CHEST Physician

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenza, dengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

Accelerated brain aging among HIV-infected adults might be caused in part by altered deep sleep patterns, new research suggests.

Using a measure known as the brain age index (BAI) – a machine-learning model that measures deviations in brain activity during sleep relative to healthy individuals – investigators identified 34 sleep electroencephalogram features that were significantly altered by HIV infection. The most notable of these was the decline in slow-wave activity during non-REM sleep, which has been previously associated with MRI markers of brain aging in healthy adults.

“One of the functions of slow-wave sleep appears to be its association with the glymphatic system, which clears [metabolic] waste products and supports memory consolidation,” study coauthor Brandon Westover, MD, PhD, associate professor of neurology at Massachusetts General Hospital/Harvard Medical School, Boston, said in an interview. “It’s also believed to be associated with an accelerated risk for dementia and other cognitive issues.”

Previous work conducted at Johns Hopkins and other institutions confirm Dr. Westerson’s hypothesis. Charlene Gamaldo, MD, medical director of Johns Hopkins Sleep Disorders Center in Baltimore, pointed to other study findings in patients with neurodegenerative disease that have shown a link between predominant habitual sleep positions and dementia, potentially driven by inefficient glymphatic transport. Dr. Gamaldo was not involved in the current study.
 

Threefold acceleration vs. healthy volunteers

“We’ve been grappling with whether people with HIV on ART experience accelerated aging or accentuated aging,” coauthor Shibani Mukerji, MD, PhD, associate director of the neuroinfectious diseases unit at Massachusetts General, said in an interview. “We have yet to have biomarkers to address this question, and most of the tools are limited to invasive or expensive diagnostics. “In general, sleep and its influence on health have been understudied in the HIV population.”

To address this question, the researchers retrospectively examined a Massachusetts General Hospital database of diagnostic sleep study participants from 2008 to 2018, identifying 3,155 healthy, HIV-negative control subjects and 43 HIV-positive participants. Thirty-four (79%) of the HIV-positive participants were men, 30 (70%) were White, and 38 (93%) were virally suppressed at the time of their sleep study. Four patients were taking efavirenz, 13 were taking an integrase strand transfer inhibitor, and all were adherent to antiretroviral therapy (ART) at the time of their sleep study.

None of the HIV-positive participants had a history of secondary brain infection or brain tumor, although one patient had recovered fully from a previous HIV-associated encephalitis.

The study findings, which were published online March 30, 2021, in Sleep, first showed that HIV-positive participants had an average BAI of 3.19 years (standard error of the mean,1.43 years), compared with the control participants, who had an average BAI of –0.16 (SEM, 0.18 years).

These findings held after adjustment for potential confounders (age, sex, race, tobacco use disorder, and alcohol use disorder), yielding a total effect of HIV on BAI of 3.35 years (P < .01).

“Despite being well controlled on ART, HIV-positive individuals who had participated in the sleep studies still had elevated brain age,” said Dr. Westover. “We didn’t have enough information to determine the pathways by which HIV increases the BAI, but chronic inflammation appears to be an important factor.”

The findings also demonstrated that comorbidities accounted for roughly a quarter of the effect of HIV on BAI. However, the lack of statistical significance (in part because of the limited sample size) precluded the ability to determine if treating or preventing them might influence the degree to which HIV affects BAI and, in turn, cognitive decline.
 

HIV, sleep EEG, and brain aging

To estimate the effect of HIV on specific EEG features, the investigators again evaluated the total effect, this time replacing BAI with individual sleep EEG as the primary outcome. Among the 34 EEG features significantly altered by HIV, none were observed in the wake state and three were altered in REM (each associated with reduced delta band power). The rest were distributed in non-REM sleep, most notably in the deepest phase, corresponding to relative reductions in delta wave power.

The study findings build on the investigators’ previous research, which demonstrated an association between greater mean BAI and dementia, psychotic disorders, and anxiety/mood disorders in HIV-negative subjects, all of which correlated to attenuated slow-wave sleep.

More research is needed to determine if BAI, as it relates to sleep EEG, can effectively track the risk for cognitive decline among HIV-positive people, and if certain confounders might attenuate or accelerate this risk.

