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Blood pressure control worsened during COVID pandemic
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
Is mindfulness key to helping physicians with mental health?
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix. 
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix.
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix.
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.
Intent to vaccinate kids against COVID higher among vaccinated parents
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
“Parental vaccine hesitancy is a major issue for schools resuming in-person instruction, potentially requiring regular testing, strict mask wearing, and physical distancing for safe operation,” wrote lead author Madhura S. Rane, PhD, from the City University of New York in New York City, and colleagues in their paper, published online in JAMA Pediatrics.
The survey was conducted in June 2021 of 1,162 parents with children ranging in age from 2 to 17 years. The majority of parents (74.4%) were already vaccinated/vaccine-willing ,while 25.6% were vaccine hesitant. The study cohort, including both 1,652 children and their parents, was part of the nationwide CHASING COVID.
Vaccinated parents overall were more willing to vaccinate or had already vaccinated their eligible children when compared with vaccine-hesitant parents: 64.9% vs. 8.3% for children 2-4 years of age; 77.6% vs. 12.1% for children 5-11 years of age; 81.3% vs. 13.9% for children 12-15 years of age; and 86.4% vs. 12.7% for children 16-17 years of age; P < .001.
The researchers found greater hesitancy among Black and Hispanic parents, compared with parents who were non-Hispanic White, women, younger, and did not have a college education. Parents of children who were currently attending school remotely or only partially, were found to be more willing to vaccinate their children when compared to parents of children who were attending school fully in person.
The authors also found that parents who knew someone who had died of COVID-19 or had experienced a prior COVID-19 infection, were more willing to vaccinate their children.
Hesitance in vaccinated parents
Interestingly, 10% of COVID-vaccinated parents said they were still hesitant to vaccinate their kids because of concern for long-term adverse effects of the vaccine.
“These data point out that vaccine concerns may exist even among vaccinated or vaccine-favorable parents, so we should ask any parent who has not vaccinated their child whether we can discuss their concerns and perhaps move their opinions,” said William T. Basco Jr, MD, MS, a professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics.
In an interview, when asked whether recent approval of the vaccine for children aged 5-11 will likely aid in overcoming parental hesitancy, Dr. Basco replied: “Absolutely. As more children get the vaccine and people know a neighbor or nephew or cousin, etc., who received the vaccine and did fine, it will engender greater comfort and allow parents to feel better about having their own child receive the vaccine.”
Advice for clinicians from outside expert
“We can always start by asking parents if we can help them understand the vaccine and the need for it. The tidal wave of disinformation is huge, but we can, on a daily basis, offer to help families navigate this decision,” concluded Dr. Basco, who was not involved with the new paper.
Funding for this study was provided through grants from the National Institute of Allergy and Infectious Diseases, the CUNY Institute of Implementation Science in Population Health, and the COVID-19 Grant Program of the CUNY Graduate School of Public Health and Health Policy. The authors and Dr. Basco have disclosed no relevant financial relationships.
FROM JAMA PEDIATRICS
Children and COVID-19: 7 million cases and still counting
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Total COVID-19 cases in children surpassed the 7-million mark as new cases rose slightly after the previous week’s decline, according to the American Academy of Pediatrics and the Children’s Hospital Association.
, the AAP and CHA said in their weekly COVID-19 report. New cases had dropped the previous week after 3 straight weeks of increases since late October.
The Centers for Disease Control and Prevention puts the total number of child COVID-19 cases at 6.2 million, but both estimates are based on all-age totals – 40 million for the CDC and 41 million for the AAP/CHA – that are well short of the CDC’s latest cumulative figure, which is now just over 49 million, so the actual figures are undoubtedly higher.
Meanwhile, the 1-month anniversary of 5- to 11-year-olds’ vaccine eligibility brought many completions: 923,000 received their second dose during the week ending Dec. 6, compared with 405,000 the previous week. About 16.9% (4.9 million) of children aged 5-11 have gotten at least one dose of the COVID-19 vaccine thus far, of whom almost 1.5 million children (5.1% of the age group) are now fully vaccinated, the CDC said on its COVID-19 Data Tracker.
The pace of vaccinations, however, is much lower for older children. Weekly numbers for all COVID-19 vaccinations, both first and second doses, dropped from 84,000 (Nov. 23-29) to 70,000 (Nov. 30 to Dec. 6), for those aged 12-17 years. In that group, 61.6% have received at least one dose and 51.8% are fully vaccinated, the CDC said.
The pace of vaccinations varies for younger children as well, when geography is considered. The AAP analyzed the CDC’s data and found that 42% of all 5- to 11-year-olds in Vermont had received at least one dose as of Dec. 1, followed by Massachusetts (33%), Maine (30%), and Rhode Island (28%). At the other end of the vaccination scale are Alabama, Louisiana, Mississippi, and West Virginia, all with 4%, the AAP reported.
As the United States puts 7 million children infected with COVID-19 in its rear view mirror, another milestone is looming ahead: The CDC’s current count of deaths in children is 974.
Proper Use and Compliance of Facial Masks During the COVID-19 Pandemic: An Observational Study of Hospitals in New York City
Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.1 However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.2 Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.2
The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.3 The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.4 Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.4 New York State mandated mask usage in public places starting on April 15, 2020.
These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.8
Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.14 Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.16 South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.17 Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.18
Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.19 Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.19 Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.20
We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.
Methods
We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00
Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).
Results
We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.
Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).
Comment
Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.22
Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.
Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al23 demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.23
Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.24 Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.25 Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.
The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.11,26-29 Extended use and reuse of masks also can result in transmission of infection.30
Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al31 found substantial adverse changes in respiratory rate, oxygen saturation, and CO2 levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al32 showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.32
Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.10 In fact, Lamb et al33 reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.10 Chu et al6 even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.18 We support a plan for masks to be covered by government-sponsored health plans.
Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.
Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.
Conclusion
As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (6 April 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/331693/WHO-2019-nCov-IPC_Masks-2020.3-eng.pdf?sequence=1ceisAllowed=y
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (5 June 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/332293/WHO- 2019-nCov-IPC_Masks-2020.4-eng.pdf?sequence=1&isAllowed=y
- Fisher KA, Barile JP, Guerin RJ, et al. Factors associated with cloth face covering use among adults during the COVID-19 pandemic—United States, April and May 2020. MMWR Morb Mortal Wkly Rep. 2020;69:933-937.
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Considerations for wearing masks (19 April 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html
- Conly J, Seto WH, Pittet D, et al. Use of medical face masks versus particulate respirators as a component of personal protective equipment for health care workers in the context of the COVID-19 pandemic. Antimicrob Resist Infect Control. 2020;9:126.
