Cardiology News

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

Clinicians all over the country already likely know this, but a survey by the Medical Group Management Association (MGMA) made it official: 97% of physician practices have experienced negative financial effects directly or indirectly related to COVID-19.

The survey, which was conducted April 7-8, also shows that 55% of practices have seen a decrease in revenue and 60% have experienced a decline in patient volume since the beginning of the COVID-19 crisis.

A significant number of medical practices have also been forced to lay off or furlough staff in response to the COVID-19 crisis, the MGMA said. Many practices that have not yet laid off or furloughed employees will consider doing so if the conditions persist over the next 30 days.

Through April 8, 22% of survey respondents reported they had laid off staff. In the same period, 48% had furloughed employees. The survey projects that, by May 8, if the COVID-19 situation hasn’t improved, 36% of practices will have laid off staff members and 60% will have furloughed them.

The survey received 724 applicable responses, the MGMA said. Approximately 75% of respondents are part of independent medical practices and employ fewer than 50 full-time-equivalent physicians. But the respondents belong to practices of all sizes and specialties.

The bare numbers only scratch the surface of the pain that many groups and owners of physician practices are feeling.

“Not only has 70% of our revenue disappeared, but our physicians are still working every day, exposing themselves to risks, taking care of patients, and taking care of their employees by continuing to pay them while they have taken over a 50% pay cut,” said a representative of an independent anesthesiology practice in Alabama in the MGMA press release.

“All doctors and administrative staff have deferred their salaries during this period,” a representative from a small independent practice in Mississippi that specializes in pain management said in the press release. “We have laid off most of our staff except five people.”

Employed groups tend to be in better financial shape than independent practices because they have the resources of large health care systems behind them. Some hospitals have laid off employees, however, and some of the cuts are starting to hit outpatient clinics.
 

Elective procedures down

In an interview conducted before the survey was released, Halee Fischer-Wright, MD, president and CEO of MGMA, said in an interview that single-specialty groups that perform elective procedures have seen “dramatic decreases in volume.” The Trump administration and at least two dozen states have asked hospitals to halt those procedures during this phase of the crisis, according to multiple media reports.

Some groups with multiple offices, Dr. Fischer-Wright noted, are deciding whether to staff them all because of their decreased volume and their concern about staff exposure to the coronavirus.

“We see them condensing down and delegating sick and well offices,” she said. “The benefit is that it allows them to be efficient with their staff use and also to place their limited PPE [personal protective equipment] supplies in the right office.”

Noting that there are costs involved in laying off staff and that practices want to retain good people if possible, Dr. Fischer-Wright advised practices to furlough employees rather than lay them off if they can.

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

The COVID-19 pandemic has changed the lives of children, teenagers, and parents worldwide. While some families are experiencing the unburdening of overly packed schedules and may be having a romantic or nostalgic “Little House on the Prairie” experience, for most it is at a minimum uncomfortable and inconvenient. For others it’s unbearable as they experience loss and feel relationship strain intensified by social distancing, seclusion, or quarantine. Some children have found respite from bullying at school, while other children have lost their only respite from being mistreated at home. Now may be as critical a time as ever for health care providers to listen carefully, empathize, validate, and proactively reach out to provide encouraging guidance and counsel, as well as express concern for families and children.

damircudic/E+

Many parents across the country are taking on an enormous, unanticipated task. Many parents have lost employment and income, while many mandatory professionals now struggle to keep up with increased work hours and work stress. Parents are trying to become multitaskers who assume the role of the music teacher, the soccer coach, the drama instructor, the friend, and of course their original role as a parent.

This seems an appropriate time to consider the work of Donald W. Winnicott, FRCP, the English pediatrician known for the concept of the “good enough parent.”¹ This notion of parental competence was in part born out of a desire to defend parents against possible erosion of their confidence in following loving instincts by encroachment from professional expertise. The concept of the “good enough” parent is also related to the idea that young children who believe their parent is perfect will eventually know better. Now is a fitting time for pediatricians to buoy up imperfect but striving parents who are plenty “good enough” as they follow loving instincts to support their children during unforeseen changes associated with the pandemic.

Social distancing has led to family condensing. Many parents and children remain within the same four walls all day, every day. For many parents, the outlet of water cooler banter or yoga classes is gone. Even the commute home, with all its frustration, may have allowed decompression in the form of an audiobook, favorite music, or verbal transference of frustration onto the stranger who just cut you off. That commute might be gone too. Now, for many the good, bad, and the ugly is all happening at home. The 3-year-old may still adorably see a parent who can do no wrong, but in the end, the truth will prevail. A timely word of encouragement to parents: It’s okay to not be omnipotent. In fact, it will help children have a richer view of the world and more realistic expectations of themselves.

