Infectious Diseases

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

A few weeks ago, I saw more than 60 responses to a post on Nextdoor.com entitled, “Toilet paper strategies?”

Asking for help is a great coping mechanism when one is struggling to find a strategy, even if it’s for toilet paper. What other kinds of coping strategies can help us through this historic and unprecedented time?

The late Stephen R. Covey, PhD, wrote about the coping strategies of highly effective people in his book, “The 7 Habits of Highly Effective People.”¹ For, no matter how smart, perfect, or careful you may be, life will never be trouble free. When trouble comes, it’s important to have coping strategies that help you navigate through choppy waters. Whether you are a practitioner trying to help your patients or someone who wants to maximize their personal resilience during a worldwide pandemic, here are my conceptualizations of the seven top strategies highly effective people use when facing challenges.
 

Strategy #1: Begin with the end in mind

In 2007, this strategy helped me not only survive but thrive when I battled for my right to practice as a holistic psychiatrist against the Maryland Board of Physicians.² From the first moment when I read the letter from the board, to the last when I read the administrative law judge’s dismissal, I turned to this strategy to help me cope with unrelenting stress.

I imagined myself remembering being the kind of person I wanted to be, wrote that script for myself, and created those memories for my future self. I wanted to remember myself as being brave, calm, strong, and grounded, so I behaved each day as if I were all of those things.

As Dr. Covey wrote, “ ‘Begin with the end in mind’ is based on the principle that all things are created twice. There’s a mental or first creation, and a physical or second creation to all things.” Imagine who you would like to remember yourself being a year or two down the road. Do you want to remember yourself showing good judgment and being positive and compassionate during this pandemic? Then, follow the script you’ve created in your mind and be that person now, knowing that you are forming memories for your future self. Your future self will look back at who you are right now with appreciation and satisfaction. Of course, this is a habit that you can apply to your entire life.
 

Strategy #2: Be proactive

Between the event and the outcome is you. You are the interpreter and transformer of the event, with the freedom to apply your will and intention on the event. Whether it is living through a pandemic or dealing with misplaced keys, every day you are revealing your nature through how you deal with life. To be proactive is different from being reactive. Within each of us there is a will, the drive, to rise above our difficult environments.

Dr. Covey wrote, “the ability to subordinate an impulse to a value is the essence of the proactive person.” A woman shared with me that she created an Excel spreadsheet with some of the things she plans to do with her free time while she stays in her NYC apartment. She doesn’t want to slip into a passive state and waste her time. That’s being proactive.
 

Strategy #3: Set proper priorities

Or, as Dr. Covey would say, “Put first things first.” During a pandemic, when the world seems to be precariously tilting at an angle, it’s easy to cling to outdated standards, expectations, and behavioral patterns. Doing so heightens our sense of regret, fear, and scarcity. If you are value-centered, you can adapt to rapid changes and shift your expectations to reflect the current reality more easily. Valuing gratitude will empower you to deal with financial loss differently because you can still remain grateful despite uncontrollable losses. We can choose “to have or to be” as psychoanalyst, Erich Fromm, PhD, would say.³ If your happiness is measured by how much money you have, then it would make sense that, when the amount shrinks, so does your happiness. However, if your happiness is a side effect of who you are, you will remain a mountain before the winds and tides of circumstance.

Strategy #4: Create a win/win mentality

This state of mind is built on character. Dr. Covey separates character into three categories: integrity, maturity, and abundance mentality. A lack of character resulted in the hoarding of toilet paper in many communities and the cry for help from Nextdoor.com. I noticed that, in the 60+ responses that included advice about using bidets, old towels, and even leaves, no one offered to share a bag of toilet paper. That’s because people experienced the fear of scarcity, in turn, causing the scarcity they feared.

During a pandemic, a highly effective person or company thinks beyond themselves to create a win/win scenario. At a grocery store in my neighborhood, a man stands at its entrance with a bottle of disinfectant spray in one hand for the shoppers and a sign on the sidewalk with guidelines for purchasing products to avoid hoarding. He tells you where the wipes are for the carts as you enter the store. People line up 6 feet apart, waiting to enter, to limit the number of shoppers inside the store, facilitating proper physical distancing. Instead of maximizing profits at the expense of everyone’s health and safety, the process is a win/win for everyone, from shoppers to employees.
 

Strategy #5: Develop empathy and understanding

Seeking to first understand and then be understood is one of the most powerful tools of effective people. In my holistic practice, every patient comes in with their own unique needs that evolve and transform over time. I must remain open, or I fail to deliver appropriately.

Learning to listen and then to clearly communicate ideas is essential to effective health care. During this time, it is critical that health care providers and political leaders first listen/understand and then communicate clearly to serve everyone in the best way possible.

