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CMS implements temporary regulatory changes to aid COVID-19 response
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.
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.
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.
Barriers to clinical trial participation revealed by gynecologic cancer patients
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.
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.
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.
SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.
FROM SGO 2020
Blood test might detect multiple cancer types, study suggests
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.
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.
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.
FROM ANNALS OF ONCOLOGY
Top 10 must-dos in ICU in COVID-19 include prone ventilation
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.
Leflunomide-hydroxychloroquine combination for Sjögren’s shows potential
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
according to results from a phase 2a, randomized clinical trial published in Lancet Rheumatology.
The combination’s statistically significant effect on the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI) score at 24 weeks, the primary endpoint of the small, double-blind, placebo-controlled trial, suggests that the combination should be studied further in larger trials, according to first author Eefje Hanna Martine van der Heijden, MD, a rheumatologist at University Medical Center Utrecht (the Netherlands), and colleagues.
The investigators decided to study leflunomide and hydroxychloroquine, which target overlapping and distinct immunopathologic pathways, because data support the safety of each drug individually, and a previous in vitro study by the authors indicated that they have complementary effects when administered together.
“To our knowledge, this is the first randomized, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome that shows significant clinical efficacy, as measured by ESSDAI, and is associated with significant improvements in other clinical parameters, including dryness and fatigue,” the investigators wrote.
Dr. van der Heijden and colleagues screened 37 patients from the outpatient clinic of their medical center and enrolled 29 (28 women) who met American-European Consensus Criteria into their study. They had moderate to active disease, defined as an ESSDAI score of 5 or higher, and a lymphocytic focus score of 1 or higher in labial salivary gland biopsy specimens that were obtained before inclusion. The population’s average age was approximately 54 years. They had an average disease duration of about 8 years, a mean ESSDAI score of about 9, and mean EULAR Sjögren’s syndrome patient reported index (ESSPRI) score of 6.7. A total of 21 patients were randomized to leflunomide 20 mg and hydroxychloroquine 400 mg daily, and 8 patients were randomized to placebos. Baseline characteristics were similar between groups, but mean serum IgG level was 19.4 g/L in the treatment group and 13.8 g/L in the placebo group. One patient in the placebo group developed polymyalgia rheumatica and required high-dose prednisone treatment. The investigators excluded this patient from the primary analysis.
At 24 weeks, the mean difference in ESSDAI score in the leflunomide-hydroxychloroquine group, compared with the placebo group, was –4.35 points after adjustment for baseline values. This difference was statistically significant.
Secondary endpoints in the study showed inconsistent statistically significant differences between the treatment groups at 8, 16, and 24 weeks. The total ESSPRI score at 16 weeks was 1.66 points lower in the treatment group than in the placebo group. Stimulated whole saliva production was increased in the leflunomide-hydroxychloroquine group at 16 weeks, compared with the placebo group. Unstimulated whole saliva production at 24 weeks was higher in the leflunomide-hydroxychloroquine group than in controls. The investigators found no differences between groups in visual analog scores for ocular or oral dryness.
No patient in the leflunomide-hydroxychloroquine group had a serious adverse event. Two serious adverse events (hospital admission for pancreatitis and hospital admission for nephrolithiasis) occurred in the placebo group. The most common adverse events in the leflunomide-hydroxychloroquine group were GI discomfort (52% vs. 25% in the placebo group), modest transient increases in ALT (48% vs. 13%), and short episodes of general malaise and shivering (43% vs. 13%).
In an accompanying editorial, Astrid Rasmussen, MD, PhD, of the Oklahoma Sjögren’s Syndrome Center of Research Translation at the Oklahoma Medical Research Foundation in Oklahoma City, wrote that the trial by Dr. van der Heijden and colleagues was limited by a small sample size and short duration. In addition, some of the findings were unexplained, such as modest changes in secondary endpoints and a concomitant decrease in ESSDAI scores at 8 weeks for both study groups.
Nevertheless, the study provides reason to think in new ways about old drugs, wrote Dr. Rasmussen. “Combination or sequential use of existing agents that target different aspects of immune dysregulation, while having acceptable safety profiles and cost-benefit ratios, should represent an avenue of further exploration. Just as importantly, subphenotyping patients on the basis of their underlying pathogenic processes and identifying sensitive outcome measures could transform the current enthusiasm for identifying effective treatments for Sjögren’s syndrome into a reality for the patients that need them the most.”
