ID Practitioner is an independent news source that provides infectious disease specialists with timely and relevant news and commentary about clinical developments and the impact of health care policy on the infectious disease specialist’s practice. Specialty focus topics include antimicrobial resistance, emerging infections, global ID, hepatitis, HIV, hospital-acquired infections, immunizations and vaccines, influenza, mycoses, pediatric infections, and STIs. Infectious Diseases News is owned by Frontline Medical Communications.

Theme
medstat_infd
Top Sections
Conference Coverage
idprac
Main menu
INFD Main Menu
Explore menu
INFD Explore Menu
Proclivity ID
18833001
Unpublish
Specialty Focus
Emerging Infections
HIV
Health Policy
Negative Keywords
financial
sofosbuvir
ritonavir with dasabuvir
discount
support path
program
ritonavir
greedy
ledipasvir
assistance
viekira pak
vpak
advocacy
needy
protest
abbvie
paritaprevir
ombitasvir
direct-acting antivirals
dasabuvir
gilead
fake-ovir
support
v pak
oasis
harvoni
Negative Keywords Excluded Elements
footer[@id='footer']
section[contains(@class, 'footer-nav-section-wrapper')]
div[contains(@class, 'pane-pub-article-idp')]
div[contains(@class, 'pane-medstat-latest-articles-articles-section')]
div[contains(@class, 'pane-pub-home-idp')]
div[contains(@class, 'pane-pub-topic-idp')]
Altmetric
Article Authors "autobrand" affiliation
ID Practitioner
DSM Affiliated
Display in offset block
Disqus Exclude
Best Practices
CE/CME
Education Center
Medical Education Library
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Featured Buckets
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Publication LayerRX Default ID
780
Non-Overridden Topics
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Use larger logo size
Off

Omics analysis links blood type to COVID-19

Article Type
Changed
Thu, 09/09/2021 - 16:19

 

A new analysis of gene expression and protein content in lung and blood tissue suggests that certain variants of the ABO gene, which plays a central role in determining blood type, may also influence susceptibility to COVID-19. Researchers at the University of British Columbia, Vancouver, analyzed data from three studies to link gene and protein expression in lungs and blood with genetic regions associated with COVID-19 susceptibility.

“These genes may also prove to be good markers for disease as well as potential drug targets,” said lead author Ana Hernandez Cordero, PhD, postdoctoral fellow with the Center for Heart Lung Innovation, University of British Columbia, in a statement. Dr. Cordero presented the study at the American Thoracic Society’s virtual international conference.

Dr. Cordero noted that genomewide association studies have been used to identify genetic regions associated with COVID-19 susceptibility, but they cannot be used to identify specific genes. To pinpoint genes, the researchers employed integrated genomics, which combines Bayesian colocalization summary-based Mendelian randomization and Mendelian randomization.
 

Searching for candidate genes

The researchers combined genetic data and transcriptomics data, which are a measurement of the messenger RNA produced in a cell. Messenger RNA is used as a blueprint for protein production. The genetics data came from the COVID-19 Host Genetics Initiative genomewide association meta-analysis version 4 (patients with COVID-19 vs. patients without COVID-19). Blood transcriptomics data came from the INTERVAL study (n = 3301), and lung transcriptomics data came from the Lung eQTL study (n = 1038). “From the integration of these three datasets we identified the candidate genes that are most likely to influence COVID-19 through gene expression. We further investigated the most consistent candidate genes and tested the causal association between their plasma protein levels and COVID-19 susceptibility using Bayesian colocalization and Mendelian randomization,” said Dr. Cordero during her talk.

Susceptibility drivers

The researchers identified six genes expressed in the lung and five expressed in blood that colocalized with COVID-19 susceptibility loci. They found that an increase in plasma levels of ABO was associated with greater risk for COVID-19 (Mendelian randomization, P = .000025) and that expression of the SLC6A20 gene in the lung was also associated with higher COVID-19 risk. They also found novel associations at genes associated with respiratory diseases, such as asthma, as well as genes associated with the host immune responses, such as neutrophil and eosinophil counts.

Possibly protective?

Within the ABO gene, the research also turned up evidence that blood type O may be protective against COVID-19. “The most significant variant used for the Mendelian randomization test was in complete linkage disagreement with the variant responsible for the blood type O genotype, conferring reduced risk,” said Dr. Cordero.

The study’s method is a powerful technique, said Jeremy Alexander Hirota, PhD, who was asked to comment. “The present study uses integrative omics to determine COVID-19 susceptibility factors which would have been challenging to identify with a single technology,” said Dr. Hirota, who is an assistant professor of medicine at McMaster University, Hamilton, Ont.; an adjunct professor of biology at the University of Waterloo (Ont.); and an affiliate professor of medicine at the University of British Columbia. He trained with the senior author of the study but was not directly involved in the research.