For children, they’ll need praise too, and the upheaval caused by the pandemic may be a fitting opportunity to make that praise more meaningful. But sports are off, the school musical is canceled, and the spelling bee is gone. The dojo is closed, the art fair is postponed, and the dance recital isn’t happening. Report cards in many schools may now transition from letter grades to pass/fail. Parents may be asking, “How on earth are we going to celebrate and praise the children?” As we’re left with fewer and fewer outcomes to celebrate, we may be left celebrating the effort, which is exactly what we should be doing in the first place.

Research has shown us that praising the process is more valuable than praising the person.² If Lucy participates in a soccer game and Javier gets his math results back, there are many possible approaches to praise. “You scored a goal!” or “You got an A on your math test!” is outcome- or product-focused praise. “You’re a good soccer player” or “You’re smart at math!” is person-focused praise. Instead, the most effective praise is process-focused praise: “You worked hard and ran hard even when it looked tiring” or “I noticed that you kept trying different strategies on those math problems until you figured them out.”

This may be a time when children face less comparison, less ranking, and receive less direct reward. With help, they can focus more on the process of learning and less on the outcomes of learning. They may more readily enjoy the efforts in their hobbies, not just the outcomes of their hobbies. When children receive praise for their work, effort, and actions rather than outcomes, externally validating things may be pleasantly replaced by internally validating traits. With process praise, children are more likely to feel self-confident, to set higher learning goals, and to accurately believe that intelligence is related to effort rather than a fixed trait that has been divided up among haves and have nots.³

Families currently face immense change, uncertainty, and discouragement largely unprecedented in their lifetimes. As care providers, we can look to lasting principles as we encourage parents in their provision of love. We can effectively provide praise and celebrate effort using evidence-based strategies uniquely fitted to our current circumstances. As we do this, we can provide healing of some of the less visible ailments associated with the COVID-19 pandemic.

Dr. Jackson is in the department of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].

References

1. “The Child, the Family, and the Outside World.” London: Penguin; 1973. p. 173.

2. Dev Psychol. 1999;35(3):835-47.

3. J Exp Child Psychol. 2018;173:116-35.

The COVID-19 pandemic has changed the lives of children, teenagers, and parents worldwide. While some families are experiencing the unburdening of overly packed schedules and may be having a romantic or nostalgic “Little House on the Prairie” experience, for most it is at a minimum uncomfortable and inconvenient. For others it’s unbearable as they experience loss and feel relationship strain intensified by social distancing, seclusion, or quarantine. Some children have found respite from bullying at school, while other children have lost their only respite from being mistreated at home. Now may be as critical a time as ever for health care providers to listen carefully, empathize, validate, and proactively reach out to provide encouraging guidance and counsel, as well as express concern for families and children.

damircudic/E+

Many parents across the country are taking on an enormous, unanticipated task. Many parents have lost employment and income, while many mandatory professionals now struggle to keep up with increased work hours and work stress. Parents are trying to become multitaskers who assume the role of the music teacher, the soccer coach, the drama instructor, the friend, and of course their original role as a parent.

This seems an appropriate time to consider the work of Donald W. Winnicott, FRCP, the English pediatrician known for the concept of the “good enough parent.”¹ This notion of parental competence was in part born out of a desire to defend parents against possible erosion of their confidence in following loving instincts by encroachment from professional expertise. The concept of the “good enough” parent is also related to the idea that young children who believe their parent is perfect will eventually know better. Now is a fitting time for pediatricians to buoy up imperfect but striving parents who are plenty “good enough” as they follow loving instincts to support their children during unforeseen changes associated with the pandemic.

Social distancing has led to family condensing. Many parents and children remain within the same four walls all day, every day. For many parents, the outlet of water cooler banter or yoga classes is gone. Even the commute home, with all its frustration, may have allowed decompression in the form of an audiobook, favorite music, or verbal transference of frustration onto the stranger who just cut you off. That commute might be gone too. Now, for many the good, bad, and the ugly is all happening at home. The 3-year-old may still adorably see a parent who can do no wrong, but in the end, the truth will prevail. A timely word of encouragement to parents: It’s okay to not be omnipotent. In fact, it will help children have a richer view of the world and more realistic expectations of themselves.

For children, they’ll need praise too, and the upheaval caused by the pandemic may be a fitting opportunity to make that praise more meaningful. But sports are off, the school musical is canceled, and the spelling bee is gone. The dojo is closed, the art fair is postponed, and the dance recital isn’t happening. Report cards in many schools may now transition from letter grades to pass/fail. Parents may be asking, “How on earth are we going to celebrate and praise the children?” As we’re left with fewer and fewer outcomes to celebrate, we may be left celebrating the effort, which is exactly what we should be doing in the first place.

