Federal Practitioner

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

[email protected]

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

[email protected]

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” CMS stated in a fact sheet highlighting the regulatory changes. “For example, a health care system can use a hotel to take care of patients needing less intensive care while using inpatient beds for COVID-19 patients.”

With these waivers, hospital systems will not have to rely on the Federal Emergency Management Agency to set up temporary hospitals and can move ahead using available community resources to help deal with the expected surge, Ms. Verma said.

These regulatory changes will be effect for the duration of the public health emergency, according to Ms. Verma.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

Additionally, for Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

CMS also is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet.

Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements, and allowed greater use of verbal orders, to allow clinicians to spend more time on direct patient care.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including emergency department visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

[email protected]

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

A new blood-based test performs well at detecting multiple types of cancers across stages and therefore has good potential for screening, according to a prospective case-control substudy.

Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.

The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.

Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.

Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.

Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.

Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).

The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.

Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.

“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”

“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”

Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
 

SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

As the first international guidelines on the management of critically ill patients with COVID-19 are understandably comprehensive, one expert involved in their development highlights the essential recommendations and explains the rationale behind prone ventilation.

A panel of 39 experts from 12 countries from across the globe developed the 50 recommendations within four domains, under the auspices of the Surviving Sepsis Campaign. They are issued by the European Society of Intensive Care Medicine (ESICM), and will subsequently be published in the journal Intensive Care Medicine.

A central aspect of the guidance is what works, and what does not, in treating critically ill patients with COVID-19 in intensive care.

Ten of the recommendations cover potential pharmacotherapies, most of which have only weak or no evidence of benefit, as discussed in a recent perspective on Medscape. All 50 recommendations, along with the associated level of evidence, are detailed in table 2 in the paper.

There is also an algorithm for the management of patients with acute hypoxemic respiratory failure secondary to COVID-19 (figure 2) and a summary of clinical practice recommendations (figure 3).

In an editorial in the Journal of the American Medical Association issued just days after these new guidelines, Francois Lamontagne, MD, MSc, and Derek C. Angus, MD, MPH, say they “represent an excellent first step toward optimal, evidence-informed care for patients with COVID-19.” Lamontagne is from Universitaire de Sherbrooke, Canada, and Angus is from University of Pittsburgh School of Medicine, Pennsylvania, and is an associate editor with JAMA.
 

Dealing With Tide of COVID-19 Patients, Protecting Healthcare Workers

Editor in chief of Intensive Care Medicine Giuseppe Citerio, MD, from University of Milano-Bicocca, Monza, Italy, said: “COVID-19 cases are rising rapidly worldwide, and so we are increasingly seeing that intensive care units [ICUs] have difficulty in dealing with the tide of patients.”

“We need more resource in ICUs, and quickly. This means more ventilators and more trained personnel. In the meantime, this guidance aims to rationalize our approach and to avoid unproven strategies,” he explains in a press release from ESICM.

“This is the first guidance to lay out what works and what doesn’t in treating coronavirus-infected patients in intensive care. It’s based on decades of research on acute respiratory infection being applied to COVID-19 patients,” added ESICM President-Elect Maurizio Cecconi, MD, from Humanitas University, Milan, Italy.

“At the same time as caring for patients, we need to make sure that health workers are following procedures which will allow themselves to be protected against infection,” he stressed.

“We must protect them, they are in the frontline. We cannot allow our healthcare workers to be at risk. On top of that, if they get infected they could also spread the disease further.”

Top-10 Recommendations

While all 50 recommendations are key to the successful management of COVID-19 patients, busy clinicians on the frontline need to zone in on those indispensable practical recommendations that they should implement immediately.

Medscape Medical News therefore asked lead author Waleed Alhazzani, MD, MSc, from the Division of Critical Care, McMaster University, Hamilton, Canada, to give his personal top 10, the first three of which are focused on limiting the spread of infection.

1. For healthcare workers performing aerosol-generating procedures¹ on patients with COVID-19 in the ICU, we recommend using fitted respirator masks (N95 respirators, FFP2, or equivalent), as compared to surgical/medical masks, in addition to other personal protective equipment (eg, gloves, gown, and eye protection such as a face shield or safety goggles.

