Dermatology News

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

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

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

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

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

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

Three problems in not being able to touch the patient

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Waivers may be weak protection

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

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

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

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

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

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

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

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

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

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

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

How you can avoid a lawsuit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Consider these extra precautions

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

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

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

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

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

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

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

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

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

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

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

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

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

Three problems in not being able to touch the patient

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Waivers may be weak protection

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

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

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

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

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

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

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

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

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

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

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

How you can avoid a lawsuit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Consider these extra precautions

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

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

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

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

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

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

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

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

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

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

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

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

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

Three problems in not being able to touch the patient

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Waivers may be weak protection

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

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

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

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

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

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

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

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

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

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

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

How you can avoid a lawsuit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Consider these extra precautions

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

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

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

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

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

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

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

About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.

Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”

The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”

Underdiagnosis impedes research

Several factors may undermine this important research.

For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.

Courtesy Michael Wong/Women's College Hospital

The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.

Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
 

Defining a risk group

Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.

However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”

Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”

Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.

One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”

Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.

That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
 

Combination biologics

One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.

Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.

Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.

Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
 

Diet as an intervention

Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.

One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.

While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.

To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.

As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”

In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.

A risk model for PsA

Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.

Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”

About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.

Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”

The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”

Underdiagnosis impedes research

Several factors may undermine this important research.

For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.

Courtesy Michael Wong/Women's College Hospital

The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.

Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
 

Defining a risk group

Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.

However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”

Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”

Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.

One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”

Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.

That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
 

Combination biologics

One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.

Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.

Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.

Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
 

Diet as an intervention

Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.

One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.

While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.

To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.

As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”

In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.

A risk model for PsA

Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.

Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”

About one-third of all patients with psoriasis will develop psoriatic arthritis (PsA), a condition that comes with a host of vague symptoms and no definitive blood test for diagnosis. Prevention trials could help to identify higher-risk groups for PsA, with a goal to catch disease early and improve outcomes. The challenge is finding enough participants in a disease that lacks a clear clinical profile, then tracking them for long periods of time to generate any significant data.

Researchers have been taking several approaches to improve outcomes in PsA, Christopher Ritchlin, MD, MPH, chief of the allergy/immunology and rheumatology division at the University of Rochester (N.Y.), said in an interview. “We are in the process of identifying biomarkers and imaging findings that characterize psoriasis patients at high risk to develop PsA.”

The next step would be to design an interventional trial to treat high-risk patients before they develop musculoskeletal inflammation, with a goal to delay onset, attenuate severity, or completely prevent arthritis. The issue now is “we don’t know which agents would be most effective in this prevention effort,” Dr. Ritchlin said. Biologics that target specific pathways significant in PsA pathogenesis are an appealing prospect. However, “it may be that alternative therapies such as methotrexate or ultraviolet A radiation therapy, for example, may help arrest the development of joint inflammation.”

Underdiagnosis impedes research

Several factors may undermine this important research.

For one, psoriasis patients are often unaware that they have PsA. “Many times they are diagnosed incorrectly by nonspecialists. As a consequence, they do not get access to appropriate medications,” said Lihi Eder, MD, PhD, staff rheumatologist and director of the psoriatic arthritis research program at the University of Toronto’s Women’s College Research Institute.

Courtesy Michael Wong/Women's College Hospital

The condition also lacks a good diagnostic tool, Dr. Eder said. There’s no blood test that identifies this condition in the same manner as RA and lupus, for example. For these conditions, a general practitioner such as a family physician may conduct a blood test, and if positive, refer them to a rheumatologist. Such a system doesn’t exist for PsA. “Instead, nonspecialists are ordering tests and when they’re negative, they assume wrongly that these patients don’t have a rheumatic condition,” she explained.

Many clinicians aren’t that well versed in PsA, although dermatology has taken steps to become better educated. As a result, more dermatologists are referring patients to rheumatologists for PsA. Despite this small step forward, the heterogeneous clinical presentation of this condition makes diagnosis especially difficult. Unlike RA, which presents with inflammation in the joints, PsA can present as back or joint pain, “which makes our life as rheumatologists much more complex,” Dr. Eder said.
 

Defining a risk group

Most experts agree that the presence of psoriasis isn’t sufficient to conduct a prevention trial. Ideally, the goal of a prevention study would be to identify a critical subgroup of psoriasis patients at high risk of developing PsA.

However, this presents a challenging task, Dr. Eder said. Psoriasis is a risk factor for PsA, but most patients with psoriasis won’t actually develop it. Given that there’s an incidence rate of 2.7% a year, “you would need to recruit many hundreds of psoriasis patients and follow them for a long period of time until you have enough events.”

Moving forward with prevention studies calls for a better definition of the PsA risk group, according to Georg Schett, MD, chair of internal medicine in the department of internal medicine, rheumatology, and immunology at Friedrich‐Alexander University, Erlangen, Germany. “That’s very important, because you need to define such a group to make a prevention trial feasible. The whole benefit of such an approach is to catch the disease early, to say that psoriasis is a biomarker that’s linked to psoriatic arthritis.”

Indicators of risk other than psoriasis, such as pain, inflammation seen in ultrasound or MRI, and other specificities of psoriasis, could be used to define a population where interception can take place, Dr. Schett added. Although it’s not always clinically recognized, the combination of pain and structural lesions can be an indicator for developing PsA.

One prospective study he and his colleagues conducted in 114 psoriasis patients cited structural entheseal lesions and low cortical volumetric bone mineral density as risk factors in developing PsA. Keeping these factors in mind, Dr. Schett expects to see more studies in biointervention in these populations, “with the idea to prevent the onset of PsA and also decrease pain and subcutaneous inflammation.”

Researchers are currently working to identify those high-risk patients to include in an interventional trial, Dr. Ritchlin said.

That said, there’s been a great deal of “clinical trial angst” among investigators, Dr. Ritchlin noted. Outcomes in clinical trials for a wide range of biologic agents have not demonstrated significant advances in outcomes, compared with initial studies with anti–tumor necrosis factor–alpha (TNF-alpha) agents 20 years ago.
 

Combination biologics

One approach that’s generated some interest is the use of combination biologics medications. Sequential inhibition of cytokines such as interleukin-17A and TNF-alpha is of interest given their central contribution in joint inflammation and damage. “The challenge here of course is toxicity,” Dr. Ritchlin said. Trials that combined blockade of IL-1 and TNF-alpha in a RA trial years ago resulted in significant adverse events without improving outcomes.

Comparatively, a recent study in The Lancet Rheumatology reported success in using the IL-17A inhibitor secukinumab (Cosentyx) to reduce PsA symptoms. Tested on patients in the FUTURE 2 trial, investigators demonstrated that secukinumab in 300- and 150-mg doses safely reduced PsA signs and symptoms over a period of 5 years. Secukinumab also outperformed the TNF-alpha inhibitor adalimumab in 853 PsA patients in the 52-week, randomized, head-to-head, phase 3b EXCEED study, which was recently reported in The Lancet. Articular outcomes were similar between the two therapies, yet the secukinumab group did markedly better in Psoriasis Area and Severity Index scores, compared with the adalimumab group.

