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CDC flips, acknowledges aerosol spread of COVID-19
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”
In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”
“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.
The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
Information deleted from website last month
On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”
The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.
A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”
The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.
It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.
The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”
Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”
Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.
Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.
“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.
This article first appeared on Medscape.com.
Substance use tied to increased COVID-19 risk
Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.
A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.
In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.
coinvestigator Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a press release.
It may also be harder for individuals with addiction to access health care services for a variety of reasons, including low socioeconomic status or stigma, she said in an interview.
Dr. Volkow said she has encountered patients with medical emergencies who refuse to seek treatment at the emergency department because of previous experiences where they have been mistreated and encountered discrimination, and “that’s really very tragic.”
The findings were published online Sept. 14 in Molecular Psychiatry.
Is nicotine protective?
Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”
Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.
However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.
Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.
“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”
Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”
The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.
EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
Racial disparities
Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.
Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).
In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.
Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10–30).
This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).
Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.
Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.
Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2 P < 10–25).
Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).
“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
Vulnerable populations
Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.
In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.
Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.
The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.
Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.
“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.
“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
‘Pretty convincing’
Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.
“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.
Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.
He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.
Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.
“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
Universal screening?
Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.
“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.
Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.
Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.
However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.
“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”
The report authors and Dr. Saxon have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.
A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.
In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.
coinvestigator Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a press release.
It may also be harder for individuals with addiction to access health care services for a variety of reasons, including low socioeconomic status or stigma, she said in an interview.
Dr. Volkow said she has encountered patients with medical emergencies who refuse to seek treatment at the emergency department because of previous experiences where they have been mistreated and encountered discrimination, and “that’s really very tragic.”
The findings were published online Sept. 14 in Molecular Psychiatry.
Is nicotine protective?
Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”
Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.
However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.
Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.
“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”
Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”
The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.
EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
Racial disparities
Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.
Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).
In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.
Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10–30).
This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).
Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.
Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.
Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2 P < 10–25).
Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).
“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
Vulnerable populations
Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.
In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.
Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.
The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.
Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.
“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.
“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
‘Pretty convincing’
Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.
“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.
Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.
He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.
Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.
“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
Universal screening?
Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.
“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.
Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.
Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.
However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.
“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”
The report authors and Dr. Saxon have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.
A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.
In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.
coinvestigator Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a press release.
It may also be harder for individuals with addiction to access health care services for a variety of reasons, including low socioeconomic status or stigma, she said in an interview.
Dr. Volkow said she has encountered patients with medical emergencies who refuse to seek treatment at the emergency department because of previous experiences where they have been mistreated and encountered discrimination, and “that’s really very tragic.”
The findings were published online Sept. 14 in Molecular Psychiatry.
Is nicotine protective?
Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”
Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.
However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.
Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.
“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”
Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”
The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.
EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
Racial disparities
Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.
Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).
In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.
Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10–30).
This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).
Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.
Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.
Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2 P < 10–25).
Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).
“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
Vulnerable populations
Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.
In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.
Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.
The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.
Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.
“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.
“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
‘Pretty convincing’
Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.
“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.
Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.
He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.
Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.
“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
Universal screening?
Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.
“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.
Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.
Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.
However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.
“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”
The report authors and Dr. Saxon have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Minorities bear brunt of pediatric COVID-19 cases
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.
“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”
In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
Minority, socioeconomic status affect pediatric outcomes too
The median age of the study population was 8 years, and approximately half were male.
The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.
Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).
After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).
The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.
“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.
Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
How to help
“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”
“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.
“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.
The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.
SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.
FROM PEDIATRICS
COVID-19 may discourage pediatric flu vaccination
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.
“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.
Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.
To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.
“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
Pandemic changes some parents’ plans
Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).
Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.
“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.
The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”
The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
Potential for ‘twindemic’ is real
The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.
“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.
Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.
“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.
“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.
Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”
Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”
However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.
The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.
“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”
Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.
“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.
In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.
Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.
SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.
FROM PEDIATRICS
Stress tests before knee, hip replacement surgeries down, with no ill effects
Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.
Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.
For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.
While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.
The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.
The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.
“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.
One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”
The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”
Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.
That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.
“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”
Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”
Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”
Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”
Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.
SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.
Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.
Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.
For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.
While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.
The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.
The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.
“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.
One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”
The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”
Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.
That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.
“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”
Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”
Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”
Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”
Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.
SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.
Cardiac stress testing before hip and knee replacements has dropped steadily since 2006, according to results from a new study that also showed major cardiac complications to be low in the absence of stress testing – even among people with established risk factors.