Research has shown us that praising the process is more valuable than praising the person.² If Lucy participates in a soccer game and Javier gets his math results back, there are many possible approaches to praise. “You scored a goal!” or “You got an A on your math test!” is outcome- or product-focused praise. “You’re a good soccer player” or “You’re smart at math!” is person-focused praise. Instead, the most effective praise is process-focused praise: “You worked hard and ran hard even when it looked tiring” or “I noticed that you kept trying different strategies on those math problems until you figured them out.”

This may be a time when children face less comparison, less ranking, and receive less direct reward. With help, they can focus more on the process of learning and less on the outcomes of learning. They may more readily enjoy the efforts in their hobbies, not just the outcomes of their hobbies. When children receive praise for their work, effort, and actions rather than outcomes, externally validating things may be pleasantly replaced by internally validating traits. With process praise, children are more likely to feel self-confident, to set higher learning goals, and to accurately believe that intelligence is related to effort rather than a fixed trait that has been divided up among haves and have nots.³

Families currently face immense change, uncertainty, and discouragement largely unprecedented in their lifetimes. As care providers, we can look to lasting principles as we encourage parents in their provision of love. We can effectively provide praise and celebrate effort using evidence-based strategies uniquely fitted to our current circumstances. As we do this, we can provide healing of some of the less visible ailments associated with the COVID-19 pandemic.

Dr. Jackson is in the department of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].

References

1. “The Child, the Family, and the Outside World.” London: Penguin; 1973. p. 173.

2. Dev Psychol. 1999;35(3):835-47.

3. J Exp Child Psychol. 2018;173:116-35.

The COVID-19 pandemic has changed the lives of children, teenagers, and parents worldwide. While some families are experiencing the unburdening of overly packed schedules and may be having a romantic or nostalgic “Little House on the Prairie” experience, for most it is at a minimum uncomfortable and inconvenient. For others it’s unbearable as they experience loss and feel relationship strain intensified by social distancing, seclusion, or quarantine. Some children have found respite from bullying at school, while other children have lost their only respite from being mistreated at home. Now may be as critical a time as ever for health care providers to listen carefully, empathize, validate, and proactively reach out to provide encouraging guidance and counsel, as well as express concern for families and children.

damircudic/E+

Many parents across the country are taking on an enormous, unanticipated task. Many parents have lost employment and income, while many mandatory professionals now struggle to keep up with increased work hours and work stress. Parents are trying to become multitaskers who assume the role of the music teacher, the soccer coach, the drama instructor, the friend, and of course their original role as a parent.

This seems an appropriate time to consider the work of Donald W. Winnicott, FRCP, the English pediatrician known for the concept of the “good enough parent.”¹ This notion of parental competence was in part born out of a desire to defend parents against possible erosion of their confidence in following loving instincts by encroachment from professional expertise. The concept of the “good enough” parent is also related to the idea that young children who believe their parent is perfect will eventually know better. Now is a fitting time for pediatricians to buoy up imperfect but striving parents who are plenty “good enough” as they follow loving instincts to support their children during unforeseen changes associated with the pandemic.

Social distancing has led to family condensing. Many parents and children remain within the same four walls all day, every day. For many parents, the outlet of water cooler banter or yoga classes is gone. Even the commute home, with all its frustration, may have allowed decompression in the form of an audiobook, favorite music, or verbal transference of frustration onto the stranger who just cut you off. That commute might be gone too. Now, for many the good, bad, and the ugly is all happening at home. The 3-year-old may still adorably see a parent who can do no wrong, but in the end, the truth will prevail. A timely word of encouragement to parents: It’s okay to not be omnipotent. In fact, it will help children have a richer view of the world and more realistic expectations of themselves.

For children, they’ll need praise too, and the upheaval caused by the pandemic may be a fitting opportunity to make that praise more meaningful. But sports are off, the school musical is canceled, and the spelling bee is gone. The dojo is closed, the art fair is postponed, and the dance recital isn’t happening. Report cards in many schools may now transition from letter grades to pass/fail. Parents may be asking, “How on earth are we going to celebrate and praise the children?” As we’re left with fewer and fewer outcomes to celebrate, we may be left celebrating the effort, which is exactly what we should be doing in the first place.

Research has shown us that praising the process is more valuable than praising the person.² If Lucy participates in a soccer game and Javier gets his math results back, there are many possible approaches to praise. “You scored a goal!” or “You got an A on your math test!” is outcome- or product-focused praise. “You’re a good soccer player” or “You’re smart at math!” is person-focused praise. Instead, the most effective praise is process-focused praise: “You worked hard and ran hard even when it looked tiring” or “I noticed that you kept trying different strategies on those math problems until you figured them out.”

