Infectious Disease Practitioner

Norovirus cases continue to rise in the United States this winter, at levels higher than the same time period in previous years, according to the latest data from the Centers for Disease Control and Prevention (CDC).

Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.

Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.

The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.

The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.

 

Clinical Takeaways

“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.

“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.

When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added. 

Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.

“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.

Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.

 

Cruise Ship Considerations

Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks. 

For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.

 

Clinical Perspective

In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.

One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said. 

For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.

Visit the CDC’s website on norovirus prevention for more information. 

Mirza and Cennimo had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

Norovirus cases continue to rise in the United States this winter, at levels higher than the same time period in previous years, according to the latest data from the Centers for Disease Control and Prevention (CDC).

Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.

Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.

The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.

The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.

 

Clinical Takeaways

“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.

“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.

When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added. 

Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.

“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.

Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.

 

Cruise Ship Considerations

Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks. 

For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.

 

Clinical Perspective

In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.

One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said. 

For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.

Visit the CDC’s website on norovirus prevention for more information. 

Mirza and Cennimo had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

Norovirus cases continue to rise in the United States this winter, at levels higher than the same time period in previous years, according to the latest data from the Centers for Disease Control and Prevention (CDC).

Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.

Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.

The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.

The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.

 

Clinical Takeaways

“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.

“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.

When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added. 

Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.

“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.

Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.

 

Cruise Ship Considerations

Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks. 

For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.

 

Clinical Perspective

In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.

“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.

One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said. 

For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.

Visit the CDC’s website on norovirus prevention for more information. 

Mirza and Cennimo had no financial conflicts to disclose.

 

A version of this article appeared on Medscape.com.

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

A new federal rule could force hospitals and doctors’ groups to boost health cybersecurity measures to better protect patients’ health information and prevent ransomware attacks. Some of the proposed requirements could be expensive for healthcare providers.

The proposed rule, issued by the US Department of Health & Human Services (HHS) and published on January 6 in the Federal Register, marks the first time in a decade that the federal government has updated regulations governing the security of private health information (PHI) that’s kept or shared online. Comments on the rule are due on March 6.

Because the risks for cyberattacks have increased exponentially, “there is a greater need to invest than ever before in both people and technologies to secure patient information,” Adam Greene, an attorney at Davis Wright Tremaine in Washington, DC, who advises healthcare clients on cybersecurity, said in an interview.

Bad actors continue to evolve and are often far ahead of their targets, added Mark Fox, privacy and research compliance officer for the American College of Cardiology.

In the proposed rule, HHS noted that breaches have risen by more than 50% since 2020. Damages from health data breaches are more expensive than in any other sector, averaging $10 million per incident, said HHS.

The damage can continue for years, as much of the data — such as date of birth — in PHI are “immutable,” unlike a credit card number, the agency said. A review of breach reports made to HHS’ Office for Civil Rights shows near-daily data breaches affecting hundreds to tens of thousands of patients. Since December 1 alone, healthcare providers reported breaches affecting nearly 3 million US patients, according to federal data.

Debi Carr, a Florida-based cybersecurity consultant for small physician and dental practices, welcomed the new proposal. “Many practices are clinging to doing things the way they have always done it, and hackers are taking full advantage of that mindset,” she said in an interview. “We have to change our mindset.”

Among the proposal’s recommendations:

• A shift away from making security specifications “addressable” to required. Fox said that many interpreted addressable to mean optional. The clarification is important. The government will require greater accountability, including a requirement to annually revise the risk analysis, to review policies and procedures and implementation, and to perform penetration testing, said Greene.
• Requiring multifactor authentication (MFA) and encryption of PHI at rest and in transit. “A reasonable person who does security will tell you that should be a requirement,” said Fox. Carr added that the February 2024 Change Healthcare ransomware attack happened because workers at the payment processing company were not using MFA.
• Requiring all entities to verify at least once a year that “business associates” have put into place the required safeguards; the associates would need to provide a written analysis of relevant electronic information systems by a subject matter expert and a written certification that the analysis has been performed and is accurate. In the past, the rule “only required that you sign a business associate agreement” with the associate, which could be a payer, a pharmacy, or another physician practice, said Fox. The rule would require all entities to get certification that the controls are in place.
• Requiring a detailed map of an electronic network. For a physician practice, that means creating an inventory of all the technology assets, including devices, applications, and anything that would touch electronic PHI, and then creating a map of how it comes into the office, flows through it, and departs, said Greene.
• Having a plan of action in the case of a breach. The rule will require written procedures to restore certain relevant systems and data within 72 hours and written incident response plans.

Some physician practices — especially those still relying on passwords instead of more sophisticated MFA or encryption — may have to invest significantly to strengthen their information security, said Greene. Smaller organizations, for example, may need to upgrade systems to ensure that user access is terminated within an hour after someone’s employment ends.

Carr said practices should not view the investments as a burden. The regulation “will force practices to implement best cybersecurity practices,” she said.

Implementing those best practices serves as insurance, said Fox. He suggests that anyone in doubt “talk to someone who’s actually lived through a breach and had to recover.”

Tampa General Hospital in Florida, for instance, recently settled a class action suit, agreeing to pay $6.8 million to patients whose PHI was compromised.

It is not certain whether or when the health cybersecurity rule will be made final.

The incoming Trump administration could cancel or delay the rulemaking process.

Even if it continues, “I would not expect a final rule in 2025,” said Greene. He estimates that the rule would not take effect until at least 2026; healthcare entities would have 180 days to comply. Still, those 180 days can go by fast.

“I would say don’t panic, but don’t ignore it either,” he said.

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

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Is there a connection between antibiotics taken before conception and adverse outcomes, such as reduced fertility, miscarriages, and congenital malformations?

A meta-analysis published in the journal eClinicalMedicine suggests a potential link between antibiotics taken before conception and negative outcomes, such as reduced fertility, miscarriages, and congenital malformations. However, a German expert in reproductive toxicology warned against drawing false conclusions.