Routine stress testing before noncardiac surgeries has come under fire in recent decades as an overuse of resources and a burden on patients. Practice guidelines issued in 2007 and 2014 by the American College of Cardiology and the American Heart Association sought to limit the use of preoperative testing to patients with specific cardiovascular risk factors who might have their management changed by the test results.
For their study, published online in JAMA Cardiology, Daniel S. Rubin, MD, of the University of Chicago and colleagues looked at employee-based insurance data, which included Medicare Advantage claims, for more than 800,000 total hip or knee arthroplasties (28% hip and 72% knee replacements) conducted between 2004 and 2017.
While some 10% of the cohort (mean age 62, 58% women) received a stress test in the 2 months before surgery, the investigators found that the frequency of preoperative stress testing dropped annually starting in late 2006, when it peaked at about 14%, to about 7% in 2017. Older age, male sex and a Revised Cardiac Risk Index score of 1 or greater were all associated with a higher likelihood of being tested.
The overall frequency of myocardial infarction or cardiac arrest was 0.24%, occurring in 1,677 of 686,067 patients. While the rate was higher in patients with at least one RCRI condition, this did not differ significantly between those who received a preoperative stress test and those who did not (0.60%; 221 of 36,554 vs. 0.57%; 694 of 122,466 patients.
The 2007 and 2014 ACC/AHA guidelines make clear that patients with zero RCRI conditions – which comprise a history of ischemic heart disease, heart failure, insulin therapy for diabetes, cerebrovascular disease, or chronic kidney disease – should not receive a stress test before an intermediate-risk surgery such as a hip or knee replacement. But in this study, Dr. Rubin and his colleagues found that almost half of patients who had no RCRI risk factors were stress tested anyway. This means, Dr. Rubin said in an interview, that “there’s still room for improvement” in reducing testing.
“I never want to question how a physician chooses to practice, but I have to applaud physicians for reining in the use of this test. We’re using less of this test and yet the incidence of myocardial infarction and cardiac arrest is also going down, which also calls into question whether we’re getting better at choosing the right patients for the test; or the test doesn’t impact outcomes; or overall health of these patients is improving,” he said.
One surprise finding in the study, Dr. Rubin noted, was a higher rate of complications among people without RCRI conditions who were stress tested, compared with those who were not, with a mean complication rate of 0.27%, compared with 0.14% among those who did not receive a test (P < .001). “The RCRI doesn’t capture certain things,” Dr. Rubin said. “And we know that no risk stratification tool is going to capture everything.”
The RCRI, he noted, is based on a clinical history. “If you haven’t been diagnosed yet, it won’t appear as a risk factor, even if you’re clearly at risk. The question then becomes for a physician, do you do the test or not? On a day-to-day basis it’s hard to make that decision because you want what’s best for the individual patient – and it’s hard to generalize from a study of 800,000 people what’s right for that one patient. That said, it doesn’t appear that stress testing improves outcomes and a decrease in testing appears appropriate.”
Dr. Rubin and his colleagues described as a weakness of their study that it did not capture the full scope of preoperative stress testing among Medicare patients, who are older and therefore more likely to be tested.
That the 2007 and 2014 practice guidelines bore on the drop in testing was not demonstrated by Dr. Rubin and colleagues’ study, which saw declines begin even before the guidelines were published. Nonetheless, the results appear to validate the approach advocated in the guidelines, said guideline coauthor Joshua Beckman, MD, of Vanderbilt University, whose recent research has focused on identifying risk factors for MI after noncardiac surgery.
“I hope that the guidelines have helped in changing the culture for the use of preoperative stress testing as a regular thing,” Dr. Beckman said in an interview. “In fact, the guidelines say you shouldn’t do anything before an operation that you wouldn’t do anyway. So these findings are certainly in agreement with what we’re suggesting and support the idea that unless you have something that is unstable or active, stress testing isn’t likely to help.”
Annemarie Thompson, MD, of Duke University in Durham, N.C., another coauthor on the 2014 guidelines, commented in an interview that Dr. Rubin and colleagues’ findings of a doubled rate of complications among people without RCRI conditions who were stress tested, compared with those who were not might mean something “other than just sheer overuse or overordering of tests inappropriately.”
Rather, she said, physicians might be seeing something in the clinic that cannot be captured by a screening tool reliant on existing diagnoses. “Maybe when they’re sitting in front of you in a clinic, they’re so immobile that you’re left wondering. Or maybe they haven’t been seen by a doctor in a long time,” Dr. Thompson said. “So they don’t have diagnoses if they haven’t been followed. I think what [this finding] shows is that clinicians are detecting something. They may not know what it is. But we have to give a little wiggle room to the clinician who is sitting there looking at a patient who looks like they may not make it through surgery.”