The host response is widely believed to be most responsible for the symptoms of COVID-19, so it isn’t surprising that host genes can be identified, according to Dr. Hirota. The identification of variants in the ABO protein is interesting, though. It suggests ‘that systemic effects beyond respiratory mucosal immunity are a driver for susceptibility.’ To my understanding, ABO protein is not expressed in the respiratory mucosa, which is a common site of first contact for SARS-CoV-2. The links between blood ABO levels and initial infection of the respiratory mucosa by SARS-CoV-2 are unclear,” he said.
 

 

 

Severity link needed

Dr. Hirota also said that although the study points toward associations with susceptibility to COVID-19, it isn’t clear from the available data whether such associations are related to severity of disease. “If the [patients with gene variants] are more susceptible but [the disease is] less severe, then the results need to be interpreted accordingly. If the susceptibility is increased and the severity is also increased, maybe measured by increased risk for ICU admission, ventilator use, or mortality, then the work carries a much more important message. Future studies extending this work and integrating measures of severity are warranted to better understand the clinical utility of these findings for managing COVID-19 patients optimally,” said Dr. Hirota.

It’s also unclear whether the study populations are reflective of the populations that are currently at highest risk for COVID-19, such as residents of India, where the burden of disease is currently severe.

Dr. Cordero and Dr. Hirota disclosed no relevant financial relationships.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

A new analysis of gene expression and protein content in lung and blood tissue suggests that certain variants of the ABO gene, which plays a central role in determining blood type, may also influence susceptibility to COVID-19. Researchers at the University of British Columbia, Vancouver, analyzed data from three studies to link gene and protein expression in lungs and blood with genetic regions associated with COVID-19 susceptibility.

“These genes may also prove to be good markers for disease as well as potential drug targets,” said lead author Ana Hernandez Cordero, PhD, postdoctoral fellow with the Center for Heart Lung Innovation, University of British Columbia, in a statement. Dr. Cordero presented the study at the American Thoracic Society’s virtual international conference.

Dr. Cordero noted that genomewide association studies have been used to identify genetic regions associated with COVID-19 susceptibility, but they cannot be used to identify specific genes. To pinpoint genes, the researchers employed integrated genomics, which combines Bayesian colocalization summary-based Mendelian randomization and Mendelian randomization.
 

Searching for candidate genes

The researchers combined genetic data and transcriptomics data, which are a measurement of the messenger RNA produced in a cell. Messenger RNA is used as a blueprint for protein production. The genetics data came from the COVID-19 Host Genetics Initiative genomewide association meta-analysis version 4 (patients with COVID-19 vs. patients without COVID-19). Blood transcriptomics data came from the INTERVAL study (n = 3301), and lung transcriptomics data came from the Lung eQTL study (n = 1038). “From the integration of these three datasets we identified the candidate genes that are most likely to influence COVID-19 through gene expression. We further investigated the most consistent candidate genes and tested the causal association between their plasma protein levels and COVID-19 susceptibility using Bayesian colocalization and Mendelian randomization,” said Dr. Cordero during her talk.

Susceptibility drivers

The researchers identified six genes expressed in the lung and five expressed in blood that colocalized with COVID-19 susceptibility loci. They found that an increase in plasma levels of ABO was associated with greater risk for COVID-19 (Mendelian randomization, P = .000025) and that expression of the SLC6A20 gene in the lung was also associated with higher COVID-19 risk. They also found novel associations at genes associated with respiratory diseases, such as asthma, as well as genes associated with the host immune responses, such as neutrophil and eosinophil counts.

Possibly protective?

Within the ABO gene, the research also turned up evidence that blood type O may be protective against COVID-19. “The most significant variant used for the Mendelian randomization test was in complete linkage disagreement with the variant responsible for the blood type O genotype, conferring reduced risk,” said Dr. Cordero.

The study’s method is a powerful technique, said Jeremy Alexander Hirota, PhD, who was asked to comment. “The present study uses integrative omics to determine COVID-19 susceptibility factors which would have been challenging to identify with a single technology,” said Dr. Hirota, who is an assistant professor of medicine at McMaster University, Hamilton, Ont.; an adjunct professor of biology at the University of Waterloo (Ont.); and an affiliate professor of medicine at the University of British Columbia. He trained with the senior author of the study but was not directly involved in the research.

The host response is widely believed to be most responsible for the symptoms of COVID-19, so it isn’t surprising that host genes can be identified, according to Dr. Hirota. The identification of variants in the ABO protein is interesting, though. It suggests ‘that systemic effects beyond respiratory mucosal immunity are a driver for susceptibility.’ To my understanding, ABO protein is not expressed in the respiratory mucosa, which is a common site of first contact for SARS-CoV-2. The links between blood ABO levels and initial infection of the respiratory mucosa by SARS-CoV-2 are unclear,” he said.
 