“It would be fatal if women who want to have children refused necessary antibiotic treatment because they are afraid of infertility, miscarriages, and malformations,” said Wolfgang Paulus, MD, from the Reproductive Toxicology Advisory Center at the University Women’s Hospital in Ulm, Germany. In an interview, the expert criticized not only the authors’ conclusions but also the selection of studies included in the meta-analysis.

 

Confusion Over Use and Exposure

The meta-analysis, conducted by Bekalu Kassie Alemu, PhD, and colleagues from the Department of Obstetrics and Gynecology at The Chinese University of Hong Kong included 15 studies involving over 1.2 million women to examine how preconception antibiotic use affects fertility and pregnancy outcomes. In most studies (n = 11) that were included in the meta-analysis, fertility was examined as an endpoint, primarily in infertile women. One study involved Danish pharmacy employees who handled antibiotics at work.

“Not only was the therapeutic use of antibiotics not examined in this study, but the biological plausibility is completely lacking in this context,” Paulus noted.

The possible effects of preconception antibiotics on miscarriages were investigated in four studies, while two studies focused on congenital malformations as an endpoint.

 

Mixed Findings on Infertility

Regarding infertility, the authors reported abnormalities in macrolides and sulfonamides. Women who had received macrolide antibiotics, such as azithromycin, before conception showed a 35% reduction in fertility rates.

However, Paulus questioned whether this was solely because of macrolides. “Macrolide antibiotics are typically used for chlamydia, and chlamydia infection is a significant factor in women with unmet fertility desires,” he explained. Often, the chlamydia has already caused damage, such as inflammatory processes in the fallopian tubes, contributing to infertility that cannot be resolved by administering antibiotics.

The meta-analysis also showed that women who received sulfonamide before conception had a 2.35-fold increased likelihood of infertility. However, this association is not always one-sided. The results for tetracyclines were heterogeneous; while chlortetracycline appeared to increase the risk for infertility, exposure to oxytetracycline appeared to decrease it.

Treatment with oxytetracycline and beta-lactam antibiotics (except penicillin G) was associated with a 64% lower likelihood of infertility. The authors also found that fluoroquinolone antibiotics were associated with a 13% lower likelihood of infertility.

 

Miscarriage and Malformation Risks

Alemu and colleagues found a significant association between the use of antibiotics before conception and adverse pregnancy outcomes, showing a 34% increased risk for miscarriages and an 85% higher risk for congenital malformations with the use of trimethoprim during preconception. These findings highlight the need for caution regarding antibiotic use in women who are planning to conceive.

“Most antibiotics have half-lives of only a few hours. Therefore, antibiotics administered before conception can hardly have a direct effect on embryonic development,” Paulus noted. He pointed out that extensive data exist on most antibiotic classes included in this meta-analysis regarding childhood anomalies when used during the sensitive phase of organ development. These data do not indicate an increased risk for malformation. Therefore, the increased risk for malformations due to exposure before conception seems less plausible.

Alemu and colleagues assumed that antibiotics might negatively affect female reproductive health by disrupting the gut microbiome. The reasons for the reduced risk for infertility associated with beta-lactams and fluoroquinolones require further investigation. They reach a significant conclusion: “Preconception antibiotics exposure in females increases the risk of infertility, miscarriage, and congenital anomalies.” However, differences exist between the antibiotic classes. While the risk for infertility, spontaneous miscarriages, and congenital malformations increases with the use of macrolide antibiotics, sulfonamides, and trimethoprim, it decreases with the use of beta-lactams and fluoroquinolone antibiotics.

 

Expert Disagreement

“It is conceivable that the use of antibiotics damages the physiological environment, such as in the vaginal area. This may allow unwanted microbes to establish themselves, leading to more adverse outcomes such as infertility and miscarriages,” Paulus acknowledged.

Disruption of the microbiome due to antibiotic therapy could also result in a deficiency in relevant vitamins and trace elements (eg, folic acid), which could contribute to organogenesis disorders. Therefore, it may be beneficial to stabilize the gut and vaginal flora using probiotics after antibiotic treatment.

However, Paulus disagrees with the study conclusions. First, the studies included in the meta-analysis, which were largely observational, did not allow for the direct effect of antibiotics on the examined outcomes. Second, “quinolone antibiotics are highlighted as positive here, as if they were less problematic for patients trying to have children.”

Quinolone antibiotics are generally “frowned upon,” regardless of whether the patient wants to have children, as they can cause damage to the tendons, muscles, joints, and nervous system. They are currently used only as reserve medications.

“Quinolone antibiotics should not be administered during pregnancy, as they have already caused problems in animal studies, and they should not be used before pregnancy because of their side-effect profile,” Paulus stressed.

 

Serious Consequences

Paulus clarified: “The message must not be that women trying to conceive should avoid antibiotics. This applies to treating bacterial infections regardless of fertility desires, as well as for women trying to conceive who have problematic pathogens found in vaginal swabs.”

In these cases, antibiotic treatment is appropriate, and there should be no fear of adverse effects on fertility or pregnancy outcomes. “If antibiotics are not given and the infection worsens, the patient will be even less likely to conceive successfully.”

This story was translated from Medscape’s German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

Higher rates of leaving the emergency department (ED) without being seen are linked to increased short-term mortality or hospitalization, according to a cohort study in Ontario, Canada.

“We found that after 2020, there was a 14% higher risk for death or hospitalization within 7 days” among patients who left without being seen (LWBS), Candace McNaughton, MD, PhD, associate professor of medicine at the University of Toronto and scientist at Sunnybrook Research Institute, both in Toronto, Ontario, Canada, told this news organization.

“When we looked at death by itself, there was a 46% higher risk after 2020,” she said. “Even 30 days after a LWBS ED visit, there was still a 5% increased risk for death/hospitalization and a 24% increased risk for death.”

The study was published in the Journal of the American College of Emergency Physicians Open.

 

LWBS Rates Increased 

Researchers used linked administrative data to analyze temporal trends in monthly rates of ED and LWBS visits for adults in Ontario from 2014 to 2023.

They compared the composite outcome of 7-day all-cause mortality or hospitalization following an LWBS ED visit in April 2022‒March 2023 (recent period) with that following an LWBS ED visit in April 2014‒March 2020 (baseline period), after adjustment for age, sex, and Charlson Comorbidity Index (CCI).