In our brains, the frontal lobes (the adult in the room) manages our amygdala (the child in the room) when we get enough sleep, meditate, spend time in nature, exercise, and eat healthy food.⁴ Stress can interfere with the frontal lobe’s ability to maintain empathy, inhibit unhealthy impulses, and delay gratification. During the pandemic, we can help to shift from the stress response, or “fight-or-flight” response, driven by the sympathetic nervous system to a “rest-and-digest” response driven by the parasympathetic system through coherent breathing, taking slow, deep, relaxed breaths (6 seconds on inhalation and 6 seconds on exhalation). The vagus nerve connected to our diaphragm will help the heart return to a healthy rhythm.⁵

Strategy #6: Synergize and integrate

All of life is interdependent, each part no more or less important than any other. Is oxygen more important than hydrogen? Is H₂O different from the oxygen and hydrogen atoms that make it?

During a pandemic, it’s important for us to appreciate each other’s contributions and work synergistically for the good of the whole. Our survival depends on valuing each other and our planet. This perspective informs the practice of physical distancing and staying home to minimize the spread of the virus and its impact on the health care system, regardless of whether an individual belongs in the high-risk group or not.

Many high-achieving people train in extremely competitive settings in which survival depends on individual performance rather than mutual cooperation. This training process encourages a disregard for others. Good leaders, however, understand that cooperation and mutual respect are essential to personal well-being.
 

Strategy #7: Practice self-care

There are five aspects of our lives that depend on our self-care: spiritual, mental, emotional, physical, and social. Unfortunately, many kind-hearted people are kinder to others than to themselves. There is really only one person who can truly take care of you properly, and that is yourself. In Seattle, where many suffered early in the pandemic, holistic psychiatrist David Kopacz, MD, is reminding people to nurture themselves in his post, “Nurture Yourself During the Pandemic: Try New Recipes!”⁶ Indeed, that is what many must do since eating out is not an option now. If you find yourself stuck at home with more time on your hands, take the opportunity to care for yourself. Ask yourself what you really need during this time, and make the effort to provide it to yourself.

After the pandemic is over, will you have grown from the experiences and become a better person from it? Despite our current circumstances, we can continue to grow as individuals and as a community, armed with strategies that can benefit all of us.

References

1. Covey SR. The 7 Habits of Highly Effective People. New York: Simon & Schuster; 1989.

2. Lee AW. Townsend Letter. 2009 Jun;311:22-3.

3. Fromm E. To Have or To Be? New York: Continuum International Publishing; 2005.

4. Rushlau K. Integrative Healthcare Symposium. 2020 Feb 21.

5. Gerbarg PL. Mind Body Practices for Post-Traumatic Stress Disorder. Presentation at Integrative Medicine for Mental Health Conference. 2016 Sep.

6. Kopacz D. Nurture Yourself During the Pandemic: Try New Recipes! Being Fully Human. 2020 Mar 22.

Dr. Lee specializes in integrative and holistic psychiatry and has a private practice in Gaithersburg, Md. She has no disclosures.




 

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

aotto@mdedge.com

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

aotto@mdedge.com

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

In the latest issue of the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention recommended hepatitis C virus screening for all adults and all pregnant women – during each of their pregnancies – in areas where prevalence of the infection is 0.1% or greater.

That’s essentially the entire United States; there’s no state with a statewide adult prevalence below 0.1%, and “few settings are known to exist” otherwise, the CDC noted (MMWR Recomm Rep. 2020 Apr 10;69(2):1-17).

The agency encouraged providers to consult state or local health departments or the CDC directly to determine local HCV prevalence. “As a general guide ... approximately 59% of anti-HCV positive persons are HCV RNA positive,” indicating active infection, the agency noted.

The advice was an expansion from the CDC’s last universal screening recommendation in 2012, which was limited to people born from 1945 to 1965; the incidence of acute infections has climbed since then and is highest now among younger people, so the guideline needed to be revisited, explained authors led by Sarah Schillie, MD, of the CDC’s Division of Viral Hepatitis, Atlanta.

The U.S. Preventive Services Task Force also recently recommended universal adult screening after previously limiting it to baby boomers.

As for pregnancy, the CDC’s past advice was to screen pregnant women with known risk factors, but that needed to be revisited as well. For one thing, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have since recommended testing all pregnant women.

But also, the CDC said, it’s an opportune time for screening because “many women only have access to health care during pregnancy and the immediate postpartum period,” when treatment, if needed, can be started. Plus, HCV status is important for management decisions, such as using amniocentesis in positive women instead of chorionic villus sampling.

The rest of CDC’s 2012 recommendations stand, including screening all people with risk factors and repeating screening while they persist. Also, “any person who requests hepatitis C testing should receive it, regardless of disclosure of risk,” because people might be reluctant to report things like IV drug use, the authors said.

Screening in the guidelines means an HCV antibody test, followed by a nucleic acid test to check for active infection. The CDC encouraged automatic reflex testing, meaning immediately checking antibody positive samples for HCV RNA. RNA in the blood indicates active, replicating virus.

