Federal Practitioner

TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.

Evidence suggests there are four main symptom clusters: pain, body psychological, gastrointestinal, and body image. Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.

“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.

Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.

Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
 

A high burden

“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”

A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
 

Accelerated aging concerns

In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.

“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.

In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”

Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.

The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
 

More research needed

“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”

Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”

Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
 

‘Absolutely useful’

The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.

“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”

People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.

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

TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.

Evidence suggests there are four main symptom clusters: pain, body psychological, gastrointestinal, and body image. Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.

“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.

Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.

Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
 

A high burden

“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”

A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
 

Accelerated aging concerns

In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.

“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.

In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”

Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.

The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
 

More research needed

“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”

Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”

Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
 

‘Absolutely useful’

The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.

“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”

People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.

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

TAMPA – People living with HIV experience many symptoms that can be grouped into “clusters” to help guide therapy and ideally treat more than one symptom at a time in an effort to improve quality of life, according to a study presented at the annual meeting of the Association of Nurses in AIDS Care.

Evidence suggests there are four main symptom clusters: pain, body psychological, gastrointestinal, and body image. Interestingly, these symptoms were more common among people living with HIV who are older than 45 years versus those who are younger, with one exception.

“In HIV, with exception of anxiety, we saw older people had more symptoms than younger ones,” said Natalie Wilson, PhD, assistant professor of community health systems at the University of California, San Francisco.

Dr. Wilson and colleagues performed a study that also suggests the older group experienced more distress from their symptoms than the younger cohort, again with the exception of anxiety.

Symptom clusters are two or more related symptoms that occur together with or without the same etiology. “Imagine you can’t sleep and the next day you’re tired and have no energy, you have trouble remembering someone’s name ... and then the next night you get so anxious about not getting sleep that it keeps you from sleeping.” That’s an example of a symptom cluster, Dr. Wilson said.
 

A high burden

“Why should we even evaluate symptom clusters?” Dr. Wilson asked. “The symptom burden is still high in people living with HIV. The medications got better but the symptoms remain.”

A high symptom burden also is linked to lower adherence to antiretrovirals. Also, considering groups of symptoms together could lead to targeted interventions that treat multiple symptoms, she said, “instead of treating one symptom at a time and increasing the pill burden for people living with HIV.”
 

Accelerated aging concerns

In addition, people living with HIV can experience accelerated aging, which is one reason Dr. Wilson and colleagues chose the 45-year-old cutoff in the study. Living with inflammation from HIV and the toxicity of earlier treatments likely contribute.

“Those over age 45 have higher rates of age-associated noncommunicable comorbidities developing at an earlier age than uninfected people with comparable lifestyles and demographics,” Dr. Wilson said.

In the full study, published in the Journal of Pain and Symptom Management, a total 2,000 people living with HIV completed the 20-item HIV Symptom Index. The participants reported their symptoms on their first visit to one of six national HIV Centers of Excellence. People were asked to report presence or absence of a particular symptom, and if they had it, how distressing it was on a scale of 1 “doesn’t bother me” to 4 “bothers me a lot.”

Younger people not only reported more anxiety but were also more distressed by it, Dr. Wilson said. The older group was more likely to be distressed by muscle aches and joint pain, trouble remembering things, and more.

The mean age in the younger group was 35 years, and it was 55 years in the older group. A total of 86% in the younger group and 87% in the older were men, and there were some differences by race, Dr. Wilson said.
 

More research needed

“These findings warrant further confirmation,” Dr. Wilson added. Future work could evaluate whether symptom clusters share etiology and how symptom clusters change over time. “We need to look at outcomes over time. Can we predict poorer outcomes, such as cardiac events, over time based on symptom clusters?”

Also, as part of HIV treatment success in recent years, “Our guidelines are moving people out further – if you’re undetectable sometimes you can come back at 6 months or 1 year.” The question, she said, is then: “Do we need to watch people with certain symptom clusters more closely?”

Limitations of the study include a lack of information on symptom causes and severity and its cross-sectional design.
 

‘Absolutely useful’

The study is “absolutely useful,” said session moderator Cheryl Netherly, an HIV nurse and clinical educator for CAN Community Health headquartered in Sarasota, Fla.

“One of the things that she mentioned was people with HIV, especially long-term HIV, they’re aging faster than the population without HIV. So, that is really important to look at.”

People living with HIV and dying from age-related comorbidities is something “we never thought would happen,” Ms. Netherly said. “Unfortunately, we’re now losing them to the different things like kidney issues, heart disease, and diabetes.”

The study was funded by the National Institute of Allergy and Infectious Diseases. Dr. Wilson and Ms. Netherly disclosed no relevant financial relationships.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

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

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

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

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

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

Intermittent fasting may reduce acid exposure time and improve symptoms for individuals with suspected gastroesophageal reflux disease (GERD), although the intervention may be hard to follow, suggests a small U.S. study.

Twenty-five individuals with suspected GERD symptoms underwent 96-hour pH monitoring. They were asked to follow their normal diet for the first 48 hours; for the second 48 hours, they were asked to switch to a 16-hour fast, which was followed by an 8-hour eating window.

