Infectious Disease Practitioner

A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.

Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.

Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.

In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.

The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.

When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.

The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.

The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.

“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”

The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.

“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.  

“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”

What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.

The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.

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

A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.

Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.

Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.

In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.

The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.

When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.

The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.

The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.

“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”

The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.

“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.  

“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”

What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.

The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.

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

A study of the nasal microbiome helped researchers predict recurrent polyps in chronic rhinosinusitis patients with more than 90% accuracy, based on data from 85 individuals.

Chronic rhinosinusitis with nasal polyps (CRSwNP) has a significant impact on patient quality of life, but the underlying mechanism of the disease has not been well studied, and treatment options remain limited, wrote Yan Zhao, MD, of Capital Medical University, Beijing, and study coauthors.

Previous research has shown that nasal microbiome composition differs in patients with and without asthma, and some studies suggest that changes in microbiota could contribute to CRSwNP, the authors wrote. The researchers wondered if features of the nasal microbiome can predict the recurrence of nasal polyps after endoscopic sinus surgery and serve as a potential treatment target.

In a study in Allergy, the researchers examined nasal swab samples from 85 adults with CRSwNP who underwent endoscopic sinus surgery between August 2014 and March 2016 at a single center in China. The researchers performed bacterial analysis and gene sequencing on all samples.

The patients ranged in age from 18-73 years, with a mean age of 46 years, and included 64 men and 21 women. The primary outcome was recurrence of polyps. Of the total, 39 individuals had recurrence, and 46 did not.

When the researchers compared microbiota from swab samples of recurrent and nonrecurrent patients, they found differences in composition based on bacterial genus abundance. “Campylobacter, Bdellovibrio, and Aggregatibacter, among others, were more abundant in swabs from CRSwNP recurrence samples, whereas Actinobacillus, Gemella, and Moraxella were more abundant in non-recurrence samples,” they wrote.

The researchers then tested their theory that distinct nasal microbiota could be a predictive marker of risk for future nasal polyp recurrence. They used a training set of 48 samples and constructed models from nasal microbiota alone, clinical features alone, and both together.

The regression model identified Porphyromonas, Bacteroides, Moryella, Aggregatibacter, Butyrivibrio, Shewanella, Pseudoxanthomonas, Friedmanniella, Limnobacter, and Curvibacter as the most important taxa that distinguished recurrence from nonrecurrence in the specimens. When the model was validated, the area under the curve was 0.914, yielding a predictor of nasal polyp recurrence with 91.4% accuracy.

“It is highly likely that proteins, nucleic acids, and other small molecules produced by nasal microbiota are associated with the progression of CRSwNP,” the researchers noted in their discussion of the findings. “Further, the nasal microbiota could maintain a stable community environment through the secretion of various chemical compounds and/or inflammatory factors, thus playing a central role in the development of CRSwNP.”

The study findings were limited by several factors, including the analysis of nasal flora only at the genus level in the screening phase, the use only of bioinformatic analysis for recurrence prediction, and the inclusion only of subjects from a single center, the researchers noted. Future studies should combine predictors to increase accuracy and include deeper sequencing, they said. However, the results support data from previous studies and suggest a strategy to meet the need for predictors of recurrence in CRSwNP, they concluded.

“There is a critical need to understand the role of the upper airway microbiome in different phenotypes of CRS,” said Emily K. Cope, PhD, assistant director at the Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, in an interview. “This was one of the first studies to evaluate the predictive power of the microbiome in recurrence of a common CRS phenotype – CRS with nasal polyps,” she said. “Importantly, the researchers were able to predict recurrence of polyps prior to the disease manifestation,” she noted.  

“Given the nascent state of current upper airway microbiome research, I was surprised that they were able to predict polyp recurrence prior to disease manifestation,” Dr. Cope said. “This is exciting, and I can imagine a future where we use microbiome data to understand risk for disease.”

What is the take-home message for clinicians? Although the immediate clinical implications are limited, Dr. Cope expressed enthusiasm for additional research. “At this point, there’s not a lot we can do without validation studies, but this study is promising. I hope we can understand the mechanism that an altered microbiome might drive (or be a result of) polyposis,” she said.