“While our team has not specifically looked at BAI, the findings in this study seem perfectly in line with what we have found with our own research,” Dr. Gamaldo said in an interview. “Not only have we observed a robust association between minimal cognitive deficits and patients’ sleep complaints (despite being virally controlled), but also, the potential value of measuring the architectural sleep features by ambulatory EEG to identify HIV patients’ vulnerability to cognitive decline.”

“BAI is a physiologic, easily repeatable measurement that can be used to track if an intervention is having a good effect,” Dr. Westover said.

Dr. Mukerji concurred, adding that “having a tool that can be used in resource-challenged settings and also be incorporated into longitudinal studies in a patient population with substantial age-related comorbidities, like HIV, would be really helpful.”

Dr. Westover and Dr. Mukerji disclosed no relevant financial relationships. Dr. Gamaldo is a consultant for Jazz Pharmaceuticals, and has received author royalties from UpToDate and honoraria from Medscape CME for content contribution.

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

I woke up from a nap on Tuesday, April 20, to a barrage of text messages and social media alerts about the Derek Chauvin verdict. Messages varied in content, from “let’s celebrate,” to “just so exciting,” to “finally.” As I took in the sentiments of others, I could barely sense what, if any, sentiments I had of my own.

There I sat, a Black DEI [diversity, equity, and inclusion] consultant who calls herself a “psychiatrist-activist,” but slept through the landmark court decision for policing African Americans and felt almost nothing about it.

However, I did have feelings about other matters such as the slide decks due for my client, sending reassuring text messages about the hospitalization of a friend’s child, and the 2 weeks of patient notes on my to-do list. So why did I feel emotionally flatlined about an issue that should stimulate the opposite – emotional intensity?

The answer to “why” could be attributed to a number of psychological buzz words like trauma, grief, desensitization, dissociation, numbness, or my new favorite term, languishing.

Despite the applicability of any of the above, I think my emotional flattening has more to do with the fact that in addition to the guilty verdict, I also woke up to news that 16-year-old Ma’Khia Bryant had been shot by a police officer in Columbus, Ohio.

I asked myself: How can anyone find time to grieve, nevertheless celebrate when (young) Black people continue to be killed by the police?

While it hurts to see individuals who look like me being shot by police, or even emboldened citizens, my hurt likely pales in comparison to someone who grew up surrounded by police gun violence. I grew up solidly middle class, lived in a house at the end of a cul-de-sac in a semi-gated community, and have many years ahead of me to reach my earning potential as a physician in one of the most liberal cities in the nation. While I have the skin color that puts me at risk of being shot by police due to racism, I am in a cushy position compared to other Black people who live in cities or neighborhoods with more police shootings.

Given this line of thinking, it seems clearer to me why I do not feel like celebrating, but instead, feel grateful to be alive. Not only do I feel grateful to be alive, but alive with the emotional stamina to help White people understand their contributions to the widespread oppression that keeps our society rooted in white supremacy.

This brings me to my point of what I want people, especially physicians, to know about the guilty verdict of Derek Chauvin: Some of us cannot really celebrate until there is actual police reform. This is not to say that anyone is wrong to celebrate, as long as there is an understanding that a landmark court decision can represent a drop in the bucket for Black and Brown people who risk being shot by the police while unarmed just for being Black or Brown.

Meanwhile, White men like Kyle Rittenhouse who are peaceably arrested after shooting a man with a semi-automatic weapon receive donations from a Virginia police lieutenant; a policeman who, in a possible world, could one day pull me over while driving through Virginia given its proximity to Washington D.C., where I currently live.

Black and Brown people cannot fully celebrate until there is actual police reform, and reform across American institutions like the health care system. Celebration comes when the leaders who run schools, hospitals, and courtrooms look more like the numbers actually reflected in U.S. racial demographics and look less like Derek Chauvin.

Until there are more doctors who look like the racial breakdown of the nation, Black and Brown patients can never fully trust their primary care doctors, orthopedic surgeons, and psychiatrists who are White. While this reality may sound harsh, it is the reality for many of us who are dealing with trauma, grief, desensitization, dissociation, emotional numbness, or languishment resulting from racist experiences.

People of color cannot and will not stop protesting in the streets, being the one who always brings up race in the meeting, or disagreeing that the new changes are “not enough” until there is actual anti-racist institutional reform. More importantly, the efforts of people of color can be made more powerful working collectively with White allies.

But we need White allies who recognize their tendency to perceive “progress” in racial equality. We need White allies who recognize that despite the passage of the Civil Rights Act, the two-time election of a Black president, and the guilty verdict of Derek Chauvin, there is still so much work to do.
 