 

 

Severity link needed

Dr. Hirota also said that although the study points toward associations with susceptibility to COVID-19, it isn’t clear from the available data whether such associations are related to severity of disease. “If the [patients with gene variants] are more susceptible but [the disease is] less severe, then the results need to be interpreted accordingly. If the susceptibility is increased and the severity is also increased, maybe measured by increased risk for ICU admission, ventilator use, or mortality, then the work carries a much more important message. Future studies extending this work and integrating measures of severity are warranted to better understand the clinical utility of these findings for managing COVID-19 patients optimally,” said Dr. Hirota.

It’s also unclear whether the study populations are reflective of the populations that are currently at highest risk for COVID-19, such as residents of India, where the burden of disease is currently severe.

Dr. Cordero and Dr. Hirota disclosed no relevant financial relationships.

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

 

A new analysis of gene expression and protein content in lung and blood tissue suggests that certain variants of the ABO gene, which plays a central role in determining blood type, may also influence susceptibility to COVID-19. Researchers at the University of British Columbia, Vancouver, analyzed data from three studies to link gene and protein expression in lungs and blood with genetic regions associated with COVID-19 susceptibility.

“These genes may also prove to be good markers for disease as well as potential drug targets,” said lead author Ana Hernandez Cordero, PhD, postdoctoral fellow with the Center for Heart Lung Innovation, University of British Columbia, in a statement. Dr. Cordero presented the study at the American Thoracic Society’s virtual international conference.

Dr. Cordero noted that genomewide association studies have been used to identify genetic regions associated with COVID-19 susceptibility, but they cannot be used to identify specific genes. To pinpoint genes, the researchers employed integrated genomics, which combines Bayesian colocalization summary-based Mendelian randomization and Mendelian randomization.
 

Searching for candidate genes

The researchers combined genetic data and transcriptomics data, which are a measurement of the messenger RNA produced in a cell. Messenger RNA is used as a blueprint for protein production. The genetics data came from the COVID-19 Host Genetics Initiative genomewide association meta-analysis version 4 (patients with COVID-19 vs. patients without COVID-19). Blood transcriptomics data came from the INTERVAL study (n = 3301), and lung transcriptomics data came from the Lung eQTL study (n = 1038). “From the integration of these three datasets we identified the candidate genes that are most likely to influence COVID-19 through gene expression. We further investigated the most consistent candidate genes and tested the causal association between their plasma protein levels and COVID-19 susceptibility using Bayesian colocalization and Mendelian randomization,” said Dr. Cordero during her talk.

Susceptibility drivers

The researchers identified six genes expressed in the lung and five expressed in blood that colocalized with COVID-19 susceptibility loci. They found that an increase in plasma levels of ABO was associated with greater risk for COVID-19 (Mendelian randomization, P = .000025) and that expression of the SLC6A20 gene in the lung was also associated with higher COVID-19 risk. They also found novel associations at genes associated with respiratory diseases, such as asthma, as well as genes associated with the host immune responses, such as neutrophil and eosinophil counts.

Possibly protective?

Within the ABO gene, the research also turned up evidence that blood type O may be protective against COVID-19. “The most significant variant used for the Mendelian randomization test was in complete linkage disagreement with the variant responsible for the blood type O genotype, conferring reduced risk,” said Dr. Cordero.

The study’s method is a powerful technique, said Jeremy Alexander Hirota, PhD, who was asked to comment. “The present study uses integrative omics to determine COVID-19 susceptibility factors which would have been challenging to identify with a single technology,” said Dr. Hirota, who is an assistant professor of medicine at McMaster University, Hamilton, Ont.; an adjunct professor of biology at the University of Waterloo (Ont.); and an affiliate professor of medicine at the University of British Columbia. He trained with the senior author of the study but was not directly involved in the research.

The host response is widely believed to be most responsible for the symptoms of COVID-19, so it isn’t surprising that host genes can be identified, according to Dr. Hirota. The identification of variants in the ABO protein is interesting, though. It suggests ‘that systemic effects beyond respiratory mucosal immunity are a driver for susceptibility.’ To my understanding, ABO protein is not expressed in the respiratory mucosa, which is a common site of first contact for SARS-CoV-2. The links between blood ABO levels and initial infection of the respiratory mucosa by SARS-CoV-2 are unclear,” he said.
 

 

 

Severity link needed

Dr. Hirota also said that although the study points toward associations with susceptibility to COVID-19, it isn’t clear from the available data whether such associations are related to severity of disease. “If the [patients with gene variants] are more susceptible but [the disease is] less severe, then the results need to be interpreted accordingly. If the susceptibility is increased and the severity is also increased, maybe measured by increased risk for ICU admission, ventilator use, or mortality, then the work carries a much more important message. Future studies extending this work and integrating measures of severity are warranted to better understand the clinical utility of these findings for managing COVID-19 patients optimally,” said Dr. Hirota.

