Air pollution is the second-leading cause of lung cancer in the world, after smoking, results of a novel analysis suggest. The researchers call for concerted action.

Ja'Crispy/iStock/Getty Images Plus

The new data show that the rate of lung cancer deaths attributable to air pollution varies widely between countries. Serbia, Poland, China, Mongolia, and Turkey are among the worst affected. The analysis shows an association between deaths from lung cancer and the proportion of national energy that is produced from coal.

“Both smoking and air pollution are important causes of lung cancer,” said study presenter Christine D. Berg, MD, former codirector of the National Lung Screening Trial, and “both need to be eliminated to help prevent lung cancer and save lives.

“As lung cancer professionals, we can mitigate the effects of air pollution on causing lung cancer by speaking out for clean energy standards,” she said.

Dr. Berg presented the new analysis on Sept. 9 at the 2021 World Conference on Lung Cancer, which was organized by the International Association for the Study of Lung Cancer.

She welcomed the recent statement issued by the IASLC in support of the International Day of Clean Air for Blue Skies, which took place on Sept. 7. It was a call for action that emphasized the need for further efforts to improve air quality to protect human health.

The findings from the new analysis are “depressing,” commented Joachim G. J. V. Aerts, MD. PhD, department of pulmonary diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.

It is now clear that air pollution has an impact not only on the incidence of lung cancer but also on its outcome, he added.

Indeed, previous research showed that each 10 mcg/m3 increase in particular matter of 2.5 mcg in size was associated with a 15%-27% increase in lung cancer mortality. There was no difference in rates between women and men.

A key question, Dr. Aerts said, is whether reducing air pollution would be beneficial.

Efforts to reduce air pollution over recent decades in the United Kingdom have not led to a reduction in lung cancer deaths. This is because of the increase in life expectancy – individuals have been exposed to pollution for longer, albeit at lower levels, he pointed out.

Because of lockdowns during the COVID pandemic, travel has been greatly reduced. This has resulted in a dramatic reduction in air pollution, “and this led to a decrease in the number of children born with low birth weight,” said Dr. Aerts.

Hopefully, that benefit will also be seen regarding other diseases, he added.

The call to action to reduce air pollution is of the “utmost importance,” he said. He noted that the focus should be on global, national, local, and personal preventive measures.

“It is time to join forces,” he added, “to ‘clean the air.’ ”

Dr. Berg’s presentation was warmly received on social media.

It was “fabulous,” commented Eric H. Bernicker, MD, director of medical thoracic oncology at Houston Methodist Cancer Center.

“Thoracic oncologists need to add air pollution to things they advocate about; we have an important voice here,” he added.

It is “so important to understand that air pollution is a human carcinogen,” commented Ivy Elkins, a lung cancer survivor and advocate and cofounder of the EGFR Resisters Lung Cancer Patient Group. “All you need are lungs to get lung cancer!”
 

Contribution of air pollution to lung cancer

In her presentation, Dr. Berg emphasized that lung cancer is the leading cause of cancer death worldwide, although the distribution between countries “depends on historical and current smoking patterns and the demographics of the population.”

Overall, data from GLOBOCAN 2018 indicate that annually there are approximately 2.1 million incident cases of lung cancer and almost 1.8 million lung cancer deaths around the globe.

A recent study estimated that, worldwide, 14.1% of all lung cancer deaths, including in never-smokers, are directly linked to air pollution.

Dr. Berg said that this makes it the “second-leading cause of lung cancer” behind smoking.

The figure is somewhat lower for the United States, where around 4.7% of lung cancer deaths each year are directly attributable to pollution. However, with “the wildfires out West, we’re going to be seeing more of a toll from air pollution,” she predicted.

She pointed out that the International Agency for Research on Cancer classifies outdoor air pollution, especially particulate matter, as a human carcinogen on the basis of evidence of an association with lung cancer.

It is thought that direct deposits and local effects of particulate matter lead to oxidative damage and low-grade chronic inflammation. These in turn result in molecular changes that affect DNA and gene transcription and inhibit apoptosis, all of which lead to the development of cancerous lesions, she explained.

Synthesizing various estimates on global burden of disease, Dr. Berg and colleagues calculated that in 2019 the rate of lung cancer deaths attributable to particular matter in people aged 50-69 years was highest in Serbia, at 36.88 attributable deaths per 100,000.

Next was Poland, with a rate of 27.97 per 100,000, followed by China at 24.63 per 100,000, Mongolia at 19.71 per 100,000, and Turkey at 19.2 per 100,000.

The major sources of air pollution in the most affected countries were transportation, indoor cooking, and energy sources, she said.

In Serbia, 70% of energy production was from coal. It was 74% in Poland, 65% in China, 80% in Mongolia, 35% in Turkey, and 19% in the United States.

At the time of the analysis, only 17.3% of U.S. adults were smokers, and the air concentration of particular matter of 2.5 mcm was 9.6% mcg/m³. Both of these rates are far below those seen in more severely affected countries.

“But 40% of our energy now comes from natural gas,” noted Dr. Berg, “which is still a pollutant and a source of methane. It’s a very potent greenhouse gas.”

No funding for the study has been reported. Dr. Berg has relationships with GRAIL and Mercy BioAnalytics. Dr. Aerts has relationships with Amphera, AstraZeneca, Bayer, BIOCAD, Bristol-Myers Squibb, Eli Lilly, and Roche.

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

Air pollution is the second-leading cause of lung cancer in the world, after smoking, results of a novel analysis suggest. The researchers call for concerted action.

Ja'Crispy/iStock/Getty Images Plus

The new data show that the rate of lung cancer deaths attributable to air pollution varies widely between countries. Serbia, Poland, China, Mongolia, and Turkey are among the worst affected. The analysis shows an association between deaths from lung cancer and the proportion of national energy that is produced from coal.

“Both smoking and air pollution are important causes of lung cancer,” said study presenter Christine D. Berg, MD, former codirector of the National Lung Screening Trial, and “both need to be eliminated to help prevent lung cancer and save lives.

“As lung cancer professionals, we can mitigate the effects of air pollution on causing lung cancer by speaking out for clean energy standards,” she said.

Dr. Berg presented the new analysis on Sept. 9 at the 2021 World Conference on Lung Cancer, which was organized by the International Association for the Study of Lung Cancer.

She welcomed the recent statement issued by the IASLC in support of the International Day of Clean Air for Blue Skies, which took place on Sept. 7. It was a call for action that emphasized the need for further efforts to improve air quality to protect human health.

The findings from the new analysis are “depressing,” commented Joachim G. J. V. Aerts, MD. PhD, department of pulmonary diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.

It is now clear that air pollution has an impact not only on the incidence of lung cancer but also on its outcome, he added.

Indeed, previous research showed that each 10 mcg/m3 increase in particular matter of 2.5 mcg in size was associated with a 15%-27% increase in lung cancer mortality. There was no difference in rates between women and men.

A key question, Dr. Aerts said, is whether reducing air pollution would be beneficial.

Efforts to reduce air pollution over recent decades in the United Kingdom have not led to a reduction in lung cancer deaths. This is because of the increase in life expectancy – individuals have been exposed to pollution for longer, albeit at lower levels, he pointed out.

Because of lockdowns during the COVID pandemic, travel has been greatly reduced. This has resulted in a dramatic reduction in air pollution, “and this led to a decrease in the number of children born with low birth weight,” said Dr. Aerts.

Hopefully, that benefit will also be seen regarding other diseases, he added.

The call to action to reduce air pollution is of the “utmost importance,” he said. He noted that the focus should be on global, national, local, and personal preventive measures.

“It is time to join forces,” he added, “to ‘clean the air.’ ”

Dr. Berg’s presentation was warmly received on social media.

It was “fabulous,” commented Eric H. Bernicker, MD, director of medical thoracic oncology at Houston Methodist Cancer Center.

“Thoracic oncologists need to add air pollution to things they advocate about; we have an important voice here,” he added.

It is “so important to understand that air pollution is a human carcinogen,” commented Ivy Elkins, a lung cancer survivor and advocate and cofounder of the EGFR Resisters Lung Cancer Patient Group. “All you need are lungs to get lung cancer!”
 

Contribution of air pollution to lung cancer

In her presentation, Dr. Berg emphasized that lung cancer is the leading cause of cancer death worldwide, although the distribution between countries “depends on historical and current smoking patterns and the demographics of the population.”

Overall, data from GLOBOCAN 2018 indicate that annually there are approximately 2.1 million incident cases of lung cancer and almost 1.8 million lung cancer deaths around the globe.