In the two periods, patient characteristics were similar across age, sex, neighborhood-level income quartile, history of being unhoused, rurality, CCI, day, time, and mode of arrival. The median age was 40 years for the baseline period and 42 years for the recent period.

Temporal trends showed sustained increases in monthly LWBS rates after 2020, despite fewer monthly ED visits. The rate of LWBS ED visits after April 1, 2020, exceeded the baseline period’s single-month LWBS maximum of 4% in 15 of 36 months.

The rate of 7-day all-cause mortality or hospitalization was 3.4% in the recent period vs 2.9% in the baseline period (adjusted risk ratio [aRR], 1.14), despite similar rates of post-ED outpatient visits (7-day recent and baseline, 38.9% and 39.7%, respectively).

Similar trends were seen at 30 days for all-cause mortality or hospitalization (6.2% in the recent period vs 5.8% at baseline; aRR, 1.05) despite similar rates of post-ED outpatient visits (59.4% and 59.7%, respectively).

After April 1, 2020, monthly ED visits and the proportion of patients who LWBS varied widely.

The proportion of LWBS visits categorized as emergent on the Canadian Triage and Acuity Scale was higher during the recent period (12.9% vs 9.2% in the baseline period), and fewer visits were categorized as semiurgent (22.6% vs 31.9%, respectively). This finding suggested a higher acuity of illness among patients who LWBS in the recent period.

 

LWBS Visits ‘Not Benign’

Results of a preplanned subgroup analysis examining the risk for all-cause mortality after an LWBS visit were “particularly notable,” the authors wrote, with a 46% higher adjusted risk for death at 7 days and 24% higher adjusted risk at 30 days.

The observational study had several limitations, however. The authors could not draw conclusions regarding direct causes of the increased risk for severe short-term adverse health outcomes after an LWBS ED visit, and residual confounding is possible. Cause-of-death information was not available to generate hypotheses for future studies of potential causes. Furthermore, the findings may not be generalizable to systems without universal access to healthcare.

Nevertheless, the findings are a “concerning signal [and] should prompt interventions to address system- and population-level causes,” the authors wrote.

“Unfortunately, because of politics, since 2020, ED closures in Ontario have become more and more common and seem to be affecting more and more Ontarians,” said McNaughton. “It would be surprising if ED closure didn’t play some role in our findings.”

She added, “It is important to note that people in our study were relatively young, with a median age in their 40s; this makes our findings all the more concerning. Clinicians should be aware that LWBS ED visits are not necessarily benign, particularly when rates of LWBS ED visits are high.”

 

Unanswered Questions

The study raised the following questions that the authors are or will be investigating, according to McNaughton: 

• Which patients are at greatest risk for bad outcomes if they leave the ED without being seen, and why?
• How much of the findings might be related to recent ED closures, longer ED wait times, or other factors? Are there geographic variations in risk?
• What can be done in the ED to prevent LWBS ED visits, and what can be changed outside the ED to prevent LWBS ED visits? For example, what can hospitals do to reduce boarding in the ED? If patients leave without being seen, should they be contacted to try to meet their health needs in other ways?
• What worked in terms of maintaining access to outpatient medical care, despite the considerable disruptions starting in 2020, and how can continued success be ensured?

To address the current situation, McNaughton said, “We need consistent, predictable, and sustained investment in our public healthcare system. We need long-term, consistent funding for primary care, ED care, as well as hospital and long-term care.”

“It takes years to recruit and train the teams of people necessary to provide the high-quality medical care that Canadians have a right to. There are no shortcuts,” she concluded.

 

‘Tragic Situation’

American College of Emergency Physicians (ACEP) spokesperson Jesse Pines, MD, chief of clinical innovation at US Acute Care Solutions; clinical professor of emergency medicine at George Washington University in Washington, DC; and professor of emergency medicine at Drexel University in Philadelphia, commented on the study for this news organization.

“Similar to what the authors found in their report, LWBS and other metrics — specifically boarding — have progressively increased in the United States, in particular, since the early part of 2021,” he said. “The primary factor in the US driving this, and one that ACEP is trying to address on a national scale, is the boarding of admitted patients.”

When the number of boarded patients increases, there is less space in the ED for new patients, and waits increase, Pines explained. Some patients leave without being seen, and a subset of those patients experience poor outcomes. “It’s a tragic situation that is worsening.”

“Emergency physicians like me always worry when patients leave without being seen,” he said. While some of those patients have self-limited conditions that will improve on their own, “some have critical life-threatening conditions that require care and hospitalization. The worry is that these patients experience poorer outcomes,” Pines said. “The authors showed that this is increasingly the case in Canada. The same is likely true in the US.”

The study was funded by the Canadian Institutes of Health Research. McNaughton and Pines declared no relevant financial relationships.

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

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

The quality and credibility of scientific publications have received increasing scrutiny. Findings from studies by Maria Ángeles Oviedo-García, PhD, from the Department of Business and Marketing at the University of Seville in Spain, highlight growing concerns about the integrity of published research. Insights from the journal Science and the US blog Retraction Watch reveal similar concerns regarding research integrity.

Artificial Intelligence (AI) Spurs Low-Quality Submissions

According to a report in Science, journals are inundated with low-quality contributions such as letters and comments generated by AI. Daniel Prevedello, MD, editor in chief of Neurosurgical Review, announced that the journal would temporarily stop accepting these submissions because of their poor quality.

Neurosurgical Review is not the only journal to experience low-quality submissions. In the journal Oral Oncology Reports (Elsevier), comments comprised 70% of the content, whereas in the International Journal of Surgery Open (Wolters Kluwer), they accounted for nearly half. In Neurosurgical Review, letters, comments, and editorials made up 58% of the total content from January to October 2024, compared with only 9% in the previous year.

This trend benefits authors by allowing them to inflate their publication lists with quickly produced contributions that bypass peer review. Publishers may also profit, as many charge fees to publish comments. Additionally, universities and research institutions find this type of content generation useful as more publications can enhance their reputation.