It’s also unclear whether the study populations are reflective of the populations that are currently at highest risk for COVID-19, such as residents of India, where the burden of disease is currently severe.

Dr. Cordero and Dr. Hirota disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Among asymptomatic, 2% may harbor 90% of community’s viral load: Study

Article Type
Changed
Thu, 08/26/2021 - 15:47

 

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

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

Publications
Topics
Sections

 

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

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

 

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

 

 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Online patient reviews and HIPAA

Article Type
Changed
Wed, 12/01/2021 - 11:44

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Publications
Topics
Sections

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Dr. Joseph S. Eastern

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

  • Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
  • Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
  • Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
  • Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Who is my neighbor? The ethics of sharing medical resources in the world

Article Type
Changed
Thu, 08/26/2021 - 15:47

India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

Publications
Topics
Sections

India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

India is in a crisis as the burden of COVID-19 has collapsed parts of the health care system. There are not enough beds, not enough oxygen, and not enough crematoria to handle the pandemic. India is also a major supplier of vaccines for itself and many other countries. That production capacity has also been affected by the local events, further worsening the response to the pandemic over the next few months.

Dr. Kevin T. Powell

This collapse is the specter that, in April 2020, placed a hospital ship next to Manhattan and rows of beds in its convention center. Fortunately, the lockdown in March 2020 sufficiently flattened the curve. The city avoided utilizing that disaster capacity, though many New Yorkers died out of sight in nursing homes. When the third and largest wave of cases in the United States peaked in January 2021, hospitals throughout California reached capacity but avoided bursting. In April 2021, localized outbreaks in Michigan, Arizona, and Ontario again tested the maximum capacity for providing modern medical treatments. Great Britain used a second lockdown in October 2020 and a third in January 2021 to control the pandemic, with Prime Minister Boris Johnson emphasizing that it was these social interventions, and not vaccines, which provided the mitigating effects. Other European Union nations adopted similar strategies. Prudent choices by government guided by science, combined with the cooperation of the public, have been and still are crucial to mollify the pandemic.

There is hope that soon vaccines will return daily life to a new normal. In the United States, the Centers for Disease Control and Prevention has loosened restrictions on social gathering. An increase in daily new cases of COVID-19 in April 2021 has turned into just a blip before continuing to recede. Perhaps that is the first sign of vaccination working at the level of public health. However, the May 2021 lockdown in highly vaccinated Seychelles is a warning that the danger remains. A single match can start a huge forest fire. The first 150 million cases of COVID-19 worldwide have, through natural rates of mutation, produced several variants that might partially evade current vaccines. The danger of newer variants persists with the next 150 million cases as the pandemic continues to rage in many nations which are just one airplane ride away. All human inhabitants of this blue-covered third rock from the sun are interconnected.

The benefits of scientific advancement have been extolled for centuries. This includes both individual discoveries as well as a mindset that favors rationalism over fatalism. On the whole, the benefits of scientific progress outweigh the negatives. Negative environmental impacts include pollution and climate change. Economic impacts include raising the mean economic standard of living but with greater inequity. Historically, governmental and social institutions have attempted to mitigate these negative consequences. Those efforts have attempted to provide guidance and a moral compass to direct the progress of scientific advancement, particularly in fields like gene therapy. Those efforts have called upon developed nations to share the bounties of progress with other nations.

Modern medicine has provided the fruit of these scientific advancements to a limited fraction of the world’s population during the 20th century. The improvements in life expectancy and infant mortality have come primarily from civil engineers getting running water into cities and sewage out. A smaller portion of the benefits are from public health measures that reduced tuberculosis, smallpox, polio, and measles. Agriculture became more reliable, productive, and nutritious. In the 21st century, medical care (control of hypertension, diabetes, and clotting) aimed at reducing heart disease and strokes have added another 2-3 years to the life expectancy in the United States, with much of that benefit erased by the epidemics of obesity and opioid abuse.

Modern medical technology has created treatments that cost $10,000 a month to add a few extra months of life to geriatric patients with terminal cancer. Meanwhile, in more mundane care, efforts like Choosing Wisely seek to save money wasted on low-value, useless, and even harmful tests and therapies. There is no single person or agency managing this chaotic process of inventing expensive new technologies while inadequately addressing the widespread shortages of mental health care, disparities in education, and other social determinants of health. The pandemic has highlighted these preexisting weaknesses in the social fabric.