A recent study estimated that, worldwide, 14.1% of all lung cancer deaths, including in never-smokers, are directly linked to air pollution.

Dr. Berg said that this makes it the “second-leading cause of lung cancer” behind smoking.

The figure is somewhat lower for the United States, where around 4.7% of lung cancer deaths each year are directly attributable to pollution. However, with “the wildfires out West, we’re going to be seeing more of a toll from air pollution,” she predicted.

She pointed out that the International Agency for Research on Cancer classifies outdoor air pollution, especially particulate matter, as a human carcinogen on the basis of evidence of an association with lung cancer.

It is thought that direct deposits and local effects of particulate matter lead to oxidative damage and low-grade chronic inflammation. These in turn result in molecular changes that affect DNA and gene transcription and inhibit apoptosis, all of which lead to the development of cancerous lesions, she explained.

Synthesizing various estimates on global burden of disease, Dr. Berg and colleagues calculated that in 2019 the rate of lung cancer deaths attributable to particular matter in people aged 50-69 years was highest in Serbia, at 36.88 attributable deaths per 100,000.

Next was Poland, with a rate of 27.97 per 100,000, followed by China at 24.63 per 100,000, Mongolia at 19.71 per 100,000, and Turkey at 19.2 per 100,000.

The major sources of air pollution in the most affected countries were transportation, indoor cooking, and energy sources, she said.

In Serbia, 70% of energy production was from coal. It was 74% in Poland, 65% in China, 80% in Mongolia, 35% in Turkey, and 19% in the United States.

At the time of the analysis, only 17.3% of U.S. adults were smokers, and the air concentration of particular matter of 2.5 mcm was 9.6% mcg/m³. Both of these rates are far below those seen in more severely affected countries.

“But 40% of our energy now comes from natural gas,” noted Dr. Berg, “which is still a pollutant and a source of methane. It’s a very potent greenhouse gas.”

No funding for the study has been reported. Dr. Berg has relationships with GRAIL and Mercy BioAnalytics. Dr. Aerts has relationships with Amphera, AstraZeneca, Bayer, BIOCAD, Bristol-Myers Squibb, Eli Lilly, and Roche.

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

Air pollution is the second-leading cause of lung cancer in the world, after smoking, results of a novel analysis suggest. The researchers call for concerted action.

Ja'Crispy/iStock/Getty Images Plus

The new data show that the rate of lung cancer deaths attributable to air pollution varies widely between countries. Serbia, Poland, China, Mongolia, and Turkey are among the worst affected. The analysis shows an association between deaths from lung cancer and the proportion of national energy that is produced from coal.

“Both smoking and air pollution are important causes of lung cancer,” said study presenter Christine D. Berg, MD, former codirector of the National Lung Screening Trial, and “both need to be eliminated to help prevent lung cancer and save lives.

“As lung cancer professionals, we can mitigate the effects of air pollution on causing lung cancer by speaking out for clean energy standards,” she said.

Dr. Berg presented the new analysis on Sept. 9 at the 2021 World Conference on Lung Cancer, which was organized by the International Association for the Study of Lung Cancer.

She welcomed the recent statement issued by the IASLC in support of the International Day of Clean Air for Blue Skies, which took place on Sept. 7. It was a call for action that emphasized the need for further efforts to improve air quality to protect human health.

The findings from the new analysis are “depressing,” commented Joachim G. J. V. Aerts, MD. PhD, department of pulmonary diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.

It is now clear that air pollution has an impact not only on the incidence of lung cancer but also on its outcome, he added.

Indeed, previous research showed that each 10 mcg/m3 increase in particular matter of 2.5 mcg in size was associated with a 15%-27% increase in lung cancer mortality. There was no difference in rates between women and men.

A key question, Dr. Aerts said, is whether reducing air pollution would be beneficial.

Efforts to reduce air pollution over recent decades in the United Kingdom have not led to a reduction in lung cancer deaths. This is because of the increase in life expectancy – individuals have been exposed to pollution for longer, albeit at lower levels, he pointed out.

Because of lockdowns during the COVID pandemic, travel has been greatly reduced. This has resulted in a dramatic reduction in air pollution, “and this led to a decrease in the number of children born with low birth weight,” said Dr. Aerts.

Hopefully, that benefit will also be seen regarding other diseases, he added.

The call to action to reduce air pollution is of the “utmost importance,” he said. He noted that the focus should be on global, national, local, and personal preventive measures.

“It is time to join forces,” he added, “to ‘clean the air.’ ”

Dr. Berg’s presentation was warmly received on social media.

It was “fabulous,” commented Eric H. Bernicker, MD, director of medical thoracic oncology at Houston Methodist Cancer Center.

“Thoracic oncologists need to add air pollution to things they advocate about; we have an important voice here,” he added.

It is “so important to understand that air pollution is a human carcinogen,” commented Ivy Elkins, a lung cancer survivor and advocate and cofounder of the EGFR Resisters Lung Cancer Patient Group. “All you need are lungs to get lung cancer!”
 

Contribution of air pollution to lung cancer

In her presentation, Dr. Berg emphasized that lung cancer is the leading cause of cancer death worldwide, although the distribution between countries “depends on historical and current smoking patterns and the demographics of the population.”

Overall, data from GLOBOCAN 2018 indicate that annually there are approximately 2.1 million incident cases of lung cancer and almost 1.8 million lung cancer deaths around the globe.

A recent study estimated that, worldwide, 14.1% of all lung cancer deaths, including in never-smokers, are directly linked to air pollution.

Dr. Berg said that this makes it the “second-leading cause of lung cancer” behind smoking.

The figure is somewhat lower for the United States, where around 4.7% of lung cancer deaths each year are directly attributable to pollution. However, with “the wildfires out West, we’re going to be seeing more of a toll from air pollution,” she predicted.

She pointed out that the International Agency for Research on Cancer classifies outdoor air pollution, especially particulate matter, as a human carcinogen on the basis of evidence of an association with lung cancer.

It is thought that direct deposits and local effects of particulate matter lead to oxidative damage and low-grade chronic inflammation. These in turn result in molecular changes that affect DNA and gene transcription and inhibit apoptosis, all of which lead to the development of cancerous lesions, she explained.

Synthesizing various estimates on global burden of disease, Dr. Berg and colleagues calculated that in 2019 the rate of lung cancer deaths attributable to particular matter in people aged 50-69 years was highest in Serbia, at 36.88 attributable deaths per 100,000.

Next was Poland, with a rate of 27.97 per 100,000, followed by China at 24.63 per 100,000, Mongolia at 19.71 per 100,000, and Turkey at 19.2 per 100,000.

The major sources of air pollution in the most affected countries were transportation, indoor cooking, and energy sources, she said.

In Serbia, 70% of energy production was from coal. It was 74% in Poland, 65% in China, 80% in Mongolia, 35% in Turkey, and 19% in the United States.

At the time of the analysis, only 17.3% of U.S. adults were smokers, and the air concentration of particular matter of 2.5 mcm was 9.6% mcg/m³. Both of these rates are far below those seen in more severely affected countries.

“But 40% of our energy now comes from natural gas,” noted Dr. Berg, “which is still a pollutant and a source of methane. It’s a very potent greenhouse gas.”

No funding for the study has been reported. Dr. Berg has relationships with GRAIL and Mercy BioAnalytics. Dr. Aerts has relationships with Amphera, AstraZeneca, Bayer, BIOCAD, Bristol-Myers Squibb, Eli Lilly, and Roche.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

At 18 months into the COVID-19 pandemic, many of the direct and indirect effects of SARS-CoV-2 on people with diabetes have become clearer, but knowledge gaps remain, say epidemiologists.

“COVID-19 has had a devastating effect on the population with diabetes, and conversely, the high prevalence of diabetes and uncontrolled diabetes has exacerbated the problem,” Edward W. Gregg, PhD, Imperial College London, lead author of a new literature review, told this news organization.

“As it becomes clear that the COVID-19 pandemic will be with us in different forms for the foreseeable future, the emphasis for people with diabetes needs to be continued primary care, glycemic management, and vaccination to reduce the long-term impact of COVID-19 in this population,” he added.

In data, mostly from case series, the review shows that more than one-third of people hospitalized with COVID-19 have diabetes. It is published in the September issue of Diabetes Care.

People with diabetes are more than three times as likely to be hospitalized for COVID-19 than those without diabetes, even after adjustment for age, sex, and other underlying conditions. Diabetes also accounts for 30%-40% of severe COVID-19 cases and deaths. Among those with diabetes hospitalized for COVID-19, 21%-43% require intensive care, and the case fatality rate is about 25%.