Based on these findings, “I suspect that studies examining the efficacy of combination biologics for treatment of PsA will surface in the near future,” Dr. Ritchlin said.

Yet another approach encompasses the spirit of personalized medicine. Clinicians often treat PsA patients empirically because they lack biomarkers that indicate which drug may be most effective for an individual patient, Dr. Ritchlin said. However, the technologies for investigating specific cell subsets in both the blood and tissues have advanced greatly over the last decade. “I am confident that a more precision medicine–based approach to the diagnosis and treatment of PsA is on the near horizon.”
 

Diet as an intervention

Other research has looked at the strong link between metabolic abnormalities and psoriasis and PsA. Some diets, such as the Mediterranean diet, show promise in improving the metabolic profile of these patients, making it a candidate as a potential intervention to reduce PsA risk. Another strategy would be to focus on limiting calories and promoting weight reduction.

One study in the British Journal of Dermatology looked at the associations between PsA and smoking, alcohol, and body mass index, identifying obesity as an important risk factor. Analyzing more than 90,000 psoriasis cases from the U.K. Clinical Practice Research Datalink between 1998 and 2014, researchers identified 1,409 PsA diagnoses. Among this cohort, researchers found an association between PsA and increased body mass index and moderate drinking. This finding underscores the need to support weight-reduction programs to reduce risk, Dr. Eder and Alexis Ogdie, MD, of the University of Pennsylvania, Philadelphia, wrote in a related editorial.

While observational studies such as this one provide further guidance for interventional trials, confounders can affect results. “Patients who lost weight could have made a positive lifestyle change (e.g., a dietary change) that was associated with the decreased risk for PsA rather than weight loss specifically, or they could have lost weight for unhealthy reasons,” Dr. Eder and Dr. Ogdie explained. Future research could address whether weight loss or other interventional factors may reduce PsA progression.

To make this work, “we would need to select patients that would benefit from diet. Secondly, we’d need to identify what kind of diet would be good for preventing PsA. And we don’t know that yet,” Dr. Eder further elaborated.

As with any prevention trial, the challenge is to follow patients over a long period of time, making sure they comply with the restrictions of the prescribed diet, Dr. Eder noted. “I do think it’s a really exciting type of intervention because it’s something that people are very interested in. There’s little risk of side effects, and it’s not very expensive.”

In other research on weight-loss methods, an observational study from Denmark found that bariatric surgery, especially gastric bypass, reduced the risk of developing PsA. This suggests that weight reduction by itself is important, “although we don’t know that yet,” Dr. Eder said.

A risk model for PsA

Dr. Eder and colleagues have been working on an algorithm that will incorporate clinical information (for example, the presence of nail lesions and the severity of psoriasis) to provide an estimated risk of developing PsA over the next 5 years. Subsequently, this information could be used to identify high-risk psoriasis patients as candidates for a prevention trial.

Other groups are looking at laboratory or imaging biomarkers to help develop PsA prediction models, she said. “Once we have these tools, we can move to next steps of prevention trials. What kinds of interventions should we apply? Are we talking biologic medications or other lifestyle interventions like diet? We are still at the early stages. However, with an improved understanding of the underlying mechanisms and risk factors we are expected to see prevention trials for PsA in the future.”

Another great morning, seeing patients in the comfort of quarantine!

Here goes. I’ll invite Gretchen by text: 617-555-5555. “TOO LONG.” How can 10 digits be too long? Trying again: 617-555-5555. “TOO LONG!” What the heck, let me leave off the last digit: 617-555-555. “TOO SHORT.”

Never mind, I’ll invite her by email.

Five minutes have gone by. Better call to see if she got the invite.

“Hello, is this Gretchen? Don’t hang up, I’m not a telemarketer! This is Dr. Rockoff. I sent you an invitation for our computer visit.

“You got it, great. Yes, you have to click on it to sign in. I know, your appointment’s at 8:30. It’s now 8:28. Let’s start early, why not?

“Hi, there! I can see you. Can you hear me? You’re nodding and your lips are moving. I can’t hear you. Did you enable your microphone?

“Nope, still can’t hear. I’ll call your cell, and we’ll talk that way.

“Yes, it’s me, Dr. Rockoff. What’s that? You enabled the microphone along with your video when you logged on? Well, there we go. How can I help today?

“You want a refill on your tretinoin gel for age management? Not a problem. Let’s see, you’ve been using it since 1996. No, you look great! Not a day over 76, really! I’ll have the staff escribe it right over.

“Okay, take care. Three years should be about right. Happy 80th!”

Wonder what happened there. Maybe things will go better for the next patient. Okay, I’m emailing an invite to Rob.

There he is! “Hi. Can you see me? Hear me? Nope, can’t hear you. Let me just call your cell.”

Okay, 972-555-5555. Ringing ... oh no, right to voicemail. “You have reached 972-555-5555. The mailbox is full and cannot accept messages. Please try some other time.”

“Okay, I’m back with you on the screen, Rob. Nope, still can’t hear you. I tried your cell but it went to voicemail. Yes, I see you’re holding the phone in your hand. Let me try you again.

“972-555-5555. Right to voicemail. Doesn’t your phone ring? You never make voice calls, only send texts? Look, please call me: 781-555-5555, write it down.

“Excellent, we’re in business. You’re worried about a mole that’s changing. You sent a photo to the office. Great, I’ll look right now on your record ... nope, not uploaded. Can you email me the photo? Please write down my email address: alanrockoffmdskincarespecialistist@myfabuloustelemedicineportal.now. Got that? Okay, please send the picture ...

“Returned as undeliverable? Show me what you typed ... Oh, wait. It’s ‘telemedicine,’ not ‘TellaMedicine.’ ” Yeah, that should do it.

“Okay, got the picture. You do fabulous super-closeups! Is that your navel next to it? Your left nostril? Okay. You tried to razor off the hair growing out it? Yes, that could account for the bleeding. Tell you what, go easy on it for the next 2 weeks, and send me another picture. Same email address.

“You have another question? Sure. You want a refill of your clindamycin gel because the tube from 2013 ran out? Guess you haven’t grown out of your acne yet. Sure, happy to send it in for you. Same pharmacy we have on file? You’re bunking with your parents in Wichita? No problem. Just need the pharmacy name and street. Boston, Wichita, whatever.

“Sure, happy to help. Enjoy your stay with your parents. You’ve been there 4 months? Are you cleaning your room? Mostly? Good. Take care. I’ll respond to your email in 2 weeks. Meantime, you might empty out your full voicemail box ... Oh, right, your generation only texts ...”

Okay, one more. Here’s Henrietta. I emailed her an invitation ... Holy Cow, she’s checked in! Let’s see, click “Join.” I can see her!

“Henrietta, is that you? Can you hear me? You can? You can hear me! Henrietta can hear me! And I can hear her!

“Yes, Henrietta, I’m all right. Just doing cartwheels around my study. Between COVID and the 95-degree heat and 100% humidity, it’s all the exercise I get.

“How can I help you today?

“Henrietta? HENRIETTA! Where have you gone, Henrietta?”

