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Low RA flare rate reported after Pfizer COVID vaccination
Patients with rheumatoid arthritis in remission had a rate of flare following vaccination with the Pfizer/BioNtech COVID-19 vaccine that appears to be on par with rates seen with other vaccines in patients with RA, according to results from a small Italian cohort study.
“Our data show a very low flare rate [7.8% (6 of 77)] after the BNT162b2 COVID-19 vaccine in patients with RA in remission and are consistent with previous findings about varicella-zoster virus (6.7%) and hepatitis B virus (2.2%) vaccinations,” Riccardo Bixio, MD, and colleagues from University of Verona (Italy) Hospital Trust wrote in ACR Open Rheumatology. “Because remission is not commonly obtained in the real world, we are aware that our findings may not be generalizable to all patients with RA receiving COVID-19 vaccination.”
Other studies of flare rate after COVID-19 vaccination in patients with a variety of rheumatic and musculoskeletal diseases have reported rates ranging from 5% to 17%, they said.
The 77 consecutive patients from the University of Verona center that conducted the study were all in clinical remission in the 3 months before vaccination based on a 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) of less than 2.6, and all had discontinued antirheumatic therapies according to American College of Rheumatology COVID-19 recommendations. The researchers defined flares as agreement between patient and rheumatologist assessments and a DAS28-CRP increase of more than 1.2.
Five of the six people with a flare had it occur after the second dose at a mean of 2.6 days later, and all flares were resolved within 2 weeks using glucocorticoids with or without anti-inflammatory drugs. One flare was called severe. The overall disease activity of the cohort after 3 months was not significantly changed after vaccination.
In noting that five out of the six patients with flares had withdrawn or delayed antirheumatic therapies around the time of vaccination according to ACR recommendations, the authors wrote that “Even if there is no direct evidence that holding therapies could occur in a higher proportion of disease flares, we suggest that clinicians consider this possibility when counseling patients about COVID-19 vaccination.”
The authors had no outside funding for the study and had no potential conflicts of interest to disclose.
Patients with rheumatoid arthritis in remission had a rate of flare following vaccination with the Pfizer/BioNtech COVID-19 vaccine that appears to be on par with rates seen with other vaccines in patients with RA, according to results from a small Italian cohort study.
“Our data show a very low flare rate [7.8% (6 of 77)] after the BNT162b2 COVID-19 vaccine in patients with RA in remission and are consistent with previous findings about varicella-zoster virus (6.7%) and hepatitis B virus (2.2%) vaccinations,” Riccardo Bixio, MD, and colleagues from University of Verona (Italy) Hospital Trust wrote in ACR Open Rheumatology. “Because remission is not commonly obtained in the real world, we are aware that our findings may not be generalizable to all patients with RA receiving COVID-19 vaccination.”
Other studies of flare rate after COVID-19 vaccination in patients with a variety of rheumatic and musculoskeletal diseases have reported rates ranging from 5% to 17%, they said.
The 77 consecutive patients from the University of Verona center that conducted the study were all in clinical remission in the 3 months before vaccination based on a 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) of less than 2.6, and all had discontinued antirheumatic therapies according to American College of Rheumatology COVID-19 recommendations. The researchers defined flares as agreement between patient and rheumatologist assessments and a DAS28-CRP increase of more than 1.2.
Five of the six people with a flare had it occur after the second dose at a mean of 2.6 days later, and all flares were resolved within 2 weeks using glucocorticoids with or without anti-inflammatory drugs. One flare was called severe. The overall disease activity of the cohort after 3 months was not significantly changed after vaccination.
In noting that five out of the six patients with flares had withdrawn or delayed antirheumatic therapies around the time of vaccination according to ACR recommendations, the authors wrote that “Even if there is no direct evidence that holding therapies could occur in a higher proportion of disease flares, we suggest that clinicians consider this possibility when counseling patients about COVID-19 vaccination.”
The authors had no outside funding for the study and had no potential conflicts of interest to disclose.
Patients with rheumatoid arthritis in remission had a rate of flare following vaccination with the Pfizer/BioNtech COVID-19 vaccine that appears to be on par with rates seen with other vaccines in patients with RA, according to results from a small Italian cohort study.
“Our data show a very low flare rate [7.8% (6 of 77)] after the BNT162b2 COVID-19 vaccine in patients with RA in remission and are consistent with previous findings about varicella-zoster virus (6.7%) and hepatitis B virus (2.2%) vaccinations,” Riccardo Bixio, MD, and colleagues from University of Verona (Italy) Hospital Trust wrote in ACR Open Rheumatology. “Because remission is not commonly obtained in the real world, we are aware that our findings may not be generalizable to all patients with RA receiving COVID-19 vaccination.”
Other studies of flare rate after COVID-19 vaccination in patients with a variety of rheumatic and musculoskeletal diseases have reported rates ranging from 5% to 17%, they said.
The 77 consecutive patients from the University of Verona center that conducted the study were all in clinical remission in the 3 months before vaccination based on a 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) of less than 2.6, and all had discontinued antirheumatic therapies according to American College of Rheumatology COVID-19 recommendations. The researchers defined flares as agreement between patient and rheumatologist assessments and a DAS28-CRP increase of more than 1.2.
Five of the six people with a flare had it occur after the second dose at a mean of 2.6 days later, and all flares were resolved within 2 weeks using glucocorticoids with or without anti-inflammatory drugs. One flare was called severe. The overall disease activity of the cohort after 3 months was not significantly changed after vaccination.
In noting that five out of the six patients with flares had withdrawn or delayed antirheumatic therapies around the time of vaccination according to ACR recommendations, the authors wrote that “Even if there is no direct evidence that holding therapies could occur in a higher proportion of disease flares, we suggest that clinicians consider this possibility when counseling patients about COVID-19 vaccination.”
The authors had no outside funding for the study and had no potential conflicts of interest to disclose.
FROM ACR OPEN RHEUMATOLOGY
Children and COVID: New cases down slightly from record high
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Weekly cases of COVID-19 in children dropped for the first time since June, and daily hospitalizations appear to be falling, even as the pace of vaccinations continues to slow among the youngest eligible recipients, according to new data.
Despite the 3.3% decline from the previous week’s record high, the new-case count still topped 243,000 for the week of Sept. 3-9, putting the total number of cases in children at almost 5.3 million since the pandemic began.
Hospitalizations seem to have peaked on Sept. 4, when the rate for children aged 0-17 years reached 0.51 per 100,000 population. The admission rate for confirmed COVID-19 has dropped steadily since then and was down to 0.45 per 100,000 on Sept. 11, the last day for which preliminary data from the Centers for Disease Control and Prevention were available.
On the prevention side, fully vaccinated children aged 12-17 years represented 5.5% of all Americans who had completed the vaccine regimen as of Sept. 13. Vaccine initiation, however, has dropped for 5 consecutive weeks in 12- to 15-year-olds and in 4 of the last 5 weeks among 16- and 17-year-olds, the CDC said on its COVID Data Tracker.
Just under 199,000 children aged 12-15 received their first dose of the COVID-19 vaccine during the week of Sept. 7-13. That’s down by 18.5% from the week before and by 51.6% since Aug. 9, the last week that vaccine initiation increased for the age group. Among 16- and 17-year-olds, the 83,000 new recipients that week was a decrease of 25.7% from the previous week and a decline of 47% since the summer peak of Aug. 9, the CDC data show.