- Chu DK, Akl EA, Duda S, et al; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395:1973-1987.
- Huang, P. Coronavirus FAQs: Why can’t the CDC make up its mind about airborne transmission? NPR. September 25, 2020. Accessed November 8, 2021. https://www.npr.org/sections/goatsandsoda/2020/09/25/916624967/coronavirus-faqs-why-cant-the-cdc-make-up-its-mind-about-airborne-transmission
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). How COVID-19 spreads (14 July 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
- Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review. JAMA. 2020;324:782-793.
- Klompas M, Morris CA, Shenoy ES. Universal masking in the covid-19 era. N Engl J Med. 2020;383:E9.
- Middleton JD, Lopes H. Face masks in the covid-19 crisis: caveats, limits, and priorities. BMJ. 2020;369:m2030.
- Cheng KK, Lam TH, Leung CC. Wearing face masks in the community during the COVID-19 pandemic: altruism and solidarity [published online April 16, 2020]. Lancet. doi:10.1016/S0140-6736(20)30918-1
- Javid B, Weekes MP, Matheson NJ. Covid-19: should the public wear face masks? BMJ. 2020;369:m1442.
- Gandhi M, Beyrer C, Goosby E. Masks do more than protect others during COVID-19: reducing the inoculum of SARS-CoV-2 to protect the wearer. J Gen Intern Med. 2020;35:3063-3066.
- Ngonghala CN, Iboi EA, Gumel AB. Could masks curtail the post-lockdown resurgence of COVID-19 in the US? Math Biosci. 2020;329:108452. doi:10.1016/j.mbs.2020.108452
- Yi-Fong Su V, Yen YF, Yang KY, et al. Masks and medical care: two keys to Taiwan’s success in preventing COVID-19 spread. Travel Med Infect Dis. 2020;38:101780.
- Lim S, Yoon HI, Song KH, et al. Face masks and containment of COVID-19: experience from South Korea. J Hosp Infect. 2020;106:206-207.
- Fisman DN, Greer AL, Tuite AR. Bidirectional impact of imperfect mask use on reproduction number of COVID-19: a next generation matrix approach. Infect Dis Model. 2020;5:405-408.
- Centers for Disease Control and Prevention. COVID data tracker. United States COVID-19 cases, deaths, and laboratory testing (NAATs) by state, territory, and jurisdiction. Accessed July 6, 2021. https://covid.cdc.gov/covid-data-tracker/#cases_totalcases
- Francescani C. Timeline: the first 100 days of New York Gov. Andrew Cuomo’s COVID-19 response. ABC News. June 17, 2020. Accessed November 8, 2021. https://abcnews.go.com/US/News/timeline-100-days-york-gov-andrew-cuomos-covid/story?id=71292880
- Zhang R, Li Y, Zhang AL, et al. Identifying airborne transmission as the dominant route for the spread of COVID-19. Proc Natl Acad Sci U S A. 2020;117:14857-14863.
- Verma S, Dhanak M, Frankenfield J. Visualizing the effectiveness of face masks in obstructing respiratory jets. Phys Fluids (1994). 2020;32:061708.
- Yang W, Shaff J, Shaman J. COVID-19 transmission dynamics and effectiveness of public health interventions in New York City during the 2020 spring pandemic wave. medRxiv. Preprint posted online September 9, 2020. doi:10.1101/2020.09.08.20190710
- Zavascki AP, Falci DR. Clinical characteristics of covid-19 in China. N Engl J Med. 2020;382:1859.
- Zhu J, Ji P, Pang J, et al. Clinical characteristics of 3062 COVID-19 patients: a meta-analysis. J Med Virol. 2020;92:1902-1914. doi:10.1002/jmv.25884
- Sommerstein R, Fux CA, Vuichard-Gysin D, et al. Risk of SARS-CoV-2 transmission by aerosols, the rational use of masks, and protection of healthcare workers from COVID-19. Antimicrob Resist Infect Control. 2020;9:100.
- Stone TE, Kunaviktikul W, Omura M, et al. Facemasks and the covid 19 pandemic: what advice should health professionals be giving the general public about the wearing of facemasks? Nurs Health Sci. 2020;22:339-342.
- Tam VC, Tam SY, Poon WK, et al. A reality check on the use of face masks during the COVID-19 outbreak in Hong Kong. EClinicalMedicine. 2020;22:100356.
- Chen YJ, Qin G, Chen J, et al. Comparison of face-touching behaviors before and during the coronavirus disease 2019 pandemic. JAMA Netw Open. 2020;3:e2016924.
- O’Dowd K, Nair KM, Forouzandeh P, et al. Face masks and respirators in the fight against the COVID-19 pandemic: a review of current materials, advances and future perspectives. Materials (Basel). 2020;13:3363.
- Matuschek C, Moll F, Fangerau H, et al. Face masks: benefits and risks during the COVID-19 crisis. Eur J Med Res. 2020;25:32.
- Chan NC, Li K, Hirsh J. Peripheral oxygen saturation in older persons wearing nonmedical face masks in community settings. JAMA. 2020;324:2323-2324. doi:10.1001/jama.2020.21905
- , , . Differential COVID‐19 case positivity in New York City neighborhoods: socioeconomic factors and mobility. Influenza Other Respir Viruses. 2021;15:209-217. doi:10.1111/irv.12816
Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.1 However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.2 Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.2
The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.3 The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.4 Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.4 New York State mandated mask usage in public places starting on April 15, 2020.
These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.8
Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.14 Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.16 South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.17 Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.18
Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.19 Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.19 Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.20
We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.
Methods
We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00
Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).
Results
We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.
Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).
Comment
Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.22
Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.
Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al23 demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.23
Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.24 Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.25 Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.
The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.11,26-29 Extended use and reuse of masks also can result in transmission of infection.30
Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al31 found substantial adverse changes in respiratory rate, oxygen saturation, and CO2 levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al32 showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.32
Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.10 In fact, Lamb et al33 reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.10 Chu et al6 even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.18 We support a plan for masks to be covered by government-sponsored health plans.
Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.
Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.
Conclusion
As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.