The study was supported by the National Natural Science Foundation of China, the program for the Changjiang scholars and innovative research team, the Beijing Bai-Qian-Wan talent project, the Public Welfare Development and Reform Pilot Project, the National Science and Technology Major Project, and the CAMS Innovation Fund for Medical Sciences. The researchers and Dr. Cope disclosed no financial conflicts.

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

Legionnaires’ disease (LD) in the United States appears to be on an upswing that started in 2003, according to a study from the Centers for Disease Control and Prevention.

The reasons for this increased incidence are unclear, the researchers write in Emerging Infectious Diseases.

“The findings revealed a rising national trend in cases, widening racial disparities between Black or African American persons and White persons, and an increasing geographic focus in the Middle Atlantic, the East North Central, and New England,” lead author Albert E. Barskey, MPH, an epidemiologist in CDC’s Division of Bacterial Diseases, Atlanta, said in an email.

“Legionnaires’ disease cannot be diagnosed based on clinical features alone, and studies estimate that it is underdiagnosed, perhaps by 50%,” he added. “Our findings may serve to heighten clinicians’ awareness of this severe pneumonia’s etiology, so with an earlier correct diagnosis, appropriate treatment can be rendered sooner.”

Mr. Barskey and his coauthors at CDC – mathematical statistician Gordana Derado, PhD, and epidemiologist Chris Edens, PhD – used surveillance data to investigate the incidence of LD in the U.S. over time. They compared LD incidence in 2018 with average incidence between 1992 and 2002. The incidence data, from over 80,000 LD cases, were age-standardized using the 2005 U.S. standard population as the reference.

The researchers analyzed LD data reported to CDC by the 50 states, New York City, and Washington, D.C., through the National Notifiable Diseases Surveillance System. They performed regression analysis to identify the optimal year when population parameters changed, and for most analyses, they compared 1992-2002 data with 2003-2018 data.
 

Legionnaires’ disease up in various groups

• The overall age-standardized average incidence grew from 0.48 per 100,000 people during 1992-2002 to 2.71 per 100,000 in 2018 (incidence risk ratio, 5.67; 95% confidence interval, 5.52-5.83).
• LD incidence more than quintupled for people over 34 years of age, with the largest relative increase in those over 85 (RR, 6.50; 95% CI, 5.82-7.27).
• Incidence in men increased slightly more (RR, 5.86; 95% CI, 5.67-6.05) than in women (RR, 5.29; 95% CI, 5.06-5.53).
• Over the years, the racial disparity in incidence grew markedly. Incidence in Black persons increased from 0.47 to 5.21 per 100,000 (RR, 11.04; 95% CI, 10.39-11.73), compared with an increase from 0.37 to 1.99 per 100,000 in White persons (RR, 5.30; 95% CI, 5.12-5.49).
• The relative increase in incidence was highest in the Northeast (RR, 7.04; 95% CI, 6.70-7.40), followed by the Midwest (RR, 6.13; 95% CI, 5.85-6.42), the South (RR, 5.97; 95% CI, 5.67-6.29), and the West (RR, 3.39; 95% CI, 3.11-3.68).

Most LD cases occurred in summer or fall, and the seasonal pattern became more pronounced over time. The average of 57.8% of cases between June and November during 1992-2002 grew to 68.9% in 2003-2018.

Although the study “was hindered by incomplete race and ethnicity data,” Mr. Barskey said, “its breadth was a strength.”
 

Consider legionella in your diagnosis

In an interview, Paul G. Auwaerter, MD, a professor of medicine and the clinical director of the Division of Infectious Diseases at Johns Hopkins University School of Medicine, Baltimore, said he was not surprised by the results. “CDC has been reporting increased incidence of Legionnaires’ disease from water source outbreaks over the years. As a clinician, I very much depend on epidemiologic trends to help me understand the patient in front of me.

“The key point is that there’s more of it around, so consider it in your diagnosis,” he advised.

“Physicians are increasingly beginning to consider Legionella. Because LD is difficult to diagnose by traditional methods such as culture, they may use a PCR test,” said Dr. Auwaerter, who was not involved in the study. “Legionella needs antibiotics that differ a bit from traditional antibiotics used to treat bacterial pneumonia, so a correct diagnosis can inform a more directed therapy.”

“Why the incidence is increasing is the big question, and the authors nicely outline a litany of things,” he said.