The cries from India have been accompanied by voices of anger from India and other nations accusing the United States of hoarding vaccines and the raw materials needed to produce them. This has been called vaccine apartheid. The United States is not alone in its political decision to prioritize domestic interests over international ones; India’s recent government is similarly nationalistic. Scientists warn that no one is safe locally as long as the pandemic rages in other countries. The Biden administration, in a delayed response to the crisis in India, finally announced plans to share some unused vaccines (of a brand not yet Food and Drug Administration approved) as well as some vaccine raw materials whose export was forbidden by a regulation under the Defense Production Act. Reading below the headlines, the promised response won’t be implemented for weeks or months. We must do better.

The logistics of sharing the benefits of advanced science are complicated. The ethics are not. Who is my neighbor? If you didn’t learn the answer to that in Sunday school, there isn’t much more I can say.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures, Email him at [email protected]

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Ear tubes no better than antibiotics for otitis media in young kids

Article Type
Changed
Thu, 05/13/2021 - 17:34

 

The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

Publications
Topics
Sections

 

The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

 

The debate over tympanostomy tubes versus antibiotics for recurrent acute otitis media (AOM) in young children is long-standing. Now, results of a randomized controlled trial show that tubes do not significantly lower the rate of episodes, compared with antibiotics, and medical management doesn’t increase antibiotic resistance.

“We found no evidence of microbial resistance from treating with antibiotics. If there’s not an impact on resistance, why take unnecessary chances on complications of surgery?” lead author Alejandro Hoberman, MD, from Children’s Hospital of Pittsburgh, said in an interview.

The study by Dr. Hoberman and colleagues was published May 13 in the New England Journal of Medicine.

AOM is the most frequent condition diagnosed in children in the United States after the common cold, affecting five of six children younger than 3 years. It is the leading indication for antimicrobial treatment, and tympanostomy tube insertion is the most frequently performed pediatric operation after the newborn period.

Randomized controlled clinical trials were conducted in the 1980s, but by the 1990s, questions of overuse arose. The American Academy of Otolaryngology–Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.

Parents must weigh the pros and cons. The use of tubes may avoid or delay the next round of drugs, but tubes cost more and introduce small risks (anesthesia, refractory otorrhea, tube blockage, premature dislocation or extrusion, and mild conductive hearing loss).

“We addressed issues that plagued older studies – a longer-term follow-up of 2 years, validated diagnoses of infection to determine eligibility – and used rating scales to measure quality of life,” Dr. Hoberman said.

The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be 6-35 months of age and have had at least three episodes of AOM within 6 months or at least four episodes within 12 months, including at least one within the preceding 6 months.

The primary outcome was the mean number of episodes of AOM per child-year. Children were assessed at 8-week intervals and within 48 hours of developing symptoms of ear infection. The medically treated children received oral amoxicillin or, if that was ineffective, intramuscular ceftriaxone.

Criteria for determining treatment failure included persistent otorrhea, tympanic membrane perforation, antibiotic-associated diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency before antibiotic treatment.

In comparing tympanostomy tubes with antibiotics, Dr. Hoberman said, “We were unable to show benefit in the rate of ear infections per child per year over a 2-year period.” As expected, the infection rate fell by about half from the first year to the second in all children.

Overall, the investigators found “no substantial differences between treatment groups” with regard to AOM frequency, percentage of severe episodes, extent of antimicrobial resistance, quality of life for the children, and parental stress.

In an intention-to-treat analysis, the rate of AOM episodes per child-year during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (P = .66).

However, randomization was not maintained in the intention-to-treat arm. Ten percent (13 of 129) of the children slated to receive tubes didn’t get them because of parental request. Conversely, 16% (54 of 121) of children in the antibiotic group received tubes, 35 (29%) of them in accordance with the trial protocol because of frequent recurrences, and 19 (16%) at parental request.

In a per-protocol analysis, rates of AOM episodes per child-year were 1.47 ± 0.08 for tubes and 1.72 ± 0.11 for antibiotics.

Tubes were associated with longer time until the first ear infection post placement, at a median of 4.34 months, compared with 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group had treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days per year with symptoms in comparison with the children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).

The frequency distribution of AOM episodes, the percentage of severe episodes, and antimicrobial resistance detected in respiratory specimens were the same for both groups.

“Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a large and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotic eardrops for new infections versus watchful waiting, with intermittent oral antibiotics, if further ear infections occur,” said Richard M. Rosenfeld, MD, MPH, MBA, distinguished professor and chairman, department of otolaryngology, SUNY Downstate Medical Center, New York.

However, in an accompanying editorial, Ellen R. Wald, MD, from the University of Wisconsin, Madison, pointed out that the sample size was smaller than desired, owing to participants switching groups.

In addition, Dr. Rosenfeld, who was the lead author of the 2013 guidelines, said the study likely underestimates the impact of tubes “because about two-thirds of the children who received them did not have persistent middle-ear fluid at baseline and would not have been candidates for tubes based on the current national guideline on tube indications.”