Those newest recipients bring at-least-one-dose status to 52.0% of those aged 12-15 and 59.9% of the 16- and 17-year-olds, while 40.3% and 48.9% were fully vaccinated as of Sept. 13. Corresponding figures for some of the older groups are 61.6%/49.7% (age 18-24 years), 73.8%/63.1% (40-49 years), and 95.1%/84.5% (65-74 years), the CDC said.
Vaccine coverage for children at the state level deviates considerably from the national averages. The highest rates for children aged 12-17 are to be found in Vermont, where 76% have received at least one dose, the AAP reported in a separate analysis. Massachusetts is just below that but also comes in at 76% by virtue of a rounding error. The other states in the top five are Connecticut (74%), Hawaii (73%), and Rhode Island (71%).
The lowest vaccination rate for children comes from Wyoming (29%), which is preceded by North Dakota (33%), West Virginia (33%), Alabama (33%), and Mississippi (34%). the AAP said based on data from the CDC, which does not include Idaho.
In a bit of a side note, West Virginia’s Republican governor, Jim Justice, recently said this about vaccine reluctance in his state: “For God’s sakes a livin’, how difficult is this to understand? Why in the world do we have to come up with these crazy ideas – and they’re crazy ideas – that the vaccine’s got something in it and it’s tracing people wherever they go? And the same very people that are saying that are carrying their cellphones around. I mean, come on. Come on.”
Over the last 3 weeks, the District of Columbia has had the largest increase in children having received at least one dose: 10 percentage points, as it went from 58% to 68%. The next-largest improvement – 7 percentage points – occurred in Georgia (34% to 41%), New Mexico (61% to 68%), New York (55% to 62%), and Washington (57% to 64%), the AAP said in its weekly vaccination trends report.
Man dies after 43 full ICUs turn him away
Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.
He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.
“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”
His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.
About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.
He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.
“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”
Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.
The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.
The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.
A version of this article first appeared on WebMD.com.
Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.
He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.
“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”
His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.
About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.
He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.
“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”
Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.
The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.
The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.
A version of this article first appeared on WebMD.com.
Ray Martin DeMonia, 73, of Cullman, Alabama, ran an antiques business for 40 years and served as an auctioneer at charity events, the obituary said.
He had a stroke in 2020 during the first months of the COVID pandemic and made sure to get vaccinated, his daughter, Raven DeMonia, told The Washington Post.
“He knew what the vaccine meant for his health and what it meant to staying alive,” she said. “He said, ‘I just want to get back to shaking hands with people, selling stuff, and talking antiques.’”
His daughter told the Post that her father went to Cullman Regional Medical Center on Aug. 23 with heart problems.
About 12 hours after he was admitted, her mother got a call from the hospital saying they’d called 43 hospitals and were unable to find a “specialized cardiac ICU bed” for him, Ms. DeMonia told the Post.
He was finally airlifted to Rush Foundation Hospital in Meridian, Mississippi, almost 200 miles from his home, but died there Sept. 1. His family decided to make a plea for increased vaccinations in his obituary.
“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” the obit said. “Due to COVID 19, CRMC emergency staff contacted 43 hospitals in 3 states in search of a Cardiac ICU bed and finally located one in Meridian, MS. He would not want any other family to go through what his did.”
Mr. DeMonia is survived by his wife, daughter, grandson, and other family members.
The Alabama Hospital Association says state hospitals are still short of ICU beds. On Sept. 12, the AHA website said the state had 1,530 staffed ICU beds to accommodate 1,541 ICU patients.
The AHA said 83% of COVID patients in ICU had not been vaccinated against COVID, 4% were partially vaccinated, and 13% were fully vaccinated. Alabama trails other states in vaccination rates. Newsweek, citing CDC data, said 53.7% of people in Alabama were fully vaccinated. In comparison, 53.8% of all Americans nationally are fully vaccinated.
A version of this article first appeared on WebMD.com.
Pandemic strategies to boost trial enrollment should stay
Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.
These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.
These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).
Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.
Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.
Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.
These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.
“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.
The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.
Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.
This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.
Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.
Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.
The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.
“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.
However, she expressed concern that “with the telehealth visits, we can create some disparities.”
“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.
Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”
Impact on lung cancer clinical trials
The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.
Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.
The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).
The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.
The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).
Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).
Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).
“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.
Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.
This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).
Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).
The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.
Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.
The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.
A version of this article first appeared on Medscape.com.
Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.
These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.
These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).
Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.
Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.
Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.
These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.
“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.
The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.
Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.
This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.
Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.
Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.
The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.
“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.
However, she expressed concern that “with the telehealth visits, we can create some disparities.”
“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.
Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”
Impact on lung cancer clinical trials
The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.
Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.
The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).
The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.
The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).
Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).
Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).
“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.
Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.
This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).
Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).
The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.
Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.
The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.
A version of this article first appeared on Medscape.com.
Although enrollment into lung cancer clinical trials fell during the early months of the COVID-19 pandemic, it increased after a number of mitigation strategies were introduced.
These strategies should now be maintained, say experts, in order to improve enrollment and access to trials and to ensure that trials are more pragmatic and streamlined.
These were the findings from a survey sent to 173 sites of clinical trials in 45 countries around the world. The findings were presented recently at the World Conference on Lung Cancer (WCLC) 2021. The meeting and the survey were organized by the International Association for the Study of Lung Cancer (IASLC).
Responses to the survey revealed that enrollment into lung cancer trials fell by 43% during the early months of the pandemic. Patients stopped attending clinics, and some trials were suspended.
Patients were less willing to visit clinical trial sites, and lockdown restrictions made travel difficult.
Organizers of clinical trials responded by implementing mitigation strategies, such as changing monitoring requirements, increasing use of telehealth, and using local non-study facilities for laboratory and radiology services.
These measures led to an increase in trial enrollment toward the end of 2020, the survey results show.
“The COVID-19 pandemic created many challenges [that led to] reductions in lung cancer clinical trial enrollment,” commented study presenter Matthew P. Smeltzer, PhD, from the Division of Epidemiology, Biostatistics, and Environmental Health, University of Memphis.
The employment of mitigation strategies allowed the removal of “barriers,” and although the pandemic “worsened, trial enrollment began to improve due in part to these strategies,” Dr. Smeltzer said.
Many of these measures were successful and should be maintained, he suggested. Strategies include allowing telehealth visits, performing testing at local laboratories, using local radiology services, mailing experimental agents “where possible,” and allowing flexibility in trial schedules.
This is a “very important” study, commented Marina Garassino, MD, professor of medicine, hematology, and oncology, the University of Chicago Medicine, in her discussion of the abstract.
Irrespective of the pandemic, the regulation and the bureaucracy of clinical trials hinder participation by patients and physicians, she said.
Many of the mitigation strategies highlighted by the survey were similar to recommendations on the conduct of clinical trials published by the American Society of Clinical Oncology during the pandemic. Those recommendations emphasize the use of telehealth and offsite strategies to help with patient monitoring, she noted.
The findings from the survey show that it is possible to conduct more “streamlined and pragmatic trials,” she said.
“More flexible approaches should be approved by the sponsors of clinical trials and global regulatory bodies,” she added.
However, she expressed concern that “with the telehealth visits, we can create some disparities.”
“We have to remember that lung cancer patients are sometimes a very old population, and they are not digitally evolved,” she commented.
Commenting on Twitter, Jennifer C. King, PhD, chief scientific officer at the GO2 Foundation for Lung Cancer, in Washington, D.C., agreed that many of the mitigation strategies identified in the study “are good for patients all of the time, not just during a pandemic.”