 

Concerns Over Peer Reviews

The troubling behavior described by Oviedo-García in the journal Scientometrics raises further doubts. An analysis of 263 peer reviews from 37 journals revealed that reviewers often used identical or very similar phrases in their evaluations, regardless of the content. In one case, the reviewer used the same wording in 52 reviews. This suggests that some reviewers read the studies that they are supposed to evaluate only superficially. Such practices can lead to valueless reviews and jeopardize the integrity of scientific literature. “Some other researchers will probably base their future research on these fake reports, which is frightening, especially when it comes to health and medicine,” Oviedo-García stated.

She suspects that the reviewers may have relied on templates to produce their reports quickly. This allowed them to list this work on their resumes for potential career advantages. Some reviewers have reportedly even “requested” the authors of the studies they reviewed to cite their own scientific work.

 

AI Complicates Peer Review

The process of research and publication has become increasingly challenging in recent years, and more standard and predatory journals allow anyone to publish their work for a fee. Roger W. Byard, MD, PhD, from the University of Adelaide in Australia, explained this trend in the journal Forensic Science, Medicine and Pathology. AI is increasingly being used to generate articles. At international conferences, experts have highlighted claims that AI can complete papers in just a few weeks and dissertations in less than a year. According to the authors of a letter in Critical Care, generative AI is infiltrating the peer review process.

Moreover, the peer review process can be bypassed by publishing research findings on online platforms (eg, preprint servers). Another issue is that some publications have hundreds of authors who can extend their publication list in this manner, even if their contribution to the publication is ambiguous or not substantial.

In a guest article for the Laborjournal, Ulrich Dirnagl, MD, PhD, from the Charité — Universitätsmedizin Berlin in Germany, emphasized that the scientific papers have become so complex that two or three experts often cannot thoroughly assess everything presented. The review process is time-consuming and can take several days for reviewers. Currently, very few people have time, especially because it is an unpaid and anonymous task. Dirnagl stated, “the self-correction of science no longer works as it claims.”

The old Russian saying ‘Dowjerjaj, no prowjerjaj: Trust, but verify’  remains a timeless recommendation that is likely to stay relevant for years to come.

This story was translated from Univadis Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

A few items bring back unpleasant memories of COVID-19, such as masks. However, they are among the simplest and most effective ways to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). If everyone had worn them correctly, the transmission could have been reduced as much as ninefold, according to a theoretical study published in Physical Review E by Richard P. Sear, PhD, from the University of Surrey, Guildford, England.

Study Overcomes Limitations

This study aimed to address the limitations of epidemiological investigations of masks, which can be complex and error-prone. Sear used data obtained from the UK’s COVID-19 app, totaling 7 million contacts, to create a mathematical model of virus transmission, focusing on the correlation between contact duration and infection. The model estimates that if all UK residents had worn masks during every potential exposure, virus transmission would have been approximately nine times lower.

Although this is a mathematical model, it adds to the growing evidence that supports the benefits of masks. Masks are among the best strategies for treating SARS-CoV-2. This conclusion has been supported by several systematic reviews and additional statistical studies. Conversely, the decision to relax and eliminate mask regulations has had consequences that have received little attention.

As expected, removing the mask mandate leads to increased virus transmission, resulting in more hospitalizations and deaths. A 2024 study estimated that in Japan, where cultural factors lead to much higher mask use in public than in Europe, the decline in mask use from 97% of the population in 2022 to 63% in October 2023 may have caused an additional 3500 deaths.

 

Impact Beyond SARS-CoV-2

One remarkable effect of non-pharmaceutical interventions during the pandemic was the probable extinction of an entire influenza strain (B/Yamagata), which could improve future influenza vaccines and significantly reduce the spread of respiratory syncytial virus. While this was not solely caused by masks, it was also influenced by emergency measures such as lockdowns and social distancing. These behavioral changes can positively alter the landscape of infectious diseases.

Masks play a role in reducing influenza transmission during pandemics. Their effectiveness has been supported by several studies and systematic reviews on a wide range of respiratory viruses. A randomized clinical trial involving 4647 Norwegian participants from February to April 2023, published in May 2024 by the British Medical Journal, suggested that wearing a mask reduces the incidence of respiratory symptoms. Specifically, 8.9% of those who wore masks reported respiratory symptoms during the study period compared with 12.2% of those who did not, representing a relative risk reduction of 27%.

Widespread mask use could also protect against other factors such as fine particulate matter, indirectly reducing the risk for various health conditions. A retrospective study involving 7.8 million residents in the Chinese city of Weifang, published in December 2024 by BMC Public Health, suggested that mask use during the pandemic may have also protected the population from pollution, reducing the number of stroke cases by 38.6% over 33 months of follow-up.

Although there are still voices in bioethics calling for the reintroduction of mask mandates in public places, it is unlikely that, barring emergencies, mask mandates are politically and socially acceptable today. Mask use is also considered a politically polarizing topic in several Western countries. Nevertheless, it is worth considering whether, as we move away from the acute phase of the COVID-19 pandemic, we can more objectively promote the use of masks in public places.

Communicating the importance of public health initiatives and persuading people to support them is a well-known challenge. However, scientific literature offers valuable insights. These include encouraging people to rely on rational thinking rather than emotions and providing information on how masks protect those around them. The fact that East Asian cultures tend to have a more positive relationship with the use of masks shows that, in principle, it is possible to make them acceptable. Data from studies suggest that, as we prepare for potential future pandemics, it may be time to move past polarization and reintroduce masks — not as a universal mandate but as an individual choice for many.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

A few items bring back unpleasant memories of COVID-19, such as masks. However, they are among the simplest and most effective ways to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). If everyone had worn them correctly, the transmission could have been reduced as much as ninefold, according to a theoretical study published in Physical Review E by Richard P. Sear, PhD, from the University of Surrey, Guildford, England.

Study Overcomes Limitations

This study aimed to address the limitations of epidemiological investigations of masks, which can be complex and error-prone. Sear used data obtained from the UK’s COVID-19 app, totaling 7 million contacts, to create a mathematical model of virus transmission, focusing on the correlation between contact duration and infection. The model estimates that if all UK residents had worn masks during every potential exposure, virus transmission would have been approximately nine times lower.