Dr. Thompson said it would be helpful, after a big-data study like this one, to go through the clinical histories of those patients – in this study fewer than 100 – who had no RCRI risk factors and yet were stress tested and ended up having complications. “Until then we’re not going to solve the mystery,” she said. “But it’s a very, very interesting study.”
Dr. Rubin is the president of DRDR Mobile Health, a company that creates mobile applications for health care and from which he has not received compensation. One of his coauthors on the study, Dr. Peter Nagele, reported fee income from Roche Diagnostics. Dr. Beckman disclosed personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and other pharmaceutical manufacturers. Dr. Thompson has no disclosures.
SOURCE: Rubin et al. JAMA Cardiol. 2020 Sep 30. doi: 10.1001/jamacardio.2020.4311.
FROM JAMA CARDIOLOGY
FDA updates info on postmarketing surveillance study of Essure
The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.
Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.
Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.
The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.
The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
Interim analysis of postmarketing surveillance study
An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.
Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.
The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
Consistent data on Essure
An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:
- Pain or abdominal pain (32,901 cases).
- Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
- Device fragment or foreign body in a patient (8,501 cases).
- Perforation (7,825 cases).
- Fatigue (7,083 cases).
- Gain or loss in weight (5,980 cases).
- Anxiety and/or depression (5,366 cases).
- Rash and/or hypersensitivity (5,077 cases)
- Hair loss (4,999 cases).
Problems with the device itself included reports of:
- Device incompatibility such as an allergy (7,515 cases).
- The device migrating (4,535 cases).
- The device breaking or fracturing (2,297 cases).
- The device dislodging or dislocating (1,797 cases).
- Improper operation including implant failure and pregnancy (1,058 cases).
In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.
To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.
In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”
She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”
Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.
The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.
Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.
Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.
The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.
The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
Interim analysis of postmarketing surveillance study
An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.
Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.
The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
Consistent data on Essure
An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:
- Pain or abdominal pain (32,901 cases).
- Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
- Device fragment or foreign body in a patient (8,501 cases).
- Perforation (7,825 cases).
- Fatigue (7,083 cases).
- Gain or loss in weight (5,980 cases).
- Anxiety and/or depression (5,366 cases).
- Rash and/or hypersensitivity (5,077 cases)
- Hair loss (4,999 cases).
Problems with the device itself included reports of:
- Device incompatibility such as an allergy (7,515 cases).
- The device migrating (4,535 cases).
- The device breaking or fracturing (2,297 cases).
- The device dislodging or dislocating (1,797 cases).
- Improper operation including implant failure and pregnancy (1,058 cases).
In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.
To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.
In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”
She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”
Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.
The Food and Drug Administration has updated its page on Essure information for patients and health care providers to add additional information on adverse events reported by its manufacturer.
Essure was a permanent implantable birth control device approved by the FDA in 2002. FDA ordered Bayer in 2016 to conduct a postmarket surveillance study of Essure following reports of safety concerns, and expanded the study from 3 years to 5 years in 2018. Bayer voluntarily removed Essure from the market at the end of 2018, citing low sales after a “black box” warning was placed on the device. All devices were returned to the company by the end of 2019.
Bayer is required to report variances in Medical Device Reporting (MDR) requirements of Essure related to litigation to the FDA, which includes adverse events such death, serious injury, and “malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The reports are limited to events Bayer becomes aware of between November 2016 and November 2020. Bayer will continue to provide these reports until April 2021.
The FDA emphasized that the collected data are based on social media reports and already may be reported to the FDA, rather than being a collection of new events. “The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health, said in an FDA In Brief statement on Aug. 11.
The FDA first uploaded an Essure MDR variance spreadsheet in August 2020, listing 1,453 events, consisting of 53 reports of deaths, 1,376 reports of serious injury, and 24 reports of device malfunction that occurred as of June 2020. In September 2020, FDA uploaded a second variance spreadsheet, which added another 1,934 events that occurred as of July.
Interim analysis of postmarketing surveillance study
An interim analysis of 1,128 patients from 67 centers in the Essure postmarket surveillance study, which compared women who received Essure with those who received laparoscopic tubal sterilization, revealed that 94.6% (265 of 280 patients) in the Essure group had a successful implantation of the device, compared with 99.6% of women who achieved bilateral tubal occlusion from laparoscopic tubal sterilization.