2. We recommend performing aerosol-generating procedures on ICU patients with COVID-19 in a negative-pressure room.

3. For healthcare workers providing usual care for nonventilated COVID-19 patients, we suggest using surgical/medical masks, as compared to respirator masks in addition to other personal protective equipment.

4. For healthcare workers performing endotracheal intubation on patients with COVID-19, we suggest using video guided laryngoscopy, over direct laryngoscopy, if available.

5. We recommend endotracheal intubation in patients with COVID-19, performed by healthcare workers experienced with airway management, to minimize the number of attempts and risk of transmission.

6. For intubated and mechanically ventilated adults with suspicion of COVID-19, we suggest obtaining endotracheal aspirates, over bronchial wash or bronchoalveolar lavage samples.

7. For adults with COVID-19 and acute hypoxemic respiratory failure, we suggest using high-flow nasal cannula [HFNC] over noninvasive positive pressure ventilation [NIPPV].

8. For adults with COVID-19 receiving NIPPV or HFNC, we recommend close monitoring for worsening of respiratory status and early intubation in a controlled setting if worsening occurs.

9. For mechanically ventilated adults with COVID-19 and moderate to severe acute respiratory distress syndrome [ARDS], we suggest prone ventilation for 12 to 16 hours over no prone ventilation.

10. For mechanically ventilated adults with COVID-19 and respiratory failure (without ARDS), we don’t recommend routine use of systemic corticosteroids.

¹ This includes endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, physical proning of the patient, disconnecting the patient from the ventilator, noninvasive positive pressure ventilation, tracheostomy, and cardiopulmonary resuscitation.
 

These choices are in broad agreement with those selected by Jason T. Poston, MD, University of Chicago, Illinois, and colleagues in their synopsis of these guidelines, published online March 26 in JAMA, although they also highlight another recommendation on infection control:

• For healthcare workers who are performing non-aerosol-generating procedures on mechanically ventilated (closed circuit) patients with COVID-19, we suggest using surgical/medical masks, as opposed to respirator masks, in addition to other personal protective equipment.

Importance of Prone Ventilation, Perhaps for Many Days

One recommendation singled out by both Alhazzani and coauthors, and Poston and colleagues, relates to prone ventilation for 12 to 16 hours in adults with moderate to severe ARDS receiving mechanical ventilation.

Michelle N. Gong, MD, MS, chief of critical care medicine at Montefiore Medical Center, New York City, also highlighted this practice in a live-stream interview with JAMA editor in chief Howard Bauchner, MD.

She explained that, in her institution, they have been “very aggressive about proning these patients as early as possible, but unlike some of the past ARDS patients…they tend to require many, many days of proning in order to get a response”.

Gong added that patients “may improve very rapidly when they are proned, but when we supinate them, they lose [the improvement] and then they get proned for upwards of 10 days or more, if need be.”

Alhazzani told Medscape Medical News that prone ventilation “is a simple intervention that requires training of healthcare providers but can be applied in most contexts.”

He explained that the recommendation “is driven by indirect evidence from ARDS,” not specifically those in COVID-19, with recent studies having shown that COVID-19 “can affect lung bases and may cause significant atelectasis and reduced lung compliance in the context of ARDS.”

“Prone ventilation has been shown to reduce mortality in patients with moderate to severe ARDS. Therefore, we issued a suggestion for clinicians to consider prone ventilation in this population.”

‘Impressively Thorough’ Recommendations, With Some Caveats

In their JAMA editorial, Lamontagne and Angus describe the recommendations as “impressively thorough and expansive.”

They note that they address resource scarcity, which “is likely to be a critical issue in low- and middle-income countries experiencing any reasonably large number of cases and in high-income countries experiencing a surge in the demand for critical care.”

The authors say, however, that a “weakness” of the guidelines is that they make recommendations for interventions that “lack supporting evidence.”

Consequently, “when prioritizing scarce resources, clinicians and healthcare systems will have to choose among options that have limited evidence to support them.”

“In future iterations of the guidelines, there should be more detailed recommendations for how clinicians should prioritize scarce resources, or include more recommendations against the use of unproven therapies.”

“The tasks ahead for the dissemination and uptake of optimal critical care are herculean,” Lamontagne and Angus say.

They include “a need to generate more robust evidence, consider carefully the application of that evidence across a wide variety of clinical circumstances, and generate supporting materials to ensure effective implementation of the guideline recommendations,” they conclude.