Dr. Cyrus is assistant professor in the department of psychiatry at Johns Hopkins University, Baltimore. She reports no relevant financial relationships.

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

I woke up from a nap on Tuesday, April 20, to a barrage of text messages and social media alerts about the Derek Chauvin verdict. Messages varied in content, from “let’s celebrate,” to “just so exciting,” to “finally.” As I took in the sentiments of others, I could barely sense what, if any, sentiments I had of my own.

There I sat, a Black DEI [diversity, equity, and inclusion] consultant who calls herself a “psychiatrist-activist,” but slept through the landmark court decision for policing African Americans and felt almost nothing about it.

However, I did have feelings about other matters such as the slide decks due for my client, sending reassuring text messages about the hospitalization of a friend’s child, and the 2 weeks of patient notes on my to-do list. So why did I feel emotionally flatlined about an issue that should stimulate the opposite – emotional intensity?

The answer to “why” could be attributed to a number of psychological buzz words like trauma, grief, desensitization, dissociation, numbness, or my new favorite term, languishing.

Despite the applicability of any of the above, I think my emotional flattening has more to do with the fact that in addition to the guilty verdict, I also woke up to news that 16-year-old Ma’Khia Bryant had been shot by a police officer in Columbus, Ohio.

I asked myself: How can anyone find time to grieve, nevertheless celebrate when (young) Black people continue to be killed by the police?

While it hurts to see individuals who look like me being shot by police, or even emboldened citizens, my hurt likely pales in comparison to someone who grew up surrounded by police gun violence. I grew up solidly middle class, lived in a house at the end of a cul-de-sac in a semi-gated community, and have many years ahead of me to reach my earning potential as a physician in one of the most liberal cities in the nation. While I have the skin color that puts me at risk of being shot by police due to racism, I am in a cushy position compared to other Black people who live in cities or neighborhoods with more police shootings.

Given this line of thinking, it seems clearer to me why I do not feel like celebrating, but instead, feel grateful to be alive. Not only do I feel grateful to be alive, but alive with the emotional stamina to help White people understand their contributions to the widespread oppression that keeps our society rooted in white supremacy.

This brings me to my point of what I want people, especially physicians, to know about the guilty verdict of Derek Chauvin: Some of us cannot really celebrate until there is actual police reform. This is not to say that anyone is wrong to celebrate, as long as there is an understanding that a landmark court decision can represent a drop in the bucket for Black and Brown people who risk being shot by the police while unarmed just for being Black or Brown.

Meanwhile, White men like Kyle Rittenhouse who are peaceably arrested after shooting a man with a semi-automatic weapon receive donations from a Virginia police lieutenant; a policeman who, in a possible world, could one day pull me over while driving through Virginia given its proximity to Washington D.C., where I currently live.

Black and Brown people cannot fully celebrate until there is actual police reform, and reform across American institutions like the health care system. Celebration comes when the leaders who run schools, hospitals, and courtrooms look more like the numbers actually reflected in U.S. racial demographics and look less like Derek Chauvin.

Until there are more doctors who look like the racial breakdown of the nation, Black and Brown patients can never fully trust their primary care doctors, orthopedic surgeons, and psychiatrists who are White. While this reality may sound harsh, it is the reality for many of us who are dealing with trauma, grief, desensitization, dissociation, emotional numbness, or languishment resulting from racist experiences.

People of color cannot and will not stop protesting in the streets, being the one who always brings up race in the meeting, or disagreeing that the new changes are “not enough” until there is actual anti-racist institutional reform. More importantly, the efforts of people of color can be made more powerful working collectively with White allies.

But we need White allies who recognize their tendency to perceive “progress” in racial equality. We need White allies who recognize that despite the passage of the Civil Rights Act, the two-time election of a Black president, and the guilty verdict of Derek Chauvin, there is still so much work to do.
 

Dr. Cyrus is assistant professor in the department of psychiatry at Johns Hopkins University, Baltimore. She reports no relevant financial relationships.

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

I woke up from a nap on Tuesday, April 20, to a barrage of text messages and social media alerts about the Derek Chauvin verdict. Messages varied in content, from “let’s celebrate,” to “just so exciting,” to “finally.” As I took in the sentiments of others, I could barely sense what, if any, sentiments I had of my own.