THERE IS A PROBLEM WITH YOUR CALL. DISCONNECT YOUR ROUTER, WAIT 65 SECONDS, RECONNECT, THEN RESTART YOUR WIFI, AND LOG IN AGAIN.

Maybe it’s time to go back to the office. A face shield and HAZMAT suit are sounding better all the time.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at [email protected].

Another great morning, seeing patients in the comfort of quarantine!

Here goes. I’ll invite Gretchen by text: 617-555-5555. “TOO LONG.” How can 10 digits be too long? Trying again: 617-555-5555. “TOO LONG!” What the heck, let me leave off the last digit: 617-555-555. “TOO SHORT.”

Never mind, I’ll invite her by email.

Five minutes have gone by. Better call to see if she got the invite.

“Hello, is this Gretchen? Don’t hang up, I’m not a telemarketer! This is Dr. Rockoff. I sent you an invitation for our computer visit.

“You got it, great. Yes, you have to click on it to sign in. I know, your appointment’s at 8:30. It’s now 8:28. Let’s start early, why not?

“Hi, there! I can see you. Can you hear me? You’re nodding and your lips are moving. I can’t hear you. Did you enable your microphone?

“Nope, still can’t hear. I’ll call your cell, and we’ll talk that way.

“Yes, it’s me, Dr. Rockoff. What’s that? You enabled the microphone along with your video when you logged on? Well, there we go. How can I help today?

“You want a refill on your tretinoin gel for age management? Not a problem. Let’s see, you’ve been using it since 1996. No, you look great! Not a day over 76, really! I’ll have the staff escribe it right over.

“Okay, take care. Three years should be about right. Happy 80th!”

Wonder what happened there. Maybe things will go better for the next patient. Okay, I’m emailing an invite to Rob.

There he is! “Hi. Can you see me? Hear me? Nope, can’t hear you. Let me just call your cell.”

Okay, 972-555-5555. Ringing ... oh no, right to voicemail. “You have reached 972-555-5555. The mailbox is full and cannot accept messages. Please try some other time.”

“Okay, I’m back with you on the screen, Rob. Nope, still can’t hear you. I tried your cell but it went to voicemail. Yes, I see you’re holding the phone in your hand. Let me try you again.

“972-555-5555. Right to voicemail. Doesn’t your phone ring? You never make voice calls, only send texts? Look, please call me: 781-555-5555, write it down.

“Excellent, we’re in business. You’re worried about a mole that’s changing. You sent a photo to the office. Great, I’ll look right now on your record ... nope, not uploaded. Can you email me the photo? Please write down my email address: alanrockoffmdskincarespecialistist@myfabuloustelemedicineportal.now. Got that? Okay, please send the picture ...

“Returned as undeliverable? Show me what you typed ... Oh, wait. It’s ‘telemedicine,’ not ‘TellaMedicine.’ ” Yeah, that should do it.

“Okay, got the picture. You do fabulous super-closeups! Is that your navel next to it? Your left nostril? Okay. You tried to razor off the hair growing out it? Yes, that could account for the bleeding. Tell you what, go easy on it for the next 2 weeks, and send me another picture. Same email address.

“You have another question? Sure. You want a refill of your clindamycin gel because the tube from 2013 ran out? Guess you haven’t grown out of your acne yet. Sure, happy to send it in for you. Same pharmacy we have on file? You’re bunking with your parents in Wichita? No problem. Just need the pharmacy name and street. Boston, Wichita, whatever.

“Sure, happy to help. Enjoy your stay with your parents. You’ve been there 4 months? Are you cleaning your room? Mostly? Good. Take care. I’ll respond to your email in 2 weeks. Meantime, you might empty out your full voicemail box ... Oh, right, your generation only texts ...”

Okay, one more. Here’s Henrietta. I emailed her an invitation ... Holy Cow, she’s checked in! Let’s see, click “Join.” I can see her!

“Henrietta, is that you? Can you hear me? You can? You can hear me! Henrietta can hear me! And I can hear her!

“Yes, Henrietta, I’m all right. Just doing cartwheels around my study. Between COVID and the 95-degree heat and 100% humidity, it’s all the exercise I get.

“How can I help you today?

“Henrietta? HENRIETTA! Where have you gone, Henrietta?”

THERE IS A PROBLEM WITH YOUR CALL. DISCONNECT YOUR ROUTER, WAIT 65 SECONDS, RECONNECT, THEN RESTART YOUR WIFI, AND LOG IN AGAIN.

Maybe it’s time to go back to the office. A face shield and HAZMAT suit are sounding better all the time.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at [email protected].

Another great morning, seeing patients in the comfort of quarantine!

Here goes. I’ll invite Gretchen by text: 617-555-5555. “TOO LONG.” How can 10 digits be too long? Trying again: 617-555-5555. “TOO LONG!” What the heck, let me leave off the last digit: 617-555-555. “TOO SHORT.”

Never mind, I’ll invite her by email.

Five minutes have gone by. Better call to see if she got the invite.

“Hello, is this Gretchen? Don’t hang up, I’m not a telemarketer! This is Dr. Rockoff. I sent you an invitation for our computer visit.

“You got it, great. Yes, you have to click on it to sign in. I know, your appointment’s at 8:30. It’s now 8:28. Let’s start early, why not?

“Hi, there! I can see you. Can you hear me? You’re nodding and your lips are moving. I can’t hear you. Did you enable your microphone?

“Nope, still can’t hear. I’ll call your cell, and we’ll talk that way.

“Yes, it’s me, Dr. Rockoff. What’s that? You enabled the microphone along with your video when you logged on? Well, there we go. How can I help today?

“You want a refill on your tretinoin gel for age management? Not a problem. Let’s see, you’ve been using it since 1996. No, you look great! Not a day over 76, really! I’ll have the staff escribe it right over.

“Okay, take care. Three years should be about right. Happy 80th!”

Wonder what happened there. Maybe things will go better for the next patient. Okay, I’m emailing an invite to Rob.

There he is! “Hi. Can you see me? Hear me? Nope, can’t hear you. Let me just call your cell.”

Okay, 972-555-5555. Ringing ... oh no, right to voicemail. “You have reached 972-555-5555. The mailbox is full and cannot accept messages. Please try some other time.”

“Okay, I’m back with you on the screen, Rob. Nope, still can’t hear you. I tried your cell but it went to voicemail. Yes, I see you’re holding the phone in your hand. Let me try you again.

“972-555-5555. Right to voicemail. Doesn’t your phone ring? You never make voice calls, only send texts? Look, please call me: 781-555-5555, write it down.

“Excellent, we’re in business. You’re worried about a mole that’s changing. You sent a photo to the office. Great, I’ll look right now on your record ... nope, not uploaded. Can you email me the photo? Please write down my email address: alanrockoffmdskincarespecialistist@myfabuloustelemedicineportal.now. Got that? Okay, please send the picture ...

“Returned as undeliverable? Show me what you typed ... Oh, wait. It’s ‘telemedicine,’ not ‘TellaMedicine.’ ” Yeah, that should do it.