In one of the few multivariate analyses that examined type 1 and type 2 diabetes separately, conducted in the U.K., the odds of in-hospital COVID-19–related deaths, compared with people without diabetes, were almost three times higher (odds ratio, 2.9) for individuals with type 1 diabetes and almost twice as high (OR, 1.8) for those with type 2, after adjustment for comorbidities.

The causes of death appear to be a combination of factors specific to the SARS-CoV-2 infection and to diabetes-related factors, Dr. Gregg said in an interview.

“Much of the increased risk is due to the fact that people with diabetes have more comorbid factors, but there are many other mechanisms that appear to further increase risk, including the inflammatory and immune responses of people with diabetes, and hyperglycemia appears to have an exacerbating effect by itself.”
 

Elevated glucose is clear risk factor for COVID-19 severity

Elevated A1c was identified among several other overall predictors of poor COVID-19 outcomes, including obesity as well as comorbid kidney and cardiovascular disease.

High blood glucose levels at the time of admission in people with previously diagnosed or undiagnosed diabetes emerged as a clear predictor of worse outcomes. For example, among 605 people hospitalized with COVID-19 in China, those with fasting plasma glucose 6.1-6.9 mmol/L (110-125 mg/dL) and ≥7 mmol/L (126 mg/dL) had odds ratios of poor outcomes within 28 days of 2.6 and 4.0 compared with FPG <6.1 mmol/L (110 mg/dL).

Population-based studies in the U.K. found that A1c levels measured months before COVID-19 hospitalization were associated with risk for intensive care unit admission and/or death, particularly among those with type 1 diabetes. Overall, the death rate was 36% higher for those with A1c of 9%-9.9% versus 6.5%-7%.

Despite the link between high A1c and death, there is as yet no clear evidence that normalizing blood glucose levels minimizes COVID-19 severity, Dr. Gregg said.

“There are data that suggest poor glycemic control is associated with higher risk of poor outcomes. This is indirect evidence that managing blood sugar will help, but more direct evidence is needed.”
 

Evidence gaps identified

Dr. Gregg and co-authors Marisa Sophiea, PhD, MSc, and Misghina Weldegiorgis, PhD, BSc, also from Imperial College London, identify three areas in which more data are needed.

First, more information is needed to determine whether exposure, infection, and hospitalization risks differ by diabetes status and how those factors affect outcomes. The same studies would also be important to identify how factors such as behavior, masking, and lockdown policies, risk factor control, and household/community environments affect risk in people with diabetes.

Second, studies are needed to better understand indirect effects of the pandemic, such as care and management factors. Some of these, such as the advent of telehealth, may turn out to be beneficial in the long run, they note.

Finally, the pandemic has “brought a wealth of natural experiments,” such as how vaccination programs and other interventions are affecting people with diabetes specifically. Finally, population studies are needed in many parts of the world beyond the U.S. and the U.K., where most of that work has been done thus far.

“Many of the most important unanswered questions lie in the potential indirect and long-term impact of the pandemic that require population-based studies,” Dr. Gregg said. “Most of our knowledge so far is from case series, which only assess patients from the time of hospitalization.”

Indeed, very little data are available for people with diabetes who get COVID-19 but are not hospitalized, so it’s not known whether they have a longer duration of illness or are at greater risk for “long COVID” than those without diabetes who experience COVID-19 at home.

“I have not seen published data on this yet, and it’s an important unanswered question,” Dr. Gregg said.  

The authors have disclosed no relevant financial relationships.

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

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.¹ Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.^2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).³

With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.⁵ Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.^6-11

The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.⁷

In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.^12,13

The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.^14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).¹⁶

Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.¹⁷

Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.¹⁶ Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.

Methods

VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.

COVID-19 Urgent Clinics Program

Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.

Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.

Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.

Results

A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).

A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30 pm).

Discussion

This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.

Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.

Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.

Conclusions

VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.

Acknowledgment

The authors thank Robert F. Walsh, MHA.

Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.¹ Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.^2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).³

With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.⁵ Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.^6-11

The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.⁷

In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.^12,13

The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.^14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).¹⁶

Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.¹⁷

Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.¹⁶ Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.

Methods

VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.

COVID-19 Urgent Clinics Program

Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.

Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.

Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.

Results

A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).

A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30 pm).

Discussion

This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.

Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.

Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.

Conclusions

VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.

Acknowledgment

The authors thank Robert F. Walsh, MHA.

Virtual care (VC) has emerged as an effective mode of health care delivery especially in settings where significant barriers to traditional in-person visits exist; a large systematic review supports feasibility of telemedicine in primary care and suggests that telemedicine is at least as effective as traditional care.¹ Nevertheless, broad adoption of VC into practice has lagged, impeded by government and private insurance reimbursement requirements as well as the persistent belief that care can best be delivered in person.^2-4 Before the COVID-19 pandemic, states that enacted parity legislation that required private insurance companies to provide reimbursement coverage for telehealth services saw a significant increase in the number of outpatient telehealth visits (about ≥ 30% odds compared with nonparity states).³

With the onset of the COVID-19 pandemic, in-person medical appointments were converted to VC visits to reduce increased exposure risks to patients and health care workers.⁵ Prior government and private sector policies were suspended, and payment restrictions lifted, enabling adoption of VC modalities to rapidly accommodate the emergent need and Centers for Disease Control and Prevention (CDC) recommendations for virtual care.^6-11

The CDC guidelines on managing operations during the COVID-19 pandemic highlighted the need to provide care in the safest way for patients and health care personnel and emphasized the importance of optimizing telehealth services. The federal government facilitated telehealth during the COVID-19 pandemic via temporary measures under the COVID-19 public health emergency declaration. This included Health Insurance Portability and Accountability Act flexibility to use everyday technology for VC visits, regulatory changes to deliver services to Medicare and Medicaid patients, permission of telehealth services across state lines, and prescribing of controlled substances via telehealth without an in-person medical evaluation.⁷

In response, health care providers (HCPs) and health care organizations created or expanded on existing telehealth infrastructure, developing virtual urgent care centers and telephone-based programs to evaluate patients remotely via screening questions that triaged them to a correct level of response, with possible subsequent virtual physician evaluation if indicated.^12,13

The Veterans Health Administration (VHA) also shifted to a VC model in response to COVID-19 guided by a unique perspective from a well-developed prior VC experience.^14-16 As a federally funded system, the VHA depends on workload documentation for budgeting. Since 2015, the VHA has provided workload credit and incentivized HCPs (via pay for performance) for the use of VC, including telephone visits, video visits, and secure messaging. These incentives resulted in higher rates of telehealth utilization before the COVID-19 pandemic compared with the private sector (with 4.2% and 0.7% of visits within the VHA being telephone and video visits, respectively, compared with telehealth utilization rates of 1.0% for Medicare recipients and 1.1% in an all-payer database).¹⁶

Historically, VHA care has successfully transitioned from in-person care models to exclusively virtual modalities to prevent suspension of medical services during natural disasters. Studies performed during these periods, specifically during the 2017 hurricane season (during which multiple VHA hospitals were closed or had limited in-person service available), supported telehealth as an efficient health care delivery method, and even recommended expanding telehealth services within non-VHA environments to accommodate needs of the general public during crises and postdisaster health care delivery.¹⁷

Armed with both a well-established telehealth infrastructure and prior knowledge gained from successful systemwide implementation of virtual care during times of disaster, US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACHS) primary care quickly transitioned to a VC model in response to COVID-19.¹⁶ Early in the pandemic, a rapid transition to virtual care (RTVC) model was developed, including implementation of virtual respiratory urgent clinics (VRUCs), defined as virtual respiratory symptom triage clinics, staffed by primary care providers (PCPs) aimed at minimizing patient and health care worker exposure risk.

Methods

VACHS consists of 8 primary care sites, including a major tertiary care center, a smaller medical center with full ambulatory services, and 6 community-based outpatient clinics with only primary care and mental health. There are 80 individual PCPs delivering care to 58,058 veterans. VRUCs were established during the COVID-19 pandemic to cover patients across the entire health care system, using a rotational schedule of VA PCPs.

COVID-19 Urgent Clinics Program

Within the first few weeks of the pandemic, VACHS primary care established VRUCS to provide expeditious virtual assessment of respiratory or flu-like symptoms. Using the established telehealth system, the intervention aimed to provide emergent screening, testing, and care to those with potential COVID-19 infections. The model also was designed to minimize exposures to the health care workforce and patients.