The new recommendations penciled out in modeling, with an incremental cost-effectiveness ratio (ICER) for universal adult screening of approximately $36,000 per quality-adjusted life year (QALY) gained, and an ICER of approximately $15,000 per QALY gained for pregnancy screening, where HCV prevalence is 0.1%; the 0.1% cost/benefit cutpoint was one of the reasons it was chosen as the prevalence threshold. An ICER under $50,000 is the conservative benchmark for cost-effectiveness, the authors noted.

There was no external funding, and the authors had no disclosures.

aotto@mdedge.com

SOURCE: Schillie S et al. MMWR Recomm Rep. 2020 Apr 10;69[2]:1-17).

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

rfranki@mdedge.com

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

rfranki@mdedge.com

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The hospitalization rate for COVID-19 is 4.6 per 100,000 population, and almost 90% of hospitalized patients have some type of underlying condition, according to the Centers for Disease Control and Prevention.

Data collected by the newly created COVID-19–Associated Hospitalization Surveillance Network (COVID-NET) put the exact prevalence of underlying conditions at 89.3% for patients hospitalized during March 1-30, 2020, Shikha Garg, MD, of the CDC’s COVID-NET team and associates wrote in the MMWR.

The hospitalization rate, based on COVID-NET data for March 1-28, increased with patient age. Those aged 65 years and older were admitted at a rate of 13.8 per 100,000, with 50- to 64-year-olds next at 7.4 per 100,000 and 18- to 49-year-olds at 2.5, they wrote.

The patients aged 65 years and older also were the most likely to have one or more underlying conditions, at 94.4%, compared with 86.4% of those aged 50-64 years and 85.4% of individuals who were aged 18-44 years, the investigators reported.

Hypertension was the most common comorbidity among the oldest patients, with a prevalence of 72.6%, followed by cardiovascular disease at 50.8% and obesity at 41%. In the two younger groups, obesity was the condition most often seen in COVID-19 patients, with prevalences of 49% in 50- to 64-year-olds and 59% in those aged 18-49, Dr. Garg and associates wrote.

“These findings underscore the importance of preventive measures (e.g., social distancing, respiratory hygiene, and wearing face coverings in public settings where social distancing measures are difficult to maintain) to protect older adults and persons with underlying medical conditions,” the investigators wrote.

COVID-NET surveillance includes laboratory-confirmed hospitalizations in 99 counties in 14 states: California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. Those counties represent about 10% of the U.S. population.

rfranki@mdedge.com

SOURCE: Garg S et al. MMWR. 2020 Apr 8;69(early release):1-7.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The COVID-19 pandemic represents a looming crisis for patients with severe mental illness (SMI) and the healthcare systems that serve them, one expert warns.

However, Benjamin Druss, MD, MPH, from Emory University’s Rollins School of Public Health in Atlanta, Georgia, says there are strategies that can help minimize the risk of exposure and transmission of the virus in SMI patients.

In a viewpoint published online April 3 in JAMA Psychiatry, Druss, professor and chair in mental health, notes that “disasters disproportionately affect poor and vulnerable populations, and patients with serious mental illness may be among the hardest hit.”

In an interview with Medscape Medical News, Druss said patients with SMI have “a whole range of vulnerabilities” that put them at higher risk for COVID-19.

These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness. In fact, estimates show 25% of the US homeless population has a serious mental illness, said Druss.

“You have to keep an eye on these overlapping circles of vulnerable populations: those with disabilities in general and people with serious mental illness in particular; people who are poor; and people who have limited social networks,” he said.
 

Tailored Communication Vital

It’s important for patients with SMI to have up-to-date, accurate information about mitigating risk and knowing when to seek medical treatment for COVID-19, Druss noted.

Communication materials developed for the general population need to be tailored to address limited health literacy and challenges in implementing physical distancing recommendations, he said.

Patients with SMI also need support in maintaining healthy habits, including diet and physical activity, as well as self-management of chronic mental and physical health conditions, he added.

He noted that even in the face of current constraints on mental health care delivery, ensuring access to services is essential. The increased emphasis on caring for, and keeping in touch with, SMI patients through telepsychiatry is one effective way of addressing this issue, said Druss.

Since mental health clinicians are often the first responders for people with SMI, these professionals need training to recognize the signs and symptoms of COVID-19 and learn basic strategies to mitigate the spread of disease, not only for their patients but also for themselves, he added.

Ensuring the safety and well-being of mental health care providers is “a clear priority,” he said. “Any given provider is going to be responsible for many, many patients, so keeping physically and mentally healthy will be vital.”

In order to ease the strain of COVID-19 on community mental health centers and psychiatric hospitals, which are at high risk for outbreaks and have limited capacity to treat medical illness, these institutions need contingency plans to detect and contain outbreaks if they occur.

“Careful planning and execution at multiple levels will be essential for minimizing the adverse outcomes of this pandemic for this vulnerable population,” Druss writes.