Although this is a mathematical model, it adds to the growing evidence that supports the benefits of masks. Masks are among the best strategies for treating SARS-CoV-2. This conclusion has been supported by several systematic reviews and additional statistical studies. Conversely, the decision to relax and eliminate mask regulations has had consequences that have received little attention.

As expected, removing the mask mandate leads to increased virus transmission, resulting in more hospitalizations and deaths. A 2024 study estimated that in Japan, where cultural factors lead to much higher mask use in public than in Europe, the decline in mask use from 97% of the population in 2022 to 63% in October 2023 may have caused an additional 3500 deaths.

 

Impact Beyond SARS-CoV-2

One remarkable effect of non-pharmaceutical interventions during the pandemic was the probable extinction of an entire influenza strain (B/Yamagata), which could improve future influenza vaccines and significantly reduce the spread of respiratory syncytial virus. While this was not solely caused by masks, it was also influenced by emergency measures such as lockdowns and social distancing. These behavioral changes can positively alter the landscape of infectious diseases.

Masks play a role in reducing influenza transmission during pandemics. Their effectiveness has been supported by several studies and systematic reviews on a wide range of respiratory viruses. A randomized clinical trial involving 4647 Norwegian participants from February to April 2023, published in May 2024 by the British Medical Journal, suggested that wearing a mask reduces the incidence of respiratory symptoms. Specifically, 8.9% of those who wore masks reported respiratory symptoms during the study period compared with 12.2% of those who did not, representing a relative risk reduction of 27%.

Widespread mask use could also protect against other factors such as fine particulate matter, indirectly reducing the risk for various health conditions. A retrospective study involving 7.8 million residents in the Chinese city of Weifang, published in December 2024 by BMC Public Health, suggested that mask use during the pandemic may have also protected the population from pollution, reducing the number of stroke cases by 38.6% over 33 months of follow-up.

Although there are still voices in bioethics calling for the reintroduction of mask mandates in public places, it is unlikely that, barring emergencies, mask mandates are politically and socially acceptable today. Mask use is also considered a politically polarizing topic in several Western countries. Nevertheless, it is worth considering whether, as we move away from the acute phase of the COVID-19 pandemic, we can more objectively promote the use of masks in public places.

Communicating the importance of public health initiatives and persuading people to support them is a well-known challenge. However, scientific literature offers valuable insights. These include encouraging people to rely on rational thinking rather than emotions and providing information on how masks protect those around them. The fact that East Asian cultures tend to have a more positive relationship with the use of masks shows that, in principle, it is possible to make them acceptable. Data from studies suggest that, as we prepare for potential future pandemics, it may be time to move past polarization and reintroduce masks — not as a universal mandate but as an individual choice for many.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

A few items bring back unpleasant memories of COVID-19, such as masks. However, they are among the simplest and most effective ways to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). If everyone had worn them correctly, the transmission could have been reduced as much as ninefold, according to a theoretical study published in Physical Review E by Richard P. Sear, PhD, from the University of Surrey, Guildford, England.

Study Overcomes Limitations

This study aimed to address the limitations of epidemiological investigations of masks, which can be complex and error-prone. Sear used data obtained from the UK’s COVID-19 app, totaling 7 million contacts, to create a mathematical model of virus transmission, focusing on the correlation between contact duration and infection. The model estimates that if all UK residents had worn masks during every potential exposure, virus transmission would have been approximately nine times lower.

Although this is a mathematical model, it adds to the growing evidence that supports the benefits of masks. Masks are among the best strategies for treating SARS-CoV-2. This conclusion has been supported by several systematic reviews and additional statistical studies. Conversely, the decision to relax and eliminate mask regulations has had consequences that have received little attention.

As expected, removing the mask mandate leads to increased virus transmission, resulting in more hospitalizations and deaths. A 2024 study estimated that in Japan, where cultural factors lead to much higher mask use in public than in Europe, the decline in mask use from 97% of the population in 2022 to 63% in October 2023 may have caused an additional 3500 deaths.

 

Impact Beyond SARS-CoV-2

One remarkable effect of non-pharmaceutical interventions during the pandemic was the probable extinction of an entire influenza strain (B/Yamagata), which could improve future influenza vaccines and significantly reduce the spread of respiratory syncytial virus. While this was not solely caused by masks, it was also influenced by emergency measures such as lockdowns and social distancing. These behavioral changes can positively alter the landscape of infectious diseases.

Masks play a role in reducing influenza transmission during pandemics. Their effectiveness has been supported by several studies and systematic reviews on a wide range of respiratory viruses. A randomized clinical trial involving 4647 Norwegian participants from February to April 2023, published in May 2024 by the British Medical Journal, suggested that wearing a mask reduces the incidence of respiratory symptoms. Specifically, 8.9% of those who wore masks reported respiratory symptoms during the study period compared with 12.2% of those who did not, representing a relative risk reduction of 27%.

Widespread mask use could also protect against other factors such as fine particulate matter, indirectly reducing the risk for various health conditions. A retrospective study involving 7.8 million residents in the Chinese city of Weifang, published in December 2024 by BMC Public Health, suggested that mask use during the pandemic may have also protected the population from pollution, reducing the number of stroke cases by 38.6% over 33 months of follow-up.

Although there are still voices in bioethics calling for the reintroduction of mask mandates in public places, it is unlikely that, barring emergencies, mask mandates are politically and socially acceptable today. Mask use is also considered a politically polarizing topic in several Western countries. Nevertheless, it is worth considering whether, as we move away from the acute phase of the COVID-19 pandemic, we can more objectively promote the use of masks in public places.

Communicating the importance of public health initiatives and persuading people to support them is a well-known challenge. However, scientific literature offers valuable insights. These include encouraging people to rely on rational thinking rather than emotions and providing information on how masks protect those around them. The fact that East Asian cultures tend to have a more positive relationship with the use of masks shows that, in principle, it is possible to make them acceptable. Data from studies suggest that, as we prepare for potential future pandemics, it may be time to move past polarization and reintroduce masks — not as a universal mandate but as an individual choice for many.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

I would like to briefly discuss a very interesting paper that appeared in Nature:“Megastudy Shows That Reminders Boost Vaccination but Adding Free Rides Does Not.” 