Retrospective analysis was performed using information obtained from the electronic health record (EHR) database to describe the characteristics of patients who received care through the VRUCs, such as demographics, era of military service, COVID-19 testing rates and results, as well as subsequent emergency department (ED) visits and hospital admissions. A secondary aim included collection of additional qualitative data via a random sample chart review.

Virtual clinics were established January 22, 2020, and data were analyzed over the next 3 months. Data were retrieved and analyzed from the EHR, and codes were used to categorize the VRUCs.

Results

A total of 445 unique patients used these clinics during this period. Unique patients were defined as individual patients (some may have used a clinic more than once but were counted only once). Of this group, 82% were male, and 48% served in the Gulf War era (1990 to present). A total of 51% of patients received a COVID-19 test (clinics began before wide testing availability), and 10% tested positive. Of all patients using the clinics, approximately 5% were admitted to the hospital, and 18% had at least 1 subsequent ED visit (Table).

A secondary aim included review of a random sample of 99 patient charts to gain additional information regarding whether the patient was given appropriate isolation precautions, was in a high-exposure occupation (eg, could expose a large number of people), and whether there was appropriate documentation of goals of care, health care proxy or referral to social work to discuss advance directives. In addition, we calculated the average length of time between patients’ initial contact with the health care system call center and the return call by the PCP (wait time).Of charts reviewed, the majority (71%) had documentation of appropriate isolation precautions. Although 25% of patients had documentation of a high-risk profession with potential to expose many people, more than half of the patients had no documentation of occupation. Most patients (86%) had no updated documentation regarding goals of care, health care proxy, or advance directives in their urgent care VC visit. The average time between the patient initiating contact with the health care system call center and a return call to the patient from a PCP was 104 minutes (excluding calls received after 3:30 pm).

Discussion

This analysis adds to the growing literature on use of VC during the COVID-19 pandemic. Specifically, we describe the population of patients who used VRUCs within a large health care system in a RTVC. This analysis was limited by lack of available testing during the initial phase of the pandemic, which contributed to the lower than expected rates of testing and test positivity in patients managed via VRUCs. In addition, chart review data are limited as the data includes only what was documented during the visit and not the entire discussion during the encounter.

Several important outcomes from this analysis can be applied to interventions in the future, which may have large public health implications: Several hundred patients who reported respiratory symptoms were expeditiously evaluated by a PCP using VC. The average wait time to full clinical assessment was about 1.5 hours. This short duration between contact and evaluation permitted early education about isolation precautions, which may have minimized spread. In addition, this innovation kept patients out of the medical center, eliminating chains of transmission to other vulnerable patients and health care workers.

Our retrospective chart review also revealed that more than half the patients were not queried about their occupation, but of those that were asked, a significant number were in high-risk professions potentially exposing large numbers of people. This would be an important aspect to add to future templated notes to minimize work-related exposures. Also, we identified that few HCPs discussed goals of care with patients. Given the nature of COVID-19 and potential for rapid decompensation especially in vulnerable patients, this also would be important to include in the future.

Conclusions

VC urgent care clinics to address possible COVID-19 symptoms facilitated expeditious PCP assessment while keeping potentially contagious patients outside of high-risk health care environments. Streamlining and optimizing clinical VC assessments will be imperative to future management of COVID-19 and potentially to other future infectious pandemics. This includes development of templated notes incorporating counseling regarding appropriate isolation, questions about high-contact occupations, and goals of care discussions.

Acknowledgment

The authors thank Robert F. Walsh, MHA.

The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The Veterans Health Administration (VHA) clinical practice recommendations endorse a power mobility device (PMD) for individuals with adequate judgment, cognitive ability, and vision who are unable to propel a manual wheelchair or walk community distances despite standard medical and rehabilitative interventions.¹ VHA supports the use of a PMD in order to access medical care and accomplish activities of daily living, both at home and in the community for veterans with mobility limitations secondary to cardiovascular disease, neurologic disorders, pulmonary disease, or musculoskeletal disorders. The goal of a PMD use is increased participation in community and social life, improved health maintenance via enhanced access to medical facilities, and an overall enhanced quality of life. However, there is a common concern among health care providers that prescribing a PMD may decrease physical activity, in turn, leading to obesity and increasing morbidity. ²

The prevalence of obesity is increasing in the United States. In the past decade 35.0% of men and 36.8% of women were classified as obese (body mass index [BMI], ≥ 30).³ Recent figures from the Centers for Disease Control and Prevention estimate that the overall prevalence of obesity in Americans is closer to 42.4%.⁴ The veteran population is not immune to this; a 2014 study of nearly 5 million veterans reported that the prevalence of obesity in this population was 41%.^5,6 In addition to obesity being implicated in exacerbating many medical problems, such as osteoarthritis, insulin resistance, and heart disease, obesity also is associated with a significant decrease in lifespan.⁷ Almost half of adults who report ambulatory dysfunction are obese.⁸ Given the increased morbidity and mortality as a result of obesity, interventions that may promote weight gain need to be appropriately identified and minimized.

Methods

The institutional review board at Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, Virginia, reviewed and approved this study. A waiver of participant consent was approved due to the nature of the research (medical records of patients, some of whom were deceased) and the type of data collected (retrospective data). In addition, each individual was assigned a sequential code to de-identify any personal information. Prosthetics department medical records of consecutive veterans who received PMDs for the first time between January 1, 2011 and June 30, 2012, were reviewed.

Data extracted from the electronic health record (EHR) included demographics, indication for power mobility, weight at time of PMD prescription, weight at 2-years postprescription, and height. Weight readings were considered valid if weight was taken within 3 months of initial prescription and then again within 3 months at the 2-year interval. Individuals without weights recorded in these time frames were excluded. In addition, we excluded medical conditions that might significantly affect body weight, including amyotrophic lateral sclerosis (ALS), amputation during the study period, or history of weight loss surgery. Cancer diagnoses were excluded as they were not an indication for power mobility in the VHA. ALS, though variable in its disease course, was specifically excluded given the likelihood of these patients dying of the natural progression of the disease before the 2-year follow-up period: Median survival times in patients diagnosed with ALS aged > 60 years was < 15 months. ^10-12

The EHRs of 399 individuals who received a PMD during the period were reviewed, and 185 veterans met criteria for data analysis. Subject exclusions in the weight and BMI analysis included death during the follow-up period (89), missing data (68), prior PMD users who came in for replacements (53), and ALS (4) (Figure 1). Patients were not excluded based on the presence or absence of intentional weight loss efforts as this information was not readily available through chart review.

Statistical Analysis

The primary outcome measure was the change in BMI and body weight from time 1 (date of PMD prescription) to time 2 (2 years later). Analyses were performed using IBM SPSS Statistics, Version 21. BMI was calculated using the weight (lb) x 703/ (height [inches]).² Dichotomization of BMI was performed using the conventional cut scores: < 30.0, not obese; and ≥ 30.0, obese. Paired t tests and SPSS general linear model (repeated measures) were used to examine change of BMI from time 1 to time 2. The exact McNemar test was used to examine change in obesity classification across time 1 and time 2. Correlating with Yang’s retrospective observational study, data were analyzed separately for aged < 65 years and aged≥ 65 years.²

Results

Of the 185 veterans, 181 were male (98%); mean age was 67.3 years (range, 26-90); and 55% were aged ≥ 65 years. Musculoskeletal disorders (41.6%) were the most common primary indication for a PMD, followed by pulmonary disorders (25.4%) and cardiovascular disorders (23.8%) (Table 1).

There was a significant decrease in BMI in the first 2 years after receiving a PMD prescription for the first time (estimated marginal means: 31.5 to 30.9 , P = .02). However, age moderated the relationship between BMI and time F[1, 183] = 12.14, P = .001, partial η² = .06 (Table 2). The 101 subjects aged > 65 years experienced a significant decrease in BMI (estimated marginal means: 30.3 to 29.1, P < .001), whereas the 84 patients aged < 65 years experienced a slight and nonsignificant increase in BMI (estimated marginal means: 32.9 to 33.1, P = .45). BMI was significantly higher for subjects aged < 65 years at Time 1 (F[1, 183] = 4.32, P = .04, partial η² = .02) and at Time 2 (F[1, 183] = 11.04, P = .001, partial η² = .06).

Discussion

This study demonstrated a significant decrease in both weight and BMI at 2 years after the initiation of a PMD in patients aged < 65 years. No significant change was found for obesity rates. However, veterans who met criteria for obesity at the time of PMD prescription saw a significant decrease in their weight at 2 years compared with those who were nonobese.