“Both tubes and intermittent antibiotic therapy are effective for managing recurrent AOM, and parents of children with persistent middle-ear effusion should engage in shared decision-making with their physician to decide on the best management option,” said Dr. Rosenfeld. “When in doubt, watchful waiting is appropriate because many children with recurrent AOM do better over time.”

Dr. Hoberman owns stock in Kaizen Bioscience and holds patents on devices to diagnose and treat AOM. One coauthor consults for Merck. Dr. Wald and Dr. Rosenfeld report no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Low-risk preterm infants may not need antibiotics

Article Type
Changed
Thu, 05/13/2021 - 16:20

Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

Selective use of antibiotics based on birth circumstances may reduce unnecessary antibiotic exposure for preterm infants at risk of early-onset sepsis, based on data from 340 preterm infants at a single center.

Dr. Kirtan Patel

Preterm infants born because of preterm labor, premature rupture of membranes, and/or intraamniotic infection (IAI) are considered at increased risk for early-onset sepsis, and current management strategies include a blood culture and initiation of empirical antibiotics, said Kirtan Patel, MD, of Texas A&M University, Dallas, and colleagues in a poster (# 1720) presented at the Pediatric Academic Societies annual meeting.

However, this blanket approach “may increase the unnecessary early antibiotic exposure in preterm infants possibly leading to future adverse health outcomes,” and physicians are advised to review the risks and benefits, Dr. Patel said.

Data from previous studies suggest that preterm infants born as a result of preterm labor and/or premature rupture of membranes with adequate Group B Streptococcus (GBS) intrapartum antibiotic prophylaxis and no indication of IAI may be managed without empiric antibiotics because the early-onset sepsis risk in these infants is much lower than the ones born through IAI and inadequate GBS intrapartum antibiotic prophylaxis.

To better identify preterm birth circumstances in which antibiotics might be avoided, the researchers conducted a retrospective cohort study of preterm infants born at 28-34 weeks’ gestation during the period from Jan. 1, 2015, to Dec. 31, 2018. These infants were in the low-risk category of preterm birth because of preterm labor or premature rupture of membranes, with no IAI and adequate GBS intrapartum antibiotic prophylaxis, and no signs of cardiovascular or respiratory instability after birth. Of these, 157 (46.2%) received empiric antibiotics soon after birth and 183 infants (53.8%) did not receive empiric antibiotics.

The mean gestational age and birth weight were significantly lower in the empiric antibiotic group, but after correcting for these variables, the factors with the greatest influence on the initiation of antibiotics were maternal intrapartum antibiotic prophylaxis (odds ratio, 3.13); premature rupture of membranes (OR, 3.75); use of continuous positive airway pressure (CPAP) in the delivery room (OR, 1.84); CPAP on admission to the neonatal intensive care unit (OR, 1.94); drawing a blood culture (OR, 13.72); and a complete blood count with immature to total neutrophil ratio greater than 0.2 (OR, 3.84).

Three infants (2%) in the antibiotics group had culture-positive early-onset sepsis with Escherichia coli, compared with no infants in the no-antibiotics group. No differences in short-term hospital outcomes appeared between the two groups. The study was limited in part by the retrospective design and sample size, the researchers noted.

However, the results support a selective approach to antibiotics for preterm infants, taking various birth circumstances into account, they said.
 

Further risk factor identification could curb antibiotic use

In this study, empiric antibiotics were cast as a wide net to avoid missing serious infections in a few patients, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“It is interesting in this retrospective review of 340 preterm infants that the three newborns that did have serious bacterial infection were correctly given empiric antibiotics from the start,” Dr. Joos noted. “The authors were very effective at elucidating the possible factors that go into starting or not starting empiric antibiotics, although there may be other factors in the clinician’s judgment that are being missed. … More studies are needed on this topic,” Dr. Joos said. “Further research examining how the septic newborns differ from the nonseptic ones could help to even further narrow the use of empiric antibiotics,” he added.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but serves as a member of the Pediatric News Editorial Advisory Board.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM PAS 2021

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CDC: Vaccinated? You don’t need a mask indoors

Article Type
Changed
Thu, 08/26/2021 - 15:47

 

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

Publications
Topics
Sections

 

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

 

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

AMA announces major commitment to health equity

Article Type
Changed
Fri, 05/14/2021 - 16:56

 

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

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

Publications
Topics
Sections

 

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

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

 

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

  • Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
  • Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
  • Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
  • Ensure equitable opportunities in innovation.
  • Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

  • End segregated health care.
  • Establish national health care equity and racial justice standards.
  • End the use of race-based clinical decision models.
  • Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
  • Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
  • Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
  • Solidify connections and coordination between health care and public health.
  • Acknowledge and repair past harms committed by institutions.
  •  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CDC recommends use of Pfizer’s COVID vaccine in 12- to 15-year-olds

Article Type
Changed
Tue, 02/14/2023 - 12:59

 

The Centers for Disease Control and Prevention’s director Rochelle Walensky, MD, signed off on an advisory panel’s recommendation May 12 endorsing the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years.