“Okay, got the picture. You do fabulous super-closeups! Is that your navel next to it? Your left nostril? Okay. You tried to razor off the hair growing out it? Yes, that could account for the bleeding. Tell you what, go easy on it for the next 2 weeks, and send me another picture. Same email address.

“You have another question? Sure. You want a refill of your clindamycin gel because the tube from 2013 ran out? Guess you haven’t grown out of your acne yet. Sure, happy to send it in for you. Same pharmacy we have on file? You’re bunking with your parents in Wichita? No problem. Just need the pharmacy name and street. Boston, Wichita, whatever.

“Sure, happy to help. Enjoy your stay with your parents. You’ve been there 4 months? Are you cleaning your room? Mostly? Good. Take care. I’ll respond to your email in 2 weeks. Meantime, you might empty out your full voicemail box ... Oh, right, your generation only texts ...”

Okay, one more. Here’s Henrietta. I emailed her an invitation ... Holy Cow, she’s checked in! Let’s see, click “Join.” I can see her!

“Henrietta, is that you? Can you hear me? You can? You can hear me! Henrietta can hear me! And I can hear her!

“Yes, Henrietta, I’m all right. Just doing cartwheels around my study. Between COVID and the 95-degree heat and 100% humidity, it’s all the exercise I get.

“How can I help you today?

“Henrietta? HENRIETTA! Where have you gone, Henrietta?”

THERE IS A PROBLEM WITH YOUR CALL. DISCONNECT YOUR ROUTER, WAIT 65 SECONDS, RECONNECT, THEN RESTART YOUR WIFI, AND LOG IN AGAIN.

Maybe it’s time to go back to the office. A face shield and HAZMAT suit are sounding better all the time.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now semiretired after 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available online. Write to him at [email protected].

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

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

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

‘Further evaluation’ needed

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

‘Further evaluation’ needed

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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

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

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

‘Further evaluation’ needed

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

An international panel of 49 melanoma specialists has come out against routine gene expression profile (GEP) testing for cutaneous melanoma, pending solid proof of clinical benefit.

“The currently published evidence is insufficient to establish that routine use of GEP testing provides additional clinical value for melanoma staging and prognostication beyond available clinicopathologic variables,” they argued.

Patients must be protected “from potentially inaccurate testing that may provide a false sense of security or perceived increased risk” that could lead to the wrong decisions, they said in a consensus statement from the United States’ national Melanoma Prevention Working Group. The statement was published on July 29 in JAMA Dermatology.

The GEP test for melanoma that is available in the United States – DecisionDx-Melanoma from Castle Biosciences – checks the expression levels of 31 genes reported to be associated with melanoma metastasis and recurrence. It uses quantitative reverse transcriptase and polymerase chain reaction on RNA from formalin-fixed, paraffin-embedded biopsy specimens.

The test stratifies patients as being at low, intermediate, or high risk. It is marketed as a guide to whether to perform sentinel lymph node biopsies (SLNB) on patients age 55 years or older with tumors less than 2 mm deep and to decide what levels of follow-up, imaging, and adjuvant treatment are appropriate for tumors at least 0.3 mm deep.

Medicare reimburses at $7,193 per test for SLNB-eligible patients.

However, this test is not endorsed by the American Academy of Dermatology or National Comprehensive Cancer Network outside of studies because the evidence of benefit is not strong enough, the consensus authors noted.

Even so, use of the test is growing, with up to 10% of cutaneous melanomas now being tested in the United States.

Company welcomes “further discussions”

“To date, thousands of clinicians – over 4,200 US clinicians in the last 12 months – have utilized our GEP test for cutaneous melanoma in their patients after reviewing our clinical data and determining that our test provides clinically actionable information that complements current melanoma staging,” said Castle Biosciences Vice President of Research and Development Bob Cook, PhD, when asked for comment.

Citing company-funded studies, he said that “the strength of the existing evidence in support of these claims has undergone rigorous evaluation to obtain Medicare reimbursement.”

“We believe that the application of the test to help guide [the] decision to pursue SLNB has the potential to realize significant cost savings by reducing unnecessary SLNB procedures, particularly in the T1 population.”

Asked for a reaction to the consensus statement, Dr. Cook said in an interview: “We recently launched two prospective studies with multiple centers nationwide that will involve thousands of patients and provide additional data relating our tests to patient outcomes. ... We welcome further discussions to promote collaborative efforts with centers that are part of the [Melanoma Prevention Working Group] to improve patient outcomes.”
 

Cart before the horse

Medicare, although it reimburses the test, has its doubts. Due to the “low strength of evidence,” the Centers for Medicare & Medicaid Services said in their local coverage determination that continued reimbursement depends on demonstration of 95% or greater distant-metastasis–free survival and melanoma-specific survival at 3 years “in patients directed to no SLNB by the test compared to standard of care, and ... evidence of higher SLNB positivity in patients selected for this procedure by the test compared to standard of care.”

The statement hints at the Achilles’ heel of GEP in melanoma – that is, the lack of evidence that test results improve outcomes. This was the main concern of the consensus statement; the cart is before the horse.

One of the consensus authors, David Polsky, MD, PhD, professor of dermatologic oncology at New York University, New York City, said that “most of the data for this test come from retrospectively collected patient groups.” The prospective studies have been generally small, with no comparator group. “While they have shown some promise in intermediate thickness melanoma, they have not yet demonstrated utility for thin, stage I melanomas.”
 

First, do no harm

A new meta-analysis of over 800 patients with cutaneous melanoma tested by DecisionDx-Melanoma, published in JAMA Dermatology alongside the consensus statement, shows how the tests perform.

Among patients with a recurrence, DecisionDx-Melanoma correctly classified 82% with stage II disease but only 29% with stage I disease as high risk. Among those without recurrence, the test correctly classified 90% of stage I patients but only 44% with stage II disease as low risk.

Similar results were seen with the melanoma GEP test available in Europe, MelaGenix (NeraCare GmbH). This test was developed from a panel that was narrowed to seven protective genes and one high-risk gene using a training cohort of 125 cutaneous melanomas.

provided by MSKCC press office

“The prognostic ability of GEP tests ... appeared to be poor at correctly identifying recurrence in patients with stage I disease, suggesting limited potential for clinical utility in these patients,” commented the meta-analysis authors, led by Michael Marchetti, MD, an assistant professor of dermatology at Weill Cornell Medical College in New York City.

“Unknown are the harms associated with a false-positive result, which were 10-fold more frequent than true-positive results in patients with stage I disease,” they pointed out.

“Further research is needed to define the incremental improvement in risk predictions provided by the test beyond ... all other known clinicopathologic factors,” which include patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and other factors proven to be linked to outcomes, they said.

Studies so far suggesting benefit have incorporated a few of those factors, but not all of them. For now, “it is not clear which patients should be tested or how to act on the results,” Dr. Marchetti and colleagues concluded.

Breast cancer standard of proof

Larger, prospective studies are needed to address whether GEP testing can replace SLNB to predict relapse “and [can identify] patients who could be spared surveillance imaging and/or benefit from adjuvant therapy,” wrote the consensus authors. Follow-up also needs to be long enough to detect delayed recurrence of thin melanomas, they added.