The authors and Dr. Auwaerter proposed a number of possible contributing factors to the increased incidence:

• an aging population
• aging municipal and residential water sources that may harbor more organisms
• racial disparities and poverty
• underlying conditions, including diabetes, end-stage renal disease, and some cancers
• occupations in transportation, repair, cleaning services, and construction
• weather patterns
• improved surveillance and reporting

“Why Legionella appears in some locations more than others has not been explained,” Dr. Auwaerter added. “For example, Pittsburgh always seemed to have much more Legionella than Baltimore.”

Mr. Barskey and his team are planning further research into racial disparities and links between weather and climate and Legionnaires’ disease.

The authors are employees of CDC. Dr. Auwaerter has disclosed no relevant financial realtionships.

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

Legionnaires’ disease (LD) in the United States appears to be on an upswing that started in 2003, according to a study from the Centers for Disease Control and Prevention.

The reasons for this increased incidence are unclear, the researchers write in Emerging Infectious Diseases.

“The findings revealed a rising national trend in cases, widening racial disparities between Black or African American persons and White persons, and an increasing geographic focus in the Middle Atlantic, the East North Central, and New England,” lead author Albert E. Barskey, MPH, an epidemiologist in CDC’s Division of Bacterial Diseases, Atlanta, said in an email.

“Legionnaires’ disease cannot be diagnosed based on clinical features alone, and studies estimate that it is underdiagnosed, perhaps by 50%,” he added. “Our findings may serve to heighten clinicians’ awareness of this severe pneumonia’s etiology, so with an earlier correct diagnosis, appropriate treatment can be rendered sooner.”

Mr. Barskey and his coauthors at CDC – mathematical statistician Gordana Derado, PhD, and epidemiologist Chris Edens, PhD – used surveillance data to investigate the incidence of LD in the U.S. over time. They compared LD incidence in 2018 with average incidence between 1992 and 2002. The incidence data, from over 80,000 LD cases, were age-standardized using the 2005 U.S. standard population as the reference.

The researchers analyzed LD data reported to CDC by the 50 states, New York City, and Washington, D.C., through the National Notifiable Diseases Surveillance System. They performed regression analysis to identify the optimal year when population parameters changed, and for most analyses, they compared 1992-2002 data with 2003-2018 data.
 

Legionnaires’ disease up in various groups

• The overall age-standardized average incidence grew from 0.48 per 100,000 people during 1992-2002 to 2.71 per 100,000 in 2018 (incidence risk ratio, 5.67; 95% confidence interval, 5.52-5.83).
• LD incidence more than quintupled for people over 34 years of age, with the largest relative increase in those over 85 (RR, 6.50; 95% CI, 5.82-7.27).
• Incidence in men increased slightly more (RR, 5.86; 95% CI, 5.67-6.05) than in women (RR, 5.29; 95% CI, 5.06-5.53).
• Over the years, the racial disparity in incidence grew markedly. Incidence in Black persons increased from 0.47 to 5.21 per 100,000 (RR, 11.04; 95% CI, 10.39-11.73), compared with an increase from 0.37 to 1.99 per 100,000 in White persons (RR, 5.30; 95% CI, 5.12-5.49).
• The relative increase in incidence was highest in the Northeast (RR, 7.04; 95% CI, 6.70-7.40), followed by the Midwest (RR, 6.13; 95% CI, 5.85-6.42), the South (RR, 5.97; 95% CI, 5.67-6.29), and the West (RR, 3.39; 95% CI, 3.11-3.68).

Most LD cases occurred in summer or fall, and the seasonal pattern became more pronounced over time. The average of 57.8% of cases between June and November during 1992-2002 grew to 68.9% in 2003-2018.

Although the study “was hindered by incomplete race and ethnicity data,” Mr. Barskey said, “its breadth was a strength.”
 

Consider legionella in your diagnosis

In an interview, Paul G. Auwaerter, MD, a professor of medicine and the clinical director of the Division of Infectious Diseases at Johns Hopkins University School of Medicine, Baltimore, said he was not surprised by the results. “CDC has been reporting increased incidence of Legionnaires’ disease from water source outbreaks over the years. As a clinician, I very much depend on epidemiologic trends to help me understand the patient in front of me.