Impact on lung cancer clinical trials
The survey, which included 64 questions, was intended to assess the impact of the COVID pandemic on lung cancer clinical trials.
Most of the survey responses came from sites in Europe (37.6%); 21.4% came from Asia, 13.3% came from the United States, and 7.5% came from Canada.
The team found that enrollment into lung cancer trials declined by 43% in 2020 compared to 2019, at an incidence rate ratio of 0.57 (P = .0115).
The largest decreases in enrollment were between April and August 2020, Dr. Smeltzer noted. However, in the last quarter of 2020 (October to December), the differences in enrollment were significantly smaller (P = .0160), despite a marked increase in global COVID-19 cases per month, he added.
The most common challenges faced by clinical trial sites during the pandemic were the following: There were fewer eligible patients (cited by 67% of respondents); compliance protocol was worse (61%); trials were suspended (60%); there was a lack of research staff (48%); and there were institutional closures (39%).
Regarding patient-related challenges, 67% of sites cited less willingness to visit the site. Other challenges included less ability to travel (cited by 60%), reduced access to the trial site (52%), quarantining because of exposure to COVID-19 (40%), and SARS-CoV-2 infection (26%).
Concerns of patients included the following: Fear of SARS-CoV-2 infection, which was cited by 83%; travel restrictions (47%); securing transportation (38%); and access to the laboratory/radiology services (14%).
“Patient willingness to visit the site was a consistent barrier reported across Europe, the U.S., and Canada,” said Dr. Smeltzer, although the effect was smaller in North America, he added.
Regarding mitigation strategies that were employed during the pandemic to combat the challenges and concerns, the team found that the most common measure was the modification of monitoring requirements, used by 44% of sites.
This was followed by the use of telehealth visits (43% sites), the use of laboratories at non-study facilities ( 27%), and alterations to the number of required visits (25%).
Other mitigation strategies included use of mail-order medications, (24%), using radiology services at a non-study site (20%), and altering the trial schedules (19%).
The most effective mitigation strategies were felt to be those that allowed flexibility with respect to location. These measures included use of remote monitoring, remote diagnostics, telehealth visits, and modified symptom monitoring.
Effective strategies that increased flexibility in time were delayed visits, delayed assessments, and changes to the Institutional Review Board.
The study was funded by the IASLC, which received industry support to conduct the project. Dr. Smeltzer reported no relevant financial relationships. Dr. Garassino has relationships with AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Ignyta, Incyte, MedImmune, Mirati, MSD International, Novartis, Pfizer, Regeneron, Roche, Takeda, and Seattle Genetics.
A version of this article first appeared on Medscape.com.
At 18 months, much still unknown about diabetes and COVID-19
At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.
“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.
“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.
In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.
People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.
In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.
The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.
“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
Elevated glucose is clear risk factor for COVID-19 severity
Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.
High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).
Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.
Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.
“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
Evidence gaps identified
Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.
First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.
Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.
Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.
“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”
Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.
“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.
“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.
“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.
In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.
People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.
In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.
The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.
“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
Elevated glucose is clear risk factor for COVID-19 severity
Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.
High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).
Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.
Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.
“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
Evidence gaps identified
Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.
First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.
Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.
Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.
“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”
Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.
“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.
“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.
“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.
In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.
People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.
In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.
The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.
“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
Elevated glucose is clear risk factor for COVID-19 severity
Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.
High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).
Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.
Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.
“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
Evidence gaps identified
Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.
First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.
Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.
Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.
“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”
Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.
“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA could authorize COVID-19 vaccine for ages 5-11 in October
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.
Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.
If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.
Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.
On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.
Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.
For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.
BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.
“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.
The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.
“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.
A version of this article first appeared on WebMD.com.
Virtual Respiratory Urgent Clinics for COVID-19 Symptoms
Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.1 Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).3
With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.5 Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.6-11
The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.7
In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.12,13
The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).16
Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.17
Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.16 Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.
Methods
VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.
COVID-19 Urgent Clinics Program
Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.
Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.
Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.
Results
A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).
A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30
Discussion
This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.
Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.
Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.
Conclusions
VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.
Acknowledgment
The authors thank Robert F. Walsh, MHA.
1. Bashshur RL, Howell JD, Krupinski EA, Harms KM, Bashshur N, Doarn CR. The empirical foundations of telemedicine interventions in primary care. Telemed J E Health. 2016;22(5):342-375. doi:10.1089/tmj.2016.0045
2. Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. Updated June 10, 2020. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html
3. Harvey JB, Valenta S, Simpson K, Lyles M, McElligott J. Utilization of outpatient telehealth services in parity and nonparity states 2010-2015. Telemed J E Health. 2019;25(2):132-136. doi:10.1089/tmj.2017.0265
4. Dorsey ER, Topol EJ. State of telehealth. N Engl J Med. 2016;375(2):154-161. doi:10.1056/NEJMra1601705
5. Rockwell KL, Gilroy AS. Incorporating telemedicine as part of COVID-19 outbreak response systems. Am J Manag Care. 2020;26(4):147-148. doi:10.37765/ajmc.2020.42784
6. Centers for Disease Control and Prevention. Healthcare facility guidance. Updated April 17, 2021. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html
7. US Department of Health and Human Services, Health Resources and Services Administration. Policy changes during COVID-19. Accessed August 20, 2021. https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency
8. Coronavirus Preparedness and Response Supplemental Appropriation Act of 2020. 134 Stat. 146. Published February 2, 2021. Accessed August 20, 2021. https://www.govinfo.gov/content/pkg/CREC-2021-02-02/html/CREC-2021-02-02-pt1-PgS226.htm
9. US Department of Health and Human Services. Notification of enforcement discretion for telehealth remote communications during the COVID-19 nationwide public health emergency. Updated January 20, 2021. Accessed August 20, 2021. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
10. Centers for Medicare and Medicaid Services. Coverage and payment related to COVID-19 Medicare. 2020. Published March 23, 2020. Accessed August 20, 2021. https://www.cms.gov/files/document/03052020-medicare-covid-19-fact-sheet.pdf
11. American Telemedicine Association. ATA commends 2020 Congress for giving HHS authority to waive restrictions on telehealth for Medicare beneficiaries in response to the COVID-19 outbreak [press release]. Published March 5, 2020. Accessed August 20, 2021. https://www.americantelemed.org/press-releases/ata-commends-congress-for-waiving-restrictions-on-telehealth-for-medicare-beneficiaries-in-response-to-the-covid-19-outbreak
12. Hollander JE, Carr BG. Virtually perfect? Telemedicine for Covid-19. N Engl J Med. 2020;382(18):1679-1681. doi:10.1056/NEJMp2003539
13. Khairat S, Meng C, Xu Y, Edson B, Gianforcaro R. Interpreting COVID-19 and Virtual Care Trends: Cohort Study. JMIR Public Health Surveill. 2020;6(2):e18811. Published 2020 Apr 15. doi:10.2196/18811
14. Ferguson JM, Jacobs J, Yefimova M, Greene L, Heyworth L, Zulman DM. Virtual care expansion in the Veterans Health Administration during the COVID-19 pandemic: clinical services and patient characteristics associated with utilization. J Am Med Inform Assoc. 2021;28(3):453-462. doi:10.1093/jamia/ocaa284
15. Baum A, Kaboli PJ, Schwartz MD. Reduced in-person and increased telehealth outpatient visits during the COVID-19 Pandemic. Ann Intern Med. 2021;174(1):129-131. doi:10.7326/M20-3026
16. Spelman JF, Brienza R, Walsh RF, et al. A model for rapid transition to virtual care, VA Connecticut primary care response to COVID-19. J Gen Intern Med. 2020;35(10):3073-3076. doi:10.1007/s11606-020-06041-4
17. Der-Martirosian C, Chu K, Dobalian A. Use of telehealth to improve access to care at the United States Department of Veterans Affairs during the 2017 Atlantic hurricane season [published online ahead of print, 2020 Apr 13]. Disaster Med Public Health Prep. 2020;1-5. doi:10.1017/dmp.2020.88
Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.1 Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).3
With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.5 Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.6-11
The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.7
In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.12,13
The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).16
Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.17
Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.16 Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.