With more research, there is reason to hope that gene expression profiling will help in melanoma; it’s already standard of care in breast cancer, they pointed out.

On the hope front, one cohort study evaluated whether DecisionDx-Melanoma could identify patients at low risk for positive lymph nodes in T1/T2 disease who were eligible for biopsy. Only 1.6% of subjects who were aged 65 years or older and identified by the test as low risk had a positive node.

“This is a promising direction of investigation ... in a narrow, defined population,” noted authors led by Carrie Kovarik, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, in an opinion piece last spring.

But still, until there’s “clear evidence that [DecisionDx-Melanoma] results affect patient outcomes, we should not use it to influence care decisions in patients with thin” melanomas. Dermatology “should expect the same standards” of proof as breast cancer, they wrote.

What to do right now?

Despite the marketing, “think twice before ordering GEP tests for” T1a melanomas is the message in an editorial that accompanies the consensus statement. The 5- and 10-year melanoma-specific survival rates are 99% and 98%, respectively. GEP tests are unlikely to change these estimates significantly. In fact, the new meta-analysis indicates “that there may be an approximately 12% misassignment rate in this population,” wrote editorialists Warren Chan, of Baylor College of Medicine, Houston and Hensin Tsao, MD, PhD, director of the melanoma genetics program at Massachusetts General Hospital, Boston.

“Even if you use GEP testing and discover a low-risk class assignment for a 2 mm thick melanoma, avoid the urge to bypass the sentinel lymph node discussion. ... Nodal sampling, for good reasons, remains part of all major guidelines and determines eligibility for adjuvant treatments. ... Many of us engaged in genomics research believe that accurate [melanoma] GEP will be developed in time, but better tools and greater tenacity are needed,” they wrote.

There was no industry funding for the consensus statement and meta-analysis. Authors on the consensus statement reported numerous ties to pharmaceutical and other companies, as listed in the paper.

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

An international panel of 49 melanoma specialists has come out against routine gene expression profile (GEP) testing for cutaneous melanoma, pending solid proof of clinical benefit.

“The currently published evidence is insufficient to establish that routine use of GEP testing provides additional clinical value for melanoma staging and prognostication beyond available clinicopathologic variables,” they argued.

Patients must be protected “from potentially inaccurate testing that may provide a false sense of security or perceived increased risk” that could lead to the wrong decisions, they said in a consensus statement from the United States’ national Melanoma Prevention Working Group. The statement was published on July 29 in JAMA Dermatology.

The GEP test for melanoma that is available in the United States – DecisionDx-Melanoma from Castle Biosciences – checks the expression levels of 31 genes reported to be associated with melanoma metastasis and recurrence. It uses quantitative reverse transcriptase and polymerase chain reaction on RNA from formalin-fixed, paraffin-embedded biopsy specimens.

The test stratifies patients as being at low, intermediate, or high risk. It is marketed as a guide to whether to perform sentinel lymph node biopsies (SLNB) on patients age 55 years or older with tumors less than 2 mm deep and to decide what levels of follow-up, imaging, and adjuvant treatment are appropriate for tumors at least 0.3 mm deep.

Medicare reimburses at $7,193 per test for SLNB-eligible patients.

However, this test is not endorsed by the American Academy of Dermatology or National Comprehensive Cancer Network outside of studies because the evidence of benefit is not strong enough, the consensus authors noted.

Even so, use of the test is growing, with up to 10% of cutaneous melanomas now being tested in the United States.

Company welcomes “further discussions”

“To date, thousands of clinicians – over 4,200 US clinicians in the last 12 months – have utilized our GEP test for cutaneous melanoma in their patients after reviewing our clinical data and determining that our test provides clinically actionable information that complements current melanoma staging,” said Castle Biosciences Vice President of Research and Development Bob Cook, PhD, when asked for comment.

Citing company-funded studies, he said that “the strength of the existing evidence in support of these claims has undergone rigorous evaluation to obtain Medicare reimbursement.”

“We believe that the application of the test to help guide [the] decision to pursue SLNB has the potential to realize significant cost savings by reducing unnecessary SLNB procedures, particularly in the T1 population.”

Asked for a reaction to the consensus statement, Dr. Cook said in an interview: “We recently launched two prospective studies with multiple centers nationwide that will involve thousands of patients and provide additional data relating our tests to patient outcomes. ... We welcome further discussions to promote collaborative efforts with centers that are part of the [Melanoma Prevention Working Group] to improve patient outcomes.”
 

Cart before the horse

Medicare, although it reimburses the test, has its doubts. Due to the “low strength of evidence,” the Centers for Medicare & Medicaid Services said in their local coverage determination that continued reimbursement depends on demonstration of 95% or greater distant-metastasis–free survival and melanoma-specific survival at 3 years “in patients directed to no SLNB by the test compared to standard of care, and ... evidence of higher SLNB positivity in patients selected for this procedure by the test compared to standard of care.”

The statement hints at the Achilles’ heel of GEP in melanoma – that is, the lack of evidence that test results improve outcomes. This was the main concern of the consensus statement; the cart is before the horse.

One of the consensus authors, David Polsky, MD, PhD, professor of dermatologic oncology at New York University, New York City, said that “most of the data for this test come from retrospectively collected patient groups.” The prospective studies have been generally small, with no comparator group. “While they have shown some promise in intermediate thickness melanoma, they have not yet demonstrated utility for thin, stage I melanomas.”
 

First, do no harm

A new meta-analysis of over 800 patients with cutaneous melanoma tested by DecisionDx-Melanoma, published in JAMA Dermatology alongside the consensus statement, shows how the tests perform.

Among patients with a recurrence, DecisionDx-Melanoma correctly classified 82% with stage II disease but only 29% with stage I disease as high risk. Among those without recurrence, the test correctly classified 90% of stage I patients but only 44% with stage II disease as low risk.

Similar results were seen with the melanoma GEP test available in Europe, MelaGenix (NeraCare GmbH). This test was developed from a panel that was narrowed to seven protective genes and one high-risk gene using a training cohort of 125 cutaneous melanomas.

provided by MSKCC press office

“The prognostic ability of GEP tests ... appeared to be poor at correctly identifying recurrence in patients with stage I disease, suggesting limited potential for clinical utility in these patients,” commented the meta-analysis authors, led by Michael Marchetti, MD, an assistant professor of dermatology at Weill Cornell Medical College in New York City.

“Unknown are the harms associated with a false-positive result, which were 10-fold more frequent than true-positive results in patients with stage I disease,” they pointed out.

“Further research is needed to define the incremental improvement in risk predictions provided by the test beyond ... all other known clinicopathologic factors,” which include patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and other factors proven to be linked to outcomes, they said.

Studies so far suggesting benefit have incorporated a few of those factors, but not all of them. For now, “it is not clear which patients should be tested or how to act on the results,” Dr. Marchetti and colleagues concluded.

Breast cancer standard of proof

Larger, prospective studies are needed to address whether GEP testing can replace SLNB to predict relapse “and [can identify] patients who could be spared surveillance imaging and/or benefit from adjuvant therapy,” wrote the consensus authors. Follow-up also needs to be long enough to detect delayed recurrence of thin melanomas, they added.