There I sat, a Black DEI [diversity, equity, and inclusion] consultant who calls herself a “psychiatrist-activist,” but slept through the landmark court decision for policing African Americans and felt almost nothing about it.

However, I did have feelings about other matters such as the slide decks due for my client, sending reassuring text messages about the hospitalization of a friend’s child, and the 2 weeks of patient notes on my to-do list. So why did I feel emotionally flatlined about an issue that should stimulate the opposite – emotional intensity?

The answer to “why” could be attributed to a number of psychological buzz words like trauma, grief, desensitization, dissociation, numbness, or my new favorite term, languishing.

Despite the applicability of any of the above, I think my emotional flattening has more to do with the fact that in addition to the guilty verdict, I also woke up to news that 16-year-old Ma’Khia Bryant had been shot by a police officer in Columbus, Ohio.

I asked myself: How can anyone find time to grieve, nevertheless celebrate when (young) Black people continue to be killed by the police?

While it hurts to see individuals who look like me being shot by police, or even emboldened citizens, my hurt likely pales in comparison to someone who grew up surrounded by police gun violence. I grew up solidly middle class, lived in a house at the end of a cul-de-sac in a semi-gated community, and have many years ahead of me to reach my earning potential as a physician in one of the most liberal cities in the nation. While I have the skin color that puts me at risk of being shot by police due to racism, I am in a cushy position compared to other Black people who live in cities or neighborhoods with more police shootings.

Given this line of thinking, it seems clearer to me why I do not feel like celebrating, but instead, feel grateful to be alive. Not only do I feel grateful to be alive, but alive with the emotional stamina to help White people understand their contributions to the widespread oppression that keeps our society rooted in white supremacy.

This brings me to my point of what I want people, especially physicians, to know about the guilty verdict of Derek Chauvin: Some of us cannot really celebrate until there is actual police reform. This is not to say that anyone is wrong to celebrate, as long as there is an understanding that a landmark court decision can represent a drop in the bucket for Black and Brown people who risk being shot by the police while unarmed just for being Black or Brown.

Meanwhile, White men like Kyle Rittenhouse who are peaceably arrested after shooting a man with a semi-automatic weapon receive donations from a Virginia police lieutenant; a policeman who, in a possible world, could one day pull me over while driving through Virginia given its proximity to Washington D.C., where I currently live.

Black and Brown people cannot fully celebrate until there is actual police reform, and reform across American institutions like the health care system. Celebration comes when the leaders who run schools, hospitals, and courtrooms look more like the numbers actually reflected in U.S. racial demographics and look less like Derek Chauvin.

Until there are more doctors who look like the racial breakdown of the nation, Black and Brown patients can never fully trust their primary care doctors, orthopedic surgeons, and psychiatrists who are White. While this reality may sound harsh, it is the reality for many of us who are dealing with trauma, grief, desensitization, dissociation, emotional numbness, or languishment resulting from racist experiences.

People of color cannot and will not stop protesting in the streets, being the one who always brings up race in the meeting, or disagreeing that the new changes are “not enough” until there is actual anti-racist institutional reform. More importantly, the efforts of people of color can be made more powerful working collectively with White allies.

But we need White allies who recognize their tendency to perceive “progress” in racial equality. We need White allies who recognize that despite the passage of the Civil Rights Act, the two-time election of a Black president, and the guilty verdict of Derek Chauvin, there is still so much work to do.
 

Dr. Cyrus is assistant professor in the department of psychiatry at Johns Hopkins University, Baltimore. She reports no relevant financial relationships.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

A common cause of infant morbidity and hospitalization in developed countries, infant viral bronchiolitis, has long been bedeviled by treatment uncertainty beyond supportive care.

Rationales for most pharmacologic treatments continue to be debated, and clinical practice guidelines generally advise respiratory and hydration support, discouraging the use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine.

Despite evidence that the latter interventions are ineffective, they are still too often applied, according to two recent studies, one in Pediatrics, the other in JAMA Pediatrics.

“The pull of the therapeutic vacuum surrounding this disease has been noted in the pages of this journal for at least 50 years, with Wright and Beem writing in 1965 that ‘energies should not be frittered away by the annoyance of unnecessary or futile medications and procedures’ for the child with bronchiolitis,” said emergency physicians Matthew J. Lipshaw, MD, MS, of the Cincinnati Children’s Hospital Medical Center, and Todd A. Florin, MD, MSCE, of Ann and Robert H. Lurie Children’s Hospital of Chicago.