Methods
VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.
COVID-19 Urgent Clinics Program
Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.
Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.
Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.
Results
A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).
A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30
Discussion
This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.
Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.
Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.
Conclusions
VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.
Acknowledgment
The authors thank Robert F. Walsh, MHA.
Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.1 Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).3
With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.5 Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.6-11
The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.7
In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.12,13
The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).16
Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.17
Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.16 Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.
Methods
VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.
COVID-19 Urgent Clinics Program
Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.
Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.
Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.
Results
A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).
A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30
Discussion
This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.
Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.
Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.
Conclusions
VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.
Acknowledgment
The authors thank Robert F. Walsh, MHA.
1. Bashshur RL, Howell JD, Krupinski EA, Harms KM, Bashshur N, Doarn CR. The empirical foundations of telemedicine interventions in primary care. Telemed J E Health. 2016;22(5):342-375. doi:10.1089/tmj.2016.0045
2. Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. Updated June 10, 2020. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html
3. Harvey JB, Valenta S, Simpson K, Lyles M, McElligott J. Utilization of outpatient telehealth services in parity and nonparity states 2010-2015. Telemed J E Health. 2019;25(2):132-136. doi:10.1089/tmj.2017.0265
4. Dorsey ER, Topol EJ. State of telehealth. N Engl J Med. 2016;375(2):154-161. doi:10.1056/NEJMra1601705
5. Rockwell KL, Gilroy AS. Incorporating telemedicine as part of COVID-19 outbreak response systems. Am J Manag Care. 2020;26(4):147-148. doi:10.37765/ajmc.2020.42784
6. Centers for Disease Control and Prevention. Healthcare facility guidance. Updated April 17, 2021. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html
7. US Department of Health and Human Services, Health Resources and Services Administration. Policy changes during COVID-19. Accessed August 20, 2021. https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency
8. Coronavirus Preparedness and Response Supplemental Appropriation Act of 2020. 134 Stat. 146. Published February 2, 2021. Accessed August 20, 2021. https://www.govinfo.gov/content/pkg/CREC-2021-02-02/html/CREC-2021-02-02-pt1-PgS226.htm
9. US Department of Health and Human Services. Notification of enforcement discretion for telehealth remote communications during the COVID-19 nationwide public health emergency. Updated January 20, 2021. Accessed August 20, 2021. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
10. Centers for Medicare and Medicaid Services. Coverage and payment related to COVID-19 Medicare. 2020. Published March 23, 2020. Accessed August 20, 2021. https://www.cms.gov/files/document/03052020-medicare-covid-19-fact-sheet.pdf
11. American Telemedicine Association. ATA commends 2020 Congress for giving HHS authority to waive restrictions on telehealth for Medicare beneficiaries in response to the COVID-19 outbreak [press release]. Published March 5, 2020. Accessed August 20, 2021. https://www.americantelemed.org/press-releases/ata-commends-congress-for-waiving-restrictions-on-telehealth-for-medicare-beneficiaries-in-response-to-the-covid-19-outbreak
12. Hollander JE, Carr BG. Virtually perfect? Telemedicine for Covid-19. N Engl J Med. 2020;382(18):1679-1681. doi:10.1056/NEJMp2003539
13. Khairat S, Meng C, Xu Y, Edson B, Gianforcaro R. Interpreting COVID-19 and Virtual Care Trends: Cohort Study. JMIR Public Health Surveill. 2020;6(2):e18811. Published 2020 Apr 15. doi:10.2196/18811
14. Ferguson JM, Jacobs J, Yefimova M, Greene L, Heyworth L, Zulman DM. Virtual care expansion in the Veterans Health Administration during the COVID-19 pandemic: clinical services and patient characteristics associated with utilization. J Am Med Inform Assoc. 2021;28(3):453-462. doi:10.1093/jamia/ocaa284
15. Baum A, Kaboli PJ, Schwartz MD. Reduced in-person and increased telehealth outpatient visits during the COVID-19 Pandemic. Ann Intern Med. 2021;174(1):129-131. doi:10.7326/M20-3026
16. Spelman JF, Brienza R, Walsh RF, et al. A model for rapid transition to virtual care, VA Connecticut primary care response to COVID-19. J Gen Intern Med. 2020;35(10):3073-3076. doi:10.1007/s11606-020-06041-4
17. Der-Martirosian C, Chu K, Dobalian A. Use of telehealth to improve access to care at the United States Department of Veterans Affairs during the 2017 Atlantic hurricane season [published online ahead of print, 2020 Apr 13]. Disaster Med Public Health Prep. 2020;1-5. doi:10.1017/dmp.2020.88
1. Bashshur RL, Howell JD, Krupinski EA, Harms KM, Bashshur N, Doarn CR. The empirical foundations of telemedicine interventions in primary care. Telemed J E Health. 2016;22(5):342-375. doi:10.1089/tmj.2016.0045
2. Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. Updated June 10, 2020. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html
3. Harvey JB, Valenta S, Simpson K, Lyles M, McElligott J. Utilization of outpatient telehealth services in parity and nonparity states 2010-2015. Telemed J E Health. 2019;25(2):132-136. doi:10.1089/tmj.2017.0265
4. Dorsey ER, Topol EJ. State of telehealth. N Engl J Med. 2016;375(2):154-161. doi:10.1056/NEJMra1601705
5. Rockwell KL, Gilroy AS. Incorporating telemedicine as part of COVID-19 outbreak response systems. Am J Manag Care. 2020;26(4):147-148. doi:10.37765/ajmc.2020.42784
6. Centers for Disease Control and Prevention. Healthcare facility guidance. Updated April 17, 2021. Accessed August 20, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html
7. US Department of Health and Human Services, Health Resources and Services Administration. Policy changes during COVID-19. Accessed August 20, 2021. https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency
8. Coronavirus Preparedness and Response Supplemental Appropriation Act of 2020. 134 Stat. 146. Published February 2, 2021. Accessed August 20, 2021. https://www.govinfo.gov/content/pkg/CREC-2021-02-02/html/CREC-2021-02-02-pt1-PgS226.htm
9. US Department of Health and Human Services. Notification of enforcement discretion for telehealth remote communications during the COVID-19 nationwide public health emergency. Updated January 20, 2021. Accessed August 20, 2021. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html
10. Centers for Medicare and Medicaid Services. Coverage and payment related to COVID-19 Medicare. 2020. Published March 23, 2020. Accessed August 20, 2021. https://www.cms.gov/files/document/03052020-medicare-covid-19-fact-sheet.pdf
11. American Telemedicine Association. ATA commends 2020 Congress for giving HHS authority to waive restrictions on telehealth for Medicare beneficiaries in response to the COVID-19 outbreak [press release]. Published March 5, 2020. Accessed August 20, 2021. https://www.americantelemed.org/press-releases/ata-commends-congress-for-waiving-restrictions-on-telehealth-for-medicare-beneficiaries-in-response-to-the-covid-19-outbreak
12. Hollander JE, Carr BG. Virtually perfect? Telemedicine for Covid-19. N Engl J Med. 2020;382(18):1679-1681. doi:10.1056/NEJMp2003539
13. Khairat S, Meng C, Xu Y, Edson B, Gianforcaro R. Interpreting COVID-19 and Virtual Care Trends: Cohort Study. JMIR Public Health Surveill. 2020;6(2):e18811. Published 2020 Apr 15. doi:10.2196/18811
14. Ferguson JM, Jacobs J, Yefimova M, Greene L, Heyworth L, Zulman DM. Virtual care expansion in the Veterans Health Administration during the COVID-19 pandemic: clinical services and patient characteristics associated with utilization. J Am Med Inform Assoc. 2021;28(3):453-462. doi:10.1093/jamia/ocaa284
15. Baum A, Kaboli PJ, Schwartz MD. Reduced in-person and increased telehealth outpatient visits during the COVID-19 Pandemic. Ann Intern Med. 2021;174(1):129-131. doi:10.7326/M20-3026
16. Spelman JF, Brienza R, Walsh RF, et al. A model for rapid transition to virtual care, VA Connecticut primary care response to COVID-19. J Gen Intern Med. 2020;35(10):3073-3076. doi:10.1007/s11606-020-06041-4
17. Der-Martirosian C, Chu K, Dobalian A. Use of telehealth to improve access to care at the United States Department of Veterans Affairs during the 2017 Atlantic hurricane season [published online ahead of print, 2020 Apr 13]. Disaster Med Public Health Prep. 2020;1-5. doi:10.1017/dmp.2020.88
Biden vaccine mandate rule could be ready within weeks
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.