“The key point is that there’s more of it around, so consider it in your diagnosis,” he advised.

“Physicians are increasingly beginning to consider Legionella. Because LD is difficult to diagnose by traditional methods such as culture, they may use a PCR test,” said Dr. Auwaerter, who was not involved in the study. “Legionella needs antibiotics that differ a bit from traditional antibiotics used to treat bacterial pneumonia, so a correct diagnosis can inform a more directed therapy.”

“Why the incidence is increasing is the big question, and the authors nicely outline a litany of things,” he said.

The authors and Dr. Auwaerter proposed a number of possible contributing factors to the increased incidence:

• an aging population
• aging municipal and residential water sources that may harbor more organisms
• racial disparities and poverty
• underlying conditions, including diabetes, end-stage renal disease, and some cancers
• occupations in transportation, repair, cleaning services, and construction
• weather patterns
• improved surveillance and reporting

“Why Legionella appears in some locations more than others has not been explained,” Dr. Auwaerter added. “For example, Pittsburgh always seemed to have much more Legionella than Baltimore.”

Mr. Barskey and his team are planning further research into racial disparities and links between weather and climate and Legionnaires’ disease.

The authors are employees of CDC. Dr. Auwaerter has disclosed no relevant financial realtionships.

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

Legionnaires’ disease (LD) in the United States appears to be on an upswing that started in 2003, according to a study from the Centers for Disease Control and Prevention.

The reasons for this increased incidence are unclear, the researchers write in Emerging Infectious Diseases.

“The findings revealed a rising national trend in cases, widening racial disparities between Black or African American persons and White persons, and an increasing geographic focus in the Middle Atlantic, the East North Central, and New England,” lead author Albert E. Barskey, MPH, an epidemiologist in CDC’s Division of Bacterial Diseases, Atlanta, said in an email.

“Legionnaires’ disease cannot be diagnosed based on clinical features alone, and studies estimate that it is underdiagnosed, perhaps by 50%,” he added. “Our findings may serve to heighten clinicians’ awareness of this severe pneumonia’s etiology, so with an earlier correct diagnosis, appropriate treatment can be rendered sooner.”

Mr. Barskey and his coauthors at CDC – mathematical statistician Gordana Derado, PhD, and epidemiologist Chris Edens, PhD – used surveillance data to investigate the incidence of LD in the U.S. over time. They compared LD incidence in 2018 with average incidence between 1992 and 2002. The incidence data, from over 80,000 LD cases, were age-standardized using the 2005 U.S. standard population as the reference.

The researchers analyzed LD data reported to CDC by the 50 states, New York City, and Washington, D.C., through the National Notifiable Diseases Surveillance System. They performed regression analysis to identify the optimal year when population parameters changed, and for most analyses, they compared 1992-2002 data with 2003-2018 data.
 

Legionnaires’ disease up in various groups

• The overall age-standardized average incidence grew from 0.48 per 100,000 people during 1992-2002 to 2.71 per 100,000 in 2018 (incidence risk ratio, 5.67; 95% confidence interval, 5.52-5.83).
• LD incidence more than quintupled for people over 34 years of age, with the largest relative increase in those over 85 (RR, 6.50; 95% CI, 5.82-7.27).
• Incidence in men increased slightly more (RR, 5.86; 95% CI, 5.67-6.05) than in women (RR, 5.29; 95% CI, 5.06-5.53).
• Over the years, the racial disparity in incidence grew markedly. Incidence in Black persons increased from 0.47 to 5.21 per 100,000 (RR, 11.04; 95% CI, 10.39-11.73), compared with an increase from 0.37 to 1.99 per 100,000 in White persons (RR, 5.30; 95% CI, 5.12-5.49).
• The relative increase in incidence was highest in the Northeast (RR, 7.04; 95% CI, 6.70-7.40), followed by the Midwest (RR, 6.13; 95% CI, 5.85-6.42), the South (RR, 5.97; 95% CI, 5.67-6.29), and the West (RR, 3.39; 95% CI, 3.11-3.68).

Most LD cases occurred in summer or fall, and the seasonal pattern became more pronounced over time. The average of 57.8% of cases between June and November during 1992-2002 grew to 68.9% in 2003-2018.

Although the study “was hindered by incomplete race and ethnicity data,” Mr. Barskey said, “its breadth was a strength.”
 