Although the universal use of masks by both health care professionals and the general public now appears routine, widely differing recommendations were distributed by different health organizations early in the pandemic. In April 2020, the World Health Organization (WHO) stated that there was no evidence that healthy individuals wearing a medical mask in the community prevented COVID-19 infection.1 However, these recommendations must be placed in the context of a national shortage of personal protective equipment early in the pandemic. The WHO guidance released on June 5, 2020, recommended continuous use of masks for health care workers in the clinical setting.2 Additional recommendations included mask replacement when wet, soiled, or damaged, and when the wearer touched the mask. The WHO also recommended mask usage by those with underlying medical comorbidities and those living in high population–density areas and in settings where physical distancing was not possible.2
The Centers for Disease Control and Prevention (CDC) officially recommended the use of face coverings for the general public to prevent COVID-19 transmission on April 3, 2020.3 The CDC highlighted that masks should not be worn by children younger than 2 years; individuals with respiratory compromise; and patients who are unconscious, incapacitated, or unable to remove a mask without assistance.4 Medical masks and respirators were only recommended for health care workers. Importantly, masks with valves/vents were not recommended, as respiratory droplets can be emitted, defeating the purpose of source control.4 New York State mandated mask usage in public places starting on April 15, 2020.
These recommendations were based on the hypothesis that COVID-19 transmission occurs primarily via droplets and contact. In reality, SARS-CoV-2 transmission more likely occurs in a continuum from larger droplets to miniscule aerosols expelled from an infected person when talking, coughing, or sneezing.5,6 It should be noted that there was a formal suggestion of the potential for airborne transmission of SARS-CoV-2 by the CDC in a statement on September 18, 2020, that was subsequently retracted 3 days later.7,8 The CDC, reversing their prior recommendations, updated their guidance on October 5, 2020, endorsing prior reports that SARS-CoV-2 can be spread through aerosol transmission.8
Mask usage helps prevent viral spread by all individuals, especially those who are presymptomatic and asymptomatic. Presymptomatic individuals account for approximately 40% to 60% of transmissions, and asymptomatic individuals account for approximately 4% to 30% of infections by some models, which suggest these individuals are the drivers of the pandemic, more so than symptomatic individuals.9-15 Additionally, masking also may in effect reduce the amount of SARS-CoV-2 to which individuals are being exposed in the community.14 Universal masking is a relatively low-cost, low-risk intervention that may provide moderate benefit to the individual but substantial benefit to communities at large.10-13 Universal masking in other countries also has clearly demonstrated major benefits during the pandemic. Implementation of universal masking in Taiwan resulted in only approximately 440 COVID-19 cases and less than 10 deaths, despite a population of 23 million.16 South Korea, having experience with Middle East respiratory syndrome, also was able to quickly institute a mask policy for its citizens, resulting in approximately 94% compliance.17 Moreover, several mathematical models have shown that even imperfect use of masks on a population level can prevent disease transmission and should be instituted.18
Given the importance and potential benefits of mask usage, we investigated compliance and proper utilization of facial masks in New York City (NYC), once the epicenter of the pandemic in the United States. New York City and the rest of New York State experienced more than 1.13 million and 1.46 million cases of COVID-19, respectively, as of early November 2021.19 Nationwide, NYC had the greatest absolute death count of more than 34,634 and the greatest rate of death per 100,000 individuals of 412. In contrast, New York State, excluding NYC, had an absolute death count of more than 21,646 and a death rate per 100,000 individuals of 195 as of early November 2021.19 Now entering 20 months since the first case of COVID-19 in NYC, it continues to be vital for facial mask protocols to be emphasized as part of a comprehensive infection prevention protocol, especially in light of continued vaccine resistance, to help stall continued spread of SARS-CoV-2.20
We seek to show that despite months of policies for universal masking in NYC, there is still considerable mask noncompliance by the general public in health care settings where the use of masks is particularly imperative. We conducted an observational study investigating proper use of face masks of adults entering the main entrance of 4 hospitals located in NYC.
Methods
We observed mask usage in adults entering 4 hospitals in September 2020 (postsurge in NYC and prior to the availability of COVID-19 vaccinations). Hospitals were chosen to represent several types of health care delivery systems available in the United States and included a city, state, federal, and private hospital. Data collection was completed during peak traffic hours (8:00
Mask usage was observed and classified into several categories: correctly fitting mask over the nose and mouth, no face mask, mask usage with nose exposed, mask usage with mouth exposed, mask usage with both nose and mouth exposed (ie, mask on the chin/neck area), loosely fitting mask, vented/valved mask, or other form of face covering (eg, bandana, scarf).
Results
We observed a consistent rate of mask compliance between 72% and 85%, with an average of 78% of the 600 individuals observed wearing correctly fitting masks across the 4 hospitals included in this study (Table). The employee entrance included in this study had the highest compliance rate of 85%. An overall low rate of complete mask noncompliance was observed, with only 9 individuals (1.5%) in the entire study not wearing any mask. The federal hospital had the highest rate of mask noncompliance. We also observed a low rate of nose and mouth exposure, with 1.8% of individuals wearing a mask with the nose and mouth exposed (ie, mask tucked under the chin). No individuals were observed with the mouth exposed but with the nose covered by a mask. Additionally, only 3 individuals (0.5%) wore a mask with a vent/valve. The most common way that masks were worn incorrectly was with the nose exposed, accounting for 9.5% of individuals observed. Overall, only 9 individuals (1.5%) wore a nontraditional face covering, with a bandana being the most commonly observed makeshift mask.
Signage regarding the requirement to wear masks and to social distance was universally instituted at all hospital entry points (both inside and outside the hospital) in this study. However, there were no illustrations demonstrating correct and incorrect forms of mask usage. All signage merely displayed a graphic of a facial mask noting the requirement to wear a mask prior to entering the building. Hospital staff also had face masks available for patients who failed to bring a mask or who wore an inappropriate mask (ie, vented/valved masks).
Comment
Mask Effectiveness—Masks reduce the spread of SARS-CoV-2 by preventing both droplets and potentially virus-bearing aerosols.6,21,22 It has been demonstrated that well-fitted cotton homemade masks and medical masks provide the most effective method of reducing droplet dispersion. Loosely fitted masks as well as bandana-style facial coverings minimally reduce small aerosolized droplets, and an uncovered mouth and nose can disperse particles at a distance much greater than 6 feet.22
Mask Compliance—We report an overall high compliance rate with mask wearing among individuals visiting a hospital; however, compliance was still imperfect. Overall, 78% of observed individuals wore a correctly fitting mask when entering a hospital, even with hospital staff positioned at entry points to ensure proper mask usage. With all the resources available at health care centers, we anticipated a much higher compliance rate for correctly fitting masks at hospital entrances. We hypothesize that given only 78% of individuals showed proper mask compliance in a setting with enforcement by health care personnel, the mask compliance rate in the larger community is likely much lower. It is imperative to enforce continued mask compliance in medical centers and other public areas given notable vaccine noncompliance in certain parts of the country.