The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.
Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.
The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.
He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.
Mr. Zients declined to set hard numbers around those goals, but other experts did.
“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.
He said immunity needs to be that high because the Delta variant is so contagious.
Mandates are seen as the most effective way to increase immunity and do it quickly.
David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.
“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.
In addition to drafting the standard, OSHA will oversee its enforcement.
Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.
Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.
“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.
The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.
Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.
But the president hit back at that notion Sept. 10.
“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.
“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”
Yet, others feel the new requirements didn’t go far enough.
“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.
Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.
“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.
Vaccines remain the cornerstone of U.S. plans to control the pandemic.
On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.
But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.
The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.
Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.
From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.
“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.
Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.
“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.
“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.
A version of this article first appeared on WebMD.com.
The Delta Factor
Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.1
I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.2 Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.3 So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?4,5
I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.6 An increasing number of these cases sadly are in children.7
According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.8
The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.9 The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.10 Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.11
Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”4 Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”5
VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.5 As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.12
The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem
Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.15 Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.16
1. CBS Good Morning. Christopher Cross on his near-fatal COVID illness. Published October 18, 2020. Accessed August 21, 2021. https://www.cbsnews.com/news/christopher-cross-on-his-near-fatal-covid-illness
2. Geppert CM. Mistrust and mandates: COVID-19 vaccination in the military. Fed Pract. 2021;38(6):254-255. doi:10.12788/fp.0143
3. Garmone J, US Department of Defense. Secretary of defense addresses vaccine hesitancy in the military. Published February 25, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military
4. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA mandates COVID-19 vaccines among its medical employees including VHA facilities staff [press release]. Published July 26, 2021. Accessed August 21, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5696
5. US Department of Defense, Secretary of Defense. Memorandum for all Department of Defense employees. Published August 9, 2021. Accessed August 23, 2021. https://media.defense.gov/2021/Aug/09/2002826254/-1/-1/0/MESSAGE-TO-THE-FORCE-MEMO-VACCINE.PDF
6. Centers for Disease Control and Prevention COVID data tracker. Variant proportions. Updated August 17, 2021. Accessed August 23, 2021. https://covid.cdc.gov/covid-data-tracker/#variant-proportions
7. American Academy of Pediatrics. Children and COVID-19: state data level report. Updated August 23, 2021. Accessed August 23, 2021. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state|-level-data-report
8. Centers for Disease Control and Prevention. Delta variant: what we know about the science. Update August 19, 2021. Accessed August 23, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html
9. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands mandate for COVID-19 vaccines among VHA employees [press release]. Published August 12, 2021. Accessed August 23, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5703
10. US Food and Drug Administration. FDA approves first COVID-19 vaccine [press release]. Published August 23, 2021. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
11. Garamone J, US Department of Defense. Biden to approve Austin’s request to make COVID-19 vaccine mandatory for service members. Published August 9, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2724982/biden-to-approve-austins-request-to-make-covid-19-vaccine-mandatory-for-service
12. Watson J. Potential military vaccine mandate brings distrust, support. Associated Press. August 5, 2021. Accessed August 23, 2021. https://apnews.com/article/joe-biden-business-health-coronavirus-pandemic-6a0f94e11f5af1e0de740d44d7931d65
13. Giubilini A. Vaccination ethics. Br Med Bull. 2021;137(1):4-12. doi:10.1093/bmb/ldaa036
14. Steinhauer J. Military and V.A. struggle with vaccination rates in their ranks. The New York Times. July 1, 2021. Accessed August 23, 2021. https://www.nytimes.com/2021/07/01/us/politics/military-va-vaccines.html
15. The White House. Press briefing by White House COVID-19 Response Team and public health officials. Published July 8, 2021. Accessed August 23, 2021. https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/08/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-44
16. Adutaleb Y, Johnson CY, Achenbach J. ‘The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe. The Washington Post. July 29, 2021. Accessed August 21, 2021 https://www.washingtonpost.com/health/2021/07/29/cdc-mask-guidance
Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.1
I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.2 Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.3 So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?4,5
I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.6 An increasing number of these cases sadly are in children.7
According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.8
The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.9 The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.10 Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.11
Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”4 Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”5
VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.5 As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.12
The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem
Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.15 Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.16
Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.1
I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.2 Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.3 So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?4,5
I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.6 An increasing number of these cases sadly are in children.7
According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.8
The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.9 The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.10 Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.11
Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”4 Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”5
VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.5 As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.12
The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem
Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.15 Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.16
1. CBS Good Morning. Christopher Cross on his near-fatal COVID illness. Published October 18, 2020. Accessed August 21, 2021. https://www.cbsnews.com/news/christopher-cross-on-his-near-fatal-covid-illness
2. Geppert CM. Mistrust and mandates: COVID-19 vaccination in the military. Fed Pract. 2021;38(6):254-255. doi:10.12788/fp.0143
3. Garmone J, US Department of Defense. Secretary of defense addresses vaccine hesitancy in the military. Published February 25, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military
4. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA mandates COVID-19 vaccines among its medical employees including VHA facilities staff [press release]. Published July 26, 2021. Accessed August 21, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5696