This may be a time when children face less comparison, less ranking, and receive less direct reward. With help, they can focus more on the process of learning and less on the outcomes of learning. They may more readily enjoy the efforts in their hobbies, not just the outcomes of their hobbies. When children receive praise for their work, effort, and actions rather than outcomes, externally validating things may be pleasantly replaced by internally validating traits. With process praise, children are more likely to feel self-confident, to set higher learning goals, and to accurately believe that intelligence is related to effort rather than a fixed trait that has been divided up among haves and have nots.³

Families currently face immense change, uncertainty, and discouragement largely unprecedented in their lifetimes. As care providers, we can look to lasting principles as we encourage parents in their provision of love. We can effectively provide praise and celebrate effort using evidence-based strategies uniquely fitted to our current circumstances. As we do this, we can provide healing of some of the less visible ailments associated with the COVID-19 pandemic.

Dr. Jackson is in the department of psychiatry at the University of Vermont, Burlington. He said he had no relevant financial disclosures. Email Dr. Jackson at [email protected].

References

1. “The Child, the Family, and the Outside World.” London: Penguin; 1973. p. 173.

2. Dev Psychol. 1999;35(3):835-47.

3. J Exp Child Psychol. 2018;173:116-35.

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

The 2019-2020 flu season is ending, but not without a revised map to reflect the COVID-induced new world order.

[email protected]

A policy of universal screening of pregnant women for the COVID-19 virus identified a high proportion of women who tested positive and were asymptomatic, based on data from 215 pregnant women in New York City.

Courtesy NIAID-RML

“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York

In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.

Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.

“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.

Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.

“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.

Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.

“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
 

Continuing challenges

“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.

However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.

Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.

To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”

“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.

“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.

“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.

Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.

“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.

“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.

Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.

A policy of universal screening of pregnant women for the COVID-19 virus identified a high proportion of women who tested positive and were asymptomatic, based on data from 215 pregnant women in New York City.

Courtesy NIAID-RML

“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York

In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.

Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.

“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.

Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.

“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.

Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.

“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
 

Continuing challenges

“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.

However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.

Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.

To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”

“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.

“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.

“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.

Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.

“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.

“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.

Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.

A policy of universal screening of pregnant women for the COVID-19 virus identified a high proportion of women who tested positive and were asymptomatic, based on data from 215 pregnant women in New York City.

Courtesy NIAID-RML

“The obstetrical population presents a unique challenge during this pandemic, since these patients have multiple interactions with the health care system and eventually most are admitted to the hospital for delivery,” wrote Desmond Sutton, MD, and colleagues at Columbia University Irving Medical Center, New York

In a letter published in the New England Journal of Medicine, the researchers reviewed their experiences with 215 pregnant women who delivered infants during March 22–April 4, 2020, at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center. All the women were screened for symptoms of the COVID-19 infection on admission.

Overall, four women (1.9%) had fevers or other symptoms on admission, and all of these women tested positive for the virus that causes COVID-19. The other 211 women were afebrile and asymptomatic at admission, and 210 of them were tested via nasopharyngeal swabs. A total of 29 asymptomatic women (13.7%) tested positive for COVID-19 infection.

“Thus, 29 of the 33 patients who were positive for SARS-CoV-2 at admission (87.9%) had no symptoms of COVID-19 at presentation,” Dr. Sutton and colleagues wrote.

Three of the 29 COVID-19-positive women who were asymptomatic on admission developed fevers before they were discharged from the hospital after a median stay of 2 days. Of these, two received antibiotics for presumed endomyometritis and one patient with presumed COVID-19 infection received supportive care. In addition, one patient who was initially negative developed COVID-19 symptoms after delivery and tested positive 3 days after her initial negative test.

“Our use of universal SARS-CoV-2 testing in all pregnant patients presenting for delivery revealed that at this point in the pandemic in New York City, most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic,” Dr. Sutton and colleagues said.

Although their numbers may not be generalizable to areas with lower infection rates, they highlight the risk of COVID-19 infection in asymptomatic pregnant women, they noted.

“The potential benefits of a universal testing approach include the ability to use COVID-19 status to determine hospital isolation practices and bed assignments, inform neonatal care, and guide the use of personal protective equipment,” they concluded.
 

Continuing challenges

“What I have seen in our institute is the debate about rapid testing and the inherent problems with false negatives and false positives,” Catherine Cansino, MD, of the University of California, Davis, said in an interview. “I think there is definitely a role for universal testing, especially in areas with high prevalence,” and the New York clinicians have made a strong case.

However, the challenge remains of obtaining quick test results that would still be reliable, as many rapid tests have a false-negative rate of as much as 20%, noted Dr. Cansino, who was not involved in the New York study.