VHA supports power mobility when there is a clear functional need that cannot be met by rehabilitation, surgical, or medical interventions to enhance veterans’ abilities to access medical care, accomplish necessary tasks of daily living, and to have greater access to their communities. Though limited by strength of association, studies involving PMD users generally found improvement in reported functional outcomes and overall satisfaction with PMD use based on a systematic review.¹³ Nonetheless, there is an implicit concern among providers that a PMD prescription, by limiting physical activity, may exacerbate obesity trends in potentially high-risk individuals.

However, a controversy exists about whether increasing physical activity alone leads to weight loss. A 2007 study followed 102 sedentary men and 100 women over 1 year randomized to moderately intensive exercise for 60 minutes, 6 days a week vs no intervention.¹⁴ The men lost an average of 4 pounds, and women lost an average of 3 pounds after 1 year. The Women’s Health Study divided 39,876 women into high, medium, and low levels of exercise groups. After 10 years, the intense exercise group did not have any significant weight loss.¹⁵

Our study was consistent with existing literature in that a PMD prescription did not correlate with weight gain.^2,9 In our veteran population aged ≥ 65 years, we observed an opposite trend of weight loss after PMD prescription. Of note, studies have shown that peak body weight occurs in the sixth decade, remains stable until about aged 70 years, and then slowly decreases thereafter, at a rate of 0.1 to 0.2 kg per year.¹⁶ This likely explains some of the weight loss trend we observed in our study of veterans aged ≥ 65 years. Possible additional explanations include improved access to health care and to more nutritional foods that promote general health and well-being.

Limitations

The data were gathered from a predominantly male veteran population, potentially limiting generalizability. The health of any individual is determined by the interaction of factors of which body weight is just a single, isolated component. As such, the effect of powered mobility on body weight is not a direct reflection on the effect on overall health. Additionally, there are many factors that may affect an individual’s body weight, such as optimal management of medical comorbidities, which could not be controlled for in this study. Also, while these values can be compared with other veteran populations, this study had no true control group.

Conclusions

Based on the findings of this study with aforementioned limitations, PMD use does not seem to be associated with significant weight changes. Further studies using control groups and assessing comorbidities are needed.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

A version of this article first appeared on WebMD.com.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Allergies to β-lactam antibiotics are among the most documented drug allergies, and approximately 10% of the US population reports an allergy specifically to penicillin.^1,2 Many allergic reactions are mediated via the antibody immunoglobulin E (IgE), producing an immediate hypersensitivity response, such as hives or anaphylaxis, which can be life threatening. Reactions also may be mediated by T cells of the immune system, which target various cell lines and can cause a drug reaction with eosinophilia and systemic symptoms or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).³Although β-lactam and penicillin allergies are frequently reported, < 5% manifest as either an IgE or T-cell–mediated response.⁴Furthermore, for the small proportion of patients who once had a true IgE-mediated reaction, including anaphylaxis, 80% experience a decrease in IgE antibodies over time, resulting in a loss of allergic response after about 10 years.² Due to this decline in IgE response and the initial mislabeling of mild non-IgE penicillin reactions, 95% of patients who are labeled as penicillin-allergic can eventually tolerate a penicillin.²

When a patient’s β-lactam allergy is never reevaluated, negative consequences can ensue. This allergy in a patient’s medical record can lead to the inappropriate avoidance of the entire β-lactam antibiotic class, which includes all penicillins, cephalosporins, and carbapenems. Withholding these antibiotics in certain situations can lead to negative patient outcomes.^5-7 For example, the drugs of choice for the infections syphilis and methicillin-susceptible Staphylococcus aureus (S aureus) are a penicillin or cephalosporin, and patients labeled as penicillin-allergic are more likely to experience treatment failure from using second-line therapies.⁸ Additionally, receiving non-β-lactam antibiotics puts patients at risk of multidrug-resistant pathogens like methicillin-resistant S aureus and vancomycin-resistant Enterococcus (VRE) as well as adverse effects, such as Clostridioides difficile infection.⁹ Using alternative, and likely broad-spectrum, antibiotics also can be financially detrimental: These medications often are more costly than their β-lactam alternatives, and the inappropriate use of therapies can result in longer hospital courses.^9-11

Penicillin allergies can complicate the antibiotic treatment strategy. The Memphis Veterans Affairs Medical Center (MVAMC) in Tennessee recently examined the negative sequelae of β-lactam allergies and found that more than half the patients received inappropriate antibiotics based on guideline recommendations, allergy history, and culture and sensitivity data.¹² To mitigate the problems for patients with β-lactam allergies, the 2016 guidelines from the Infectious Diseases Society of America (IDSA) on the Implementation of Antimicrobial Stewardship Programs (ASP) recommend that these patients undergo allergy assessment and penicillin skin testing.¹³In November 2017, MVAMC implemented such a process. The purpose of this study was to describe our pharmacist-run β-lactam allergy assessment (BLAA) protocol and penicillin allergy clinic (PAC) and evaluate their overall outcomes: the proportion of patients who have been cleared to receive an alternative β-lactam antibiotic or who have had their allergy removed altogether.

Methods

We conducted a retrospective, observational study with approval from the institutional review board at MVAMC. This institution is an academic teaching center with 240 acute care beds and a variety of outpatient clinics available at the main campus, serving veterans in Memphis and the Mid-South area, including west Tennessee, northern Mississippi, and northeastern Arkansas. Patients were consecutively evaluated from November 2017 through February 2020. All MVAMC patients with a documented β-lactam allergy were eligible for inclusion; there were no exclusion criteria. Electronic health record data were assessed and included basic patient demographics, allergy history, and the outcome of the BLAA and PAC. Descriptive statistics were used for data analysis.

The purpose of the BLAA process is to evaluate, clarify, and potentially clear patients of their β-lactam allergies. Started in November 2017, the process includes appropriate patient screening with documentation of the β-lactam allergy. When patients with a β-lactam allergy are admitted to the hospital, they are interviewed by an inpatient CPS. This pharmacist then enters an assessment into the patient’s chart, which includes details of the allergen, reaction, and timing of the event. Based on this information, the CPS provides recommendations: clearance for alternative β-lactams, avoidance of all β-lactams, or removal of the allergy.

In January 2019, the pharmacist-driven penicillin allergy clinic (PAC) was started. Eligible patients receive a skin test to confirm or rule out their allergy after hospital discharge. To facilitate patient identification and screening, the ASP/infectious diseases (ID) clinical pharmacist runs a daily report of hospitalized patients with documented β-lactam allergies. All inpatient CPSs had access to this report and could easily identify and interview patients. Following the interview, the pharmacist enters a note in the patient’s chart, using the BLAA template (eFigures 1 and 2). On completion, a note is viewable in the Notes section adjacent to the patient’s allergies. The pharmacist then can enter a PAC consult for eligible patients. Although most patients qualify for PAC, exclusion criteria include non–IgE-mediated allergies (ie, SJS/TEN), allergies to β-lactams other than penicillins, or recent reactions (ie, within the past 5 years). Each inpatient CPS is trained on this BLAA process, which includes patient screening, chart review, patient interviewing, and the BLAA template and note completion. Pharmacists must demonstrate competency in completing 5 BLAA notes with review from the ASP/ID pharmacist. Once training is completed, this process is integrated into the pharmacist’s everyday workflow.

Results

We evaluated 278 patients, using the BLAA protocol. In this veteran population, patients were generally older males and evenly split between African American and White patients (Table 2). Most patients reported an allergy to penicillin, with a rash being the most common reaction (Table 3).

Of the 278 assessed, 246 patients were evaluated via our BLAA alone and were not seen in PAC. We were able to remove 25% of these patients’ allergies by performing a thorough assessment. Of the 184 patients whose allergies could not be removed via the BLAA alone, 147 (80%) were still eligible for PAC but are awaiting scheduling. Patients ineligible for PAC included those with a cephalosporin allergy or a severe and non–IgE-mediated reaction. Other ineligible patients who were not eligible included those with diseases where risk of testing outweighed the benefits.

Of the 32 patients who were seen in PAC, 75% of allergies were removed through direct testing. No differences between race or gender were observed. Of the 8 patients (25%) whose allergies were not removed, 5 had confirmed penicillin allergies with a positive reaction; 4 of these patients have since tolerated an alternative β-lactam (either a cephalosporin or carbapenem). Three patients had inconclusive tests, most often because their positive control was nonreactive during the percutaneous portion of the skin test; these allergies could neither be confirmed nor removed. Two of these patients have since tolerated alternative β-lactams (both cephalosporins). Although these 8 patients should not be rechallenged with a penicillin antibiotic, they could still be considered for alternative β-lactams, based on the nature and histories of their allergies.