5. US Department of Defense, Secretary of Defense. Memorandum for all Department of Defense employees. Published August 9, 2021. Accessed August 23, 2021. https://media.defense.gov/2021/Aug/09/2002826254/-1/-1/0/MESSAGE-TO-THE-FORCE-MEMO-VACCINE.PDF
6. Centers for Disease Control and Prevention COVID data tracker. Variant proportions. Updated August 17, 2021. Accessed August 23, 2021. https://covid.cdc.gov/covid-data-tracker/#variant-proportions
7. American Academy of Pediatrics. Children and COVID-19: state data level report. Updated August 23, 2021. Accessed August 23, 2021. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state|-level-data-report
8. Centers for Disease Control and Prevention. Delta variant: what we know about the science. Update August 19, 2021. Accessed August 23, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html
9. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands mandate for COVID-19 vaccines among VHA employees [press release]. Published August 12, 2021. Accessed August 23, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5703
10. US Food and Drug Administration. FDA approves first COVID-19 vaccine [press release]. Published August 23, 2021. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
11. Garamone J, US Department of Defense. Biden to approve Austin’s request to make COVID-19 vaccine mandatory for service members. Published August 9, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2724982/biden-to-approve-austins-request-to-make-covid-19-vaccine-mandatory-for-service
12. Watson J. Potential military vaccine mandate brings distrust, support. Associated Press. August 5, 2021. Accessed August 23, 2021. https://apnews.com/article/joe-biden-business-health-coronavirus-pandemic-6a0f94e11f5af1e0de740d44d7931d65
13. Giubilini A. Vaccination ethics. Br Med Bull. 2021;137(1):4-12. doi:10.1093/bmb/ldaa036
14. Steinhauer J. Military and V.A. struggle with vaccination rates in their ranks. The New York Times. July 1, 2021. Accessed August 23, 2021. https://www.nytimes.com/2021/07/01/us/politics/military-va-vaccines.html
15. The White House. Press briefing by White House COVID-19 Response Team and public health officials. Published July 8, 2021. Accessed August 23, 2021. https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/08/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-44
16. Adutaleb Y, Johnson CY, Achenbach J. ‘The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe. The Washington Post. July 29, 2021. Accessed August 21, 2021 https://www.washingtonpost.com/health/2021/07/29/cdc-mask-guidance
1. CBS Good Morning. Christopher Cross on his near-fatal COVID illness. Published October 18, 2020. Accessed August 21, 2021. https://www.cbsnews.com/news/christopher-cross-on-his-near-fatal-covid-illness
2. Geppert CM. Mistrust and mandates: COVID-19 vaccination in the military. Fed Pract. 2021;38(6):254-255. doi:10.12788/fp.0143
3. Garmone J, US Department of Defense. Secretary of defense addresses vaccine hesitancy in the military. Published February 25, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2516511/secretary-of-defense-addresses-vaccine-hesitancy-in-military
4. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA mandates COVID-19 vaccines among its medical employees including VHA facilities staff [press release]. Published July 26, 2021. Accessed August 21, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5696
5. US Department of Defense, Secretary of Defense. Memorandum for all Department of Defense employees. Published August 9, 2021. Accessed August 23, 2021. https://media.defense.gov/2021/Aug/09/2002826254/-1/-1/0/MESSAGE-TO-THE-FORCE-MEMO-VACCINE.PDF
6. Centers for Disease Control and Prevention COVID data tracker. Variant proportions. Updated August 17, 2021. Accessed August 23, 2021. https://covid.cdc.gov/covid-data-tracker/#variant-proportions
7. American Academy of Pediatrics. Children and COVID-19: state data level report. Updated August 23, 2021. Accessed August 23, 2021. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state|-level-data-report
8. Centers for Disease Control and Prevention. Delta variant: what we know about the science. Update August 19, 2021. Accessed August 23, 2021. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html
9. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands mandate for COVID-19 vaccines among VHA employees [press release]. Published August 12, 2021. Accessed August 23, 2021. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5703
10. US Food and Drug Administration. FDA approves first COVID-19 vaccine [press release]. Published August 23, 2021. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
11. Garamone J, US Department of Defense. Biden to approve Austin’s request to make COVID-19 vaccine mandatory for service members. Published August 9, 2021. Accessed August 23, 2021. https://www.defense.gov/Explore/News/Article/Article/2724982/biden-to-approve-austins-request-to-make-covid-19-vaccine-mandatory-for-service
12. Watson J. Potential military vaccine mandate brings distrust, support. Associated Press. August 5, 2021. Accessed August 23, 2021. https://apnews.com/article/joe-biden-business-health-coronavirus-pandemic-6a0f94e11f5af1e0de740d44d7931d65
13. Giubilini A. Vaccination ethics. Br Med Bull. 2021;137(1):4-12. doi:10.1093/bmb/ldaa036
14. Steinhauer J. Military and V.A. struggle with vaccination rates in their ranks. The New York Times. July 1, 2021. Accessed August 23, 2021. https://www.nytimes.com/2021/07/01/us/politics/military-va-vaccines.html
15. The White House. Press briefing by White House COVID-19 Response Team and public health officials. Published July 8, 2021. Accessed August 23, 2021. https://www.whitehouse.gov/briefing-room/press-briefings/2021/07/08/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-44
16. Adutaleb Y, Johnson CY, Achenbach J. ‘The war has changed’: Internal CDC document urges new messaging, warns delta infections likely more severe. The Washington Post. July 29, 2021. Accessed August 21, 2021 https://www.washingtonpost.com/health/2021/07/29/cdc-mask-guidance
Right Ventricle Dilation Detected on Point-of-Care Ultrasound Is a Predictor of Poor Outcomes in Critically Ill Patients With COVID-19
Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.1 During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).2
In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.3
The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.
Methods
The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.
Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.
To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.
The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.
The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).6 IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.7 POCUS was also used for the placement of central and arterial lines and to guide fluid management.8
The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.
Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.
Results
Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.
Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).
Serial POCUS documented development or progression of RV dilation and dysfunction from the time of ICU admission in 4 of the patients. The presence of B lines with irregular pleura was predictive of a lower arterial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) by a value of 71 compared with those without B lines with irregular pleura (P = .005, adjusted R2 = 0.238). All patients with RV dilation had bilateral B lines with pleural irregularities on lung ultrasound. Vascular POCUS detected 4 deep vein thromboses (DVT).7 An arterial thrombus was also detected on focused examination. There was a higher mortality in patients who required mechanical ventilation; however, there was no difference in POCUS characteristics between the groups (Table 2).
Two severely hypoxemic patients received systemic tissue plasminogen activator (TPA) after findings of massive RV dilation with signs of volume and pressure overload and clinical suspicion of pulmonary embolism (PE). One of these patients also had a popliteal DVT. Both patients were too unstable to transport for additional imaging or therapies. Therapeutic anticoagulation was initiated on 4 patients with positive DVT examinations. In a fifth case an arterial thrombectomy and anticoagulation was required after diminished pulses led to the finding of an occlusive brachial artery thrombus on vascular POCUS.
Discussion
POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO2 to FiO2 ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.
Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO2/FiO2 (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.9 This has particular implications in overwhelmed and resource poor health care settings.
We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.15 While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.16
While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.17 Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.18
Limitations
Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.
Conclusions
POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.
Additional point-of-care ultrasound videos.
Acknowledgments
We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.