Her institution is using a test with a higher level of accuracy, “but it can take several hours or a day to get the results,” at which point the women may have gone through labor and delivery and been in contact with multiple health care workers who have used personal protective equipment accordingly if they don’t know a patient’s status.

To help guide policies, Dr. Cansino said that outcome data would be useful. “It’s hard to know how outcomes are different, and it would be good to know how transmission rates differ between symptomatic carriers and those who are asymptomatic.”

“As SARS-CoV-2, the virus responsible for COVID-19, continues to spread, pregnant women remain a unique population with required frequent health system contacts and ultimate need for delivery,” Iris Krishna, MD, of the Emory Healthcare Network in Atlanta, said in an interview. “This report in a high prevalence area demonstrated 1 out of 8 asymptomatic pregnant patients presenting for delivery were SARS-CoV-2 positive, illustrating a need for universal screening.

“As this pandemic evolves, we are learning more and more, and it is important to expand our understanding of asymptomatic transmission and the risk this may pose,” said Dr. Krishna, who was not part of the New York study.

“Key benefits to universal screening are the capability for labor and delivery units to implement best hospital practices in their care of mothers and babies, such as admitting positive patients to cohort units,” she noted. Such units would “allow for closer monitoring of mothers and babies, as well as ensuring proper use of personal protective equipment by health care teams” and also would help preserve supplies of personal protective equipment.

Dr. Krishna cited hospital testing capacity as an obvious barrier to universal screening of pregnant women, as well as factors including the need for additional protective equipment to be used during swab collection. Also, “If you get a negative result and there is a strong suspicion for COVID-19 infection, when do you retest?” she asked. “These are key questions or areas of assessment that should be considered before embarking on universal screening for pregnant women.” In addition, some patients may refuse testing out of fear of stigma or separation from their newborn.

“Implementing an ‘opt out’ approach to screening is encouraged, whereby a patient is informed that a test will be included in standard preventive screening, and they may decline the test,” Dr. Krishna said. “Routine, opt-out screening approaches have proven to be highly effective as it removes the stigma associated with testing, fosters earlier diagnosis and treatment, reduces risk of transmission, and has proven to be cost effective. Pregnant women should be reassured that universal screening is beneficial for their care and the care of their newborn baby,” she emphasized.

“Institutions should consider implementing universal screening on labor and delivery as several geographic areas are predicted to reach their peak time of COVID-19 transmission, and it is clear that asymptomatic individuals continue to play a role in its transmission,” Dr. Krishna concluded.

Dr. Sutton and associates had no financial conflicts to disclose. Neither Dr. Cansino nor Dr. Krishna had any financial conflicts to disclose. Dr. Cansino and Dr. Krishna are members of the Ob.Gyn. News Editorial Advisory Board.

SOURCE: Sutton D et al. N Engl J Med. 2020 Apr 13. doi: 10.1056/NEJMc2009316.

The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

• Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
• The ability to diagnose, treat, and isolate individuals with COVID-19.
• Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
• Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

[email protected]

The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

• Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
• The ability to diagnose, treat, and isolate individuals with COVID-19.
• Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
• Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

[email protected]

The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

• Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
• The ability to diagnose, treat, and isolate individuals with COVID-19.
• Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
• Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

[email protected]

Exposing contaminated N95 respirators to vaporized hydrogen peroxide (VHP) or ultraviolet (UV) light appears to eliminate the SARS-CoV-2 virus from the material and preserve the integrity of the masks fit for up to three uses, a National Institutes of Health (NIH) study shows.

Dry heat (70° C) was also found to eliminate the virus on masks but was effective for two uses instead of three.

Robert Fischer, PhD, with the National Institute of Allergy and Infectious Diseases in Hamilton, Montana, and colleagues posted the findings on a preprint server on April 15. The paper has not yet been peer reviewed.

Four methods tested

Fischer and colleagues compared four methods for decontaminating the masks, which are designed for one-time use: UV radiation (260-285 nm); 70° C dry heat; 70% ethanol spray; and VHP.

For each method, the researchers compared the rate at which SARS-CoV-2 is inactivated on N95 filter fabric to that on stainless steel.

All four methods eliminated detectable SARS-CoV-2 virus from the fabric test samples, though the time needed for decontamination varied. VHP was the quickest, requiring 10 minutes. Dry heat and UV light each required approximately 60 minutes. Ethanol required an intermediate amount of time.

To test durability over three uses, the researchers treated intact, clean masks with the same decontamination method and assessed function via quantitative fit testing.

Volunteers from the Rocky Mountain laboratory wore the masks for 2 hours to test fit and seal.

The researchers found that masks that had been decontaminated with ethanol spray did not function effectively after decontamination, and they did not recommend use of that method.