Consider legionella in your diagnosis

In an interview, Paul G. Auwaerter, MD, a professor of medicine and the clinical director of the Division of Infectious Diseases at Johns Hopkins University School of Medicine, Baltimore, said he was not surprised by the results. “CDC has been reporting increased incidence of Legionnaires’ disease from water source outbreaks over the years. As a clinician, I very much depend on epidemiologic trends to help me understand the patient in front of me.

“The key point is that there’s more of it around, so consider it in your diagnosis,” he advised.

“Physicians are increasingly beginning to consider Legionella. Because LD is difficult to diagnose by traditional methods such as culture, they may use a PCR test,” said Dr. Auwaerter, who was not involved in the study. “Legionella needs antibiotics that differ a bit from traditional antibiotics used to treat bacterial pneumonia, so a correct diagnosis can inform a more directed therapy.”

“Why the incidence is increasing is the big question, and the authors nicely outline a litany of things,” he said.

The authors and Dr. Auwaerter proposed a number of possible contributing factors to the increased incidence:

• an aging population
• aging municipal and residential water sources that may harbor more organisms
• racial disparities and poverty
• underlying conditions, including diabetes, end-stage renal disease, and some cancers
• occupations in transportation, repair, cleaning services, and construction
• weather patterns
• improved surveillance and reporting

“Why Legionella appears in some locations more than others has not been explained,” Dr. Auwaerter added. “For example, Pittsburgh always seemed to have much more Legionella than Baltimore.”

Mr. Barskey and his team are planning further research into racial disparities and links between weather and climate and Legionnaires’ disease.

The authors are employees of CDC. Dr. Auwaerter has disclosed no relevant financial realtionships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Potential immigrants to the United States from countries with high rates of tuberculosis tend to follow through with TB tests and treatment before they travel, and their compliance helps control TB spread, according to a study published online Feb. 16, 2022, in Emerging Infectious Diseases.

“In our study of U.S.-bound immigrants in Vietnam during their required overseas medical examination prior to migration to the United States, we identified a high proportion of U.S.-bound immigrants with latent TB infection (LTBI) and offered them preventive TB treatment,” coauthor Christina R. Phares, PhD, of the Centers for Disease Control and Prevention, Atlanta, said in an interview.

“Overall, 88% of those who started treatment completed their treatment,” she said in an interview. “This is a higher treatment completion rate than has been found in many postarrival strategies in the U.S.”

“This study demonstrated that providing LTBI testing and treatment during the overseas medical examination is feasible, yields high initiation and completion rates, and should be considered as a viable strategy to address LTBI in U.S.-bound migrants,” lead author Amera Khan, DrPH, of the Stop TB Partnership in Geneva, said in an interview.

The research team began the 1-year Preventing Tuberculosis Overseas Pilot Study (PTOPS) in Vietnam in 2018 among applicants for U.S. immigrant visas. Study participants were 12 years of age or older and were undergoing required medical examinations, which included the interferon-gamma release assay (IGRA) tuberculosis blood test.

Eligible IGRA-positive participants who planned to complete their LTBI treatment before traveling to the United States were offered free 3HP (12 weekly doses of isoniazid and rifapentine). Of 5,311 people recruited into the study, 2,438 (46%) enrolled; 2,276 had an IGRA processed; and 484 (21%) tested positive. Of the 452 participants eligible for 3HP, 304 (67%) began, and 268 (88%) completed, their treatment.
 

Preimmigration strategies needed

Worldwide, TB is now the second-leading cause of death by infectious disease, behind COVID-19, Dr. Khan said. The U.S. has seen a slow, steady decline in incidence with an increasing proportion of TB found in people born outside the country.

“Approximately 70% of U.S. TB cases occur in persons born outside the U.S., with the vast majority due to reactivation of latent TB infection acquired prior to their travel to the U.S.,” she said. “To progress towards elimination TB in the U.S., we need innovative strategies to address the high burden of LTBI among immigrants.”