With more research, there is reason to hope that gene expression profiling will help in melanoma; it’s already standard of care in breast cancer, they pointed out.

On the hope front, one cohort study evaluated whether DecisionDx-Melanoma could identify patients at low risk for positive lymph nodes in T1/T2 disease who were eligible for biopsy. Only 1.6% of subjects who were aged 65 years or older and identified by the test as low risk had a positive node.

“This is a promising direction of investigation ... in a narrow, defined population,” noted authors led by Carrie Kovarik, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, in an opinion piece last spring.

But still, until there’s “clear evidence that [DecisionDx-Melanoma] results affect patient outcomes, we should not use it to influence care decisions in patients with thin” melanomas. Dermatology “should expect the same standards” of proof as breast cancer, they wrote.

What to do right now?

Despite the marketing, “think twice before ordering GEP tests for” T1a melanomas is the message in an editorial that accompanies the consensus statement. The 5- and 10-year melanoma-specific survival rates are 99% and 98%, respectively. GEP tests are unlikely to change these estimates significantly. In fact, the new meta-analysis indicates “that there may be an approximately 12% misassignment rate in this population,” wrote editorialists Warren Chan, of Baylor College of Medicine, Houston and Hensin Tsao, MD, PhD, director of the melanoma genetics program at Massachusetts General Hospital, Boston.

“Even if you use GEP testing and discover a low-risk class assignment for a 2 mm thick melanoma, avoid the urge to bypass the sentinel lymph node discussion. ... Nodal sampling, for good reasons, remains part of all major guidelines and determines eligibility for adjuvant treatments. ... Many of us engaged in genomics research believe that accurate [melanoma] GEP will be developed in time, but better tools and greater tenacity are needed,” they wrote.

There was no industry funding for the consensus statement and meta-analysis. Authors on the consensus statement reported numerous ties to pharmaceutical and other companies, as listed in the paper.

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

An international panel of 49 melanoma specialists has come out against routine gene expression profile (GEP) testing for cutaneous melanoma, pending solid proof of clinical benefit.

“The currently published evidence is insufficient to establish that routine use of GEP testing provides additional clinical value for melanoma staging and prognostication beyond available clinicopathologic variables,” they argued.

Patients must be protected “from potentially inaccurate testing that may provide a false sense of security or perceived increased risk” that could lead to the wrong decisions, they said in a consensus statement from the United States’ national Melanoma Prevention Working Group. The statement was published on July 29 in JAMA Dermatology.

The GEP test for melanoma that is available in the United States – DecisionDx-Melanoma from Castle Biosciences – checks the expression levels of 31 genes reported to be associated with melanoma metastasis and recurrence. It uses quantitative reverse transcriptase and polymerase chain reaction on RNA from formalin-fixed, paraffin-embedded biopsy specimens.

The test stratifies patients as being at low, intermediate, or high risk. It is marketed as a guide to whether to perform sentinel lymph node biopsies (SLNB) on patients age 55 years or older with tumors less than 2 mm deep and to decide what levels of follow-up, imaging, and adjuvant treatment are appropriate for tumors at least 0.3 mm deep.

Medicare reimburses at $7,193 per test for SLNB-eligible patients.

However, this test is not endorsed by the American Academy of Dermatology or National Comprehensive Cancer Network outside of studies because the evidence of benefit is not strong enough, the consensus authors noted.

Even so, use of the test is growing, with up to 10% of cutaneous melanomas now being tested in the United States.

Company welcomes “further discussions”

“To date, thousands of clinicians – over 4,200 US clinicians in the last 12 months – have utilized our GEP test for cutaneous melanoma in their patients after reviewing our clinical data and determining that our test provides clinically actionable information that complements current melanoma staging,” said Castle Biosciences Vice President of Research and Development Bob Cook, PhD, when asked for comment.

Citing company-funded studies, he said that “the strength of the existing evidence in support of these claims has undergone rigorous evaluation to obtain Medicare reimbursement.”

“We believe that the application of the test to help guide [the] decision to pursue SLNB has the potential to realize significant cost savings by reducing unnecessary SLNB procedures, particularly in the T1 population.”

Asked for a reaction to the consensus statement, Dr. Cook said in an interview: “We recently launched two prospective studies with multiple centers nationwide that will involve thousands of patients and provide additional data relating our tests to patient outcomes. ... We welcome further discussions to promote collaborative efforts with centers that are part of the [Melanoma Prevention Working Group] to improve patient outcomes.”
 

Cart before the horse

Medicare, although it reimburses the test, has its doubts. Due to the “low strength of evidence,” the Centers for Medicare & Medicaid Services said in their local coverage determination that continued reimbursement depends on demonstration of 95% or greater distant-metastasis–free survival and melanoma-specific survival at 3 years “in patients directed to no SLNB by the test compared to standard of care, and ... evidence of higher SLNB positivity in patients selected for this procedure by the test compared to standard of care.”

The statement hints at the Achilles’ heel of GEP in melanoma – that is, the lack of evidence that test results improve outcomes. This was the main concern of the consensus statement; the cart is before the horse.

One of the consensus authors, David Polsky, MD, PhD, professor of dermatologic oncology at New York University, New York City, said that “most of the data for this test come from retrospectively collected patient groups.” The prospective studies have been generally small, with no comparator group. “While they have shown some promise in intermediate thickness melanoma, they have not yet demonstrated utility for thin, stage I melanomas.”
 

First, do no harm

A new meta-analysis of over 800 patients with cutaneous melanoma tested by DecisionDx-Melanoma, published in JAMA Dermatology alongside the consensus statement, shows how the tests perform.

Among patients with a recurrence, DecisionDx-Melanoma correctly classified 82% with stage II disease but only 29% with stage I disease as high risk. Among those without recurrence, the test correctly classified 90% of stage I patients but only 44% with stage II disease as low risk.

Similar results were seen with the melanoma GEP test available in Europe, MelaGenix (NeraCare GmbH). This test was developed from a panel that was narrowed to seven protective genes and one high-risk gene using a training cohort of 125 cutaneous melanomas.

provided by MSKCC press office

“The prognostic ability of GEP tests ... appeared to be poor at correctly identifying recurrence in patients with stage I disease, suggesting limited potential for clinical utility in these patients,” commented the meta-analysis authors, led by Michael Marchetti, MD, an assistant professor of dermatology at Weill Cornell Medical College in New York City.

“Unknown are the harms associated with a false-positive result, which were 10-fold more frequent than true-positive results in patients with stage I disease,” they pointed out.

“Further research is needed to define the incremental improvement in risk predictions provided by the test beyond ... all other known clinicopathologic factors,” which include patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and other factors proven to be linked to outcomes, they said.

Studies so far suggesting benefit have incorporated a few of those factors, but not all of them. For now, “it is not clear which patients should be tested or how to act on the results,” Dr. Marchetti and colleagues concluded.