By contrast, masks decontaminated with UV and VHP could be used up to three times and function properly. Masks decontaminated with dry heat could be used two times before function declined.

“Our results indicate that N95 respirators can be decontaminated and reused in times of shortage for up to three times for UV and HPV, and up to two times for dry heat,” the authors write. “However, utmost care should be given to ensure the proper functioning of the N95 respirator after each decontamination using readily available qualitative fit testing tools and to ensure that treatments are carried out for sufficient time to achieve desired risk-reduction.”

Reassurance for clinicians

The results will reassure clinicians, many of whom are already using these decontamination methods, Ravina Kullar, PharmD, MPH, an infectious disease expert with the Infectious Diseases Society of America, told Medscape Medical News.

Kullar, who is also an adjunct faculty member at the David Geffen School of Medicine of the University of California, Los Angeles, said the most widely used methods have been UV light and VPH.

UV light has been used for years to decontaminate rooms, she said. She also said that so far, supplies of hydrogen peroxide are adequate.

A shortcoming of the study, Kullar said, is that it tested the masks for only 2 hours, whereas in clinical practice, they are being worn for much longer periods.

After the study is peer reviewed, the Centers for Disease Control and Prevention (CDC) may update its recommendations, she said.

So far, she noted, the CDC has not approved any method for decontaminating masks, “but it has said that it does not object to using these sterilizers, disinfectants, devices, and air purifiers for effectively killing this virus.”

Safe, multiple use of the masks is critical in the COVID-19 crisis, she said.

“We have to look at other mechanisms to keep these N95 respirators in use when there’s such a shortage,” she said.

Integrity of the fit was an important factor in the study.

“All health care workers have to go through a fitting to have that mask fitted appropriately. That’s why these N95s are only approved for health care professionals, not the lay public,” she said.

The study was supported by the National Institutes of Health; the Defense Advanced Research Projects Agency; the University of California, Los Angeles; the US National Science Foundation; and the US Department of Defense.

This article first appeared on Medscape.com.

Exposing contaminated N95 respirators to vaporized hydrogen peroxide (VHP) or ultraviolet (UV) light appears to eliminate the SARS-CoV-2 virus from the material and preserve the integrity of the masks fit for up to three uses, a National Institutes of Health (NIH) study shows.

Dry heat (70° C) was also found to eliminate the virus on masks but was effective for two uses instead of three.

Robert Fischer, PhD, with the National Institute of Allergy and Infectious Diseases in Hamilton, Montana, and colleagues posted the findings on a preprint server on April 15. The paper has not yet been peer reviewed.

Four methods tested

Fischer and colleagues compared four methods for decontaminating the masks, which are designed for one-time use: UV radiation (260-285 nm); 70° C dry heat; 70% ethanol spray; and VHP.

For each method, the researchers compared the rate at which SARS-CoV-2 is inactivated on N95 filter fabric to that on stainless steel.

All four methods eliminated detectable SARS-CoV-2 virus from the fabric test samples, though the time needed for decontamination varied. VHP was the quickest, requiring 10 minutes. Dry heat and UV light each required approximately 60 minutes. Ethanol required an intermediate amount of time.

To test durability over three uses, the researchers treated intact, clean masks with the same decontamination method and assessed function via quantitative fit testing.

Volunteers from the Rocky Mountain laboratory wore the masks for 2 hours to test fit and seal.

The researchers found that masks that had been decontaminated with ethanol spray did not function effectively after decontamination, and they did not recommend use of that method.

By contrast, masks decontaminated with UV and VHP could be used up to three times and function properly. Masks decontaminated with dry heat could be used two times before function declined.

“Our results indicate that N95 respirators can be decontaminated and reused in times of shortage for up to three times for UV and HPV, and up to two times for dry heat,” the authors write. “However, utmost care should be given to ensure the proper functioning of the N95 respirator after each decontamination using readily available qualitative fit testing tools and to ensure that treatments are carried out for sufficient time to achieve desired risk-reduction.”

Reassurance for clinicians

The results will reassure clinicians, many of whom are already using these decontamination methods, Ravina Kullar, PharmD, MPH, an infectious disease expert with the Infectious Diseases Society of America, told Medscape Medical News.

Kullar, who is also an adjunct faculty member at the David Geffen School of Medicine of the University of California, Los Angeles, said the most widely used methods have been UV light and VPH.

UV light has been used for years to decontaminate rooms, she said. She also said that so far, supplies of hydrogen peroxide are adequate.

A shortcoming of the study, Kullar said, is that it tested the masks for only 2 hours, whereas in clinical practice, they are being worn for much longer periods.

After the study is peer reviewed, the Centers for Disease Control and Prevention (CDC) may update its recommendations, she said.