These remarks came in their editorial in Pediatrics wryly titled: “Don’t Just Do Something, Stand There” and published online to accompany a recent study of three network meta-analyses.

Led by Sarah A. Elliott, PhD, of the Alberta Research Centre for Health Evidence at the University of Alberta in Edmonton, this analysis amalgamated 150 randomized, controlled trials comparing a placebo or active comparator with any bronchodilator, glucocorticoid steroid, hypertonic saline solution, antibiotic, helium-oxygen therapy, or high-flow oxygen therapy. It then looked at the following outcomes in children aged 2 years and younger: hospital admission rate on day 1, hospital admission rate within 7 days, and total hospital length of stay.

Few treatments seemed more effective than nebulized placebo (0.9% saline) for short-term outcomes, the authors found. While nebulized epinephrine and nebulized hypertonic saline plus salbutamol appeared to reduce admission rates during the index ED presentation, and hypertonic saline, alone or in combination with epinephrine, seemed to reduce hospital stays, such treatment had no effect on admissions within 7 days of initial presentation. Furthermore, most benefits disappeared in higher-quality studies.

Concluding, albeit with weak evidence and low confidence, that some benefit might accrue with hypertonic saline with salbutamol to reduce admission rates on initial presentation to the ED, the authors called for well-designed studies on treatments in inpatients and outpatients.

According to Dr. Lipshaw, assistant professor of clinical pediatrics, the lack of benefit observed in superior studies limits the applicability of Dr. Elliott and colleagues’ results to immediate clinical practice. “These findings could be used, however, to target future high-quality studies toward the medications that they found might be useful,” he said in an interview.

For the present, other recent research augurs well for strategically reducing unnecessary care. In a paper published online in JAMA Pediatrics, Libby Haskell, MN, of the ED at Starship Children’s Hospital in Auckland, New Zealand, and associates reported on a cluster-randomized, controlled trial of targeted interventions.

Conducted in 2017 at 26 hospitals and with 3,727 babies in New Zealand and Australia, the study addressed drivers of non–evidence-based approaches with behavior-modifying approaches such as on-site clinical leads, stakeholder meetings, a train-the-trainer workshop, education, and audit and feedback.

The authors reported a 14.1% difference in rates of compliance during the first 24 hours of hospitalization favoring the intervention group for all five bronchiolitis guideline recommendations. The greatest change was seen in albuterol and chest radiography use, with other improvements in ED visits, inpatient consultations, and throughout hospitalization.

“These results provide clinicians and hospitals with clear implementation strategies to address unnecessary treatment of infants with bronchiolitis,” Dr. Haskell’s group wrote. Dr. Lipshaw agreed that multifaceted deimplementation packages including clinician and family education, audit and feedback, and clinical decision support have been successful. “Haskell et al. demonstrated that it is possible to successfully deimplement non–evidence-based practices for bronchiolitis with targeted inventions,” he said. “It would be wonderful to see their success replicated in the U.S.”


 

Why the slow adoption of guidelines?

The American Academy of Pediatrics issued bronchiolitis guidelines for babies to 23 months in 2014 and updated them in 2018. Why, then, has care in some centers been seemingly all over the map and counter to guidelines? “Both parents and clinicians are acting in what they believe to be the best interests of the child, and in the absence of high-value interventions, can feel the need to do something, even if that something is not supported by evidence,” Dr. Lipshaw said. 

Furthermore, with children in obvious distress, breathing fast and with difficulty, and sometimes unable to eat or drink, “we feel like we should have some way to make them feel better quicker. Unfortunately, none of the medications we have tried seem to be useful for most children, and we are left with supportive care measures such as suctioning their noses, giving them oxygen if their oxygen is low, and giving them fluids if they are dehydrated.”

Other physicians agree that taking a less-is-more approach can be challenging and even counterintuitive. “To families, seeing their child’s doctor ‘doing less’ can be frustrating,” admitted Diana S. Lee, MD, assistant professor of pediatrics at Icahn School of Medicine at Mount Sinai, New York.

Beyond that, altering practice behavior will need more than guidelines, Dr. Lee said in an interview. “Haskell et al. showed targeted behavior-change interventions improved compliance with bronchiolitis guidelines, but such change requires motivation and resources, and the sustainability of this effect over time remains to be seen.”