ESICM recommendations coauthor Yaseen Arabi is the principal investigator on a clinical trial for lopinavir/ritonavir and interferon in Middle East respiratory syndrome (MERS) and he was a nonpaid consultant on antiviral active for MERS- coronavirus (CoV) for Gilead Sciences and SAB Biotherapeutics. He is an investigator on REMAP-CAP trial and is a Board Members of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). Coauthor Eddy Fan declared receiving consultancy fees from ALung Technologies and MC3 Cardiopulmonary. Coauthor Maurizio Cecconi declared consultancy work with Edwards Lifesciences, Directed Systems, and Cheetah Medical.

JAMA Clinical Guidelines Synopsis coauthor Poston declares receiving honoraria for the CHEST Critical Care Board Review Course.

Editorialist Lamontagne reported receiving grants from the National Institute for Health Research (NIHR), Fonds de recherche du Québec-Santé, and the Lotte & John Hecht Foundation, unrelated to this work. Editorialist Angus participated in the development of Surviving Sepsis Campaign guidelines for sepsis, but had no role in the creation of the current COVID-19 guidelines, nor the decision to create these guidelines.

This article first appeared on Medscape.com.

I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.

For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.¹

In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).² Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.³ In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.⁴

This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.⁵ As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.⁶ Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.⁷ Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.

The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.⁸

The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.

The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”⁹ In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.

The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”¹⁰ Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.

The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.¹¹

The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.¹¹

There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.

I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.

For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.¹

In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).² Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.³ In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.⁴

This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.⁵ As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.⁶ Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.⁷ Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.

The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.⁸

The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.

The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”⁹ In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.

The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”¹⁰ Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.

The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.¹¹

The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.¹¹

There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.

I am writing this editorial on a beautiful day in the high desert of the Southwest: a bright blue clear sky such as you see only in the mountain air, a sun warm and comforting, and birds singing as if they had not a care in the world. Spring has come early as if to dramatize the cognitive dissonance between this idyllic scene and a seemingly invincible winter of disease and death that has gripped the globe.

For now, my editorials will focus on the most threatening infectious disease outbreak since, perhaps, 1918. I have been teaching public health and pandemic ethics to health care professionals and trainees for more than a decade. I always tell the medical students, “it is not if but when” the next viral wave overwhelms society. It is human nature to disbelieve this inevitability and to ignore, dismiss, or even attack the infectious disease experts and science journalists who, like Cassandra, warn us of the return of the plague.¹

In the early 2000s, virologists were concerned that Avian influenza with a mortality rate of > 60% would mutate into a virus capable of jumping the species barrier with sustained human transmission; however, that threat has not materialized (yet).² Instead, in 2009 the H1N1 influenza pandemic struck viciously. The always capricious genetic mutations of viral combinations outwitted vaccine manufacturers, offering little protection, resulting in an estimated 12,469 deaths, tragically many of them children, young, and middle-aged people.³ In between, there were periodic eruptions of the deadly Ebola virus in Africa. In 2014, 11 Americans who had either served as health care workers or traveled in the region were treated in the US.⁴

This much abridged survey of recent pandemics reminds us of how wrong were those who returning victorious from World War II with newly developed antibiotics and at the zenith of American military medicine argued that we would also beat infectious disease.⁵ As my Army pediatrician father would tell me, “the bugs will always be smarter than the drugs.” For now, COVID-19 is outwitting those in science and medicine who are engaged in a desperate race to discover a vaccine or a drug to “stop the virus in its tracks” as the media is so fond of saying.⁶ Irresponsible news outlets are giving a panicked citizenry false hope. Experts recently testified before the US House of Representatives that according to the most optimistic estimates, a vaccine is a year away.⁷ Yet information is a double-edged sword, as the Internet also is able to communicate accurate lifesaving information from the Centers of Disease Control and Prevention and state health departments with unprecedented speed and reach.

The best chance for civilization to “flatten the curve” of the pandemic is, as it has been so many times before, through precautionary measures and preventive public health efforts. There is a reason that in 2007, readers of the prestigious British Journal of Medicine ranked public health interventions as the most important advances in medical history.⁸

The initial installment of this pandemic series will offer a primer in public health ethics. Just as almost everything else in daily life has rapidly and radically changed, from cancelled church services to school closures, so too public health ethics is significantly different in many important aspects from the clinical health ethics we are accustomed to in our practice.