Breast cancer standard of proof

Larger, prospective studies are needed to address whether GEP testing can replace SLNB to predict relapse “and [can identify] patients who could be spared surveillance imaging and/or benefit from adjuvant therapy,” wrote the consensus authors. Follow-up also needs to be long enough to detect delayed recurrence of thin melanomas, they added.

With more research, there is reason to hope that gene expression profiling will help in melanoma; it’s already standard of care in breast cancer, they pointed out.

On the hope front, one cohort study evaluated whether DecisionDx-Melanoma could identify patients at low risk for positive lymph nodes in T1/T2 disease who were eligible for biopsy. Only 1.6% of subjects who were aged 65 years or older and identified by the test as low risk had a positive node.

“This is a promising direction of investigation ... in a narrow, defined population,” noted authors led by Carrie Kovarik, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, in an opinion piece last spring.

But still, until there’s “clear evidence that [DecisionDx-Melanoma] results affect patient outcomes, we should not use it to influence care decisions in patients with thin” melanomas. Dermatology “should expect the same standards” of proof as breast cancer, they wrote.

What to do right now?

Despite the marketing, “think twice before ordering GEP tests for” T1a melanomas is the message in an editorial that accompanies the consensus statement. The 5- and 10-year melanoma-specific survival rates are 99% and 98%, respectively. GEP tests are unlikely to change these estimates significantly. In fact, the new meta-analysis indicates “that there may be an approximately 12% misassignment rate in this population,” wrote editorialists Warren Chan, of Baylor College of Medicine, Houston and Hensin Tsao, MD, PhD, director of the melanoma genetics program at Massachusetts General Hospital, Boston.

“Even if you use GEP testing and discover a low-risk class assignment for a 2 mm thick melanoma, avoid the urge to bypass the sentinel lymph node discussion. ... Nodal sampling, for good reasons, remains part of all major guidelines and determines eligibility for adjuvant treatments. ... Many of us engaged in genomics research believe that accurate [melanoma] GEP will be developed in time, but better tools and greater tenacity are needed,” they wrote.

There was no industry funding for the consensus statement and meta-analysis. Authors on the consensus statement reported numerous ties to pharmaceutical and other companies, as listed in the paper.

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

Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.

“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”

The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.

In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.

The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.

The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.

Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”

Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”

He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”

Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.

The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.

“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”

Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”

This story was originally published by ProPublica.

Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.

“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”

The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.

In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.

The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.

The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.

Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”

Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”

He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”

Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.

The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.

“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”

Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”

This story was originally published by ProPublica.

Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.

“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”

The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.

In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.

The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.

The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.

Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”

Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”

He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”

Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.

The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.

“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”

Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”

This story was originally published by ProPublica.

The US Food and Drug Administration has removed two senior public relations employees, one of whom advised the agency against unbridled promotion of convalescent blood plasma as a treatment for people with COVID-19, multiple media outlets reported Aug. 28.

Officials claim the dismissals are coincidental and are not related to a controversy about whether claims regarding convalescent plasma therapy that were put forth by President Donald Trump and FDA Commissioner Stephen M. Hahn, MD, were exaggerated, according to reports from The New York Times , CNN, and elsewhere.

One of the PR employees, Emily Miller, was on the job less than 2 weeks. The White House named her FDA chief spokeswoman 11 days ago, but Hahn removed her from that post Aug. 28.

On Aug. 27, the US Department of Health and Human Services terminated the contract for Wayne L. Pines, a PR consultant to the FDA. Pines reportedly advised Hahn to apologize for making misleading claims about the therapeutic benefits of convalescent plasma therapy for COVID-19.

The FDA did not respond to multiple requests for comment.

The controversy stems from comments Hahn made about the announcement of the emergency use authorization for convalescent plasma for patients with COVID-19. He said that plasma had been found to save the lives of 35 out of every 100 people who were treated. That statement was later found to be erroneous because he presented a relative risk reduction as an absolute decrease in risk. He later apologized via Twitter.

Researchers running clinical trials to evaluate the efficacy of convalescent plasma for COVID-19 are concerned that the emergency use authorization could thwart efforts to recruit participants for their studies.

This article first appeared on Medscape.com.

The US Food and Drug Administration has removed two senior public relations employees, one of whom advised the agency against unbridled promotion of convalescent blood plasma as a treatment for people with COVID-19, multiple media outlets reported Aug. 28.

Officials claim the dismissals are coincidental and are not related to a controversy about whether claims regarding convalescent plasma therapy that were put forth by President Donald Trump and FDA Commissioner Stephen M. Hahn, MD, were exaggerated, according to reports from The New York Times , CNN, and elsewhere.

One of the PR employees, Emily Miller, was on the job less than 2 weeks. The White House named her FDA chief spokeswoman 11 days ago, but Hahn removed her from that post Aug. 28.

On Aug. 27, the US Department of Health and Human Services terminated the contract for Wayne L. Pines, a PR consultant to the FDA. Pines reportedly advised Hahn to apologize for making misleading claims about the therapeutic benefits of convalescent plasma therapy for COVID-19.

The FDA did not respond to multiple requests for comment.

The controversy stems from comments Hahn made about the announcement of the emergency use authorization for convalescent plasma for patients with COVID-19. He said that plasma had been found to save the lives of 35 out of every 100 people who were treated. That statement was later found to be erroneous because he presented a relative risk reduction as an absolute decrease in risk. He later apologized via Twitter.

Researchers running clinical trials to evaluate the efficacy of convalescent plasma for COVID-19 are concerned that the emergency use authorization could thwart efforts to recruit participants for their studies.

This article first appeared on Medscape.com.

The US Food and Drug Administration has removed two senior public relations employees, one of whom advised the agency against unbridled promotion of convalescent blood plasma as a treatment for people with COVID-19, multiple media outlets reported Aug. 28.

Officials claim the dismissals are coincidental and are not related to a controversy about whether claims regarding convalescent plasma therapy that were put forth by President Donald Trump and FDA Commissioner Stephen M. Hahn, MD, were exaggerated, according to reports from The New York Times , CNN, and elsewhere.

One of the PR employees, Emily Miller, was on the job less than 2 weeks. The White House named her FDA chief spokeswoman 11 days ago, but Hahn removed her from that post Aug. 28.

On Aug. 27, the US Department of Health and Human Services terminated the contract for Wayne L. Pines, a PR consultant to the FDA. Pines reportedly advised Hahn to apologize for making misleading claims about the therapeutic benefits of convalescent plasma therapy for COVID-19.

The FDA did not respond to multiple requests for comment.

The controversy stems from comments Hahn made about the announcement of the emergency use authorization for convalescent plasma for patients with COVID-19. He said that plasma had been found to save the lives of 35 out of every 100 people who were treated. That statement was later found to be erroneous because he presented a relative risk reduction as an absolute decrease in risk. He later apologized via Twitter.

Researchers running clinical trials to evaluate the efficacy of convalescent plasma for COVID-19 are concerned that the emergency use authorization could thwart efforts to recruit participants for their studies.

This article first appeared on Medscape.com.