Tools to Prevent Disease Transmission—Mask usage by the general public in NYC helped in its response to the COVID-19 pandemic. Yang et al23 demonstrated through mathematical modeling that mask usage in NYC was associated with a 6.6% reduction in transmission overall and a 20% decrease in transmission for individuals 65 years and older during the first month of the universal mask policy going into effect. The authors extrapolated these data during the NYC reopening and found that universal masking reduced transmission by approximately 9% to 11%, accounting for the increase in hours spent outside home quarantine. The authors also hypothesized that if universal masking was as effective in its reduction of transmission for everyone in NYC as it was for older adults, the potential reduction in transmission of SARS-CoV-2 could be as high as 28% to 32%.23
Temperature checks at entrance barricades were standard protocol during the observation period. Although the main purpose of this study was to investigate compliance with and proper use of facial masks in a health care setting, it should be mentioned that, although temperature checks were being done on almost every person entering a hospital, the uniformity and practicality of this intervention has not been backed by substantial evidence. Although many nontouch thermometers are intended to capture a forehead temperature for the most accurate reading, the authors will share that in their observation, medical personnel screening individuals at hospital entrances were observed checking temperatures at any easily accessible body part, such as the forearm, hand, or neck. Furthermore, it has been reported that only approximately 40% of individuals with COVID-19 present with a fever.24 Many hospitals, including the 4 that were included in this investigation, have formal protocols for patients presenting with a fever, especially those presenting to an ambulatory center. Patients are usually instructed to call ahead if they have a fever, and a decision regarding next steps will be discussed with a health care provider. In addition, 1 meta-analysis on the symptoms of COVID-19 suggested that approximately 12% of infected patients are asymptomatic, likely a conservative estimate.25 Although we do not suggest that hospitals stop temperature checks, consistent temperature checks in anatomic locations intended for the specific thermometer used must be employed. Alternatively, a thermographic camera system that could detect heat signatures may be a way to screen faster, only necessitating that those above a threshold be assessed further.
The results of this study suggest that much greater effort is being placed on these temperature checks than on other equally important components of the entrance health assessment. This initial encounter at hospital entrances should serve as an opportunity for education on proper choice and use of masks with clear instructions that masks should not be removed unless directed by a health care provider and in a designated area, such as an examination room. The COVID-19 pandemic in the United States is likely the first time an individual is wearing these types of masks. Reiterating when and how often a mask should be changed (eg, when wet or soiled), how a soiled mask is not an effective mask, how a used mask should be discarded, ways to prevent self-contamination (ie, proper donning and doffing), and the importance of other infection-prevention behaviors—hand hygiene; social distancing; avoidance of touching the eyes, nose, and mouth with unwashed hands; and regular disinfecting of surfaces—should be practiced.11,26-29 Extended use and reuse of masks also can result in transmission of infection.30
Throughout the pandemic, our personal experience is that some patients often overtly refuse to wear a mask, citing underlying respiratory issues. The implications of patients not wearing a mask in a medical office and endangering other patients and staff are beyond the scope of this analysis. We will, however, comment briefly on the evidence behind this common concern. Matuschek et al31 found substantial adverse changes in respiratory rate, oxygen saturation, and CO2 levels in patients with severe chronic obstructive pulmonary disease who were wearing N95 respirators during a 6-minute walk test. Another study by Chan et al32 showed that nonmedical masks in healthy older adults in the community setting had no impact on oxygen saturation. Ultimately, the most effective mask a patient can wear is a mask that will be worn consistently.32
Populations With Limited Access to Masks—The COVID-19 pandemic disproportionately impacted disadvantaged populations, both in socioeconomic status and minority status. A disproportionate number of COVID-19 hospitalizations and deaths occurred in lower-income and minority populations.10 In fact, Lamb et al33 reported that NYC neighborhoods with a larger proportion of uninsured individuals with limited access to health care and overall lower socioeconomic status had a higher rate of SARS-CoV-2 positivity. A retrospective study in Louisiana showed that Black individuals accounted for 77% of hospitalizations and 71% of deaths due to COVID-19 in a population where only 31% of individuals identified as Black.10 Chu et al6 even asserted that policies should be put into place to address equity issues for populations with limited access to masks. We agree that policies should be put into action to ensure that individuals lacking the means to obtain appropriate masks or unable to obtain an adequate supply of masks be provided this new necessity. It has been calculated that the impact of masks in reducing virus transmission would be greatest if mask availability to disadvantaged populations is ensured.18 We support a plan for masks to be covered by government-sponsored health plans.
Study Limitations—Several limitations exist in our study that should be discussed. Although the data collectors observed a large number of individuals, each hospital entrance was only observed for 1 half-day morning session. There may be variations in the number of people wearing a mask at different times of day and different days of the week with fluctuations in hospital traffic. Although data were collected at a variety of hospitals representing the diverse health care delivery models available in the United States, the NYC hospitals included in this study may have different resources available for infection-prevention strategies than hospitals across the country, given NYC’s unique population density and demographics.
Study Strengths—The generalizability of the study should be recognized. Data were collected by all major health care delivery models available in the United States—private, state, city, and federal hospital systems. This study can be easily replicated in other health care delivery systems to further investigate potential gaps in mask usage and infection prevention. Repeating this study in areas where a large portion of the population does not believe in the virus also will likely show lower levels of mask use.
Conclusion
As the country grapples with vaccine hesitancy and with the new variants of SARS-CoV-2, continued universal masking is still imperative. The effectiveness of universal masking has been demonstrated, and with the combination of vaccinations, we can be assured that the world will continue to emerge from the pandemic.
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (6 April 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/331693/WHO-2019-nCov-IPC_Masks-2020.3-eng.pdf?sequence=1ceisAllowed=y
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (5 June 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/332293/WHO- 2019-nCov-IPC_Masks-2020.4-eng.pdf?sequence=1&isAllowed=y
- Fisher KA, Barile JP, Guerin RJ, et al. Factors associated with cloth face covering use among adults during the COVID-19 pandemic—United States, April and May 2020. MMWR Morb Mortal Wkly Rep. 2020;69:933-937.
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Considerations for wearing masks (19 April 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html
- Conly J, Seto WH, Pittet D, et al. Use of medical face masks versus particulate respirators as a component of personal protective equipment for health care workers in the context of the COVID-19 pandemic. Antimicrob Resist Infect Control. 2020;9:126.
- Chu DK, Akl EA, Duda S, et al; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395:1973-1987.