Obviously, the paper has a provocative title. This is really an excellent example of what one might call implementation research, or quite frankly, what might work and what might not work in terms of having a very pragmatic goal. In this case, it was how do we get people to receive vaccinations. 

This specific study looked at individuals who were scheduled to receive or were candidates to receive COVID-19 booster vaccinations. The question came up: If you gave them free rides to the location — this is obviously a high-risk population — would that increase the vaccination rate vs the other item that they were looking at here, which was potentially texting them to remind them?

The study very importantly and relevantly demonstrated, quite nicely, that offering free rides did not make a difference, but sending texts to remind them increased the 30-day vaccination rate in this population by 21%. 

Again, it was a very pragmatic question that the trial addressed, and one might use this information in the future to increase the vaccination rate of a population where it is critical to do so. This type of research, which involves looking at very pragmatic questions and answering what is the optimal and most cost-effective way of doing it, should be encouraged. 

I encourage you to look at this paper if you’re interested in this topic.

Markman, Professor of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center; President, Medicine & Science, City of Hope Atlanta, Chicago, Phoenix, has disclosed ties with GlaxoSmithKline and AstraZeneca.

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

This transcript has been edited for clarity. 

I would like to briefly discuss a very interesting paper that appeared in Nature:“Megastudy Shows That Reminders Boost Vaccination but Adding Free Rides Does Not.” 

Obviously, the paper has a provocative title. This is really an excellent example of what one might call implementation research, or quite frankly, what might work and what might not work in terms of having a very pragmatic goal. In this case, it was how do we get people to receive vaccinations. 

This specific study looked at individuals who were scheduled to receive or were candidates to receive COVID-19 booster vaccinations. The question came up: If you gave them free rides to the location — this is obviously a high-risk population — would that increase the vaccination rate vs the other item that they were looking at here, which was potentially texting them to remind them?

The study very importantly and relevantly demonstrated, quite nicely, that offering free rides did not make a difference, but sending texts to remind them increased the 30-day vaccination rate in this population by 21%. 

Again, it was a very pragmatic question that the trial addressed, and one might use this information in the future to increase the vaccination rate of a population where it is critical to do so. This type of research, which involves looking at very pragmatic questions and answering what is the optimal and most cost-effective way of doing it, should be encouraged. 

I encourage you to look at this paper if you’re interested in this topic.

Markman, Professor of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center; President, Medicine & Science, City of Hope Atlanta, Chicago, Phoenix, has disclosed ties with GlaxoSmithKline and AstraZeneca.

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

This transcript has been edited for clarity. 

I would like to briefly discuss a very interesting paper that appeared in Nature:“Megastudy Shows That Reminders Boost Vaccination but Adding Free Rides Does Not.” 

Obviously, the paper has a provocative title. This is really an excellent example of what one might call implementation research, or quite frankly, what might work and what might not work in terms of having a very pragmatic goal. In this case, it was how do we get people to receive vaccinations. 

This specific study looked at individuals who were scheduled to receive or were candidates to receive COVID-19 booster vaccinations. The question came up: If you gave them free rides to the location — this is obviously a high-risk population — would that increase the vaccination rate vs the other item that they were looking at here, which was potentially texting them to remind them?

The study very importantly and relevantly demonstrated, quite nicely, that offering free rides did not make a difference, but sending texts to remind them increased the 30-day vaccination rate in this population by 21%. 

Again, it was a very pragmatic question that the trial addressed, and one might use this information in the future to increase the vaccination rate of a population where it is critical to do so. This type of research, which involves looking at very pragmatic questions and answering what is the optimal and most cost-effective way of doing it, should be encouraged. 

I encourage you to look at this paper if you’re interested in this topic.

Markman, Professor of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center; President, Medicine & Science, City of Hope Atlanta, Chicago, Phoenix, has disclosed ties with GlaxoSmithKline and AstraZeneca.

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

The pediatrician’s first patient of the day was an 8-year-old boy, accompanied by both of his parents. It was the boy’s third visit in just over a week for fever and left-sided neck swelling, and the family was understandably anxious for answers.

“The antibiotics don’t seem to be working,” the mother explained. “He still has fever every day, as high as 104, and his neck looks just as swollen.”

A quick review of the chart revealed the boy’s initial diagnosis had been bacterial lymphadenitis, for which amoxicillin-clavulanate had been prescribed. Three days later, given lack of clinical improvement, therapy was transitioned to clindamycin. On examination, the boy was febrile and ill-appearing with a 3-cm by 5-cm tender, non-fluctuant swelling over the left sternocleidomastoid muscle. 

 

The pediatrician ran through a quick mental checklist of diagnostic possibilities for his patient’s continued symptoms. Staphylococcal lymphadenitis still seemed possible. Could the boy be infected with methicillin-resistant Staphylococcus aureus that was also clindamycin resistant? Alternately, perhaps the problem was “source control” and the boy had developed an occult neck abscess that needed to be drained. An ultrasound could help sort that out. Finally, the pediatrician considered less common bacterial causes of lymph node swelling and fever. He placed Bartonella henselae, the cause of cat scratch disease, near the top of his list. “I’ve never seen it,” he told the parents, “But we could also consider tularemia.”

Tularemia is a rare zoonotic infection caused by Francisella tularenis. On average, 200 cases of tularemia are reported in the United States each year, and the incidence of disease is increasing, according to a surveillance report released by the Centers for Disease Control and Prevention in December 2023.¹

Between 2011 and 2022, 2462 tularemia cases were reported in the United States. That translated to an average annual incidence of 0.064 per 100,000 population, an increase of 56% compared with 2001-2010. Forty-seven states reported at least one case of tularemia, although half of all reported cases came from four states — Arkansas (18%), Kansas (11%), Missouri (11%), and Oklahoma (10%). The incidence of tularemia was highest in children ages 5-9 years old, older men, and American Indian or Alaska Natives individuals. Although cases occurred year-round, 78% had symptom onset May through September. 