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

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

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

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

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

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

Learning to be an attending

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

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

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

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

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

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

Organizing the crisis response

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

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

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

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

The reality of public health

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

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

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

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

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

Expediting transfers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Reference

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

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

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

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

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

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

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

Learning to be an attending

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

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

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

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

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

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

Organizing the crisis response

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

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

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

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

The reality of public health

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

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

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

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

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

Expediting transfers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Reference

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

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

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

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

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

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

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

Learning to be an attending

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

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

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

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

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

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

Organizing the crisis response

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

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

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

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

The reality of public health

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

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

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

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

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

Expediting transfers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Reference

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

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.

In a previous column, I addressed some of the issues that quickly arose in the context of the COVID-19 pandemic and their implications for reproductive psychiatry. These issues ranged from the importance of sustaining well-being in pregnant and postpartum women during the pandemic, to temporary restrictions that were in place during the early part of the pandemic with respect to performing infertility procedures, to the practical issues of limiting the number of people who could attend to women during labor and delivery in the hospital.

lechatnoir/E+

Five months later, we’ve learned a great deal about trying to sustain emotional well-being among pregnant women during COVID-19. There is a high rate of anxiety among women who are pregnant and women who have particularly young children around the various issues of juggling activities of daily living during the pandemic, including switching to remote work and homeschooling children. There is fear of contracting COVID-19 during pregnancy, the exact effects of which are still somewhat unknown. We have seen a shift to telemedicine for prenatal and postpartum obstetrics visits, and a change with respect to visitors and even in-home nurses that would help during the first weeks of life for some couples.

We wondered whether we would see a falloff in the numbers of women presenting to our clinic with questions about the reproductive safety of taking psychiatric medications during pregnancy. We were unclear as to whether women would defer plans to get pregnant given some of the uncertainties that have come with COVID-19. What we’ve seen, at least early on in the pandemic in Massachusetts, has been the opposite. More women during the first 4 months of the pandemic have been seen in our center compared with the same corresponding period over the last 5 years. The precise reasons for this are unclear, but one reason may be that shifting the practice of reproductive psychiatry and pregnancy planning for reproductive-age women to full virtual care has dropped the number of missed appointments to essentially zero. Women perhaps feel an urgency to have a plan for using psychiatric medication during pregnancy. They may also see the benefit of being able to have extended telemedicine consultations that frequently involve their partners, a practice we have always supported, but posed logistical challenges for some.

As our colleagues learned that we had shifted our clinical rounds at the Center for Women’s Mental Health, which we’ve been doing for 25 years, to a virtual format, we began offering a free 1-hour forum to discuss relevant issues around caring for psychiatrically ill women, with a focus on some of the issues that were particularly relevant during the pandemic. The most common reasons for consultation on our service are the appropriate, safest use of antidepressants and mood stabilizers during pregnancy, and that continues to be the case.

If there has been one guiding principle in treating perinatal depression during pregnancy, it has been our long-standing, laser-like focus on keeping women emotionally well during pregnancy, and to highlight the importance of this with women during consultations prior to and during pregnancy. Relapse of psychiatric disorder during pregnancy is one the strongest predictors of postpartum depression, and the impact of untreated depression during pregnancy has been described in the literature and over the years in this column. However, the implications of having severe relapse of a mood disorder, for example, such as depression or bipolar disorder during the pandemic, takes on a new context where we want to minimize, if possible, severe onset of illness requiring hospitalization or emergent attention considering it may make social distancing and some of the other mitigating factors vis-à-vis COVID-19 more challenging.

Despite the accumulated data over the last 2 decades on the reproductive safety of antidepressants, women continue to have questions about the safety of these medications during pregnancy. Studies show now that many women would prefer, if at all possible, to defer treatment with antidepressants, and so they come to us with questions about their reproductive safety, the potential of switching to nonpharmacologic interventions, and the use of alternative interventions that might be used to treat their underlying mood disorder.

Investigators at the University of British Columbia recently have tried to inform the field with still another look, not at reproductive safety per se, but at risk of relapse of depression if women discontinue those medicines during pregnancy.¹ There is a timeliness to this investigation, which was a systematic review and meta-analysis of studies that met a priori criteria for inclusion. Since some of our own group’s early work over 15 years ago on relapse of psychiatric disorder during pregnancy,² which indicated a substantial difference in risk of relapse between women who continued versus who discontinued antidepressants, other investigators have showed the difference in risk for relapse is not as substantial, and that continuation of medication did not appear to mitigate risk for relapse. In fact, in the systematic review, the investigators demonstrated that as a group, maintaining medicine did not appear to confer particular benefit to patients relative to risk for relapse compared to discontinuation of antidepressants.

However, looking more closely, Bayrampour and colleagues note for women with histories of more severe recurrent, major depression, relapse did in fact appear to be greater in women who discontinued compared with those with cases of mild to moderate depression. It is noteworthy that in both our early and later work, and certainly dovetailing with our clinical practice, we have noted severity of illness does not appear to correlate with the actual decisions women ultimately make regarding what they will do with antidepressants. Specifically, some women with very severe illness histories will discontinue antidepressants regardless of their risk for relapse. Alternatively, women with mild to moderate illness will sometimes elect to stay on antidepressant therapy. With all the information that we have about fetal exposure to antidepressants on one hand, the “unknown unknowns” are an understandable concern to both patients and clinicians. Clinicians are faced with the dilemma of how to best counsel women on continuing or discontinuing antidepressants as they plan to conceive or during pregnancy and in the postpartum period.

The literature cited and clinical experience over the last 3 decades suggests rather strongly that there is a relatively low likelihood women with histories of severe recurrent disease will be able to successfully discontinue antidepressants in the absence of relapse. A greater question is, what is the best way to proceed for women who have been on maintenance therapy and had more moderate symptoms?

I am inspired by some of the more recent literature that has tried to elucidate the role of nonpharmacologic interventions such as mindfulness-based cognitive therapy (MBCT) in an effort to mitigate risk for depressive relapse in pregnant women who are well with histories of depression. To date, data do not inform the question as to whether MBCT can be used to mitigate risk of depressive relapse in pregnant women who continue or discontinue antidepressants. That research question is actively being studied by several investigators, including ourselves.

Of particular interest is whether the addition of mindfulness practices such as MBCT in treatment could mitigate risk for depressive relapse in pregnant women who continue or discontinue antidepressant treatment, as that would certainly be a no-harm intervention that could mitigate risk even in a lower risk sample of patients. The question of how to “thread the needle” during the pandemic and best approach woman with a history of recurrent major depression on antidepressants is particularly timely and critical.

Regardless, we make clinical decisions collaboratively with patients based on their histories and individual wishes, and perhaps what we have learned over the last 5 months is the use of telemedicine does afford us the opportunity, regardless of the decisions that patients make, to more closely follow the clinical trajectory of women during pregnancy and the postpartum period so that regardless of treatment, we have an opportunity to intervene early when needed and to ascertain changes in clinical status early to mitigate the risk of frank relapse. From a reproductive psychiatric point of view, that is a silver lining with respect to the associated challenges that have come along with the pandemic.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

References

1. J Clin Psychiatry 2020;81(4):19r13134.

2. JAMA. 2006 Feb 1;295(5):499-507.