ED [emergency department] visits under age 14, one study showed a 71% to 72% decrease post COVID,” Dr. Dias said. This included a 97% reduction in ED visits for flu and more than an 80% reduction in visits for asthma, otitis media, and nausea or vomiting.

It is not clear when children will return to the hospital in pre-COVID-19 numbers, but it might not be soon if the a second wave of infections follows the first, according to Dr. Dias. She suggested that pediatric hospitalists should be thinking about how to expand their services.

“One thing we are really good at in terms of working in the community hospital is diversification. We are used to working in more than one area and being flexible,” Dr. Dias said. Quoting Charles Darwin, who concluded that adaption to change predicts species survival, Dr. Dias advised pediatric hospitalists to look for new opportunities.

Taking on a broader range of responsibilities will not be a significant leap for many pediatric hospitalists. In a survey conducted several years ago by the American Academy of Pediatrics (AAP), hospital staff pediatricians were associated with activities ranging from work in the neonatal intensive care unit to primary ED coverage, according to Dr. Dias. Now with declining patient volumes on pediatric floors, she foresees an even greater expansion, including the care of young adults.

One organization formed in response to the COVID-19 pandemic, called the Pediatric Overflow Planning Contingency Response Network (POPCoRN) has been taking a lead in guiding the delivery of adult care in a pediatric environment. As a cochair of a community hospital special interest group within POPCoRN, Dr. Dias said she has participated in these discussions.

“At some centers, they have gone from age 18 to 21, some have gone up to age 25, some have gone up to 30 years,” she said.

Many centers are working to leverage telemedicine to reach pediatric patients no longer coming to the hospital, according to Dr. Dias.

“There are a lot of people being very creative in telemedicine,” she said. While it is considered as one way “to keep children at your institution,” Dr. Dias said others are considering how telemedicine might provide new opportunities. For one example, telemedicine might be an opportunity to deliver care in rural hospitals without pediatric services.

In an AAP survey of pediatric hospitalists conducted several years ago, justifying services was listed as the second most important concern right after access to subspecialty support. Due to COVID-19, Dr. Dias expects the order of these concerns to flip. Indeed, she predicted that many pediatric hospitalists are going to need to reassess their programs.

“We have started looking at what are our opportunities for building back revenue as well as how to recession-proof our practices should there be another surge and another decrease in pediatric volume,” Dr. Dias said.

The changes in pediatric care are not confined to the hospital setting. According to Amy H. Porter, MD, assistant professor of pediatrics at the Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., COVID-19 has “changed the way pediatric medicine is being practiced.”

Although she works in outpatient pediatric care, she said that routine care “is way down” in this setting as well. Like Dr. Dias, she has witnessed a major increase in the use of telemedicine to reach pediatric patients, but she is very concerned about the large proportion of children who are missing routine care, including vaccinations.

“We were already seeing outbreaks of whooping cough and measles pre COVID, so we are quite worried that we will see more,” Dr. Porter said.

A reduction in demand for care does not have the same immediate effect on revenue at a large health maintenance organization like Kaiser Permanente, but growing unemployment in the general population will mean fewer HMO members. In turn, this could have an impact on the entire system.

“When membership goes down, then it will have implications for how we can provide services,” Dr. Porter said.

In the meantime, social workers at Kaiser Permanente “are tirelessly working” to help parents losing benefits to obtain medicines for sick children with chronic diseases, according to Dr. Porter. She echoed the comments of Dr. Dias in predicting major changes in pediatric care if the COVID-19 pandemic and its economic consequences persist.

The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The rapid decline in pediatric hospital visits that came quickly after COVID-19 has emerged as a major public health threat, creating the need for adaptations among those offering hospital-based care, according to an objective look at patient numbers that was presented at the virtual Pediatric Hospital Medicine.

“Pre-COVID, operating margins had already taken a significant decline – and there are lots of different reasons for why this was happening – but a lot of hospitals in the United States were going from seeing about a 5% operating margin to closer to 2% to 3%,” said Magna Dias, MD, medical director, pediatric inpatient services, at Yale New Haven Children’s Hospital, Bridgeport, Conn.

This nearly 50% decline “was already putting pressure on us in the community hospital setting where pediatrics is not necessarily generating a ton of revenue to justify our programs, but post COVID, our operating revenue – and this is a report from May – was down 282%,” Dr. Dias reported.

Dr. Dias said that hundreds of hospitals have furloughed workers in the United States since the pandemic began. Although the job losses are not confined to pediatric care, statistics show that pediatrics is one of the hardest hit specialties.