Voice of Experience

Commenting on the article for Medscape Medical News, Lloyd I. Sederer, MD, distinguished advisor for the New York State Office of Mental Health and adjunct professor at the Columbia School of Public Health in New York City, commended Druss for highlighting the need for more mental health services during the pandemic.

However, although Druss “has made some very good general statements,” these don’t really apply “in the wake of a real catastrophic event, which is what we’re having here,” Sederer said.

Sederer led Project Liberty, a massive mental health disaster response effort established in the wake of the Sept. 11 attacks in New York. Druss seems to infer that the mental health workforce is capable of expanding, but “what we learned is that the mental health system in this country is vastly undersupplied,” said Sederer.

During a disaster, the system “actually contracts” because clinics close and workforces are reduced. In this environment, some patients with a serious mental illness let their treatment “erode,” Sederer said.

While Druss called for clinics to have protocols for identifying and referring patients at risk for COVID-19, Sederer pointed out that “all the clinics are closed.”

However, he did note that many mental health clinics and hospitals are continuing to reach out to their vulnerable patients during this crisis.

On the 10th anniversary of the 9/11 attacks, Sederer and colleagues published an article in Psychiatric Services that highlighted the “lessons learned” from the Project Liberty experience. One of the biggest lessons was the need for crisis counseling, which is “a recognized, proven intervention,” said Sederer.

Such an initiative involves trained outreach workers, identifying the untreated seriously mentally ill in the community, and “literally shepherding them to services,” he added.

In this current pandemic, it would be up to the federal government to mobilize such a crisis counseling initiative, Sederer explained.

Sederer noted that rapid relief groups like the Federal Emergency Management Agency do not cover mental health services. In order to be effective, disaster-related mental health services need to include funding for treatment, including focused therapies and medication.

Druss and Sederer have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

The first protocol for the use of lung ultrasound to quantitatively and reproducibly assess the degree of lung involvement in patients suspected of having COVID-19 infection has been published by a team of Italian experts with experience using the technology on the front line.

Particularly in Spain and Italy — where the pandemic has struck hardest in Europe — hard-pressed clinicians seeking to quickly understand whether patients with seemingly mild disease could be harboring more serious lung involvement have increasingly relied upon lung ultrasound in the emergency room.

Now Libertario Demi, PhD, head of the ultrasound laboratory, University of Trento, Italy, and colleagues have developed a protocol, published online March 30 in the Journal of Ultrasound Medicine, to standardize practice.

Their research, which builds on previous work by the team, offers broad agreement with industry-led algorithms and emphasizes the use of wireless, handheld ultrasound devices, ideally consisting of a separate probe and tablet, to make sterilization easy.

Firms such as the Butterfly Network, Phillips, Clarius, GE Healthcare, and Siemens are among numerous companies that produce one or more such devices, including some that are completely integrated.
 

Not Universally Accepted

However, lung ultrasound is not yet universally accepted as a tool for diagnosing pneumonia in the context of COVID-19 and triaging patients.

The National Health Service in England does not even mention lung ultrasound in its radiology decision tool for suspected COVID-19, specifying instead chest X-ray as the first-line diagnostic imaging tool, with CT scanning in equivocal cases.

But Giovanni Volpicelli, MD, University Hospital San Luigi Gonzaga, Turin, Italy, who has previously described his experience to Medscape Medical News, says many patients with COVID-19 in his hospital presented with a negative chest X-ray but were found to have interstitial pneumonia on lung ultrasound.

Moreover, while CT scan remains the gold standard, the risk of nosocomial infection is more easily controlled if patients do not have to be transported to the radiology department but remain in the emergency room and instead undergo lung ultrasound there, he stressed.
 

Experts Share Experience of Lung Ultrasound in COVID-19

In developing and publishing their protocol, Demi, senior author of the article, and other colleagues from the heavily affected cities of Northern Italy, say their aim is “to share our experience and to propose a standardization with respect to the use of lung ultrasound in the management of COVID-19 patients.”

They reviewed an anonymized database of around 60,000 ultrasound images of confirmed COVID-19 cases and reviewers were blinded to patients’ clinical backgrounds.

For image acquisition, the authors recommend scanning 14 areas in each patient for 10 seconds, making the scans intercostal to cover the widest possible surface area.

They advise the use of a single focal point on the pleural line, which they write, optimizes the beam shape for observing the lung surface.

The authors also urge that the mechanical index (MI) be kept low because high MIs sustained for long periods “may result in damaging the lung.”

They also stress that cosmetic filters and modalities such as harmonic imaging, contrast, doppler, and compounding should be avoided, alongside saturation phenomena.
 

What Constitutes Intermediate Disease?

Once the images have been taken, they are scored on a 0-3 scale for each of the 14 areas, with no weighting on any individual area.

A score of 0 is given when the pleural line is continuous and regular, with the presence of A-lines, denoting that the lungs are unaffected.