The study was funded by ZonMw. The authors of the study reported no conflicts of interest. Dr. Rasmussen reported having no conflicts of interest.
SOURCE: van der Heijden EHM et al. Lancet Rheumatol. 2020 Mar 26. doi: 10.1016/S2665-9913(20)30057-6.
FROM LANCET RHEUMATOLOGY
Cardiovascular disease is implicated in link between air pollution and dementia
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
Virtually all of the association between air pollution and dementia seemed to occur through the presence or the development of cardiovascular disease, which suggests a need to optimize treatment of concurrent cardiovascular disease and risk-factor control in older adults at higher risk for dementia and living in polluted urban areas, said lead author Giulia Grande, MD, a researcher at the Aging Research Center, Karolinska Institutet and Stockholm University, in Solna, Sweden.
In the longitudinal, population-based cohort study, investigators studied 2,927 randomly selected residents in a district of Stockholm who were aged 60 years or older (mean, 74.1 years), lived at home or in institutions, and were free of dementia at baseline (March 2001 through August 2004).
The investigators assessed the participants’ exposure to two major air pollutants – particulate matter ≤2.5 mcm and nitrogen oxide – yearly starting in 1990, from outdoor levels at their residential addresses. Both pollutants are generated by road traffic, among other sources.
Results reported in JAMA Neurology showed that, with a mean follow-up of 6.01 years, 12.4% of the older adults received a dementia diagnosis.
Dementia risk increased with the level of air pollutants at their residential address in the past, with strongest associations seen for exposure in the preceding 5 years: The hazard ratio (HR) for dementia was 1.54 for an interquartile range difference of 0.88 mcg/m3 in particulate matter ≤2.5 mcm and 1.14 for an interquartile range difference of 8.35 mcg/m3 in nitrogen oxide during that time period.
Of note, the study cohort lived in an area having “comparatively good ambient air quality” in which restrictions on air pollution have increased in recent decades, Dr. Grande and coinvestigators noted. “Interestingly, the higher limit reported herein is not only below the current European limit for fine particulate matter but also below the US standard. In other words, we were able to establish harmful effects at levels below current standards,” they wrote.
In analyses of effect modification, the elevation of risk related to particulate matter ≤2.5 mcm exposure and nitrogen oxide exposure was significantly greater among older adults who had heart failure (HRs, 1.93 and 1.43, respectively). Risk was marginally greater among those with ischemic heart disease (HRs, 1.67 and 1.36, respectively).
Analyses of potential mediators showed that preceding stroke accounted for the largest share of all dementia cases related to particulate matter ≤2.5 mcm exposure, at 49.4%.
The stronger association for exposure in the past 5 years is noteworthy for the big picture, they added. “From a policy point of view, this result is encouraging because it might imply that reducing air pollutant levels today could yield better outcomes already in the shorter term, reinforcing the need for appropriately set air quality standards,” they said.
Dr. Grande disclosed no relevant conflicts of interest. The study was funded by the Swedish National Study on Aging and Care in Kungsholmen (SNAC-K); the Swedish Ministry of Health and Social Affairs; the participating County Councils and Municipalities; the Swedish Research Council; funding for doctoral education from the Karolinska Institutet; and the Swedish Research Council for Health, Working Life and Welfare.
SOURCE: Grande G et al. JAMA Neurol. 2020. doi:10.1001/jamaneurol.2019.4914.
FROM JAMA NEUROLOGY
Innovation in colorectal cancer screening
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
ginews@gastro.org
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
ginews@gastro.org
Disregard what is currently accepted as state of the art, reimagine the present as an imperfect stepping stone, and envision a future in which colorectal cancer (CRC) screening and surveillance are optimized. This was the direction for attendees of AGA’s consensus conference — Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes.
The AGA Center for GI Innovation and Technology invited leading academic and industry experts to a working meeting to identify barriers to the optimization of CRC screening and surveillance, and to define a roadmap for overcoming these barriers.