- Huang, P. Coronavirus FAQs: Why can’t the CDC make up its mind about airborne transmission? NPR. September 25, 2020. Accessed November 8, 2021. https://www.npr.org/sections/goatsandsoda/2020/09/25/916624967/coronavirus-faqs-why-cant-the-cdc-make-up-its-mind-about-airborne-transmission
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). How COVID-19 spreads (14 July 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
- Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review. JAMA. 2020;324:782-793.
- Klompas M, Morris CA, Shenoy ES. Universal masking in the covid-19 era. N Engl J Med. 2020;383:E9.
- Middleton JD, Lopes H. Face masks in the covid-19 crisis: caveats, limits, and priorities. BMJ. 2020;369:m2030.
- Cheng KK, Lam TH, Leung CC. Wearing face masks in the community during the COVID-19 pandemic: altruism and solidarity [published online April 16, 2020]. Lancet. doi:10.1016/S0140-6736(20)30918-1
- Javid B, Weekes MP, Matheson NJ. Covid-19: should the public wear face masks? BMJ. 2020;369:m1442.
- Gandhi M, Beyrer C, Goosby E. Masks do more than protect others during COVID-19: reducing the inoculum of SARS-CoV-2 to protect the wearer. J Gen Intern Med. 2020;35:3063-3066.
- Ngonghala CN, Iboi EA, Gumel AB. Could masks curtail the post-lockdown resurgence of COVID-19 in the US? Math Biosci. 2020;329:108452. doi:10.1016/j.mbs.2020.108452
- Yi-Fong Su V, Yen YF, Yang KY, et al. Masks and medical care: two keys to Taiwan’s success in preventing COVID-19 spread. Travel Med Infect Dis. 2020;38:101780.
- Lim S, Yoon HI, Song KH, et al. Face masks and containment of COVID-19: experience from South Korea. J Hosp Infect. 2020;106:206-207.
- Fisman DN, Greer AL, Tuite AR. Bidirectional impact of imperfect mask use on reproduction number of COVID-19: a next generation matrix approach. Infect Dis Model. 2020;5:405-408.
- Centers for Disease Control and Prevention. COVID data tracker. United States COVID-19 cases, deaths, and laboratory testing (NAATs) by state, territory, and jurisdiction. Accessed July 6, 2021. https://covid.cdc.gov/covid-data-tracker/#cases_totalcases
- Francescani C. Timeline: the first 100 days of New York Gov. Andrew Cuomo’s COVID-19 response. ABC News. June 17, 2020. Accessed November 8, 2021. https://abcnews.go.com/US/News/timeline-100-days-york-gov-andrew-cuomos-covid/story?id=71292880
- Zhang R, Li Y, Zhang AL, et al. Identifying airborne transmission as the dominant route for the spread of COVID-19. Proc Natl Acad Sci U S A. 2020;117:14857-14863.
- Verma S, Dhanak M, Frankenfield J. Visualizing the effectiveness of face masks in obstructing respiratory jets. Phys Fluids (1994). 2020;32:061708.
- Yang W, Shaff J, Shaman J. COVID-19 transmission dynamics and effectiveness of public health interventions in New York City during the 2020 spring pandemic wave. medRxiv. Preprint posted online September 9, 2020. doi:10.1101/2020.09.08.20190710
- Zavascki AP, Falci DR. Clinical characteristics of covid-19 in China. N Engl J Med. 2020;382:1859.
- Zhu J, Ji P, Pang J, et al. Clinical characteristics of 3062 COVID-19 patients: a meta-analysis. J Med Virol. 2020;92:1902-1914. doi:10.1002/jmv.25884
- Sommerstein R, Fux CA, Vuichard-Gysin D, et al. Risk of SARS-CoV-2 transmission by aerosols, the rational use of masks, and protection of healthcare workers from COVID-19. Antimicrob Resist Infect Control. 2020;9:100.
- Stone TE, Kunaviktikul W, Omura M, et al. Facemasks and the covid 19 pandemic: what advice should health professionals be giving the general public about the wearing of facemasks? Nurs Health Sci. 2020;22:339-342.
- Tam VC, Tam SY, Poon WK, et al. A reality check on the use of face masks during the COVID-19 outbreak in Hong Kong. EClinicalMedicine. 2020;22:100356.
- Chen YJ, Qin G, Chen J, et al. Comparison of face-touching behaviors before and during the coronavirus disease 2019 pandemic. JAMA Netw Open. 2020;3:e2016924.
- O’Dowd K, Nair KM, Forouzandeh P, et al. Face masks and respirators in the fight against the COVID-19 pandemic: a review of current materials, advances and future perspectives. Materials (Basel). 2020;13:3363.
- Matuschek C, Moll F, Fangerau H, et al. Face masks: benefits and risks during the COVID-19 crisis. Eur J Med Res. 2020;25:32.
- Chan NC, Li K, Hirsh J. Peripheral oxygen saturation in older persons wearing nonmedical face masks in community settings. JAMA. 2020;324:2323-2324. doi:10.1001/jama.2020.21905
- , , . Differential COVID‐19 case positivity in New York City neighborhoods: socioeconomic factors and mobility. Influenza Other Respir Viruses. 2021;15:209-217. doi:10.1111/irv.12816
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (6 April 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/331693/WHO-2019-nCov-IPC_Masks-2020.3-eng.pdf?sequence=1ceisAllowed=y
- World Health Organization. Advice on the use of masks in the context of COVID-19. Interim guidance (5 June 2020). Accessed November 8, 2021. https://apps.who.int/iris/bitstream/handle/10665/332293/WHO- 2019-nCov-IPC_Masks-2020.4-eng.pdf?sequence=1&isAllowed=y
- Fisher KA, Barile JP, Guerin RJ, et al. Factors associated with cloth face covering use among adults during the COVID-19 pandemic—United States, April and May 2020. MMWR Morb Mortal Wkly Rep. 2020;69:933-937.
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Considerations for wearing masks (19 April 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html
- Conly J, Seto WH, Pittet D, et al. Use of medical face masks versus particulate respirators as a component of personal protective equipment for health care workers in the context of the COVID-19 pandemic. Antimicrob Resist Infect Control. 2020;9:126.
- Chu DK, Akl EA, Duda S, et al; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395:1973-1987.
- Huang, P. Coronavirus FAQs: Why can’t the CDC make up its mind about airborne transmission? NPR. September 25, 2020. Accessed November 8, 2021. https://www.npr.org/sections/goatsandsoda/2020/09/25/916624967/coronavirus-faqs-why-cant-the-cdc-make-up-its-mind-about-airborne-transmission
- Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). How COVID-19 spreads (14 July 2021). Accessed November 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
- Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review. JAMA. 2020;324:782-793.