An area is given a score of 3 when the scan shows dense and largely extended white lung tissue, with or without consolidations, indicating severe disease.

At both ends of this spectrum, there is agreement between the Italian protocol and an algorithm developed by the Butterfly Network.

However, the two differ when it comes to scoring intermediate cases. On the Butterfly algorithm, the suggestion is to look for B-lines, caused by fluid and cellular infiltration into the interstitium, and to weigh that against the need for supplementary oxygen.

The Italian team, in contrast, says a score of 1 is given when the pleural line is indented, with vertical areas of white visible below.

A score of 2 is given when the pleural line is broken, with small to large areas of consolidation and associated areas of white below.

Demi told Medscape Medical News that they did not refer to B-lines in their protocol as their visibility depends entirely on the imaging frequency and the probe used.

“This means that scoring on B-lines, people with different machines would give completely different scores for the same patient.”

He continued: “We prefer to refer to horizontal and vertical artifacts, and provide an analysis of the patterns, which is related to the physics of the interactions between the ultrasound waves and lung surface.”

In response, Mike Stone, MD, Legacy Emanuel Medical Center, Portland, Oregon, and director of education at Butterfly, said there appears to be wide variation in lung findings that “may or may not correlate with the severity of symptoms.”

He told Medscape Medical News it is “hard to know exactly if someone with pure B-lines will progress to serious illness or if someone with some subpleural consolidations will do well.”
 

A Negative Ultrasound Is the Most Useful

Volpicelli believes that, in any case, any patient with an intermediate pattern will require further diagnosis, such as other imaging modalities and blood exams, and the real role of lung ultrasound is in assessing patients at either end of the spectrum.

“In other words, there are situations where lung ultrasound can be considered definitive,” he told Medscape Medical News. “For instance, if I see a patient with mild signs of the disease, just fever, and I perform lung ultrasound and see nothing, lung ultrasound rules out pneumonia.”

“This patient may have COVID-19 of course, but they do not have pneumonia, and they can be treated at home, awaiting the result of the swab test. And this is useful because you can reduce the burden in the emergency department.”

Volpicelli continued: “On the other hand, there are patients with acute respiratory failure in respiratory distress. If the lung ultrasound is normal, you can rule out COVID-19 and you need to use other diagnostic procedures to understand the problem.”

“This is also very important for us because it’s crucial to be able to remove the patient from the isolation area and perform CT scan, chest radiography, and all the other diagnostic tools that we need.”
 

Are Wireless Machines Needed? Not Necessarily

With regard to the use of wireless technology, the Italian team says that “in the setting of COVID-19, wireless probes and tablets represent the most appropriate ultrasound equipment” because they can “easily be wrapped in single-use plastic covers, reducing the risk of contamination,” and making sterilization easy.

Stone suggests that integrated portable devices, however, are no more likely to cause cross-contamination than separate probes and tablets, as they can fit within a sterile sheath as a single unit.

Volpicelli, for his part, doesn’t like what he sees as undue focus on wireless devices for lung ultrasound in the COVID-19 protocols.

He is concerned that recommending them as the best approach may be sending out the wrong message, which could be very “dangerous” as people may then think they cannot perform this screening with standard ultrasound machines.

For him, the issue of cross contamination with standard lung ultrasound machines is “nonexistent. Cleaning the machine is quite easy and I do it hundreds of times per week.”

He does acknowledge, however, that if the lung ultrasound is performed under certain circumstances, for example when a patient is using a continuous positive airway pressure (CPAP) machine, “the risk of having the machine contaminated is a little bit higher.”

“In these situations...we have a more intensive cleaning procedure to avoid cross-contamination.”

He stressed: “Not all centers have wireless machines, whereas a normal machine is usually in all hospitals.”

“The advantages of using lung ultrasound [in COVID-19] are too great to be limited by something that is not important in my opinion,” he concluded.

Stone is director of education at the Butterfly Network. No other conflicts of interest were declared.

This article first appeared on Medscape.com.

In the wake of the attacks on the World Trade Center, the public mental health system in the New York City area mounted the largest mental health disaster response in history. I was New York City’s mental health commissioner at the time. We called the initiative Project Liberty and over 3 years obtained $137 million in funding from the Federal Emergency Management Agency (FEMA) to support it.

Through Project Liberty, New York established the Crisis Counseling Assistance and Training Program (CCP). And it didn’t take us long to realize that what affected people need following a disaster is not necessarily psychotherapy, as might be expected, but in fact crisis counseling, or helping impacted individuals and their families regain control of their anxieties and effectively respond to an immediate disaster. This proved true not only after 9/11 but also after other recent disasters, including hurricanes Katrina and Sandy. The mental health system must now step up again to assuage fears and anxieties—both individual and collective—around the rapidly spreading COVID-19 pandemic.
 

So, what is crisis counseling?