Jonathan E. Golub, PhD, MPH, an infectious diseases specialist and a professor of medicine, epidemiology, and international health at Johns Hopkins University, Baltimore, was not involved in the study but welcomed its results. “This study clearly shows that a predeparture screening and treatment strategy for LTBI can be successfully implemented,” he told this news organization. “While the study highlights areas of the LTBI care cascade that need improvement, the message is clear that predeparture screening and treatment has the potential to significantly impact TB rates among non–U.S.-born persons in the U.S.”

Dr. Golub went on to explain that new technologies for LTBI screening have been underutilized. “New, shorter LTBI treatment regimens provide more feasible choices for both providers and people applying for immigration visas. Combining IGRA with 3HP creates an efficient and effective strategy. This strategy had not been tested prior to the study and the results are exciting.”

Dr. Golub highlighted one important aspect of the study: that many participants started treatment in Vietnam and completed it in the U.S. “This shows that such a protocol provides needed flexibility and can be followed by the health care systems and patients,” Dr. Golub said. “If TB is to ever be eliminated in the U.S., reducing TB among non–U.S.-born persons must be prioritized.”

The rifapentine used in the study was donated by Sanofi, the drug’s manufacturer. Dr. Khan, Dr. Phares, and Dr. Golub reported no relevant financial relationships. The study was supported by a CDC Cooperative Agreement.

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

Potential immigrants to the United States from countries with high rates of tuberculosis tend to follow through with TB tests and treatment before they travel, and their compliance helps control TB spread, according to a study published online Feb. 16, 2022, in Emerging Infectious Diseases.

“In our study of U.S.-bound immigrants in Vietnam during their required overseas medical examination prior to migration to the United States, we identified a high proportion of U.S.-bound immigrants with latent TB infection (LTBI) and offered them preventive TB treatment,” coauthor Christina R. Phares, PhD, of the Centers for Disease Control and Prevention, Atlanta, said in an interview.

“Overall, 88% of those who started treatment completed their treatment,” she said in an interview. “This is a higher treatment completion rate than has been found in many postarrival strategies in the U.S.”

“This study demonstrated that providing LTBI testing and treatment during the overseas medical examination is feasible, yields high initiation and completion rates, and should be considered as a viable strategy to address LTBI in U.S.-bound migrants,” lead author Amera Khan, DrPH, of the Stop TB Partnership in Geneva, said in an interview.

The research team began the 1-year Preventing Tuberculosis Overseas Pilot Study (PTOPS) in Vietnam in 2018 among applicants for U.S. immigrant visas. Study participants were 12 years of age or older and were undergoing required medical examinations, which included the interferon-gamma release assay (IGRA) tuberculosis blood test.

Eligible IGRA-positive participants who planned to complete their LTBI treatment before traveling to the United States were offered free 3HP (12 weekly doses of isoniazid and rifapentine). Of 5,311 people recruited into the study, 2,438 (46%) enrolled; 2,276 had an IGRA processed; and 484 (21%) tested positive. Of the 452 participants eligible for 3HP, 304 (67%) began, and 268 (88%) completed, their treatment.
 

Preimmigration strategies needed

Worldwide, TB is now the second-leading cause of death by infectious disease, behind COVID-19, Dr. Khan said. The U.S. has seen a slow, steady decline in incidence with an increasing proportion of TB found in people born outside the country.

“Approximately 70% of U.S. TB cases occur in persons born outside the U.S., with the vast majority due to reactivation of latent TB infection acquired prior to their travel to the U.S.,” she said. “To progress towards elimination TB in the U.S., we need innovative strategies to address the high burden of LTBI among immigrants.”

Jonathan E. Golub, PhD, MPH, an infectious diseases specialist and a professor of medicine, epidemiology, and international health at Johns Hopkins University, Baltimore, was not involved in the study but welcomed its results. “This study clearly shows that a predeparture screening and treatment strategy for LTBI can be successfully implemented,” he told this news organization. “While the study highlights areas of the LTBI care cascade that need improvement, the message is clear that predeparture screening and treatment has the potential to significantly impact TB rates among non–U.S.-born persons in the U.S.”

Dr. Golub went on to explain that new technologies for LTBI screening have been underutilized. “New, shorter LTBI treatment regimens provide more feasible choices for both providers and people applying for immigration visas. Combining IGRA with 3HP creates an efficient and effective strategy. This strategy had not been tested prior to the study and the results are exciting.”