In the United States, most human cases of tularemia have been arthropod borne, transmitted by the bite of an infected tick or deer fly. Infection also can be spread through contact with infected animals or animal tissue, particularly rabbits, hares, muskrats, prairie dogs, and other rodents, including hamsters. Outbreaks of tularemia have occurred among pet store hamsters, and at least one child in the United States developed tularemia after being bitten by a pet hamster.

Tularemia is almost always associated with fever but other clinical manifestations vary by the type of exposure. Ulceroglandular disease occurs after a tick or deer fly bite or after handling an infected animal. An ulcer develops at the site where the bacteria entered the body, along with enlargement of regional lymph nodes. Less commonly, lymph node swelling can occur without the development of an ulcer. If the bacteria enter through the eye, symptoms include conjunctivitis and swelling of pre-auricular lymph nodes. Eating or drinking contaminated food or water is associated with sore throat, mouth ulcers, tonsillitis, and swelling of lymph glands in the neck. Pneumonic tularemia, the most serious form of the disease, typically happens after inhaling bacteria-containing dust or aerosols and is associated with cough, chest pain, and difficulty breathing. Pneumonic tularemia can develop if other forms of tularemia are untreated, and the bacteria spread to the lung.

Back in the exam room, the pediatrician carefully re-examined the boy’s scalp. A 1-cm poorly healing ulcer on the left occiput added support for the diagnosis of ulceroglandular tularemia, the most common form of the disease in children. Serologic testing ultimately confirmed the diagnosis and the boy’s symptoms resolved with treatment.

Gentamicin administered intravenously or intramuscularly is the drug of choice for the treatment of tularemia in children. Ciprofloxacin is considered an alternative but is not approved by the U.S. Food and Drug Administration for this indication.

The pediatrician reported the case of tularemia to his local health department. Tularemia is a nationally notifiable disease in the United States; state health departments report to the CDC through the National Notifiable Diseases Surveillance System. In turn, public health authorities shared information to prevent tularemia. Steps to prevent tick and deer fly bites include the use of an Environmental Protection Agency–registered insect repellent. Individuals who hunt, trap, or skin animals are encouraged to wear gloves when handling animals —especially rabbits, muskrats, and prairie dogs — and cook game meat thoroughly. Tularemia can be inadvertently aerosolized if an infected animal or carcass is run over with a tractor or lawnmower. Checking for carcasses before mowing may reduce the risk.

 

Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected]. (Also [email protected].) 

Reference

1. Rich SN et al. Tularemia—United States, 2011-2022. MMWR Morb Mortal Wkly Rep 2025;73:1152–1156. doi: 

The pediatrician’s first patient of the day was an 8-year-old boy, accompanied by both of his parents. It was the boy’s third visit in just over a week for fever and left-sided neck swelling, and the family was understandably anxious for answers.

“The antibiotics don’t seem to be working,” the mother explained. “He still has fever every day, as high as 104, and his neck looks just as swollen.”

A quick review of the chart revealed the boy’s initial diagnosis had been bacterial lymphadenitis, for which amoxicillin-clavulanate had been prescribed. Three days later, given lack of clinical improvement, therapy was transitioned to clindamycin. On examination, the boy was febrile and ill-appearing with a 3-cm by 5-cm tender, non-fluctuant swelling over the left sternocleidomastoid muscle. 

 

The pediatrician ran through a quick mental checklist of diagnostic possibilities for his patient’s continued symptoms. Staphylococcal lymphadenitis still seemed possible. Could the boy be infected with methicillin-resistant Staphylococcus aureus that was also clindamycin resistant? Alternately, perhaps the problem was “source control” and the boy had developed an occult neck abscess that needed to be drained. An ultrasound could help sort that out. Finally, the pediatrician considered less common bacterial causes of lymph node swelling and fever. He placed Bartonella henselae, the cause of cat scratch disease, near the top of his list. “I’ve never seen it,” he told the parents, “But we could also consider tularemia.”

Tularemia is a rare zoonotic infection caused by Francisella tularenis. On average, 200 cases of tularemia are reported in the United States each year, and the incidence of disease is increasing, according to a surveillance report released by the Centers for Disease Control and Prevention in December 2023.¹

Between 2011 and 2022, 2462 tularemia cases were reported in the United States. That translated to an average annual incidence of 0.064 per 100,000 population, an increase of 56% compared with 2001-2010. Forty-seven states reported at least one case of tularemia, although half of all reported cases came from four states — Arkansas (18%), Kansas (11%), Missouri (11%), and Oklahoma (10%). The incidence of tularemia was highest in children ages 5-9 years old, older men, and American Indian or Alaska Natives individuals. Although cases occurred year-round, 78% had symptom onset May through September. 

In the United States, most human cases of tularemia have been arthropod borne, transmitted by the bite of an infected tick or deer fly. Infection also can be spread through contact with infected animals or animal tissue, particularly rabbits, hares, muskrats, prairie dogs, and other rodents, including hamsters. Outbreaks of tularemia have occurred among pet store hamsters, and at least one child in the United States developed tularemia after being bitten by a pet hamster.

Tularemia is almost always associated with fever but other clinical manifestations vary by the type of exposure. Ulceroglandular disease occurs after a tick or deer fly bite or after handling an infected animal. An ulcer develops at the site where the bacteria entered the body, along with enlargement of regional lymph nodes. Less commonly, lymph node swelling can occur without the development of an ulcer. If the bacteria enter through the eye, symptoms include conjunctivitis and swelling of pre-auricular lymph nodes. Eating or drinking contaminated food or water is associated with sore throat, mouth ulcers, tonsillitis, and swelling of lymph glands in the neck. Pneumonic tularemia, the most serious form of the disease, typically happens after inhaling bacteria-containing dust or aerosols and is associated with cough, chest pain, and difficulty breathing. Pneumonic tularemia can develop if other forms of tularemia are untreated, and the bacteria spread to the lung.