A person’s usual adaptive, problem-solving capabilities are often compromised after a disaster, but they are there, and if accessed, they can help those afflicted with mental symptoms following a crisis to mentally endure. Ensuring safety and promoting return to functioning, as well as being informed about immediately available resources, are the central objectives of crisis counseling, thereby making it a different approach from traditional psychotherapy.

The five key concepts in crisis counseling are:

• It is strength-based, which means its foundation is rooted in the assumption that resilience and competence are innate human qualities.
• Crisis counseling also employs anonymity. Impacted individuals should not be diagnosed or labeled. As a result, there are no resulting medical records.
• The approach is outreach-oriented, in which counselors provide services out in the community rather than in traditional mental health settings. This occurs primarily in homes, community centers, and settings, as well as in disaster shelters.
• It is culturally attuned, whereby all staff appreciate and respect a community’s cultural beliefs, values, and primary language.
• It is aimed at supporting, not replacing, existing community support systems (eg, a crisis counselor supports but does not organize, deliver, or manage community recovery activities).

Crisis counselors are required to be licensed psychologists or have obtained a bachelor’s degree or higher in psychology, human services, or another health-related field. In other words, crisis counseling draws on a broad, though related, group of individuals. Before deployment into a disaster area, an applicant must complete the FEMA Crisis Counseling Assistance and Training, which is offered in the disaster area by the FEMA-funded CCP.

Crisis counselors provide trustworthy and actionable information about the disaster at hand and where to turn for resources and assistance. They assist with emotional support. And they aim to educate individuals, families, and communities about how to be resilient.

Crisis counseling, however, may not suffice for everyone impacted. We know that a person’s severity of response to a crisis is highly associated with the intensity and duration of exposure to the disaster (especially when it is life-threatening) and/or the degree of a person’s serious loss (of a loved one, home, job, health). We also know that previous trauma (eg, from childhood, domestic violence, or forced immigration) also predicts the gravity of the response to a current crisis. Which is why crisis counselors also are taught to identify those experiencing significant and persistent mental health and addiction problems because they need to be assisted, literally, in obtaining professional treatment.

Only in recent years has trauma been a recognized driver of stress, distress, and mental and addictive disorders. Until relatively recently, skill with, and access to, crisis counseling—and trauma-informed care—was rare among New York’s large and talented mental health professional community. Few had been trained in it in graduate school or practiced it because New York had been spared a disaster on par with 9/11. Following the attacks, Project Liberty’s programs served nearly 1.5 million affected individuals of very diverse ages, races, cultural backgrounds, and socioeconomic status. Their levels of “psychological distress,” the term we used and measured, ranged from low to very high.

The coronavirus pandemic now presents us with a tragically similar, catastrophic moment. The human consequences we face—psychologically, economically, and socially—are just beginning. But this time, the need is not just in New York but throughout our country.

We humans are resilient. We can bend the arc of crisis toward the light, to recovering our existing but overwhelmed capabilities. We can achieve this in a variety of ways. We can practice self-care. This isn’t an act of selfishness but is rather like putting on your own oxygen mask before trying to help your friend or loved one do the same. We can stay connected to the people we care about. We can eat well, get sufficient sleep, take a walk.

Identifying and pursuing practical goals is also important, like obtaining food, housing that is safe and reliable, transportation to where you need to go, and drawing upon financial and other resources that are issued in a disaster area. We can practice positive thinking and recall how we’ve mastered our troubles in the past; we can remind ourselves that “this too will pass.” Crises create an unusually opportune time for change and self-discovery. As Churchill said to the British people in the darkest moments of the start of World War II, “Never give up.”

Worthy of its own itemization are spiritual beliefs, faith—that however we think about a higher power (religious or secular), that power is on our side. Faith can comfort and sustain hope, particularly at a time when doubt about ourselves and humanity is triggered by disaster.

Maya Angelou’s words remind us at this moment of disaster: “...let us try to help before we have to offer therapy. That is to say, let’s see if we can’t prevent being ill by trying to offer a love of prevention before illness.”

Dr. Sederer is the former chief medical officer for the New York State Office of Mental Health and an adjunct professor in the Department of Epidemiology at the Columbia University School of Public Health. His latest book is The Addiction Solution: Treating Our Dependence on Opioids and Other Drugs.

This article first appeared on Medscape.com.

In the wake of the attacks on the World Trade Center, the public mental health system in the New York City area mounted the largest mental health disaster response in history. I was New York City’s mental health commissioner at the time. We called the initiative Project Liberty and over 3 years obtained $137 million in funding from the Federal Emergency Management Agency (FEMA) to support it.

Through Project Liberty, New York established the Crisis Counseling Assistance and Training Program (CCP). And it didn’t take us long to realize that what affected people need following a disaster is not necessarily psychotherapy, as might be expected, but in fact crisis counseling, or helping impacted individuals and their families regain control of their anxieties and effectively respond to an immediate disaster. This proved true not only after 9/11 but also after other recent disasters, including hurricanes Katrina and Sandy. The mental health system must now step up again to assuage fears and anxieties—both individual and collective—around the rapidly spreading COVID-19 pandemic.
 