- Klompas M, Morris CA, Shenoy ES. Universal masking in the covid-19 era. N Engl J Med. 2020;383:E9.
- Middleton JD, Lopes H. Face masks in the covid-19 crisis: caveats, limits, and priorities. BMJ. 2020;369:m2030.
- Cheng KK, Lam TH, Leung CC. Wearing face masks in the community during the COVID-19 pandemic: altruism and solidarity [published online April 16, 2020]. Lancet. doi:10.1016/S0140-6736(20)30918-1
- Javid B, Weekes MP, Matheson NJ. Covid-19: should the public wear face masks? BMJ. 2020;369:m1442.
- Gandhi M, Beyrer C, Goosby E. Masks do more than protect others during COVID-19: reducing the inoculum of SARS-CoV-2 to protect the wearer. J Gen Intern Med. 2020;35:3063-3066.
- Ngonghala CN, Iboi EA, Gumel AB. Could masks curtail the post-lockdown resurgence of COVID-19 in the US? Math Biosci. 2020;329:108452. doi:10.1016/j.mbs.2020.108452
- Yi-Fong Su V, Yen YF, Yang KY, et al. Masks and medical care: two keys to Taiwan’s success in preventing COVID-19 spread. Travel Med Infect Dis. 2020;38:101780.
- Lim S, Yoon HI, Song KH, et al. Face masks and containment of COVID-19: experience from South Korea. J Hosp Infect. 2020;106:206-207.
- Fisman DN, Greer AL, Tuite AR. Bidirectional impact of imperfect mask use on reproduction number of COVID-19: a next generation matrix approach. Infect Dis Model. 2020;5:405-408.
- Centers for Disease Control and Prevention. COVID data tracker. United States COVID-19 cases, deaths, and laboratory testing (NAATs) by state, territory, and jurisdiction. Accessed July 6, 2021. https://covid.cdc.gov/covid-data-tracker/#cases_totalcases
- Francescani C. Timeline: the first 100 days of New York Gov. Andrew Cuomo’s COVID-19 response. ABC News. June 17, 2020. Accessed November 8, 2021. https://abcnews.go.com/US/News/timeline-100-days-york-gov-andrew-cuomos-covid/story?id=71292880
- Zhang R, Li Y, Zhang AL, et al. Identifying airborne transmission as the dominant route for the spread of COVID-19. Proc Natl Acad Sci U S A. 2020;117:14857-14863.
- Verma S, Dhanak M, Frankenfield J. Visualizing the effectiveness of face masks in obstructing respiratory jets. Phys Fluids (1994). 2020;32:061708.
- Yang W, Shaff J, Shaman J. COVID-19 transmission dynamics and effectiveness of public health interventions in New York City during the 2020 spring pandemic wave. medRxiv. Preprint posted online September 9, 2020. doi:10.1101/2020.09.08.20190710
- Zavascki AP, Falci DR. Clinical characteristics of covid-19 in China. N Engl J Med. 2020;382:1859.
- Zhu J, Ji P, Pang J, et al. Clinical characteristics of 3062 COVID-19 patients: a meta-analysis. J Med Virol. 2020;92:1902-1914. doi:10.1002/jmv.25884
- Sommerstein R, Fux CA, Vuichard-Gysin D, et al. Risk of SARS-CoV-2 transmission by aerosols, the rational use of masks, and protection of healthcare workers from COVID-19. Antimicrob Resist Infect Control. 2020;9:100.
- Stone TE, Kunaviktikul W, Omura M, et al. Facemasks and the covid 19 pandemic: what advice should health professionals be giving the general public about the wearing of facemasks? Nurs Health Sci. 2020;22:339-342.
- Tam VC, Tam SY, Poon WK, et al. A reality check on the use of face masks during the COVID-19 outbreak in Hong Kong. EClinicalMedicine. 2020;22:100356.
- Chen YJ, Qin G, Chen J, et al. Comparison of face-touching behaviors before and during the coronavirus disease 2019 pandemic. JAMA Netw Open. 2020;3:e2016924.
- O’Dowd K, Nair KM, Forouzandeh P, et al. Face masks and respirators in the fight against the COVID-19 pandemic: a review of current materials, advances and future perspectives. Materials (Basel). 2020;13:3363.
- Matuschek C, Moll F, Fangerau H, et al. Face masks: benefits and risks during the COVID-19 crisis. Eur J Med Res. 2020;25:32.
- Chan NC, Li K, Hirsh J. Peripheral oxygen saturation in older persons wearing nonmedical face masks in community settings. JAMA. 2020;324:2323-2324. doi:10.1001/jama.2020.21905
- , , . Differential COVID‐19 case positivity in New York City neighborhoods: socioeconomic factors and mobility. Influenza Other Respir Viruses. 2021;15:209-217. doi:10.1111/irv.12816
Practice Points
- Enormous financial and human resources have been utilized by health care systems to prevent the spread of COVID-19 in health care settings, including universal temperature checks, clinical symptom triage, and masking policies. Despite these mitigation practices, mask noncompliance continues to be a major problem in hospitals.
- Mask compliance among 600 individuals entering 4 New York City hospitals was observed to be 78%, despite months of policies for universal masking and the city’s high mortality rates during the first COVID-19 wave.
- Masks have been shown to reduce the spread of COVID-19, and proper mask compliance is an important issue that must be addressed by health care administrations and governmental agencies.
Pityriasis Rosea Associated With COVID-19 Vaccination: A Common Rash Following Administration of a Novel Vaccine
Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.1 The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.2 Pityriasis rosea also has been reported following the administration of new medications and vaccinations.1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.
Case Report
A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.
Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.
Comment
A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.4 Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.5 COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.6 Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.7 Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.8 There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.3 In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.
Conclusion
We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.
- Papakostas D, Stavropoulos PG, Papafragkaki D, et al. An atypical case of pityriasis rosea gigantea after influenza vaccination. Case Rep Dermatol. 2014;6:119-123.
- Chen FJ, Chian CP, Chen YF, et al. Pityriasis rosea following influenza (H1N1) vaccination. J Chin Med Assoc. 2011;74:280-282.
- Li A, Li P, Li Y, et al. Recurrent pityriasis rosea: a case report. Hum Vaccin Immunother. 2018;4:1024-1026.