Meeting conclusions
Although colonoscopy is widely considered to be an excellent tool for CRC screening and surveillance, barriers to optimal effectiveness exist. Barriers include lack of access to health care, financial cost, suboptimal uptake even among individuals with health insurance and financial resources, imperfect adherence to guidelines, and development of early-age, and interval cancers despite adherence to guidelines.
Novel cost-effective, sensitive, specific, and personalized strategies are needed to address these barriers.
To read about the emerging technologies discussed at the meeting, review the meeting summary in Gastroenterology.
ginews@gastro.org
Top AGA Community patient cases
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.
Here are some recent clinical discussions in the forum regarding the coronavirus and your patients:
1. Biologic treatment for IBD in the COVID-19 era (http://ow.ly/9akD50yKW8E)
A GI colleague from Italy asks how others are managing IBD patients on ongoing biologic treatment during the coronavirus pandemic.
2. COVID-19 and colonoscopy (http://ow.ly/uYUD50yKWfS)
AGA members discuss recommendations for infection control in endoscopy centers.
3. IBD patients concerned about visiting infusion centers (http://ow.ly/gKED50yKWVZ)
How would you address patient concerns about picking up coronavirus from asymptomatic carriers at bustling infusion centers?
Join these discussions and more at https://community.gastro.org/discussions.
AGA app improves your patient’s health and bottom line
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
AGA has partnered with Rx.Health, a digital health company, to create a colorectal cancer (CRC) preparatory app.
You want to find ways to improve your patient outcomes and reduce your practice costs? Now, there is an app for that. The CRC preparatory app can reduce expenses you lose from aborted or incomplete colonoscopies.
Launched in 2019, the CRC app is already generating remarkable results. The Arizona Center for Digestive Health used the CRC app and recorded a 24% improvement in bowel preparation by colonoscopy patients, a 50% reduction in aborted procedures and a 93% patient satisfaction rate. Research conducted by Rx.Health also determined patients were using the CRC app two to four times longer than competing apps, and the CRC app was saving gastroenterologists between $20,000 and $40,000 annually.
Plans are underway between AGA and Rx.Health to expand the partnership to build apps for colorectal cancer surveillance, an inflammatory bowel disease (IBD) registry, fecal microbiota transplantation (FMT), and other GI disorders.
Interested in learning more? Visit rx.health/gi.
The Return of the Plague: A Primer on Pandemic Ethics
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.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.
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.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.
1. Garrett L. The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books, 1995.
2. World Health Organization. FAQS: H5N1 influenza. https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed March 20, 2020.
3. Centers for Disease Control and Prevention. 2009 H1N1 pandemic. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html. Updated June 11, 2019. Accessed March 20, 2020.
4. Centers for Disease Control and Prevention. 2014-2016 Ebola outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html. Updated March 8, 2019. March 20, 2020.
5. Pier GB. On the greatly exaggerated reports of the death of infectious diseases. Clin Infect Dis. 2008;47(8):1113-1114.
6. Digital staff. Coronavirus Australia: researchers say they are close to a cure. https://7news.com.au/sunrise/on-the-show/coronavirus-australia-researchers-say-theyre-close-to-a-cure-c-746508. Published March 15, 2020. Accessed March 20, 2020.
7. Hoetz P. Testimony of Peter Hoetz, M.D, Ph.D. Before the House Committee on Space, Science and Technology of the United States House of Representatives, March 5, 2020. https://science.house.gov/imo/media/doc/Hotez%20Testimony.pdf. Accessed March 15, 2020.
8. Ferriman A. BMJ readers choose the “sanitary revolution” as greatest medical advance since 1840. BMJ. 2007;334(7585):111.
9. Institute of Medicine (US) Committee on Assuring the Health of the Public in the 21st Century. The Future of the Public’s Health in the 21st Century. Washington, DC: National Academies Press; 2002.
10. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus (COVID-19) disease outbreak. https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. Published March 13, 2020. Accessed March 20, 2020.
11. US Department of Veterans Affairs, Veterans Health Administration, National Center for Ethics in Health Care. Meeting the challenge of pandemic influenza: ethical guidance for leaders and health care professionals in the Veterans Health Administration. https://www.ethics.va.gov/activities/pandemic_influenza_preparedness.asp. Published July 2010. Accessed March 20, 2020.