“Looking specifically at ED [emergency department] visits under age 14, one study showed a 71% to 72% decrease post COVID,” Dr. Dias said. This included a 97% reduction in ED visits for flu and more than an 80% reduction in visits for asthma, otitis media, and nausea or vomiting.

It is not clear when children will return to the hospital in pre-COVID-19 numbers, but it might not be soon if the a second wave of infections follows the first, according to Dr. Dias. She suggested that pediatric hospitalists should be thinking about how to expand their services.

“One thing we are really good at in terms of working in the community hospital is diversification. We are used to working in more than one area and being flexible,” Dr. Dias said. Quoting Charles Darwin, who concluded that adaption to change predicts species survival, Dr. Dias advised pediatric hospitalists to look for new opportunities.

Taking on a broader range of responsibilities will not be a significant leap for many pediatric hospitalists. In a survey conducted several years ago by the American Academy of Pediatrics (AAP), hospital staff pediatricians were associated with activities ranging from work in the neonatal intensive care unit to primary ED coverage, according to Dr. Dias. Now with declining patient volumes on pediatric floors, she foresees an even greater expansion, including the care of young adults.

One organization formed in response to the COVID-19 pandemic, called the Pediatric Overflow Planning Contingency Response Network (POPCoRN) has been taking a lead in guiding the delivery of adult care in a pediatric environment. As a cochair of a community hospital special interest group within POPCoRN, Dr. Dias said she has participated in these discussions.

“At some centers, they have gone from age 18 to 21, some have gone up to age 25, some have gone up to 30 years,” she said.

Many centers are working to leverage telemedicine to reach pediatric patients no longer coming to the hospital, according to Dr. Dias.

“There are a lot of people being very creative in telemedicine,” she said. While it is considered as one way “to keep children at your institution,” Dr. Dias said others are considering how telemedicine might provide new opportunities. For one example, telemedicine might be an opportunity to deliver care in rural hospitals without pediatric services.

In an AAP survey of pediatric hospitalists conducted several years ago, justifying services was listed as the second most important concern right after access to subspecialty support. Due to COVID-19, Dr. Dias expects the order of these concerns to flip. Indeed, she predicted that many pediatric hospitalists are going to need to reassess their programs.

“We have started looking at what are our opportunities for building back revenue as well as how to recession-proof our practices should there be another surge and another decrease in pediatric volume,” Dr. Dias said.

The changes in pediatric care are not confined to the hospital setting. According to Amy H. Porter, MD, assistant professor of pediatrics at the Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., COVID-19 has “changed the way pediatric medicine is being practiced.”

Although she works in outpatient pediatric care, she said that routine care “is way down” in this setting as well. Like Dr. Dias, she has witnessed a major increase in the use of telemedicine to reach pediatric patients, but she is very concerned about the large proportion of children who are missing routine care, including vaccinations.

“We were already seeing outbreaks of whooping cough and measles pre COVID, so we are quite worried that we will see more,” Dr. Porter said.

A reduction in demand for care does not have the same immediate effect on revenue at a large health maintenance organization like Kaiser Permanente, but growing unemployment in the general population will mean fewer HMO members. In turn, this could have an impact on the entire system.

“When membership goes down, then it will have implications for how we can provide services,” Dr. Porter said.

In the meantime, social workers at Kaiser Permanente “are tirelessly working” to help parents losing benefits to obtain medicines for sick children with chronic diseases, according to Dr. Porter. She echoed the comments of Dr. Dias in predicting major changes in pediatric care if the COVID-19 pandemic and its economic consequences persist.

The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

sworcester@mdedge.com

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

sworcester@mdedge.com

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.

Immune checkpoint inhibition was not associated with an increased mortality risk from COVID-19 in patients with cancer in an international observational study.

The study included 113 cancer patients who had laboratory-confirmed COVID-19 within 12 months of receiving immune checkpoint inhibitor therapy. The patients did not receive chemotherapy within 3 months of testing positive for COVID-19.

In all, 33 patients were admitted to the hospital, including 6 who were admitted to the ICU, and 9 patients died.

“Nine out of 113 patients is a mortality rate of 8%, which is in the middle of the earlier reported rates for cancer patients in general [7.6%-12%],” said Aljosja Rogiers, MD, PhD, of the Melanoma Institute Australia in Sydney.

COVID-19 was the primary cause of death in seven of the patients, including three of those who were admitted to the ICU, Dr. Rogiers noted.