Back in the exam room, the pediatrician carefully re-examined the boy’s scalp. A 1-cm poorly healing ulcer on the left occiput added support for the diagnosis of ulceroglandular tularemia, the most common form of the disease in children. Serologic testing ultimately confirmed the diagnosis and the boy’s symptoms resolved with treatment.

Gentamicin administered intravenously or intramuscularly is the drug of choice for the treatment of tularemia in children. Ciprofloxacin is considered an alternative but is not approved by the U.S. Food and Drug Administration for this indication.

The pediatrician reported the case of tularemia to his local health department. Tularemia is a nationally notifiable disease in the United States; state health departments report to the CDC through the National Notifiable Diseases Surveillance System. In turn, public health authorities shared information to prevent tularemia. Steps to prevent tick and deer fly bites include the use of an Environmental Protection Agency–registered insect repellent. Individuals who hunt, trap, or skin animals are encouraged to wear gloves when handling animals —especially rabbits, muskrats, and prairie dogs — and cook game meat thoroughly. Tularemia can be inadvertently aerosolized if an infected animal or carcass is run over with a tractor or lawnmower. Checking for carcasses before mowing may reduce the risk.

 

Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected]. (Also [email protected].) 

Reference

1. Rich SN et al. Tularemia—United States, 2011-2022. MMWR Morb Mortal Wkly Rep 2025;73:1152–1156. doi: 

The pediatrician’s first patient of the day was an 8-year-old boy, accompanied by both of his parents. It was the boy’s third visit in just over a week for fever and left-sided neck swelling, and the family was understandably anxious for answers.

“The antibiotics don’t seem to be working,” the mother explained. “He still has fever every day, as high as 104, and his neck looks just as swollen.”

A quick review of the chart revealed the boy’s initial diagnosis had been bacterial lymphadenitis, for which amoxicillin-clavulanate had been prescribed. Three days later, given lack of clinical improvement, therapy was transitioned to clindamycin. On examination, the boy was febrile and ill-appearing with a 3-cm by 5-cm tender, non-fluctuant swelling over the left sternocleidomastoid muscle. 

 

The pediatrician ran through a quick mental checklist of diagnostic possibilities for his patient’s continued symptoms. Staphylococcal lymphadenitis still seemed possible. Could the boy be infected with methicillin-resistant Staphylococcus aureus that was also clindamycin resistant? Alternately, perhaps the problem was “source control” and the boy had developed an occult neck abscess that needed to be drained. An ultrasound could help sort that out. Finally, the pediatrician considered less common bacterial causes of lymph node swelling and fever. He placed Bartonella henselae, the cause of cat scratch disease, near the top of his list. “I’ve never seen it,” he told the parents, “But we could also consider tularemia.”

Tularemia is a rare zoonotic infection caused by Francisella tularenis. On average, 200 cases of tularemia are reported in the United States each year, and the incidence of disease is increasing, according to a surveillance report released by the Centers for Disease Control and Prevention in December 2023.¹

Between 2011 and 2022, 2462 tularemia cases were reported in the United States. That translated to an average annual incidence of 0.064 per 100,000 population, an increase of 56% compared with 2001-2010. Forty-seven states reported at least one case of tularemia, although half of all reported cases came from four states — Arkansas (18%), Kansas (11%), Missouri (11%), and Oklahoma (10%). The incidence of tularemia was highest in children ages 5-9 years old, older men, and American Indian or Alaska Natives individuals. Although cases occurred year-round, 78% had symptom onset May through September. 

In the United States, most human cases of tularemia have been arthropod borne, transmitted by the bite of an infected tick or deer fly. Infection also can be spread through contact with infected animals or animal tissue, particularly rabbits, hares, muskrats, prairie dogs, and other rodents, including hamsters. Outbreaks of tularemia have occurred among pet store hamsters, and at least one child in the United States developed tularemia after being bitten by a pet hamster.

Tularemia is almost always associated with fever but other clinical manifestations vary by the type of exposure. Ulceroglandular disease occurs after a tick or deer fly bite or after handling an infected animal. An ulcer develops at the site where the bacteria entered the body, along with enlargement of regional lymph nodes. Less commonly, lymph node swelling can occur without the development of an ulcer. If the bacteria enter through the eye, symptoms include conjunctivitis and swelling of pre-auricular lymph nodes. Eating or drinking contaminated food or water is associated with sore throat, mouth ulcers, tonsillitis, and swelling of lymph glands in the neck. Pneumonic tularemia, the most serious form of the disease, typically happens after inhaling bacteria-containing dust or aerosols and is associated with cough, chest pain, and difficulty breathing. Pneumonic tularemia can develop if other forms of tularemia are untreated, and the bacteria spread to the lung.

Back in the exam room, the pediatrician carefully re-examined the boy’s scalp. A 1-cm poorly healing ulcer on the left occiput added support for the diagnosis of ulceroglandular tularemia, the most common form of the disease in children. Serologic testing ultimately confirmed the diagnosis and the boy’s symptoms resolved with treatment.

Gentamicin administered intravenously or intramuscularly is the drug of choice for the treatment of tularemia in children. Ciprofloxacin is considered an alternative but is not approved by the U.S. Food and Drug Administration for this indication.

The pediatrician reported the case of tularemia to his local health department. Tularemia is a nationally notifiable disease in the United States; state health departments report to the CDC through the National Notifiable Diseases Surveillance System. In turn, public health authorities shared information to prevent tularemia. Steps to prevent tick and deer fly bites include the use of an Environmental Protection Agency–registered insect repellent. Individuals who hunt, trap, or skin animals are encouraged to wear gloves when handling animals —especially rabbits, muskrats, and prairie dogs — and cook game meat thoroughly. Tularemia can be inadvertently aerosolized if an infected animal or carcass is run over with a tractor or lawnmower. Checking for carcasses before mowing may reduce the risk.

 

Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected]. (Also [email protected].) 

Reference

1. Rich SN et al. Tularemia—United States, 2011-2022. MMWR Morb Mortal Wkly Rep 2025;73:1152–1156. doi: 

Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

A study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.

Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

A study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.

Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

A study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.