So far, she noted, the CDC has not approved any method for decontaminating masks, “but it has said that it does not object to using these sterilizers, disinfectants, devices, and air purifiers for effectively killing this virus.”

Safe, multiple use of the masks is critical in the COVID-19 crisis, she said.

“We have to look at other mechanisms to keep these N95 respirators in use when there’s such a shortage,” she said.

Integrity of the fit was an important factor in the study.

“All health care workers have to go through a fitting to have that mask fitted appropriately. That’s why these N95s are only approved for health care professionals, not the lay public,” she said.

The study was supported by the National Institutes of Health; the Defense Advanced Research Projects Agency; the University of California, Los Angeles; the US National Science Foundation; and the US Department of Defense.

This article first appeared on Medscape.com.

Exposing contaminated N95 respirators to vaporized hydrogen peroxide (VHP) or ultraviolet (UV) light appears to eliminate the SARS-CoV-2 virus from the material and preserve the integrity of the masks fit for up to three uses, a National Institutes of Health (NIH) study shows.

Dry heat (70° C) was also found to eliminate the virus on masks but was effective for two uses instead of three.

Robert Fischer, PhD, with the National Institute of Allergy and Infectious Diseases in Hamilton, Montana, and colleagues posted the findings on a preprint server on April 15. The paper has not yet been peer reviewed.

Four methods tested

Fischer and colleagues compared four methods for decontaminating the masks, which are designed for one-time use: UV radiation (260-285 nm); 70° C dry heat; 70% ethanol spray; and VHP.

For each method, the researchers compared the rate at which SARS-CoV-2 is inactivated on N95 filter fabric to that on stainless steel.

All four methods eliminated detectable SARS-CoV-2 virus from the fabric test samples, though the time needed for decontamination varied. VHP was the quickest, requiring 10 minutes. Dry heat and UV light each required approximately 60 minutes. Ethanol required an intermediate amount of time.

To test durability over three uses, the researchers treated intact, clean masks with the same decontamination method and assessed function via quantitative fit testing.

Volunteers from the Rocky Mountain laboratory wore the masks for 2 hours to test fit and seal.

The researchers found that masks that had been decontaminated with ethanol spray did not function effectively after decontamination, and they did not recommend use of that method.

By contrast, masks decontaminated with UV and VHP could be used up to three times and function properly. Masks decontaminated with dry heat could be used two times before function declined.

“Our results indicate that N95 respirators can be decontaminated and reused in times of shortage for up to three times for UV and HPV, and up to two times for dry heat,” the authors write. “However, utmost care should be given to ensure the proper functioning of the N95 respirator after each decontamination using readily available qualitative fit testing tools and to ensure that treatments are carried out for sufficient time to achieve desired risk-reduction.”

Reassurance for clinicians

The results will reassure clinicians, many of whom are already using these decontamination methods, Ravina Kullar, PharmD, MPH, an infectious disease expert with the Infectious Diseases Society of America, told Medscape Medical News.

Kullar, who is also an adjunct faculty member at the David Geffen School of Medicine of the University of California, Los Angeles, said the most widely used methods have been UV light and VPH.

UV light has been used for years to decontaminate rooms, she said. She also said that so far, supplies of hydrogen peroxide are adequate.

A shortcoming of the study, Kullar said, is that it tested the masks for only 2 hours, whereas in clinical practice, they are being worn for much longer periods.

After the study is peer reviewed, the Centers for Disease Control and Prevention (CDC) may update its recommendations, she said.

So far, she noted, the CDC has not approved any method for decontaminating masks, “but it has said that it does not object to using these sterilizers, disinfectants, devices, and air purifiers for effectively killing this virus.”

Safe, multiple use of the masks is critical in the COVID-19 crisis, she said.

“We have to look at other mechanisms to keep these N95 respirators in use when there’s such a shortage,” she said.

Integrity of the fit was an important factor in the study.

“All health care workers have to go through a fitting to have that mask fitted appropriately. That’s why these N95s are only approved for health care professionals, not the lay public,” she said.

The study was supported by the National Institutes of Health; the Defense Advanced Research Projects Agency; the University of California, Los Angeles; the US National Science Foundation; and the US Department of Defense.

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.

There was no hand sanitizer on the hospital’s psychiatric ward for fear patients would drink it; they slept together on futons in communal rooms and the windows were sealed shut to prevent suicide attempts — all conditions that created the perfect environment for the rapid spread of a potentially deadly virus.

This scenario may sound like a something out of a horror film, but as reported last month by the UK newspaper The Independent, it was the reality in the psychiatric ward of South Korea’s Daenam Hospital after COVID-19 struck. Eventually health officials put the ward on lockdown, but it wasn’t long before all but two of the unit’s 103 patients were positive for the virus.