Discussion

We have implemented a unique and efficient way to evaluate, clarify, and clear β-lactam allergies. Our BLAA protocol allows for a smooth process by distributing the workload of evaluating and clarifying patients’ allergies over many inpatient CPS. Furthermore, the BLAA is readily accessible to health care providers (HCPs), allowing for optimal clinical decision making. HCPs can quickly gather further information on the β-lactam allergy, while seeing actionable recommendations, along with documentation of the PAC visit and subsequent events, if the patient has been seen.

This study demonstrated the promotion of alternative β-lactam use for nearly all patients: 99% of our patient population were deemed candidates for a β-lactam type antibiotic. This percentage included patients whose allergies have been fully cleared, both through BLAA alone and in PAC. Also included are patients who have been cleared for an alternative β-lactam and not necessarily a penicillin.

In our PAC, 8 patients were not cleared for penicillins: 5 had penicillin allergies confirmed, and 3 had inconclusive results. Based on the nature of their reactions and previous tolerance of alternative β-lactams, those 5 patients are still eligible for alternative β-lactams. Additionally, the 3 patients with inconclusive results are also eligible for alternative β-lactams for the same reasons. The patients for whom β-lactam antibiotic avoidance was recommended (4 patients, 1%) have not been seen in PAC, as their reactions disqualify them from penicillin skin testing. Two of these patients had anaphylaxis < 5 years ago and will be eligible for PAC if they do not experience anaphylaxis within the 5-year period.

Limitations

Although our study demonstrates many benefits of implementation of a BLAA protocol and PAC, it has several limitations. This analysis was a retrospective review of the limited number of patients who had assessments completed. Additionally, many patients were waiting to be seen in PAC. This delay is largely due to the length of time to establish our pharmacist-run PAC, the limited number of pharmacists trained and available for skin testing, the time constraints of our staff, and COVID-19 pandemic. Additionally, only pharmacists administer the BLAA questionnaire, but this process could be expanded to other professionals such as nursing staff. Also, this study was not set up as a before-and-after analysis that examined outcomes associated with individual patients. Future directions include assessing the clinical impact of this protocol, such as evaluating provider utilization of β-lactam antibiotics for patients with penicillin allergies and determining associated cost savings.

Conclusions

This study demonstrated that implementation of a pharmacist-driven BLAA protocol and PAC can effectively remove inaccurate penicillin allergy labels and clear patients for alternative β-lactam antibiotic use. The BLAA process in conjunction with PAC will continue to be used to better evaluate, clarify, and clear patient allergies to optimize their care.

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

Point-of-care ultrasound (POCUS) is increasingly being used by critical care physicians to augment the physical examination and guide clinical decision making, and several protocols have been established to standardize the POCUS evaluation.¹ During the COVID-19 pandemic, POCUS has been a valuable tool as standard imaging techniques were used judiciously to minimize exposure of personnel and use of personal protective equipment (PPE).²

In the US Department of Veterans Affairs (VA) New York Harbor Healthcare System (VANYHHS) intensive care unit (ICU) on initial clinical examination included POCUS, which was helpful to examine deep vein thromboses, cardiac function, and the presence and extent of pneumonia. An international expert consensus on the use of POCUS for COVID-19 published in December 2020 called for further studies defining the role of lung and cardiac ultrasound in risk stratification, outcomes, and clinical management.³

The objective of this study was to review POCUS findings and correlate them with severity of illness and 30-day outcomes in critically ill patients with COVID-19.

Methods

The study was submitted to and reviewed by the VANYHHS Research and Development committee and study approval and informed consent waiver was granted. The study was a retrospective chart review of patients admitted to the VANYHHS ICU between March and April 2020, a tertiary health care center designated as a COVID-19 hospital.

Patients admitted to the ICU aged > 18 years with a diagnosis of acute hypoxemic respiratory failure, diagnosis of COVID-19, and documentation of POCUS findings in the chart were included in the study. A patient was considered to have a COVID-19 diagnosis following a positive SARS-CoV-2 polymerase chain reaction test documented in the electronic health record (EHR). Acute respiratory failure was defined as hypoxemia < 94% and the need for either supplemental oxygen by nasal cannula > 2 L/min, high flow nasal cannula, noninvasive ventilation, or mechanical ventilation.

To minimize personnel exposure, initial patient evaluations and POCUS examinations were performed by the most senior personnel (ie, fellowship trained, board-certified pulmonary critical care attending physicians or pulmonary and critical care fellowship trainees). Three members of the team had certification in advanced critical care echocardiography by the National Board of Echocardiography and oversaw POCUS imaging. POCUS examinations were performed with a GE Heathcare Venue POCUS or handheld unit. After use, ultrasound probes and ultrasound units were disinfected with wipes designated by the manufacturer and US Environmental Protection Agency for use during the COVID-19 pandemic.

The POCUS protocol used by members of the team was as follows: POCUS lung—at least 2 anterior fields and 1 posterior/lateral field looking at the costophrenic angle on each hemithorax with a phased array or curvilinear probe. A linear probe was used to look for subpleural changes per physician discretion.^4,5 Lung ultrasound findings in anterior lung fields were documented as A lines, B lines (as defined by the bedside lung ultrasound in emergency [BLUE] protocol)anterior pleural abnormalities or consolidations.^4,5 The costophrenic point findings were documented as presence of consolidation or pleural effusion.

The POCUS cardiac examination consisted of parasternal long and short axis views, apical 4 chamber view, subcostal and inferior vena cava (IVC) view. Left ventricular (LV) ejection fraction was visually estimated as reduced or normal. Right ventricular (RV) dilation was considered present if RV size approached or exceeded LV size in the apical 4 chamber view. RV dysfunction was considered present if in addition there was flattening of interventricular septum, RV free wall hypokinesis or reduced tricuspid annular plane systolic excursion (TAPSE).⁶ IVC was documented as collapsible or plethoric by size and respirophasic variability (2 cm and 50%). Other POCUS examinations including venous compression were done at the discretion of the treating physician.⁷ POCUS was also used for the placement of central and arterial lines and to guide fluid management.⁸

The VA EHR and Venue image local archives were reviewed for patient demographics, laboratory findings, imaging studies and outcomes. All ICU attending physician and fellow notes were reviewed for POCUS lung, cardiac and vascular findings. The chart was also reviewed for management changes as a result of POCUS findings. Patients who had at minimum a POCUS lung or cardiac examination documented in the EHR were included in the study. For patients with serial POCUS the most severe findings were included.

Patients were divided into 2 groups based on 30-day outcome: discharge home vs mortality for comparison. POCUS findings were also compared by need for mechanical ventilation. Patients still hospitalized or transferred to other facilities were excluded from the analysis. A Student t test was used for comparison between the groups for continuous normally distributed variables. Linear and stepwise regression models were used to evaluate univariate and multivariate associations of baseline characteristics, biomarker, and ultrasound findings with patient outcomes. Analyses were performed using R 4.0.2 statistical software.

Results

Eighty-two patients were admitted to the VANYHHS ICU in March and April 2020, including 12 nonveterans. Sixty-four had COVID-19 and acute respiratory failure. POCUS findings were documented in 43 (67%) patients. Thirty-nine patients had documented lung examinations, and 25 patients had documented cardiac examinations. Patients were divided into 2 groups by 30-day outcome (discharge home vs mortality) for statistical analysis. Five patients who were either still hospitalized or had been transferred to another facility were excluded.

Baseline characteristics of patients included in the study stratified by 30-day outcomes are shown in Table 1. The study group was predominantly male (95%). Patients with poor 30-day outcomes were older, had higher white blood cell counts, more severe hypoxemia, higher rates of mechanical ventilation and RV dilation (Figures 1, 2, 3, 4, and 5). RV dilation was an independent predictor of mortality (odds ratio [OR], 12.0; P = .048).

Discussion

POCUS identified both lung and cardiac features that were associated with worse outcomes. While lung ultrasound abnormalities were very prevalent and associated with worse PaO₂ to FiO₂ ratios, the presence of RV dilation was associated most clearly with mortality and poor 30-day outcomes in the critical care setting.

Lung ultrasound abnormalities were pervasive in patients with acute respiratory failure and COVID-19. On linear regression we found that presence with bilateral B lines and pleural thickening was predictive of a lower PaO₂/FiO₂ (coefficient, -70; P = .005). Our study found that B lines with pleural irregularities, otherwise known as a B’ profile per the BLUE protocol, was seen in patients with severe COVID-19. Thus severe acute respiratory failure secondary to COVID-19 has similar lung ultrasound findings as non-COVID-19 acute respiratory distress syndrome (ARDS).^4,5 Based on prior lung ultrasound studies in ARDS, lung ultrasound findings can be used as an alternate to chest radiography for the diagnosis of ARDS in COVID-19 and predict the severity of ARDS.⁹ This has particular implications in overwhelmed and resource poor health care settings.