The first difference is focus. In clinical health ethics the focus of the individual health care practitioner is the individual patient, but public health ethics focuses on “what we as a society do to keep people healthy.”⁹ In a pandemic when decisions must be made (to paraphrase Mr. Spock) “for the good of the many” this creates an intrinsic ethical tension for the health care practitioner whose ethos is to advocate for his or her patient.

The second difference is that in order to accomplish these communitarian aims, the law and political and cultural factors have much more influence in medical decision making than within the ideal dyad of a health care practitioner and the patient engaged in shared decision making about the patient’s health. This is nowhere more evident than in the President’s recent declaration of a public health emergency. “The Federal Government, along with State and Local governments, has taken preventive and proactive measures to slow the spread of the virus and treat those affected. . .”¹⁰ Federal and state governments can exercise wide-ranging powers that can restrict individual liberties in ways that would never be legal or ethically justifiable in the course of routine clinical care.

The third difference relates to the ethical principles that guide public health care decision making in comparison with those of clinical ethics. The primacy of autonomy in modern American medical ethics must for the health of the public sometimes yield to the overarching goal of preventing serious harm to the public and mitigating the transmission of the infection. Values such as nonmaleficence and justice become even more important than individual self-determination especially as the pandemic worsens and the demand for scarce ventilators and other life-saving resources outstrips the supply.¹¹

The fourth difference is that in nonemergent care, whether in the clinic or the hospital, the health care provider bears the primary responsibility for making decisions. Practitioners bring their knowledge and experience and patients their values and preferences to arrive at a mutually acceptable treatment plan. In stark contrast the profound and tragic life and death decisions made in a pandemic should not be left to the individual clinician who to the degree possible should remain faithful to the individual patient’s interests to preserve his or her professional integrity. Instead, decisions should be in the hands of highly trained and respected committees with diverse membership and expertise in accordance with evidence-based scientific protocols that are in response to changing pandemic conditions and the best available evidence. This process ensures that the values of consistency, transparency, and fairness which take center place in a public health emergency are the moral basis of decisions rather than ad hoc decisions that risk bias and inequity especially regarding vulnerable populations.¹¹

There is one characteristic of medical decision making that does not change whether in a routine checkup or resource allocation in an intensive care unit in a pandemic: the need to respect individual human dignity and to show compassion for the suffering of those who will not survive. In the Star Trek episode “Wrath of Khan,” Spock sacrificed himself to save his ship, his comrades, and his friends who mourned his death and honored his life.

The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.

The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.

Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.

Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.

Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.

Interestingly, people with serious mental illnesses, such as schizophrenia and nonaffective and affective psychoses, seem to be less vulnerable to the stress-inducing effects of catastrophe. It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.

How to Cope With an Unprecedented Situation

For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.

The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.

When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.

There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”

Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.

Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.

Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.

Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.

We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.

Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.

Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.

This article first appeared on Medscape.com.

The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.

The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.

Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.

Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.

Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.

Interestingly, people with serious mental illnesses, such as schizophrenia and nonaffective and affective psychoses, seem to be less vulnerable to the stress-inducing effects of catastrophe. It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.

How to Cope With an Unprecedented Situation

For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.

The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.

When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.

There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”

Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.

Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.

Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.

Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.

We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.

Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.

Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.

This article first appeared on Medscape.com.

The COVID-19 pandemic is an experience that is unprecedented in our lifetime. It is having a pervasive effect due to how mysterious, potentially dangerous, and sustained it is. We don’t know how bad it’s going to get or how long it’s going to last. We have natural disasters like hurricanes and earthquakes, but they are limited in time and scope. But this global pandemic is something we can’t put our arms around just yet, breeding uncertainty, worry, and fear. This is where mental health professionals need to come in.

The populations being affected by this pandemic can be placed into different groups on the basis of their mental health consequences and needs. First you have, for lack of a better term, “the worried well.” These are people with no preexisting mental disorder who are naturally worried by this and are trying to take appropriate actions to protect themselves and prepare. For such individuals, the equivalent of mental health first-aid should be useful (we’ll come back to that in a moment). Given the proper guidance and sources of information, most such people should be able to manage the anxiety, worry, and dysphoria associated with this critical pandemic.