So, what is crisis counseling?

A person’s usual adaptive, problem-solving capabilities are often compromised after a disaster, but they are there, and if accessed, they can help those afflicted with mental symptoms following a crisis to mentally endure. Ensuring safety and promoting return to functioning, as well as being informed about immediately available resources, are the central objectives of crisis counseling, thereby making it a different approach from traditional psychotherapy.

The five key concepts in crisis counseling are:

• It is strength-based, which means its foundation is rooted in the assumption that resilience and competence are innate human qualities.
• Crisis counseling also employs anonymity. Impacted individuals should not be diagnosed or labeled. As a result, there are no resulting medical records.
• The approach is outreach-oriented, in which counselors provide services out in the community rather than in traditional mental health settings. This occurs primarily in homes, community centers, and settings, as well as in disaster shelters.
• It is culturally attuned, whereby all staff appreciate and respect a community’s cultural beliefs, values, and primary language.
• It is aimed at supporting, not replacing, existing community support systems (eg, a crisis counselor supports but does not organize, deliver, or manage community recovery activities).

Crisis counselors are required to be licensed psychologists or have obtained a bachelor’s degree or higher in psychology, human services, or another health-related field. In other words, crisis counseling draws on a broad, though related, group of individuals. Before deployment into a disaster area, an applicant must complete the FEMA Crisis Counseling Assistance and Training, which is offered in the disaster area by the FEMA-funded CCP.

Crisis counselors provide trustworthy and actionable information about the disaster at hand and where to turn for resources and assistance. They assist with emotional support. And they aim to educate individuals, families, and communities about how to be resilient.

Crisis counseling, however, may not suffice for everyone impacted. We know that a person’s severity of response to a crisis is highly associated with the intensity and duration of exposure to the disaster (especially when it is life-threatening) and/or the degree of a person’s serious loss (of a loved one, home, job, health). We also know that previous trauma (eg, from childhood, domestic violence, or forced immigration) also predicts the gravity of the response to a current crisis. Which is why crisis counselors also are taught to identify those experiencing significant and persistent mental health and addiction problems because they need to be assisted, literally, in obtaining professional treatment.

Only in recent years has trauma been a recognized driver of stress, distress, and mental and addictive disorders. Until relatively recently, skill with, and access to, crisis counseling—and trauma-informed care—was rare among New York’s large and talented mental health professional community. Few had been trained in it in graduate school or practiced it because New York had been spared a disaster on par with 9/11. Following the attacks, Project Liberty’s programs served nearly 1.5 million affected individuals of very diverse ages, races, cultural backgrounds, and socioeconomic status. Their levels of “psychological distress,” the term we used and measured, ranged from low to very high.

The coronavirus pandemic now presents us with a tragically similar, catastrophic moment. The human consequences we face—psychologically, economically, and socially—are just beginning. But this time, the need is not just in New York but throughout our country.

We humans are resilient. We can bend the arc of crisis toward the light, to recovering our existing but overwhelmed capabilities. We can achieve this in a variety of ways. We can practice self-care. This isn’t an act of selfishness but is rather like putting on your own oxygen mask before trying to help your friend or loved one do the same. We can stay connected to the people we care about. We can eat well, get sufficient sleep, take a walk.

Identifying and pursuing practical goals is also important, like obtaining food, housing that is safe and reliable, transportation to where you need to go, and drawing upon financial and other resources that are issued in a disaster area. We can practice positive thinking and recall how we’ve mastered our troubles in the past; we can remind ourselves that “this too will pass.” Crises create an unusually opportune time for change and self-discovery. As Churchill said to the British people in the darkest moments of the start of World War II, “Never give up.”

Worthy of its own itemization are spiritual beliefs, faith—that however we think about a higher power (religious or secular), that power is on our side. Faith can comfort and sustain hope, particularly at a time when doubt about ourselves and humanity is triggered by disaster.

Maya Angelou’s words remind us at this moment of disaster: “...let us try to help before we have to offer therapy. That is to say, let’s see if we can’t prevent being ill by trying to offer a love of prevention before illness.”

Dr. Sederer is the former chief medical officer for the New York State Office of Mental Health and an adjunct professor in the Department of Epidemiology at the Columbia University School of Public Health. His latest book is The Addiction Solution: Treating Our Dependence on Opioids and Other Drugs.

This article first appeared on Medscape.com.

In the wake of the attacks on the World Trade Center, the public mental health system in the New York City area mounted the largest mental health disaster response in history. I was New York City’s mental health commissioner at the time. We called the initiative Project Liberty and over 3 years obtained $137 million in funding from the Federal Emergency Management Agency (FEMA) to support it.