Dr. Golub highlighted one important aspect of the study: that many participants started treatment in Vietnam and completed it in the U.S. “This shows that such a protocol provides needed flexibility and can be followed by the health care systems and patients,” Dr. Golub said. “If TB is to ever be eliminated in the U.S., reducing TB among non–U.S.-born persons must be prioritized.”

The rifapentine used in the study was donated by Sanofi, the drug’s manufacturer. Dr. Khan, Dr. Phares, and Dr. Golub reported no relevant financial relationships. The study was supported by a CDC Cooperative Agreement.

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

Potential immigrants to the United States from countries with high rates of tuberculosis tend to follow through with TB tests and treatment before they travel, and their compliance helps control TB spread, according to a study published online Feb. 16, 2022, in Emerging Infectious Diseases.

“In our study of U.S.-bound immigrants in Vietnam during their required overseas medical examination prior to migration to the United States, we identified a high proportion of U.S.-bound immigrants with latent TB infection (LTBI) and offered them preventive TB treatment,” coauthor Christina R. Phares, PhD, of the Centers for Disease Control and Prevention, Atlanta, said in an interview.

“Overall, 88% of those who started treatment completed their treatment,” she said in an interview. “This is a higher treatment completion rate than has been found in many postarrival strategies in the U.S.”

“This study demonstrated that providing LTBI testing and treatment during the overseas medical examination is feasible, yields high initiation and completion rates, and should be considered as a viable strategy to address LTBI in U.S.-bound migrants,” lead author Amera Khan, DrPH, of the Stop TB Partnership in Geneva, said in an interview.

The research team began the 1-year Preventing Tuberculosis Overseas Pilot Study (PTOPS) in Vietnam in 2018 among applicants for U.S. immigrant visas. Study participants were 12 years of age or older and were undergoing required medical examinations, which included the interferon-gamma release assay (IGRA) tuberculosis blood test.

Eligible IGRA-positive participants who planned to complete their LTBI treatment before traveling to the United States were offered free 3HP (12 weekly doses of isoniazid and rifapentine). Of 5,311 people recruited into the study, 2,438 (46%) enrolled; 2,276 had an IGRA processed; and 484 (21%) tested positive. Of the 452 participants eligible for 3HP, 304 (67%) began, and 268 (88%) completed, their treatment.
 

Preimmigration strategies needed

Worldwide, TB is now the second-leading cause of death by infectious disease, behind COVID-19, Dr. Khan said. The U.S. has seen a slow, steady decline in incidence with an increasing proportion of TB found in people born outside the country.

“Approximately 70% of U.S. TB cases occur in persons born outside the U.S., with the vast majority due to reactivation of latent TB infection acquired prior to their travel to the U.S.,” she said. “To progress towards elimination TB in the U.S., we need innovative strategies to address the high burden of LTBI among immigrants.”

Jonathan E. Golub, PhD, MPH, an infectious diseases specialist and a professor of medicine, epidemiology, and international health at Johns Hopkins University, Baltimore, was not involved in the study but welcomed its results. “This study clearly shows that a predeparture screening and treatment strategy for LTBI can be successfully implemented,” he told this news organization. “While the study highlights areas of the LTBI care cascade that need improvement, the message is clear that predeparture screening and treatment has the potential to significantly impact TB rates among non–U.S.-born persons in the U.S.”

Dr. Golub went on to explain that new technologies for LTBI screening have been underutilized. “New, shorter LTBI treatment regimens provide more feasible choices for both providers and people applying for immigration visas. Combining IGRA with 3HP creates an efficient and effective strategy. This strategy had not been tested prior to the study and the results are exciting.”

Dr. Golub highlighted one important aspect of the study: that many participants started treatment in Vietnam and completed it in the U.S. “This shows that such a protocol provides needed flexibility and can be followed by the health care systems and patients,” Dr. Golub said. “If TB is to ever be eliminated in the U.S., reducing TB among non–U.S.-born persons must be prioritized.”

The rifapentine used in the study was donated by Sanofi, the drug’s manufacturer. Dr. Khan, Dr. Phares, and Dr. Golub reported no relevant financial relationships. The study was supported by a CDC Cooperative Agreement.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

The first condom specifically designed for use during anal sex has gained Food and Drug Administration approval.

Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.

The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.

The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.

The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.

ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.