We found no difference in 30-day mortality based on lung ultrasound findings or profile, probably because of small sample size or because the findings were tabulated as profiles and not differentiated further with lung ultrasound scores.^10,11 However, there was a significant difference in RV dilation between the 2 groups by 30 days and its presence was found to be a predictor of mortality even when controlled for hypertension and diabetes mellitus (P = .048) with an OR of 12. RV dysfunction in patients with ARDS on mechanical ventilation ranges from 22 to 25% and is typically associated with high driving pressures.^12-14 The mechanism is thought to be multifactorial including hypoxemic vasoconstriction in the pulmonary vasculature in addition to the increased transpulmonary pressure.¹⁵ While all of the above are at play in COVID-19 infection, there is reported damage to the pulmonary vascular endothelium and resultant hypercoagulability and thrombosis that further increases the RV afterload.¹⁶

While RV strain and dysfunction indices done by an echocardiographer would be ideal, given the surge in infections and hospitalizations and strain on health care resources, POCUS by the treating or examining clinician was considered the only feasible way to screen a large number of patients.¹⁷ Identification of RV dilation could influence clinical management including workup for venous thromboembolic disease and optimization of lung protective strategies. Further studies are needed to understand the particular etiology and pathophysiology of COVID-19 associated RV dilation. Given increased thrombosis events in COVID-19 infection we believe a POCUS vascular examination should be included as part of evaluation especially in the presence of increased D-dimers and has been discussed above for its important role in working up RV dilation.¹⁸

Limitations

Our study has several limitations. It was retrospective in nature and involved a small group of individuals. There was some variation in POCUS examinations done at the discretion of the examining physician. We did not have a blinded observer independently review all images. Since RV dilation was documented only when RV size approached or exceeded LV size in the apical 4 chamber view representing moderate or severe dilation, we may be underreporting the prevalence in critically ill patients.

Conclusions

POCUS is an invaluable adjunct to clinical evaluation and procedures in patients with severe COVID-19 with the ability to identity patients at risk for worse outcomes. B lines with pleural thickening is a sign of severe ARDS and RV dilatation is predictive of mortality. POCUS should be made available to the treating physician for monitoring and risk stratification and can be incorporated into management algorithms.

Additional point-of-care ultrasound videos.

Acknowledgments

We thank frontline healthcare workers and intensive care unit staff of the US Department of Veterans Affairs New York Harbor Healthcare System (NYHHS) for their dedication to the care of veterans and civilians during the COVID-19 pandemic in New York City. The authors acknowledge the NYHHS research and development committee and administration for their support.

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).

The United States is facing an opioid crisis in which approximately 10 million people have misused opioids in the past year, and an estimated 2 million people have an opioid use disorder (OUD).¹ Compared with the general population, veterans treated in the Veterans Health Administration (VHA) facilities are at nearly twice the risk for accidental opioid overdose.² The implementation of opioid safety measures in VHA facilities across all care settings is a priority in addressing this public health crisis. Hence, VHA leadership is working to minimize veteran risk of fatal opioid overdoses and to increase veteran access to medication-assisted treatments (MAT) for OUD.³

Since the administration of our survey, the VHA has shifted to using the term medication for opioid use disorder (MOUD) instead of MAT for OUD. However, for consistency with the survey we distributed, we use MAT in this analysis.

Acute care settings represent an opportunity to offer appropriate opioid care and treatment options to patients at risk for OUD or opioid-related overdose. VHA facilities offer 2 outpatient acute care settings for emergent ambulatory care: emergency departments (EDs) and urgent care centers (UCCs). Annually, these settings see an estimated 2.5 million patients each year, making EDs and UCCs critical access points of OUD care for veterans. Partnering with key national VHA stakeholders from Pharmacy Benefits Management (PBM), the Office of Emergency Medicine, and Academic Detailing Services (ADS), we developed the Emergency Department Opioid Safety Initiative (ED OSI) aimed at implementing and evaluating opioid safety measures in VHA outpatient acute care settings.

The US Department of Veterans Affairs (VA)/Department of Defense (DoD) Clinical Practice Guidelines for Opioid Therapy for Chronic Pain (CPG) makes recommendations for the initiation and continuation of opioids, risk mitigation, taper of opioids, and opioid therapy for acute pain in VHA facilities.⁴ Using these recommendations, we developed the broad aims of the ED OSI quality improvement (QI) program. The CPG is clear about the prioritization of safe opioid prescribing practices. New opioid prescriptions written in the ED have been associated with continued and chronic opioid use.⁵ At the time of prescription, patients not currently and chronically on opioids who receive more than a 3-day supply are at increased risk of becoming long-term opioid users.⁶ Given the annual volume of patients seen, VHA ED/UCCs are a crucial area for implementing better opioid prescribing practices.

The CPG also includes recommendations for the prescribing or coprescribing of naloxone rescue kits. The administration of naloxone following opioid overdose has been found to be an effective measure against fatal overdose. Increasing provider awareness of common risk factors for opioid-related overdose (eg, frequent ED visits or hospitalizations) helps facilitate a discussion on naloxone prescribing at discharge. Prior studies provide evidence that naloxone distribution and accompanying education also are effective in reducing opioid overdose mortalityand ED visits related to adverse opioid-related events.^7,8

Similarly, the guidelines provide recommendations for the use of MAT for veterans with OUD. MAT for OUD is considered a first-line treatment option for patients with moderate-to-severe OUD. When used to treat patients with unsafe opioid use, this treatment helps alleviate symptoms of withdrawal, which can increase opioid taper adherence and has a protective effect against opioid overdose mortality.⁹ MAT initiated in the ED can increase patient engagement to addiction services.¹⁰

These 3 CPG recommendations serve as the basis for the broad goals of the ED OSI program. We aim to develop, implement, and evaluate programs and initiatives to (aim 1) reduce inappropriate opioid prescribing from VHA EDs; (aim 2) increase naloxone distribution from VHA EDs; and (aim 3) increase access to MAT initiation from VHA EDs through the implementation of ED-based MAT-initiation programs with EDs across the VHA. Aim 1 was a focused and strategic QI effort to implement an ED-based program to reduce inappropriate opioid prescribing. The ED OSI prescribing program offered a 4-step bundled approach: (1) sharing of opioid prescribing dashboard data with ED medical director and academic detailer; (2) education of ED providers and implementation of toolkit resources; (3) academic detailers conduct audit and feedback session(s) with highest prescribers; and (4) quarterly reports of opioid prescribing data to ED providers.

Results from the pilot suggested that our program was associated with accelerating the rate at which ED prescribing rates decreased.¹¹ In addition, the pilot found that ED-based QI initiatives in VHA facilities are a feasible practice. As we work to develop and implement the next 2 phases of the QI program, a major consideration is to identify facilitators and address any existing barriers to the implementation of naloxone distribution (aim 2) and MAT-initiation (aim 3) programs for treatment-naïve patients from VHA EDs. To date, there have been no recent published studies examining the barriers and facilitators to use or implementation of MAT initiation or naloxone distribution in VHA facilities or, more specifically, from VHA EDs.¹² As part of our QI program, we set out to better understand VHA ED provider perceptions of barriers and facilitators to implementation of programs aimed at increasing naloxone distribution and initiation of MAT for treatment-naïve patients in the ED.

Methods 

This project received a QI designation from the Office of PBM Academic Detailing Service Institutional Review Board at the Edward Hines, Jr. Veterans Affairs Hospital VA Medical Center (VAMC). This designation was reviewed and approved by the Rocky Mountain Regional VAMC Research and Development service. In addition, we received national union approval to disseminate this survey nationally across all VA Integrated Service Networks (VISNs).

Survey

We worked with VHA subject matter experts, key stakeholders, and the VA Collaborative Evaluation Center (VACE) to develop the survey. Subject matter experts and stakeholders included VHA emergency medicine leadership, ADS leadership, and mental health and substance treatment providers. VACE is an interdisciplinary group of mixed-method researchers. The survey questions aimed to capture perceptions and experiences regarding naloxone distribution and new MAT initiation of VHA ED/UCC providers.

We used a variety of survey question formats. Close-ended questions with a predefined list of answer options were used to capture discrete domains, such as demographic information, comfort level, and experience level. To capture health care provider (HCP) perceptions on barriers and facilitators, we used multiple-answer multiple-choice questions. Built into this question format was a free-response option, which allowed respondents to offer additional barriers or facilitators. Respondents also had the option of not answering individual questions.