Through Project Liberty, New York established the Crisis Counseling Assistance and Training Program (CCP). And it didn’t take us long to realize that what affected people need following a disaster is not necessarily psychotherapy, as might be expected, but in fact crisis counseling, or helping impacted individuals and their families regain control of their anxieties and effectively respond to an immediate disaster. This proved true not only after 9/11 but also after other recent disasters, including hurricanes Katrina and Sandy. The mental health system must now step up again to assuage fears and anxieties—both individual and collective—around the rapidly spreading COVID-19 pandemic.
 

So, what is crisis counseling?

A person’s usual adaptive, problem-solving capabilities are often compromised after a disaster, but they are there, and if accessed, they can help those afflicted with mental symptoms following a crisis to mentally endure. Ensuring safety and promoting return to functioning, as well as being informed about immediately available resources, are the central objectives of crisis counseling, thereby making it a different approach from traditional psychotherapy.

The five key concepts in crisis counseling are:

• It is strength-based, which means its foundation is rooted in the assumption that resilience and competence are innate human qualities.
• Crisis counseling also employs anonymity. Impacted individuals should not be diagnosed or labeled. As a result, there are no resulting medical records.
• The approach is outreach-oriented, in which counselors provide services out in the community rather than in traditional mental health settings. This occurs primarily in homes, community centers, and settings, as well as in disaster shelters.
• It is culturally attuned, whereby all staff appreciate and respect a community’s cultural beliefs, values, and primary language.
• It is aimed at supporting, not replacing, existing community support systems (eg, a crisis counselor supports but does not organize, deliver, or manage community recovery activities).

Crisis counselors are required to be licensed psychologists or have obtained a bachelor’s degree or higher in psychology, human services, or another health-related field. In other words, crisis counseling draws on a broad, though related, group of individuals. Before deployment into a disaster area, an applicant must complete the FEMA Crisis Counseling Assistance and Training, which is offered in the disaster area by the FEMA-funded CCP.

Crisis counselors provide trustworthy and actionable information about the disaster at hand and where to turn for resources and assistance. They assist with emotional support. And they aim to educate individuals, families, and communities about how to be resilient.

Crisis counseling, however, may not suffice for everyone impacted. We know that a person’s severity of response to a crisis is highly associated with the intensity and duration of exposure to the disaster (especially when it is life-threatening) and/or the degree of a person’s serious loss (of a loved one, home, job, health). We also know that previous trauma (eg, from childhood, domestic violence, or forced immigration) also predicts the gravity of the response to a current crisis. Which is why crisis counselors also are taught to identify those experiencing significant and persistent mental health and addiction problems because they need to be assisted, literally, in obtaining professional treatment.

Only in recent years has trauma been a recognized driver of stress, distress, and mental and addictive disorders. Until relatively recently, skill with, and access to, crisis counseling—and trauma-informed care—was rare among New York’s large and talented mental health professional community. Few had been trained in it in graduate school or practiced it because New York had been spared a disaster on par with 9/11. Following the attacks, Project Liberty’s programs served nearly 1.5 million affected individuals of very diverse ages, races, cultural backgrounds, and socioeconomic status. Their levels of “psychological distress,” the term we used and measured, ranged from low to very high.

The coronavirus pandemic now presents us with a tragically similar, catastrophic moment. The human consequences we face—psychologically, economically, and socially—are just beginning. But this time, the need is not just in New York but throughout our country.

We humans are resilient. We can bend the arc of crisis toward the light, to recovering our existing but overwhelmed capabilities. We can achieve this in a variety of ways. We can practice self-care. This isn’t an act of selfishness but is rather like putting on your own oxygen mask before trying to help your friend or loved one do the same. We can stay connected to the people we care about. We can eat well, get sufficient sleep, take a walk.

Identifying and pursuing practical goals is also important, like obtaining food, housing that is safe and reliable, transportation to where you need to go, and drawing upon financial and other resources that are issued in a disaster area. We can practice positive thinking and recall how we’ve mastered our troubles in the past; we can remind ourselves that “this too will pass.” Crises create an unusually opportune time for change and self-discovery. As Churchill said to the British people in the darkest moments of the start of World War II, “Never give up.”

Worthy of its own itemization are spiritual beliefs, faith—that however we think about a higher power (religious or secular), that power is on our side. Faith can comfort and sustain hope, particularly at a time when doubt about ourselves and humanity is triggered by disaster.

Maya Angelou’s words remind us at this moment of disaster: “...let us try to help before we have to offer therapy. That is to say, let’s see if we can’t prevent being ill by trying to offer a love of prevention before illness.”

Dr. Sederer is the former chief medical officer for the New York State Office of Mental Health and an adjunct professor in the Department of Epidemiology at the Columbia University School of Public Health. His latest book is The Addiction Solution: Treating Our Dependence on Opioids and Other Drugs.

This article first appeared on Medscape.com.