- Ng SM. Prolonged dermatological manifestation 4 weeks following recovery of COVID-19 in a child. BMJ Case Rep. 2020;13:e237056. doi:10.1136/bcr-2020-237056
- Johansen M, Chisolm SS, Aspey LD, et al. Pityriasis rosea in otherwise asymptomatic confirmed COVID-19-positive patients: a report of 2 cases. JAAD Case Rep. 2021;7:93-94.
- Dursun R, Temiz SA. The clinics of HHV-6 infection in COVID-19 pandemic: pityriasis rosea and Kawasaki disease. Dermatol Ther. 2020;33:e13730. doi:10.1111/dth.13730
- Leerunyakul K, Pakornphadungsit K, Suchonwanit P. Case report: pityriasis rosea-like eruption following COVID-19 vaccination [published online September 7, 2021]. Front Med. doi:10.3389/fmed.2021.752443
- Marcantonio-Santa Cruz OY, Vidal-Navarro A, Pesqué D, et al. Pityriasis rosea developing after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:E721-E722. doi:10.1111/jdv.17498
Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.1 The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.2 Pityriasis rosea also has been reported following the administration of new medications and vaccinations.1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.
Case Report
A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.
Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.
Comment
A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.4 Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.5 COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.6 Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.7 Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.8 There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.3 In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.
Conclusion
We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.
Pityriasis rosea is a papulosquamous eruption that favors the trunk and proximal extremities. It occurs most commonly in adolescents and young adults.1 The rash typically presents with a solitary lesion, known as a “herald patch,” which is followed by a scaly erythematous eruption along the cleavage lines of the skin. The condition is self-limited and often resolves in 6 to 8 weeks. Recent evidence suggests that viral reactivation of human herpesvirus 6 and human herpesvirus 7 may play a role in the development of skin lesions.2 Pityriasis rosea also has been reported following the administration of new medications and vaccinations.1-3 We report a case of a 30-year-old woman who developed pityriasis rosea 3 days after receiving the second dose of the COVID-19 vaccine.
Case Report
A 30-year-old woman presented to the dermatology office for evaluation of a rash on the trunk and upper extremities that had been present for 5 days. She reported an initial solitary lesion on the left upper back, subsequently followed by the appearance of a mildly pruritic rash on the trunk and upper extremities. The rash first appeared 3 days after she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She was otherwise asymptomatic after vaccination and denied fever, chills, headache, and myalgia. She denied any rash following her first dose of the COVID-19 vaccine, history of known COVID-19 infection or exposures, or new medications. Notably, the patient worked in health care.
Physical examination revealed a 2-cm, erythematous, thin, scaly plaque over the left side of the upper back (Figure, A). Erythematous, scaly, thin papules of varying sizes were distributed along the cleavage lines of the trunk and upper extremities (Figure, B). No biopsy was performed because of the classic clinical presentation of this self-limited condition and the patient’s history of hypertrophic scarring. No additional laboratory workup was performed. She was prescribed triamcinolone cream 0.1% as needed for pruritus and was reassured about the benign nature of this cutaneous eruption.
Comment
A broad spectrum of cutaneous manifestations has been reported in association with acute COVID-19 infection, including a papulovesicular rash, perniolike eruptions, urticaria, livedo reticularis, and petechiae.4 Several cases of pityriasis rosea in association with acute COVID-19 infection also have been reported.5 COVID-19 infection has been linked to reactivation of the herpesvirus, which may explain the connection between acute COVID-19 infection and the development of pityriasis rosea.6 Pityriasis rosea associated with administration of the COVID-19 vaccine is a rare complication with few reports in the literature.7 Similar to our patient, there are reports of pityriasis rosea developing after the second dose of the vaccine, with some patients reporting a reactivation of skin lesions.8 There is a paucity of reports describing pityriasis rosea associated with the influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine.3 In such cases, the onset of skin lesions was thought to be related to vaccine-induced stimulation of the immune system or a component of the vaccine.
Conclusion
We presented a unique case of pityriasis rosea following COVID-19 vaccination. Because additional laboratory workup and a skin biopsy were not performed, we are unable to infer causation. However, the classic clinical presentation, rash development within 3 days of vaccination, and prior reports of vaccine-associated pityriasis rosea strengthen the aforementioned association. We hope this case adds to the growing understanding of the novel COVID-19 vaccine. As more individuals become vaccinated, both clinicians and patients should be aware of this benign cutaneous eruption that can develop following COVID-19 vaccination.
- Papakostas D, Stavropoulos PG, Papafragkaki D, et al. An atypical case of pityriasis rosea gigantea after influenza vaccination. Case Rep Dermatol. 2014;6:119-123.
- Chen FJ, Chian CP, Chen YF, et al. Pityriasis rosea following influenza (H1N1) vaccination. J Chin Med Assoc. 2011;74:280-282.
- Li A, Li P, Li Y, et al. Recurrent pityriasis rosea: a case report. Hum Vaccin Immunother. 2018;4:1024-1026.
- Ng SM. Prolonged dermatological manifestation 4 weeks following recovery of COVID-19 in a child. BMJ Case Rep. 2020;13:e237056. doi:10.1136/bcr-2020-237056
- Johansen M, Chisolm SS, Aspey LD, et al. Pityriasis rosea in otherwise asymptomatic confirmed COVID-19-positive patients: a report of 2 cases. JAAD Case Rep. 2021;7:93-94.
- Dursun R, Temiz SA. The clinics of HHV-6 infection in COVID-19 pandemic: pityriasis rosea and Kawasaki disease. Dermatol Ther. 2020;33:e13730. doi:10.1111/dth.13730
- Leerunyakul K, Pakornphadungsit K, Suchonwanit P. Case report: pityriasis rosea-like eruption following COVID-19 vaccination [published online September 7, 2021]. Front Med. doi:10.3389/fmed.2021.752443
- Marcantonio-Santa Cruz OY, Vidal-Navarro A, Pesqué D, et al. Pityriasis rosea developing after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:E721-E722. doi:10.1111/jdv.17498
- Papakostas D, Stavropoulos PG, Papafragkaki D, et al. An atypical case of pityriasis rosea gigantea after influenza vaccination. Case Rep Dermatol. 2014;6:119-123.
- Chen FJ, Chian CP, Chen YF, et al. Pityriasis rosea following influenza (H1N1) vaccination. J Chin Med Assoc. 2011;74:280-282.
- Li A, Li P, Li Y, et al. Recurrent pityriasis rosea: a case report. Hum Vaccin Immunother. 2018;4:1024-1026.