To avoid a similar catastrophe, staff at an Israeli hospital have created what they describe as the “world’s first” dedicated COVID-19 unit for psychiatric inpatients.

Clinicians at Israel’s national hospital, Sheba Medical Center Tel HaShomer in Tel Aviv, believe the 16-bed unit, which officially opened on March 26, will stop psychiatric inpatients with the virus — who may have trouble with social distancing — from spreading it to others on the ward.

“Psychiatric patients are going to get sick from coronavirus just like anybody else,” Mark Weiser, MD, head of the psychiatric division at the institution told Medscape Medical News. “But we’re concerned that, on a psychiatric ward, a patient who is COVID-19 positive can also be psychotic, manic, cognitively impaired, or have poor judgment … making it difficult for that patient to keep social distancing, and very quickly you’ll have an entire ward of patients infected.

“So the basic public health issue is how to prevent a single psychiatric patient who is hospitalized and COVID-19-positive from making everybody else sick,” he added.
 

Unique Challenges, Rapid Response

Adapting an existing psychiatric ward to one exclusively used by inpatients with COVID-19 required significant planning, coordination, and modifications to ensure the well-being of patients and staff.

First, the ward’s air conditioning system was re-engineered to separate it from the hospital’s main system. A dedicated entrance for the exclusive use of infected psychiatric inpatients was also created.

In addition, two-way television cameras in patients’ rooms were installed to facilitate a constant flow of communication and enable therapeutic sessions and family visits. All of these modifications were completed in under a week.

“Under normal circumstances, we have cameras in the public areas of our wards, but in order to respect people’s privacy, we do not have cameras in their rooms.

“In this specific ward, on the other hand, we did put cameras in the rooms, so if a patient needs to be watched more closely, it could be done remotely without exposing staff to the virus. We have a person who’s watching the screens at all times, just to see what’s going on and see what patients are doing,” said Weiser.

Protective personal equipment (PPE) and clothing for staff was tailored to the unique challenges posed by the ward’s patient population.

“Of course, you need to wear clothes that are protective against the virus,” said Weiser. “But sometimes our patients can get agitated or even violent, so you’ve got protect against that as well.”

With this in mind, all personnel working on the ward must put on an extra layer of PPE as well as a tear-proof robe. The institution has also implemented a strict protocol that dictates the order in which PPE is donned and doffed.

“It’s got to be done in a very careful and very specific way,” said Weiser. “We have all of it organized with a poster that explains what should be taken off or put on, and in what order.”

For institutions considering setting up a similar unit, Weiser said close proximity to an active care hospital with the capacity to provide urgent care is key.

“We’re psychiatrists; we’re not great at treating acute respiratory problems. So patients with significant respiratory problems need a place to get appropriate care quickly,” he said.

In setting up the unit, there were still a few obstacles, Weiser noted. For instance, despite the many protective and safety measures undertaken by the institution, some of the hospital staff were concerned about their risk of contracting the virus.

To address these concerns, the hospital’s leadership brought in infectious disease experts to educate hospital personnel about the virus and transmission risk.

“They told our staff that given all the precautions we had taken, there was very little risk anyone else could become infected,” Weiser said.

Despite the many challenges, Weiser said he and his colleagues are thrilled with the dedicated ward and the positive reception it has received.

“My colleagues and the directors of psychiatric hospitals all around the country are very happy with this because now they’re not hospitalizing infected patients. They’re very happy for us to take care of this,” he said.
 

“No Easy Solutions”

Commenting on the initiative for Medscape Medical News, John M. Oldham, MD, chief of staff at Baylor College of Medicine’s Menninger Clinic in Houston, Texas, raised some questions.

“Is it really going to be the treatment unit or a quarantine unit? Because if you don’t have a comparable level of established, effective treatment for these patients, then you’re simply herding them off to a different place where they’re going to suffer both illnesses,” he cautioned.

Nevertheless, Oldham recognized that the issue of how to treat psychiatric patients who test positive for COVID-19 is complex.

“We’re still wrestling with that question here at Menninger. We have created an enclosed section of the inpatient area reserved for this possibility.

“If we have a patient who tests positive, we will immediately put that patient in one of these rooms in the quarantine section. Then we will use protective equipment for our staff to go and provide care for the patient,” he said.

However, he acknowledged that a psychiatric hospital is in no position to treat patients who develop severe illness from COVID-19.

“We’re certainly worried about it,” he said, “because how many inpatient general medical units are going to want to take a significantly symptomatic COVID-19 patient who was in the hospital for being acutely suicidal? There are no easy solutions.”
 

This article first appeared on Medscape.com.