Then there are those who have preexisting mental conditions related to mood, anxiety, stress, or obsessive tendencies. They are probably going to have an increase in their symptoms, and as such, a corresponding need for adjusting treatment. This may require an increase in their existing medications or the addition of an ad hoc medication, or perhaps more frequent contact with their doctor or therapist.

Because travel and direct visitation is discouraged at the moment, virtual methods of communication should be used to speak with these patients. Such methods have long existed but haven’t been adopted in large numbers; this may be the impetus to finally make it happen. Using the telephone, FaceTime, Skype, WebEx, Zoom, and other means of videoconferencing should be feasible. As billing procedures are being adapted for this moment, there’s no reason why individuals shouldn’t be able to contact their mental health provider.

Substance abuse is also a condition vulnerable to the stress effects of this pandemic. This will prompt or tempt those to use substances that they’ve abused or turned to in the past as a way of self-medicating and assuaging their anxiety and worry.

Interestingly, people with serious mental illnesses, such as schizophrenia and nonaffective and affective psychoses, seem to be less vulnerable to the stress-inducing effects of catastrophe. It’s possible that the pandemic could find its way into delusions or exacerbate symptoms, but somewhat paradoxically, people with serious mental illnesses often respond more calmly to crises than do individuals without them. As a result, the number of these patients requiring emergency room admission for possible exacerbation of symptoms is probably not going to be that much greater than normal.

How to Cope With an Unprecedented Situation

For the worried well and for the clinicians who have understandable fears about exposure, there are several things you can try to manage your anxiety. There are concentric circles of concern that you have to maintain. Think of it like the instructions on an airplane when, if there’s a drop in cabin pressure, you’re asked to apply your own oxygen mask first before placing one on your child. In the same way, you must first think about protecting yourself by limiting your exposure and monitoring your own physical state for any symptoms. But then you must be concerned about your family, your friends, and also society. This is a situation where the impulse and the ethos of worrying about your fellow persons—being your brother’s keeper—is imperative.

The epidemic has been successfully managed in some countries, like Singapore and China, which, once they got on top of it, were able to limit contagion in a very dramatic way. But these are authoritarian governments. The United States doesn’t work that way, which is what makes appealing to the principle of caring for others so crucial. You can protect yourself, but if other people aren’t also protected, it may not matter. You have to worry not just about yourself but about everyone else.

When it comes to stress management, I recommend not catastrophizing or watching the news media 24/7. Distract yourself with other work or recreational activities. Reach out and communicate—virtually, of course—with friends, family, and healthcare providers as needed. Staying in touch acts not just as a diversion but also as an outlet for assuaging your feelings, your sense of being in this alone, feeling isolated.

There are also cognitive reframing mechanisms you can employ. Consider that although this is bad, some countries have already gone through it. And we’ll get through it too. You’ll understandably ask yourself what it would mean if you were to be exposed. In most cases you can say, “I’m going to have the flu and symptoms that are not going to be pleasant, but I’ve had the flu or serious sickness before.”

Remember that there are already antiretroviral treatments being tested in clinical trials and showing efficacy. It’s good to know that before this pandemic ends, some of these treatments will probably be clinically applied, mostly to those who are severely affected and in intensive care.

Diagnose yourself. Monitor your state. Determine whether the stress is really having an impact on you. Is it affecting your sleep, appetite, concentration, mood? And if you do have a preexisting psychiatric condition, don’t feel afraid to reach out to your mental health provider. Understand that you’re going to be anxious, which may aggravate your symptoms and require an adjustment in your treatment. That’s okay. It’s to be expected and your provider should be available to help you.

Controlling this outbreak via the same epidemiologic infectious disease prevention guidance that works in authoritarian societies is not going to be applicable here because of the liberties that we experience in American society. What will determine our success is the belief that we’re in this together, that we’re going to help each other. We should be proud of that, as it shows how Americans and people around the world stand up in situations like this.

Let’s also note that even though everybody is affected and undergoing previously unimaginable levels of anticipated stress and dislocation, it’s the healthcare providers who are really on the frontlines. They’re under tremendous pressure to continue to perform heroically, at great risk to themselves. They deserve a real debt of gratitude.

We will get through this, but as we do, it will not end until we’ve undergone an extreme test of our character. I certainly hope and trust that we will be up to it.