Earlier in the day the CDC’s Advisory Committee on Immunization Practices voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.

“CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away,” Dr. Walensky said in an official statement.

The Food and Drug Administration on May 10 issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 12-15 years old. The FDA first cleared the Pfizer-BioNTech vaccine through an EUA in December 2020 for those ages 16 and older. Pfizer this month also initiated steps with the FDA toward a full approval of its vaccine.

Dr. Walenksy urged parents to seriously consider vaccinating their children.

“Understandably, some parents want more information before their children receive a vaccine,” she said. “I encourage parents with questions to talk to your child’s healthcare provider or your family doctor to learn more about the vaccine.”
 

Vaccine “safe and effective”

Separately, the American Academy of Pediatrics issued a statement May 12 in support of vaccinating all children ages 12 and older who are eligible for the federally authorized COVID-19 vaccine.

“As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected,” said AAP President Lee Savio Beers, MD, in a statement. “The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”

The expanded clearance for the Pfizer vaccine is seen as a critical step for allowing teens to resume activities on which they missed out during the pandemic.

“We’ve seen the harm done to children’s mental and emotional health as they’ve missed out on so many experiences during the pandemic,” Dr. Beers said. “Vaccinating children will protect them and allow them to fully engage in all of the activities – school, sports, socializing with friends and family – that are so important to their health and development.”

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

Publications
Topics
Sections

 

The Centers for Disease Control and Prevention’s director Rochelle Walensky, MD, signed off on an advisory panel’s recommendation May 12 endorsing the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years.

Earlier in the day the CDC’s Advisory Committee on Immunization Practices voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.

“CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away,” Dr. Walensky said in an official statement.

The Food and Drug Administration on May 10 issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 12-15 years old. The FDA first cleared the Pfizer-BioNTech vaccine through an EUA in December 2020 for those ages 16 and older. Pfizer this month also initiated steps with the FDA toward a full approval of its vaccine.

Dr. Walenksy urged parents to seriously consider vaccinating their children.

“Understandably, some parents want more information before their children receive a vaccine,” she said. “I encourage parents with questions to talk to your child’s healthcare provider or your family doctor to learn more about the vaccine.”
 

Vaccine “safe and effective”

Separately, the American Academy of Pediatrics issued a statement May 12 in support of vaccinating all children ages 12 and older who are eligible for the federally authorized COVID-19 vaccine.

“As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected,” said AAP President Lee Savio Beers, MD, in a statement. “The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”

The expanded clearance for the Pfizer vaccine is seen as a critical step for allowing teens to resume activities on which they missed out during the pandemic.

“We’ve seen the harm done to children’s mental and emotional health as they’ve missed out on so many experiences during the pandemic,” Dr. Beers said. “Vaccinating children will protect them and allow them to fully engage in all of the activities – school, sports, socializing with friends and family – that are so important to their health and development.”

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

 

The Centers for Disease Control and Prevention’s director Rochelle Walensky, MD, signed off on an advisory panel’s recommendation May 12 endorsing the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years.

Earlier in the day the CDC’s Advisory Committee on Immunization Practices voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.

“CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away,” Dr. Walensky said in an official statement.

The Food and Drug Administration on May 10 issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 12-15 years old. The FDA first cleared the Pfizer-BioNTech vaccine through an EUA in December 2020 for those ages 16 and older. Pfizer this month also initiated steps with the FDA toward a full approval of its vaccine.

Dr. Walenksy urged parents to seriously consider vaccinating their children.

“Understandably, some parents want more information before their children receive a vaccine,” she said. “I encourage parents with questions to talk to your child’s healthcare provider or your family doctor to learn more about the vaccine.”
 

Vaccine “safe and effective”

Separately, the American Academy of Pediatrics issued a statement May 12 in support of vaccinating all children ages 12 and older who are eligible for the federally authorized COVID-19 vaccine.

“As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected,” said AAP President Lee Savio Beers, MD, in a statement. “The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”

The expanded clearance for the Pfizer vaccine is seen as a critical step for allowing teens to resume activities on which they missed out during the pandemic.

“We’ve seen the harm done to children’s mental and emotional health as they’ve missed out on so many experiences during the pandemic,” Dr. Beers said. “Vaccinating children will protect them and allow them to fully engage in all of the activities – school, sports, socializing with friends and family – that are so important to their health and development.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Reassuring data on impact of mild COVID-19 on the heart

Article Type
Changed
Thu, 08/26/2021 - 15:47

 

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

Publications
Topics
Sections

 

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

 

Six months after mild SARS-CoV-2 infection in a representative health care workforce, no long-term cardiovascular sequelae were detected, compared with a matched SARS-CoV-2 seronegative group.