1. Cardenas-Garcia J, Mayo PH. Bedside ultrasonography for the intensivist. Crit Care Clin. 2015;31(1):43-66. doi:10.1016/j.ccc.2014.08.003
2. Vetrugno L, Baciarello M, Bignami E, et al. The “pandemic” increase in lung ultrasound use in response to Covid-19: can we complement computed tomography findings? A narrative review. Ultrasound J. 2020;12(1):39. Published 2020 Aug 17. doi:10.1186/s13089-020-00185-4
3. Hussain A, Via G, Melniker L, et al. Multi-organ point-of-care ultrasound for COVID-19 (PoCUS4COVID): international expert consensus. Crit Care. 2020;24(1):702. Published 2020 Dec 24. doi:10.1186/s13054-020-03369-5
4. Lichtenstein DA, Mezière GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol [published correction appears in Chest. 2013 Aug;144(2):721]. Chest. 2008;134(1):117-125. doi:10.1378/chest.07-2800
5. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012;38(4):577-591. doi:10.1007/s00134-012-2513-4
6. Narasimhan M, Koenig SJ, Mayo PH. Advanced echocardiography for the critical care physician: part 1. Chest. 2014;145(1):129-134. doi:10.1378/chest.12-2441
7. Kory PD, Pellecchia CM, Shiloh AL, Mayo PH, DiBello C, Koenig S. Accuracy of ultrasonography performed by critical care physicians for the diagnosis of DVT. Chest. 2011;139(3):538-542. doi:10.1378/chest.10-1479
8. Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will this hemodynamically unstable patient respond to a bolus of intravenous fluids? JAMA. 2016;316(12):1298-1309. doi:10.1001/jama.2016.12310
9. See KC, Ong V, Tan YL, Sahagun J, Taculod J. Chest radiography versus lung ultrasound for identification of acute respiratory distress syndrome: a retrospective observational study. Crit Care. 2018;22(1):203. Published 2018 Aug 18. doi:10.1186/s13054-018-2105-y
10. Deng Q, Zhang Y, Wang H, et al. Semiquantitative lung ultrasound scores in the evaluation and follow-up of critically ill patients with COVID-19: a single-center study. Acad Radiol. 2020;27(10):1363-1372. doi:10.1016/j.acra.2020.07.002
11. Brahier T, Meuwly JY, Pantet O, et al. Lung ultrasonography for risk stratification in patients with COVID-19: a prospective observational cohort study [published online ahead of print, 2020 Sep 17]. Clin Infect Dis. 2020;ciaa1408. doi:10.1093/cid/ciaa1408
12. Vieillard-Baron A, Schmitt JM, Augarde R, et al. Acute cor pulmonale in acute respiratory distress syndrome submitted to protective ventilation: incidence, clinical implications, and prognosis [published correction appears in Crit Care Med. 2002 Mar;30(3):726]. Crit Care Med. 2001;29(8):1551-1555. doi:10.1097/00003246-200108000-00009
13. Boissier F, Katsahian S, Razazi K, et al. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrome. Intensive Care Med. 2013;39(10):1725-1733. doi:10.1007/s00134-013-2941-9
14. Jardin F, Vieillard-Baron A. Is there a safe plateau pressure in ARDS? The right heart only knows. Intensive Care Med. 2007;33(3):444-447. doi:10.1007/s00134-007-0552-z
15. Repessé X, Vieillard-Baron A. Right heart function during acute respiratory distress syndrome. Ann Transl Med 2017;5(14):295. doi:10.21037/atm.2017.06.66
16. Abou-Ismail MY, Diamond A, Kapoor S, Arafah Y, Nayak L. The hypercoagulable state in COVID-19: Incidence, pathophysiology, and management [published correction appears in Thromb Res. 2020 Nov 26]. Thromb Res. 2020;194:101-115. doi:10.1016/j.thromres.2020.06.029
17. Kim J, Volodarskiy A, Sultana R, et al. Prognostic utility of right ventricular remodeling over conventional risk stratification in patients with COVID-19. J Am Coll Cardiol. 2020;76(17):1965-1977. doi:10.1016/j.jacc.2020.08.066
18. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520
Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.1 During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).2
In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.3
The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.
Methods
The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.
Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.
To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.
The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.
The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).6 IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.7 POCUS was also used for the placement of central and arterial lines and to guide fluid management.8
The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.
Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.
Results
Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.
Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).
Serial POCUS documented development or progression of RV dilation and dysfunction from the time of ICU admission in 4 of the patients. The presence of B lines with irregular pleura was predictive of a lower arterial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) by a value of 71 compared with those without B lines with irregular pleura (P = .005, adjusted R2 = 0.238). All patients with RV dilation had bilateral B lines with pleural irregularities on lung ultrasound. Vascular POCUS detected 4 deep vein thromboses (DVT).7 An arterial thrombus was also detected on focused examination. There was a higher mortality in patients who required mechanical ventilation; however, there was no difference in POCUS characteristics between the groups (Table 2).
Two severely hypoxemic patients received systemic tissue plasminogen activator (TPA) after findings of massive RV dilation with signs of volume and pressure overload and clinical suspicion of pulmonary embolism (PE). One of these patients also had a popliteal DVT. Both patients were too unstable to transport for additional imaging or therapies. Therapeutic anticoagulation was initiated on 4 patients with positive DVT examinations. In a fifth case an arterial thrombectomy and anticoagulation was required after diminished pulses led to the finding of an occlusive brachial artery thrombus on vascular POCUS.
Discussion
POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO2 to FiO2 ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.
Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO2/FiO2 (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.9 This has particular implications in overwhelmed and resource poor health care settings.
We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.15 While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.16
While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.17 Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.18
Limitations
Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.
Conclusions
POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.
Additional point-of-care ultrasound videos.
Acknowledgments
We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.
Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.1 During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).2
In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.3
The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.
Methods
The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.
Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.
To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.
The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.
The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).6 IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.7 POCUS was also used for the placement of central and arterial lines and to guide fluid management.8
The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.
Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.
Results
Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.
Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).
Serial POCUS documented development or progression of RV dilation and dysfunction from the time of ICU admission in 4 of the patients. The presence of B lines with irregular pleura was predictive of a lower arterial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) by a value of 71 compared with those without B lines with irregular pleura (P = .005, adjusted R2 = 0.238). All patients with RV dilation had bilateral B lines with pleural irregularities on lung ultrasound. Vascular POCUS detected 4 deep vein thromboses (DVT).7 An arterial thrombus was also detected on focused examination. There was a higher mortality in patients who required mechanical ventilation; however, there was no difference in POCUS characteristics between the groups (Table 2).
Two severely hypoxemic patients received systemic tissue plasminogen activator (TPA) after findings of massive RV dilation with signs of volume and pressure overload and clinical suspicion of pulmonary embolism (PE). One of these patients also had a popliteal DVT. Both patients were too unstable to transport for additional imaging or therapies. Therapeutic anticoagulation was initiated on 4 patients with positive DVT examinations. In a fifth case an arterial thrombectomy and anticoagulation was required after diminished pulses led to the finding of an occlusive brachial artery thrombus on vascular POCUS.
Discussion
POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO2 to FiO2 ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.
Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO2/FiO2 (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.9 This has particular implications in overwhelmed and resource poor health care settings.
We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.15 While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.16
While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.17 Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.18
Limitations
Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.
Conclusions
POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.
Additional point-of-care ultrasound videos.
Acknowledgments
We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.