Dr. Jeffrey A. Lieberman is chairman of the Department of Psychiatry at Columbia University. He is a former president of the American Psychiatric Association.

Disclosure: Jeffrey A. Lieberman, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Clintara; Intracellular Therapies. Received research grant from Alkermes; Biomarin; EnVivo/Forum; Genentech; Novartis/Novation; Sunovion. Patent: Repligen.

This article first appeared on Medscape.com.

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The message everywhere is “stay home!” But what if staying home threatens your mental health? Veterans are a doubly vulnerable group these days—vulnerable both to the COVID-19 infection and to the mental stress that self-isolation can inflict. To help relieve that pressure and, in particular, to reach veterans who might not otherwise seek counseling and mental health support, the US Department of Veterans Affairs (VA) has been shifting some outpatient care to telehealth and deploying Mobile Vet Center units to coronavirus-crisis areas.

The VA received some money to beef up its telehealth system from the $2 trillion CARES (Coronavirus Aid, Relief, and Economic Security) Act relief package passed and signed last week: $14.4 billion to expand telehealth services and another $2.15 billion to expand coronavirus-related services, including the purchase of mHealth devices.

Several of the provisions in the CARES Act directly address the needs of rural and underserved veterans. For instance, the Act authorizes the VA to expand telemental health services and enter into short-term agreements with telecommunications companies to provide temporary broadband services to veterans, a critical need among rural residents who may be physically isolated from mental healthcare. The act also allows federally qualified health centers and rural health clinics, 2 types of facilities that serve rural and underserved populations, to be designated as distant sites for telehealth.

Between 2002, when telemental health services were launched, and 2019, veterans have worked with a counselor nearly 3 million times. In 2017, the VA says, psychiatric hospitalizations dropped 31%. Veterans have said they prefer videoconferencing over in-person therapy because they can are more at ease at home.

Using video telehealth, veterans can connect with care teams from anywhere—a safer alternative to traveling to appointments—using the camera on a phone, computer, or Apple or Android devices. Veterans also can use My HealtheVet’s secure messaging feature for non-urgent health questions. VA mental health professionals use both synchronous and asynchronous care: The first to connect patients to providers through a communication link, usually videoconferencing, the second to send data to specialists.

The current pandemic puts a strain on both patients and providers, but the Mobile Vet Centers may help relieve some of that strain. An extension of the VA’s brick-and-mortar Vet Centers, the mobile units provide a range of services, including individual, group, marriage, and family counseling. They also can refer active duty service members, veterans, and their families to VA care or other care facilities.

The mobile units are staffed by Vet Center employees who volunteer to deploy in emergencies, such as hurricanes and wildfires. The first units responding to the COVID-19 pandemic were dispatched to New York City, San Francisco, New Orleans, and Los Angeles.

“In times like this, it’s important to stand shoulder to shoulder with our local communities, support their local needs, and [assure] them they are not alone in navigating this crisis,” said Brooklyn Vet Center Director Gabe Botero.

Although the VA’s top priority remains keeping veterans safe while also making sure they receive the mental and physical healthcare they need , it has been criticized recently for “pausing” the Mission Act, which allows some veterans to get healthcare outside VA centers. The concern was that seeking outside care could expose veterans to the virus and potentially tax private health resources.

Government spokespeople have said the VA is not stopping or pausing the law, but “ensuring the best medical interests of America’s veterans are met.”

The Chinese Society of Cardiology (CSC) has issued a consensus statement on the management of cardiac emergencies during the COVID-19 pandemic.

The document first appeared in the Chinese Journal of Cardiology, and a translated version was published in Circulation. The consensus statement was developed by 125 medical experts in the fields of cardiovascular disease and infectious disease. This included 23 experts currently working in Wuhan, China.

Three overarching principles guided their recommendations.

• The highest priority is prevention and control of transmission (including protecting staff).
• Patients should be assessed both for COVID-19 and for cardiovascular issues.
• At all times, all interventions and therapies provided should be in concordance with directives of infection control authorities.

“Considering that some asymptomatic patients may be a source of infection and transmission, all patients with severe emergent cardiovascular diseases should be managed as suspected cases of COVID-19 in Hubei Province,” noted writing chair and cardiologist Yaling Han, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

In areas outside Hubei Province, where COVID-19 was less prevalent, this “infected until proven otherwise” approach was also recommended, although not as strictly.