“Mild COVID-19 left no measurable cardiovascular impact on LV structure, function, scar burden, aortic stiffness, or serum biomarkers,” the researchers reported in an article published online May 8 in JACC: Cardiovascular Imaging.

“We provide societal reassurance and support for the position that screening in asymptomatic individuals following mild disease is not indicated,” first author George Joy, MBBS, University College London, said in presenting the results at EuroCMR, the annual CMR congress of the European Association of Cardiovascular Imaging (EACVI).

Briefing comoderator Leyla Elif Sade, MD, University of Baskent, Ankara, Turkey, said, “This is the hot topic of our time because of obvious reasons and I think [this] study is quite important to avoid unnecessary further testing, surveillance testing, and to avoid a significant burden of health care costs.”
 

‘Alarming’ early data

Early cardiac magnetic resonance (CMR) studies in patients recovered from mild COVID-19 were “alarming,” Dr. Joy said.

As previously reported, one study showed cardiac abnormalities after mild COVID-19 in up to 78% of patients, with evidence of ongoing myocardial inflammation in 60%. The CMR findings correlated with elevations in troponin T by high-sensitivity assay (hs-TnT).

To investigate further, Dr. Joy and colleagues did a nested case-control study within the COVIDsortium, a prospective study of 731 health care workers from three London hospitals who underwent weekly symptom, polymerase chain reaction, and serology assessment over 4 months during the first wave of the pandemic.

A total of 157 (21.5%) participants seroconverted during the study period.

Six months after infection, 74 seropositive (median age, 39; 62% women) and 75 age-, sex-, and ethnicity-matched seronegative controls underwent cardiovascular phenotyping (comprehensive phantom-calibrated CMR and blood biomarkers). The analysis was blinded, using objective artificial intelligence analytics when available.

The results showed no statistically significant differences between seropositive and seronegative participants in cardiac structure (left ventricular volumes, mass, atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterization (T1, T2, extracellular volume fraction mapping, late gadolinium enhancement) or biomarkers (troponin, N-terminal pro–B-type natriuretic peptide).

Cardiovascular abnormalities were no more common in seropositive than seronegative otherwise healthy health care workers 6 months post mild SARS-CoV-2 infection. Measured abnormalities were “evenly distributed between both groups,” Dr. Joy said.

Therefore, it’s “important to reassure patients with mild SARS-CoV-2 infection regarding its cardiovascular effects,” Dr. Joy and colleagues concluded.
 

Limitations and caveats

They caution, however, that the study provides insight only into the short- to medium-term sequelae of patients aged 18-69 with mild COVID-19 who did not require hospitalization and had low numbers of comorbidities.

The study does not address the cardiovascular effects after severe COVID-19 infection requiring hospitalization or in those with multiple comorbid conditions, they noted. It also does not prove that apparently mild SARS-CoV-2 never causes chronic myocarditis.

“The study design would not distinguish between people who had sustained completely healed myocarditis and pericarditis and those in whom the heart had never been affected,” the researchers noted.

They pointed to a recent cross-sectional study of athletes 1-month post mild COVID-19 that found significant pericardial involvement (late enhancement and/or pericardial effusion), although no baseline pre-COVID-19 imaging was performed. In the current study at 6 months post infection the pericardium was normal.

The coauthors of a linked editorial say this study provides “welcome, reassuring information that in healthy individuals who experience mild infection with COVID-19, persisting evidence of cardiovascular complications is very uncommon. The results do not support cardiovascular screening in individuals with mild or asymptomatic infection with COVID-19.”  

Colin Berry, PhD, and Kenneth Mangion, PhD, both from University of Glasgow, cautioned that the population is restricted to health care workers; therefore, the findings may not necessarily be generalized to a community population .

“Healthcare workers do not reflect the population of individuals most clinically affected by COVID-19 illness. The severity of acute COVID-19 infection is greatest in older individuals and those with preexisting health problems. Healthcare workers are not representative of the wider, unselected, at-risk, community population,” they pointed out.

Cardiovascular risk factors and concomitant health problems (heart and respiratory disease) may be more common in the community than in health care workers, and prior studies have highlighted their potential impact for disease pathogenesis in COVID-19.

Dr. Berry and Dr. Mangion also noted that women made up nearly two-thirds of the seropositive group. This may reflect a selection bias or may naturally reflect the fact that proportionately more women are asymptomatic or have milder forms of illness, whereas severe SARS-CoV-2 infection requiring hospitalization affects men to a greater degree.

COVIDsortium funding was donated by individuals, charitable trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. The authors have disclosed no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article