He reported these results during the AACR virtual meeting: COVID-19 and Cancer.
 

Study details

Patients in this study were treated at 19 hospitals in North America, Europe, and Australia, and the data cutoff was May 15, 2020. Most patients (64%) were treated in Europe, which was the epicenter for the COVID-19 pandemic at the time of data collection, Dr. Rogiers noted. A third of patients were in North America, and 3% were in Australia.

The patients’ median age was 63 years (range, 27-86 years). Most patients were men (65%), and most had Eastern Cooperative Oncology Group performance scores of 0-1 (90%).

The most common malignancies were melanoma (57%), non–small cell lung cancer (17%), and renal cell carcinoma (9%). Treatment was for early cancer in 26% of patients and for advanced cancer in 74%. Comorbidities included cardiovascular disease in 27% of patients, diabetes in 15%, pulmonary disease in 12%, and renal disease in 5%.

Immunosuppressive therapy equivalent to a prednisone dose of 10 mg or greater daily was given in 13% of patients, and other immunosuppressive therapies, such as infliximab, were given in 3%.

Among the 60% of patients with COVID-19 symptoms, 68% had fever, 59% had cough, 34% had dyspnea, and 15% had myalgia. Most of the 40% of asymptomatic patients were tested because they had COVID-19–positive contact, Dr. Rogiers noted.

Immune checkpoint inhibitor treatment included monotherapy with a programmed death–1/PD–ligand 1 inhibitor in 82% of patients, combination anti-PD-1 and anti-CTLA4 therapy in 13%, and other therapy – usually a checkpoint inhibitor combined with a different type of targeted agent – in 5%.

At the time of COVID-19 diagnosis, 30% of patients had achieved a partial response, complete response, or had no evidence of disease, 18% had stable disease, and 15% had progression. Response data were not available in 37% of cases, usually because treatment was only recently started prior to COVID-19 diagnosis, Dr. Rogiers said.

Treatments administered for COVID-19 included antibiotic therapy in 25% of patients, oxygen therapy in 20%, glucocorticoids in 10%, antiviral drugs in 6%, and intravenous immunoglobulin or anti–interleukin-6 in 2% each.

Among patients admitted to the ICU, 3% required mechanical ventilation, 2% had vasopressin, and 1% received renal replacement therapy.

At the data cutoff, 20 of 33 hospitalized patients (61%) had been discharged, and 4 (12%) were still in the hospital.
 

Mortality results

Nine patients died. The rate of death was 8% overall and 27% among hospitalized patients.

“The mortality rate of COVID-19 in the general population without comorbidities is about 1.4%,” Dr. Rogiers said. “For cancer patients, this is reported to be in the range of 7.6%-12%. To what extent patients on immune checkpoint inhibition are at a higher risk of mortality is currently unknown.”

Theoretically, immune checkpoint inhibition could either mitigate or exacerbate COVID-19 infection. It has been hypothesized that immune checkpoint inhibitors could increase the risk of severe acute lung injury or other complications of COVID-19, Dr. Rogiers said, explaining the rationale for the study.

The study shows that the patients who died had a median age of 72 years (range, 49-81 years), which is slightly higher than the median overall age of 63 years. Six patients were from North America, and three were from Italy.

“Two melanoma patients and two non–small cell lung cancer patients died,” Dr. Rogiers said. He noted that two other deaths were in patients with renal cell carcinoma, and three deaths were in other cancer types. All patients had advanced or metastatic disease.

Given that 57% of patients in the study had melanoma and 17% had NSCLC, this finding may indicate that COVID-19 has a slightly higher mortality rate in NSCLC patients than in melanoma patients, but the numbers are small, Dr. Rogiers said.

Notably, six of the patients who died were not admitted to the ICU. In four cases, this was because of underlying malignancy; in the other two cases, it was because of a constrained health care system, Dr. Rogiers said.

Overall, the findings show that the mortality rate of patients with COVID-19 and cancer treated with immune checkpoint inhibitors is similar to the mortality rate reported in the general cancer population, Dr. Rogiers said.

“Treatment with immune checkpoint inhibition does not seem to pose an additional mortality risk for cancer patients with COVID-19,” he concluded.

Dr. Rogiers reported having no conflicts of interest. There was no funding disclosed for the study.

sworcester@mdedge.com

SOURCE: Rogiers A et al. AACR: COVID-19 and Cancer, Abstract S02-01.

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.