At Dr. Lipshaw’s institution, treatment depends on the attending physician, “but we have an emergency department care algorithm, which does not recommend any inhaled medications or steroids in accordance with the 2014 AAP guidelines,” he said.

Similarly at Mount Sinai, practitioners strive to follow the AAP guidelines, although their implementation has not been immediate, Dr. Lee said. “This is a situation where we must make the effort to choose not to do more, given current evidence.”

But Michelle Dunn, MD, an attending physician in the division of general pediatrics at the Children’s Hospital of Philadelphia, said the American practice norm already tends more to the observance than the breach of the guidelines, noting that since 2014 quality improvement efforts have been made throughout the country. “At our institution, we have effectively reduced the use of albuterol in patients with bronchiolitis and we use evidence-based therapy as much as possible, which in the case of bronchiolitis generally involves supportive management alone,” she said in an interview.

Still, Dr. Dunn added, many patients receive unnecessary diagnostic testing and ineffective therapies, with some providers facing psychological barriers to doing less. “However, with more and more evidence to support this, hopefully, physicians will become more comfortable with this.”

To that end, Dr. Lipshaw’s editorial urges physicians to “curb the rampant use of therapies repeatedly revealed to be ineffective,” citing team engagement, clear practice guidelines, and information technology as key factors in deimplementation. In the meantime, his mantra remains: “Don’t just do something, stand there.”

The study by Dr. Elliot and colleagues was supported by the Canadian Institutes of Health Research Knowledge Synthesis grant program. One coauthor is supported by a University of Ottawa Tier I Research Chair in Pediatric Emergency Medicine. Another is supported by a Tier 1 Canada Research Chair in Knowledge Synthesis and Translation and the Stollery Science Laboratory. Dr. Lipshaw and Dr. Florin disclosed no financial relationships relevant to their commentary. Dr. Haskell and colleagues were supported, variously, by the National Health and Medical Research Council of New Zealand, the Center of Research Excellence for Pediatric Emergency Medicine, the Victorian Government’s Operational Infrastructure Support Program, Cure Kids New Zealand, the Royal Children’s Hospital Foundation, and the Starship Foundation. Dr. Lee and Dr. Dunn had no competing interests to disclose with regard to their comments.

New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite the decline in new cases, which fell from 88,000 to just under 80,000, or 9.7%, during the week of April 16-22, children represented 20.8% of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.

The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.

Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.

Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.

rfranki@mdedge.com

New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite the decline in new cases, which fell from 88,000 to just under 80,000, or 9.7%, during the week of April 16-22, children represented 20.8% of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.

The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.

Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.

Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.

rfranki@mdedge.com

New cases of COVID-19 dropped among children for just the second time in the past 6 weeks, but that was not enough to reverse the trend in children’s share of the weekly total, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite the decline in new cases, which fell from 88,000 to just under 80,000, or 9.7%, during the week of April 16-22, children represented 20.8% of all COVID-19 cases reported for the week, surpassing the pandemic-high 20.6% seen just a week earlier, the AAP/CHA report shows.

The total number of cases in children is now over 3.7 million – that’s 13.7% of cases in all ages – since the start of the pandemic, and the cumulative rate of infection has reached 4,931 per 100,000 children, based on data from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Cases of more severe illness in children continue to trend lower. The cumulative number of hospitalizations in children (15,187) is only 2.0% of the total of almost 760,000 in the 25 jurisdictions (24 states and New York City) that report such data, and deaths in children now number 296, which is just 0.06% of all COVID-19–related mortality in 43 states, New York City, Puerto Rico, and Guam, the AAP and CHA said in their report.

Among those 46 jurisdictions, Texas has reported the most deaths (51) in children, followed by Arizona (29) and New York City (23), while 9 states and the District of Columbia have reported no deaths so far. Children represent the highest proportion of deaths (0.19%) in Colorado, but Guam, with 2 child deaths among its total of 136, has by far the highest rate at 1.47%, the AAP/CHA data show.

Data from the 25 reporting jurisdictions show that children make up the largest share of hospitalizations (3.1%) in Colorado and Minnesota, while New York City (1.9%), Georgia (1.3%), and Rhode Island (1.3%) have the highest hospitalization rates among children diagnosed with SARS-CoV-2 infection, the two groups reported.

rfranki@mdedge.com