- Ng SM. Prolonged dermatological manifestation 4 weeks following recovery of COVID-19 in a child. BMJ Case Rep. 2020;13:e237056. doi:10.1136/bcr-2020-237056
- Johansen M, Chisolm SS, Aspey LD, et al. Pityriasis rosea in otherwise asymptomatic confirmed COVID-19-positive patients: a report of 2 cases. JAAD Case Rep. 2021;7:93-94.
- Dursun R, Temiz SA. The clinics of HHV-6 infection in COVID-19 pandemic: pityriasis rosea and Kawasaki disease. Dermatol Ther. 2020;33:e13730. doi:10.1111/dth.13730
- Leerunyakul K, Pakornphadungsit K, Suchonwanit P. Case report: pityriasis rosea-like eruption following COVID-19 vaccination [published online September 7, 2021]. Front Med. doi:10.3389/fmed.2021.752443
- Marcantonio-Santa Cruz OY, Vidal-Navarro A, Pesqué D, et al. Pityriasis rosea developing after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:E721-E722. doi:10.1111/jdv.17498
Practice Points
- Clinicians should be aware of the association between COVID-19 vaccination and the development of pityriasis rosea.
- Pityriasis rosea has been linked to reactivation of human herpesvirus 6 and human herpesvirus 7 and has been reported following administration of the influenza and human papillomavirus vaccines.
- Pityriasis rosea is a self-limited, cutaneous eruption that resolves within 6 to 8 weeks, and patients should be educated on the benign nature of this condition.
Is it time to change the definition of ‘fully vaccinated’?
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
As more indoor venues require proof of vaccination for entrance and with winter — as well as omicron, a new COVID variant — looming,
It’s been more than six months since many Americans finished their vaccination course against COVID; statistically, their immunity is waning.
At the same time, cases of infections with the Omicron variant have been reported in at least 17 states, as of Dec. 6. Omicron is distinguished by at least 50 mutations, some of which appear to be associated with increased transmissibility. The World Health Organization dubbed it a variant of concern on Nov. 26.
The Centers for Disease Control and Prevention has recommended that everyone 18 and older get a COVID booster shot, revising its narrower guidance that only people 50 and up “should” get a shot while younger adults could choose whether or not to do so. Scientists assume the additional shots will offer significant protection from the new variant, though they do not know for certain how much.
Anthony Fauci, MD, chief medical adviser to President Joe Biden, during a White House press briefing was unequivocal in advising the public. “Get boosted now,” Dr. Fauci said, adding urgency to the current federal guidance. About a quarter of U.S. adults have received additional vaccine doses.
“The definition of ‘fully vaccinated’ has not changed. That’s, you know, after your second dose of a Pfizer or Moderna vaccine, after your single dose of a Johnson & Johnson vaccine,” said the CDC’s director, Dr. Rochelle Walensky, during a Nov. 30 White House briefing on COVID. “We are absolutely encouraging those who are eligible for a boost six months after those mRNA doses to get your boost. But we are not changing the definition of ‘fully vaccinated’ right now.” A booster is recommended two months after receiving the J&J shot.
But that, she noted, could change: “As that science evolves, we will look at whether we need to update our definition of ‘fully vaccinated.’”
Still, the Democratic governors of Connecticut and New Mexico are sending a different signal in their states, as are some countries — such as Israel, which arguably has been the most aggressive nation in its approach. Some scientists point out that many vaccines involve three doses over six months for robust long-term protection, such as the shot against hepatitis. So “fully vaccinated” may need to include shot No. 3 to be considered a full course.
“In my view, if you were vaccinated more than six months ago, you’re not fully vaccinated,” Connecticut Gov. Ned Lamont said Nov. 18 during a press briefing. He was encouraging everyone to get boosted at that time, even before the federal government authorized extra shots for everyone.
New Mexico Gov. Michelle Lujan Grisham had a similar response in mid-November, saying she defined “fully vaccinated” as receiving three shots of the mRNA type. She also opened up booster eligibility to all of her state residents before the CDC and Food and Drug Administration did.
What do the varying views on the evolving science mean for vaccine requirements imposed on travelers, or by schools or workplaces? And what about businesses that have required patrons to provide proof of vaccination?
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, said the CDC’s stronger recommendation for everyone to get boosted signals to him that a booster is now part of the vaccine regimen. Yet Dr. Offit, who is also a member of the FDA’s vaccine advisory committee, wrote a joint op-ed this week in which he and two other scientists argued that boosters were not yet needed for everyone and that healthy young people should wait to see whether an Omicron-specific booster might be needed.
“I think when the CDC said they are recommending a third dose, they just made the statement that this is a three-dose vaccine series,” Dr. Offit told KHN. “And, frankly, I think it’s going to throw a wrench into mandates.”
Yet to be determined is whether restaurants or other places of business will look more closely at vaccine cards for the booster.
Dr. Georges Benjamin, executive director of the American Public Health Association, said it’s too early to say. “For now, businesses should stay focused on current guidelines,” he said.
Dr. Marc Siegel, an associate professor of medicine at the George Washington School of Medicine and Health Sciences, in Washington, said the question of whether you are fully vaccinated with just two doses or need a booster is a question of semantics. COVID immunity level is the more important issue.
Dr. Siegel said he thinks more suitable terminology would be to call someone “appropriately” or “adequately” vaccinated against COVID rather than “fully” vaccinated, since it’s possible that more boosters could be needed in the future — making “full vaccination” a moving target.
But, as with so many aspects of the pandemic, ambiguity prevails — both in federal guidance on the definition of “fully vaccinated” and in entrance policies, which vary by state, school and business.
Right now, businesses don’t appear to be checking for boosters, but that could change. So, it may be wise to first check the requirements — lest patrons present a two-shot vaccine passport, only to be turned away as inadequately protected.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Seven legal risks of promoting unproven COVID-19 treatments
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
Telemedicine, triaging, remote monitoring top list of COVID-era innovations in oncology
When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.
A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.
Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.
Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
Remote monitoring
Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.
If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.
Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.
“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.
Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.
At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”
MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.
Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.
“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”
Mr. Raine and Mr. Begue did not report any disclosures.
When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.
A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.
Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.
Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
Remote monitoring
Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.
If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.
Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.
“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.
Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.
At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”
MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.
Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.
“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”
Mr. Raine and Mr. Begue did not report any disclosures.
When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.
A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.
Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.
Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
Remote monitoring
Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.
If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.
Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.
“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.
Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.
At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”
MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.
Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.
“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”
Mr. Raine and Mr. Begue did not report any disclosures.
FROM JADPRO 2021
Cardiologist positive for Omicron after London conference
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.