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

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

On Feb. 17, 2022, the updated Recommended Childhood and Adolescent Immunization Schedule was released by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. Pediatric providers across the country eagerly await this annual update to learn what changes lie in store for recommended immunization practices. During the week that has gone by since the 2022 release, I’ve had a chance to reflect on some of the highlights that are worth noting.

The SARS-CoV-2 (COVID-19) vaccines are not on the schedule yet, undoubtedly because of the preliminary nature of the vaccine data for children and the emergency use authorization vaccine status. We currently have interim recommendations for childhood COVID-19 vaccines.
 

Brand new in 2022

Two new items in the 2022 schedules are worth reviewing. The first is an entirely new recommendation to administer dengue vaccine to children aged 9-16 years living in endemic areas, but only if they already have laboratory-confirmed past dengue infection. For U.S. practitioners, the endemic areas to remember are Puerto Rico and the U.S. Virgin islands in the Caribbean, as well as Pacific island areas, such as the Marshall Islands, Palau, and the Federated States of Micronesia. There is a link in the document to additional recommendations.

The second totally new item is the combination preparation, Vaxelis, which contains DTaP, inactivated poliovirus, Haemophilus influenzae b conjugate, and hepatitis B vaccines. There are extensive recommendations for how to work it into the vaccine schedule, including some situations when it should not be used.
 

Selected reminders in childhood immunization

I’ll start with some key reminders about what not to do. Remember that the live inactivated influenza virus vaccine (LAIV) is recommended to begin only at age 2 years and older, compared with the inactivated influenza vaccine, which begins at 6 months. In addition, LAIV is contraindicated in patients aged 2-4 years who have a history of asthma or wheezing. Remember to avoid live virus vaccines, such as LAIV, MMR, and varicella, during pregnancy but be ready to administer those vaccines right after delivery. Similarly, HPV vaccine should be delayed until after pregnancy.

There are many special situation recommendations; I’ll highlight only a few here. One reminder is that although MMR and hepatitis A are both recommended to begin at 12 months, infants aged 6-11 months who are undergoing international travel to high-risk areas can begin with one dose before departure and then receive a two-dose series after turning 12 months of age.

Pneumococcal vaccination. Some children should receive both the pneumococcal conjugate vaccine (PCV13) and the pneumococcal polysaccharide vaccine (PPSV23). Those groups include children with chronic heart disease, chronic lung disease, diabetes, cerebral spinal fluid leaks or cochlear implants, and sickle cell disease, as well as many other immunocompromising conditions. Kids who need both preparations should receive the conjugate vaccine first, but they should never receive the conjugate vaccine and the polysaccharide vaccine at the same visit.

Meningococcal vaccination. Meningococcal vaccine special situations can be quite complicated. For meningococcus A,C,W,Y (MenACWY) vaccination, children with immunocompromising conditions should receive different schedules from those of typical children, but the recommendations vary by preparation.

For adolescents aged 16-23 years, the decision whether to administer the meningococcal serogroup B (MenB) vaccine is based on shared clinical decision-making, a recommendation that began in 2020. Patients with certain immunocompromising conditions are considered at higher risk and should more routinely receive MenB vaccination, with recommendations varying depending on the preparation utilized. The MenB preparations are not interchangeable. In addition, patients may receive both MenACWY and MenB vaccines on the same day, but they should be given at different body sites.
 

A few final reminders

In certain cases, you might avoid administering what would otherwise be routine vaccinations. For example, the rotavirus series should not begin if the infant is aged 15 weeks or older. Only one dose of Haemophilus influenzae b vaccine is indicated after age 15 months and none at 60 months or older if the child does not have high-risk conditions.

Finally, the total number of doses for some vaccines, such as pneumococcus and polio, vary depending on how old the child is if not already fully vaccinated. For example, for pneumococcal conjugate vaccine catch-up in a healthy child, one dose after age 24 months would bring the child up to date. For inactivated poliovirus in children aged 4 years or older, a third dose given at least 6 months after the second dose would bring that child up to date.

The tables can be a challenge to interpret, but fortunately simpler tables for parents are available. These make excellent handouts to have available in the office!
 

Dr. Basco is professor of pediatrics at the Medical University of South Carolina, Charleston, and director of the division of general pediatrics. He disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.