Regarding safety, 9.1% of women in the Essure group and 4.5% in the laparoscopic tubal sterilization group reported chronic lower abdominal and/or pelvic pain, and 16.3% in the Essure group and 10.2% in the laparoscopic tubal sterilization group reported new or worsening abnormal uterine bleeding. In the Essure group, 22.3% of women said they experienced hypersensitivity, an allergic reaction, and new “autoimmune-like reactions” compared with 12.5% of women in the laparoscopic tubal sterilization group.
The interim analysis also showed 19.7% of women in the Essure group and 3.0% in the laparoscopic tubal sterilization group underwent gynecologic surgical procedures, which were “driven primarily by Essure removal and endometrial ablation procedures in Essure patients.” Device removal occurred in 6.8% of women with the Essure device.
Consistent data on Essure
An FDA search of the Manufacturer and User Facility Device Experience (MAUDE) database in January of 2020 revealed 47,856 medical device reports of Essure between November 2002 and December 2019. The most common adverse events observed during this period were:
- Pain or abdominal pain (32,901 cases).
- Heavy or irregular menses (14,573 cases). Headache (8,570 cases).
- Device fragment or foreign body in a patient (8,501 cases).
- Perforation (7,825 cases).
- Fatigue (7,083 cases).
- Gain or loss in weight (5,980 cases).
- Anxiety and/or depression (5,366 cases).
- Rash and/or hypersensitivity (5,077 cases)
- Hair loss (4,999 cases).
Problems with the device itself included reports of:
- Device incompatibility such as an allergy (7,515 cases).
- The device migrating (4,535 cases).
- The device breaking or fracturing (2,297 cases).
- The device dislodging or dislocating (1,797 cases).
- Improper operation including implant failure and pregnancy (1,058 cases).
In 2019, Essure received 15,083 medical device reports, an increase from 6,000 reports in 2018 and 11,854 reports in 2017.
To date, nearly 39,000 women in the United States have made claims to injuries related to the Essure device. In August, Bayer announced it would pay approximately $1.6 billion U.S. dollars to settle 90% of these cases in exchange for claimants to “dismiss their cases or not file.” Bayer also said in a press release that the settlement is not an admission of wrongdoing or liability on the part of the company.
In an interview, Catherine Cansino, MD, MPH, of the department of obstetrics and gynecology at the University of California, Davis, said the latest adverse event reports show “consistent info from [the] MAUDE database when comparing 2019 to previous years, highlighting most common problems related to pain and heavy or irregular bleeding.”
She emphasized ob.gyns with patients who have an Essure device should “consider Essure-related etiology that may necessitate device removal when evaluating patients with gynecological problems, especially with regard to abdominal/pelvic pain and heavy/irregular bleeding.”
Dr. Cansino reported no relevant financial disclosures. She is a member of the Ob.Gyn. News Editorial Advisory Board.
Children’s opioid harms vary by race, location
or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.
Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.
In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.
Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.
Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.
The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.
And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.
“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.
SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.
or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.
Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.
In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.
Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.
Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.
The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.
And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.
“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.
SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.
or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.
Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.
In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.
Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.
Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.
The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.
And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.
“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.
SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.
FROM HEALTH AFFAIRS
Music’s charms may soothe heart failure’s effects
Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.
A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.
Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.
Music as a calming influence
The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.
“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.
Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
An add-on to standard care
The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.
“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”
“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.
The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.
“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.
Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.
Music as exercise
The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.
The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.
“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”
Harmonizing with the NIH
“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.
Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.
The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.
Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.
A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.
Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.
Music as a calming influence
The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.
“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.
Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
An add-on to standard care
The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.
“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”
“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.
The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.
“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.
Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.
Music as exercise
The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.
The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.
“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”
Harmonizing with the NIH
“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.
Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.
The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.
Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.
A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.
Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.
Music as a calming influence
The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.
“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.
Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
An add-on to standard care
The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.
“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”
“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.
The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.
“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.
Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.
Music as exercise
The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.
The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.
“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”
Harmonizing with the NIH
“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.
Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.
The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.
Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
Divergent COVID-19 mental health impacts seen in Spain and China
Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.
The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).
Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
Mental health findings
Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.
Satisfaction with the public health response
Spanish respondents reported less confidence in their COVID-related medical services.
“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.
Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.
Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.
Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
Use of face masks
Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.
but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”
Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
SOURCE: Ho R. ECNP 2020, Session ISE01.
Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.
The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).
Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
Mental health findings
Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.
Satisfaction with the public health response
Spanish respondents reported less confidence in their COVID-related medical services.
“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.
Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.
Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.
Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
Use of face masks
Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.
but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”
Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
SOURCE: Ho R. ECNP 2020, Session ISE01.
Spain and China used very different public health responses to the COVID-19 crisis, and that has had significant consequences in terms of the mental health as well as physical health of the two countries’ citizens, Roger Ho, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.
Dr. Ho, a psychiatrist at the National University of Singapore, presented a first-of-its-kind cross-cultural comparative study of the impact of the COVID-19 pandemic in two epicenters on opposite sides of the world. A total of 1,539 participants drawn from the general populations in the two countries completed the online National University of Singapore COVID-19 Questionnaire. The survey was conducted in late February/early March in China and in mid-April in Spain, times of intense disease activity in the countries.
The questionnaire assesses knowledge and concerns about COVID, precautionary measures taken in the last 14 days, contact history, and physical symptoms related to COVID in the last 14 days. The pandemic’s psychological impact was evaluated using the Impact of Event Scale–Revised (IES-R). Participants also completed the Depression, Anxiety, and Stress-21 Scale (DASS-21).
Of note, the pandemic has taken a vastly greater physical toll in Spain than China. As of May 5, there were 83,000 confirmed cases of COVID-19 in China, with a population of 1.39 billion, compared with 248,000 in Spain, with a population of 46.9 million. The Spanish case rate of 5,500 per 1 million population was 100 times greater than China’s; the Spanish mortality rate of 585 per million was 185-fold greater.
Mental health findings
Spaniards experienced significantly higher levels of stress and depression as reflected in DASS-21 subscale scores of 14.22 and 8.65, respectively, compared with 7.86 and 6.38, in Chinese respondents. Spanish subjects also reported greater anxiety levels than the Chinese on the DASS-21 anxiety subscale, although not to a statistically significant extent. Yet, counterintuitively, given the DASS-21 results, the pandemic had a greater adverse psychological impact on the Chinese subjects as reflected in their significantly higher average IES-D score of 30.76 versus 27.64 in Spain. Dr. Ho offered a hypothesis as to why: The survey documented that many Chinese respondents felt socially stigmatized, and that their nation had been discriminated against by the rest of the world because the pandemic started in China.
Satisfaction with the public health response
Spanish respondents reported less confidence in their COVID-related medical services.
“This could be due to the rising number of infected health care workers in Spain. In contrast, the Chinese had more confidence in their medical services, probably because the government quickly deployed medical personnel and treated COVID-19 patients at rapidly built hospitals,” according to Dr. Ho.
Spain and other European countries shared four shortcomings in their pandemic response, he continued: lack of personal protective equipment for health care workers, delay in developing response strategies, a shortage of hospital beds, and inability to protect vulnerable elderly individuals from infection in nursing homes.
Experiencing cough, shortness of breath, myalgia, or other physical symptoms potentially associated with COVID-19 within the past 14 days was associated with worse depression, anxiety, and stress scores in both China and Spain. This underscores from a mental health standpoint the importance of rapid and accurate testing for the infection, Dr. Ho said.
Significantly more Spanish respondents felt there was too much unnecessary worry about COVID-19, suggesting a need for better health education regarding the pandemic.
Use of face masks
Consistent use of face masks regardless of the presence or absence of symptoms was far more common in the Chinese epicenter, where, unlike in Spain, this precautionary measure was associated with significantly lower IES-R and DASS-21 scores.
but for the Spanish, wearing a face mask was associated with higher IES-R scores,” Dr. Ho said. “We understand that it is difficult for Europeans to accept the need to use masks for healthy people because mask-wearing suggests vulnerability to sickness and concealment of identity. The Chinese have a collective culture. They believe they should wear a face mask to protect their health and that of other people.”
Dr. Ho reported no financial conflicts regarding his study, conducted with coinvestigators at Huaibei (China) Normal University and Complutense University of Madrid.
SOURCE: Ho R. ECNP 2020, Session ISE01.
FROM ECNP 2020
Inside the flawed White House testing scheme that did not protect Trump
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.
The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests.
An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.
Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.
The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials.
The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.
The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.
Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.
Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.
“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”
The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.
However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.
“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.
Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.
At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.
“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.
Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.
He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.
While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.
“I wonder how much virus was floating in that room that night,” Osterholm said.
Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine.
Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.
It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”
In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.
“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.
Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.
Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.
“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.