1. Cardenas-Garcia J, Mayo PH. Bedside ultrasonography for the intensivist. Crit Care Clin. 2015;31(1):43-66. doi:10.1016/j.ccc.2014.08.003
2. Vetrugno L, Baciarello M, Bignami E, et al. The “pandemic” increase in lung ultrasound use in response to Covid-19: can we complement computed tomography findings? A narrative review. Ultrasound J. 2020;12(1):39. Published 2020 Aug 17. doi:10.1186/s13089-020-00185-4
3. Hussain A, Via G, Melniker L, et al. Multi-organ point-of-care ultrasound for COVID-19 (PoCUS4COVID): international expert consensus. Crit Care. 2020;24(1):702. Published 2020 Dec 24. doi:10.1186/s13054-020-03369-5
4. Lichtenstein DA, Mezière GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol [published correction appears in Chest. 2013 Aug;144(2):721]. Chest. 2008;134(1):117-125. doi:10.1378/chest.07-2800
5. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012;38(4):577-591. doi:10.1007/s00134-012-2513-4
6. Narasimhan M, Koenig SJ, Mayo PH. Advanced echocardiography for the critical care physician: part 1. Chest. 2014;145(1):129-134. doi:10.1378/chest.12-2441
7. Kory PD, Pellecchia CM, Shiloh AL, Mayo PH, DiBello C, Koenig S. Accuracy of ultrasonography performed by critical care physicians for the diagnosis of DVT. Chest. 2011;139(3):538-542. doi:10.1378/chest.10-1479
8. Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will this hemodynamically unstable patient respond to a bolus of intravenous fluids? JAMA. 2016;316(12):1298-1309. doi:10.1001/jama.2016.12310
9. See KC, Ong V, Tan YL, Sahagun J, Taculod J. Chest radiography versus lung ultrasound for identification of acute respiratory distress syndrome: a retrospective observational study. Crit Care. 2018;22(1):203. Published 2018 Aug 18. doi:10.1186/s13054-018-2105-y
10. Deng Q, Zhang Y, Wang H, et al. Semiquantitative lung ultrasound scores in the evaluation and follow-up of critically ill patients with COVID-19: a single-center study. Acad Radiol. 2020;27(10):1363-1372. doi:10.1016/j.acra.2020.07.002
11. Brahier T, Meuwly JY, Pantet O, et al. Lung ultrasonography for risk stratification in patients with COVID-19: a prospective observational cohort study [published online ahead of print, 2020 Sep 17]. Clin Infect Dis. 2020;ciaa1408. doi:10.1093/cid/ciaa1408
12. Vieillard-Baron A, Schmitt JM, Augarde R, et al. Acute cor pulmonale in acute respiratory distress syndrome submitted to protective ventilation: incidence, clinical implications, and prognosis [published correction appears in Crit Care Med. 2002 Mar;30(3):726]. Crit Care Med. 2001;29(8):1551-1555. doi:10.1097/00003246-200108000-00009
13. Boissier F, Katsahian S, Razazi K, et al. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrome. Intensive Care Med. 2013;39(10):1725-1733. doi:10.1007/s00134-013-2941-9
14. Jardin F, Vieillard-Baron A. Is there a safe plateau pressure in ARDS? The right heart only knows. Intensive Care Med. 2007;33(3):444-447. doi:10.1007/s00134-007-0552-z
15. Repessé X, Vieillard-Baron A. Right heart function during acute respiratory distress syndrome. Ann Transl Med 2017;5(14):295. doi:10.21037/atm.2017.06.66
16. Abou-Ismail MY, Diamond A, Kapoor S, Arafah Y, Nayak L. The hypercoagulable state in COVID-19: Incidence, pathophysiology, and management [published correction appears in Thromb Res. 2020 Nov 26]. Thromb Res. 2020;194:101-115. doi:10.1016/j.thromres.2020.06.029
17. Kim J, Volodarskiy A, Sultana R, et al. Prognostic utility of right ventricular remodeling over conventional risk stratification in patients with COVID-19. J Am Coll Cardiol. 2020;76(17):1965-1977. doi:10.1016/j.jacc.2020.08.066
18. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520
1. Cardenas-Garcia J, Mayo PH. Bedside ultrasonography for the intensivist. Crit Care Clin. 2015;31(1):43-66. doi:10.1016/j.ccc.2014.08.003
2. Vetrugno L, Baciarello M, Bignami E, et al. The “pandemic” increase in lung ultrasound use in response to Covid-19: can we complement computed tomography findings? A narrative review. Ultrasound J. 2020;12(1):39. Published 2020 Aug 17. doi:10.1186/s13089-020-00185-4
3. Hussain A, Via G, Melniker L, et al. Multi-organ point-of-care ultrasound for COVID-19 (PoCUS4COVID): international expert consensus. Crit Care. 2020;24(1):702. Published 2020 Dec 24. doi:10.1186/s13054-020-03369-5
4. Lichtenstein DA, Mezière GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol [published correction appears in Chest. 2013 Aug;144(2):721]. Chest. 2008;134(1):117-125. doi:10.1378/chest.07-2800
5. Volpicelli G, Elbarbary M, Blaivas M, et al. International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012;38(4):577-591. doi:10.1007/s00134-012-2513-4
6. Narasimhan M, Koenig SJ, Mayo PH. Advanced echocardiography for the critical care physician: part 1. Chest. 2014;145(1):129-134. doi:10.1378/chest.12-2441
7. Kory PD, Pellecchia CM, Shiloh AL, Mayo PH, DiBello C, Koenig S. Accuracy of ultrasonography performed by critical care physicians for the diagnosis of DVT. Chest. 2011;139(3):538-542. doi:10.1378/chest.10-1479
8. Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will this hemodynamically unstable patient respond to a bolus of intravenous fluids? JAMA. 2016;316(12):1298-1309. doi:10.1001/jama.2016.12310
9. See KC, Ong V, Tan YL, Sahagun J, Taculod J. Chest radiography versus lung ultrasound for identification of acute respiratory distress syndrome: a retrospective observational study. Crit Care. 2018;22(1):203. Published 2018 Aug 18. doi:10.1186/s13054-018-2105-y
10. Deng Q, Zhang Y, Wang H, et al. Semiquantitative lung ultrasound scores in the evaluation and follow-up of critically ill patients with COVID-19: a single-center study. Acad Radiol. 2020;27(10):1363-1372. doi:10.1016/j.acra.2020.07.002
11. Brahier T, Meuwly JY, Pantet O, et al. Lung ultrasonography for risk stratification in patients with COVID-19: a prospective observational cohort study [published online ahead of print, 2020 Sep 17]. Clin Infect Dis. 2020;ciaa1408. doi:10.1093/cid/ciaa1408
12. Vieillard-Baron A, Schmitt JM, Augarde R, et al. Acute cor pulmonale in acute respiratory distress syndrome submitted to protective ventilation: incidence, clinical implications, and prognosis [published correction appears in Crit Care Med. 2002 Mar;30(3):726]. Crit Care Med. 2001;29(8):1551-1555. doi:10.1097/00003246-200108000-00009
13. Boissier F, Katsahian S, Razazi K, et al. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrome. Intensive Care Med. 2013;39(10):1725-1733. doi:10.1007/s00134-013-2941-9
14. Jardin F, Vieillard-Baron A. Is there a safe plateau pressure in ARDS? The right heart only knows. Intensive Care Med. 2007;33(3):444-447. doi:10.1007/s00134-007-0552-z
15. Repessé X, Vieillard-Baron A. Right heart function during acute respiratory distress syndrome. Ann Transl Med 2017;5(14):295. doi:10.21037/atm.2017.06.66
16. Abou-Ismail MY, Diamond A, Kapoor S, Arafah Y, Nayak L. The hypercoagulable state in COVID-19: Incidence, pathophysiology, and management [published correction appears in Thromb Res. 2020 Nov 26]. Thromb Res. 2020;194:101-115. doi:10.1016/j.thromres.2020.06.029
17. Kim J, Volodarskiy A, Sultana R, et al. Prognostic utility of right ventricular remodeling over conventional risk stratification in patients with COVID-19. J Am Coll Cardiol. 2020;76(17):1965-1977. doi:10.1016/j.jacc.2020.08.066
18. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520