We identified physicians, nurse practitioners (NPs), and physician assistants (PAs) who saw at least 100 patients in the ED or UCC in at least one 3-month period in the prior year and obtained an email address for each. In total, 2228 ED or UCC providers across 132 facilities were emailed a survey; 1883 (84.5%) were ED providers and 345 (15.5%) were UCC providers.

We used Research Electronic Data Capture (REDCap) software to build and disseminate the survey via email. Surveys were initially disseminated in late January 2019. During the 3-month survey period, recipients received 3 automated email reminders from REDCap to complete the survey. Survey data were exported from REDCap. Results were analyzed using descriptive statistics analyses with Microsoft Excel.

Results 

One respondent received the survey in error and was excluded from the analysis. The survey response rate was 16.7%: 372 responses from 103 unique facilities. Each VISN had a mean 20 respondents. The majority of respondents (n = 286, 76.9%) worked in highly complex level 1 facilities characterized by high patient volume and more high-risk patients and were teaching and research facilities. Respondents were asked to describe their most recent ED or UCC role. While 281 respondents (75.5%) were medical doctors, 61 respondents (16.4%) were NPs, 30 (8.1%) were PAs, and 26 (7.0%) were ED/UCC chiefs or medical directors (Table 1). Most respondents (80.4%) reported at least 10 years of health care experience.

The majority of respondents (72.9%) believed that HCPs at their VHA facility should be prescribing naloxone. When asked to specify which HCPs should be prescribing naloxone, most HCP respondents selected pharmacists (76.4%) and substance abuse providers (71.6%). Less than half of respondents (45.0%) felt that VA ED/UCC providers also should be prescribing naloxone. However, 58.1% of most HCP respondents reported being comfortable or very comfortable with prescribing naloxone to a patient in the ED or UCC who already had an existing prescription of opioids. Similarly, 52.7% of respondents reported being comfortable or very comfortable with coprescribing naloxone when discharging a patient with an opioid prescription from the ED/UCC. Notably, while 36.7% of PAs reported being comfortable/very comfortable coprescribing naloxone, 46.7% reported being comfortable/very comfortable prescribing naloxone to a patient with an existing opioid prescription. Physicians and NPs expressed similar levels of comfort with coprescribing and prescribing naloxone.

Respondents across provider types indicated a number of barriers to prescribing naloxone to medically appropriate patients (Table 2). Many respondents indicated prescribing naloxone was beyond the ED/UCC provider scope of practice (35.2%), followed by the perceived stigma associated with naloxone (33.3%), time required to prescribe naloxone (23.9%), and concern with patient’s ability to use naloxone (22.8%).

Discussion

To the best of our knowledge, there have not been any studies examining HCP perceptions of the barriers and facilitators to naloxone distribution or the initiation of MAT in VHA ED and UCCs. Veterans are at an increased risk of overdose when compared with the general population, and increasing access to opioid safety measures (eg, safer prescribing practices, naloxone distribution) and treatment with MAT for OUD across all clinical settings has been a VHA priority.³

National guidance from VHA leadership, the Centers for Disease Control and Prevention (CDC), the US Surgeon General, and the US Department of Health and Human Services (HHS) call for an all-hands-on-deck approach to combatting opioid overdose with naloxone distribution or MAT (such as buprenorphine) initiation.¹³ VHA ED and UCC settings provide acute outpatient care to patients with medical or psychiatric illnesses or injuries that the patient believes requires emergent or immediate medical attention or for which there is a critical need for treatment to prevent deterioration of the condition or the possible impairment of recovery.¹⁴ However, ED and UCC environments are often regarded as settings meant to stabilize a patient until they can be seen by a primary care or long-term care provider.

A major barrier identified by HCPs was that MAT for OUD was outside their ED/UCC scope of practice, which suggests a need for a top-down or peer-to-peer reexamination of the role of HCPs in ED/UCC settings. Any naloxone distribution and/or MAT-initiation program in VHA ED/UCCs should consider education about the role of ED/UCC HCPs in opioid safety and treatment. According to a VHA Support Service Center (VSSC) employee report database, in fiscal year 2018, per diem/fee-basis and contract HCPs comprised nearly 40% of clinical emergency medicine physician full-time equivalent employees, which presents a unique barrier to HCP education. Fee-basis and per diem HCPs may be less aware of, engaged in, or committed to VHA goals. Additionally, short-term HCPs may have fewer opportunities for training and education regarding naloxone or MAT use.

Only 25.3% of HCPs reported that their facility leadership was supportive or very supportive of MAT prescribing. This suggests that facility leadership should be engaged in any efforts to implement a MAT-initiation program in the facility’s ED. Engaging leadership in efforts to implement ED-based MAT programs will allow for a better understanding of leadership goals as related to opioid safety and an opportunity to address concerns regarding prescribing MAT in the ED. We recommend engaging facility leadership early in MAT implementation efforts. Respectively, 12.4% and 28.2% of HCP respondents reported discomfort prescribing naloxone or using MAT, suggesting a need for more education. Similarly, only 6.8% of HCPs reported comfort with using MAT.

A consideration for implementing ED/UCC-based MAT should be the inclusion of a training component. An evidence-based clinical treatment pathway that is appropriate to the ED/UCC setting and facility on the administration of MAT also could be beneficial. A clinical treatment pathway that includes ED/UCC-initiated discharge recommendations would address HCP concerns of unclear follow-up plans and system for referral of care. To this end, a key implementation task is coordinating with other outpatient services (eg, pain management clinic, substance use disorder treatment clinic) equipped for long-term patient follow-up to develop a system for referral of care. For example, as part of the clinical treatment pathway, an ED can develop a system of referral for patients initiated on MAT in the ED in which patients are referred for follow-up at the facility’s substance use disorder treatment clinic to be seen within 72 hours to continue the administration of MAT (such as buprenorphine).

In addition to HCP education, results suggest that patient/veteran education regarding naloxone and/or MAT should be considered. HCPs indicated that having help from a pharmacist to educate the patient about the medications would be a facilitator to naloxone distribution and MAT initiation. Similarly, patient knowledge of the medications also was endorsed as a facilitator. As such, a consideration for any future ED/UCC-based naloxone distribution or MAT-initiation programs in the VHA should be patient education whether by a clinically trained professional or an educational campaign for veterans.

Expanded naloxone distribution and initiation of MAT for OUD for EDs/UCCs across the VHA could impact the lives of veterans on long-term opioid therapy, with OUD, or who are otherwise at risk for opioid overdose. Steps taken to address the barriers and leverage the facilitators identified by HCP respondents can greatly reduce current obstacles to widespread implementation of ED/UCC-based naloxone distribution and MAT initiation nationally within the VHA.

Limitations

This survey had a low response rate (16.7%). One potential explanation for the low response rate is that when the survey was deployed, many of the VHA ED/UCC physicians were per-diem employees. Per-diem physicians may be less engaged and aware of site facilitators or barriers to naloxone and MAT prescribing. This, too, may have potentially skewed the collected data. However, the survey did not ask HCPs to disclose their employment status; thus, exact rates of per diem respondents are unknown.

We aimed to capture only self-perceived barriers to prescribing naloxone and MAT in the ED, but we did not capture or measure HCP respondent’s actual prescribing rates of MAT or naloxone. Understanding HCP perceptions of naloxone distribution and MAT initiation in the ED may have been further informed by comparing HCP responses to their actual clinical practice as related to their prescribing of these medications. In future research, we will link HCPs with the actual numbers of naloxone and MAT medications prescribed. Additionally, we do not know how many of these barriers or proposed facilitators will impact clinical practice.

Conclusions

A key aim for VHA leadership is to increase veteran access to naloxone distribution and MAT for OUD across clinical areas. The present study aimed to identify HCP perceptions of barriers and facilitators to the naloxone distribution and MAT-initiation programs in VHA ED/UCCs to inform the development of a targeted QI program to implement these opioid safety measures. Although the survey yielded a low response rate, results allowed us to identify important action items for our QI program, such as the development of clear protocols, follow-up plans, and systems for referral of care and HCP educational materials related to MAT and naloxone. We hope this work will serve as the basis for ED/UCC-tailored programs that can provide customized educational programs for HCPs designed to overcome known barriers to naloxone and MAT initiation.

Acknowledgments
This work was supported by the VA Office of Specialty Care Services 10P11 and through funding provided by the Comprehensive Addiction and Recovery Act (CARA).