Just over a third of participants were fully compliant with the 16:8 intermittent fasting. But those who followed the regimen experienced a mild reduction in mean acid exposure time and self-reported GERD symptoms scores.

The research was published online by the Journal of Clinical Gastroenterology.
 

Costly condition

The prevalence of GERD in the United States is estimated at 18%-28%. Annual costs of the condition are more than $18 billion per year, largely through pharmacologic therapies and diagnostic testing, write lead author Yan Jiang, MD, division of gastrointestinal and liver D-diseases, Keck Medicine of University of Southern California, Los Angeles, and colleagues.

Proton pump inhibitor (PPI) therapy is one of the most prescribed classes of medications in the United States, the authors write. But concerns over the long-term safety of the drugs, as well as the fact that half of patients report breakthrough GERD symptoms, have generated interest in non-PPI treatments among patients and providers.

The role of diet in the management of GERD, however, remains poorly understood, despite the fact that obesity and weight gain have been linked to reflux.

The authors note that intermittent fasting has shown benefits in coronary artery disease, inflammatory disorders, obesity, and diabetes. Proposed mechanisms include anti-inflammatory effects, weight loss, and alterations in hormone secretion.
 

Intervention test in a 96-hour clinical evaluation for GERD

To investigate the effects of intermittent fasting in GERD, the researchers screened patients referred to the Stanford University gastrointestinal clinic for diagnostic 96-hour ambulatory wireless pH monitoring of suspected acid reflux symptoms.

They excluded patients younger than 18 years, pregnant women, those with insulin-dependent diabetes, and those who had used PPIs within the previous 7 days. There were other exclusion criteria as well.

The study was completed by 25 participants. The mean age of the patients was 43.5 years; 52% were women. Just under half (44%) were White, and the mean body mass index was 25.8 kg/m².

For the first 48 hours of the pH monitoring, the patients followed their baseline diet. For the second 48 hours, they were asked to follow an intermittent fasting regimen.

In that regimen, during a 24-hour period, there was an 8-hour caloric intake window and no caloric intake during the other 16 consecutive hours. Participants who fasted for at least 15 hours, as indicated on a self-report food log, were considered successful.

Only 36% of participants were fully adherent to the fasting regimen; 84% were partially compliant, defined as following the regimen for at least 1 of the 2 days of intermittent fasting.

On intermittent fasting days, the mean acid exposure time was 3.5%, compared with 4.3% on the baseline diet. The team calculated that adhering to the 16:8 intermittent fasting regimen reduced the mean acid exposure time by 0.64%.

Intermittent fasting was also associated with a reduction in total GERD symptom scores, at 9.9 following day 4 versus 14.3 following day 2. There were reductions in heartburn symptoms scores of 2.6 and in regurgitation scores of 1.8.

When the researchers compared individuals who were compliant with intermittent fasting with those who were only partially compliant, they found that there was still an improvement in GERD symptoms, with a reduction in scores of 3.2.
 

More acid, bigger benefits

There could be several explanations for the findings, Dr. Jiang said in an interview.

In the short-term study, fewer meals during intermittent fasting and more hours between the last meal and bedtime can help with the supine symptoms of GERD, Dr. Jiang said.

Over the longer term, he added, previous studies have suggested that fasting-induced alterations in inflammatory cytokines or cells could be a contributory mechanism, “but it’s not something that we can glean from our study.”

Participants with elevated acid exposure at baseline and who were more likely to have GERD diagnosed by the pH monitoring seemed to experience the greatest benefit from intermittent fasting, Dr. Jiang pointed out.

“This study looked at all comers with GERD symptoms,” he said. “But if you were to do another study with people with proven GERD, they might experience a bigger impact with intermittent fasting.”

Dr. Jiang added, “If a patient is willing to do intermittent fasting, and certainly if they have other reasons [for doing so], I think it doesn’t hurt, and it might actually help them a little bit in their current symptoms.”
 

Larger scale, longer follow-up studies needed

Luigi Bonavina, MD, department of biomedical sciences for health, University of Milan, IRCCS Policlinico San Donato, Italy, said in an interview that it was a “nice, original study.”

It is “noteworthy that only one previous study explored the effect of Ramadan on GERD symptoms and found a small improvement of GERD symptoms,” Dr. Bonavina said. “Unfortunately, the magnitude of effect [in the current study] was not as one may have expected, due to small sample size and low compliance with intermittent fasting.”

Although the effect was “mild compared to that seen with PPIs,” it would “be interesting to see whether the results of this pilot, proof-of-concept study can be confirmed on a larger scale with longer follow-up to prove that reflux symptoms will not worsen over time,” he said.

“Intermittent fasting may be recommended, especially in overweight-obese patients with GERD symptoms who are poor responders to gastric acid inhibitors,” Dr. Bonavina added. “Reduction of inflammation, reduction of meal intake, and going to bed with an empty stomach may also work in patients with GERD.”

No funding for the study has been declared. The authors and Dr. Bonavina report no relevant financial relationships.

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

Intermittent fasting may reduce acid exposure time and improve symptoms for individuals with suspected gastroesophageal reflux disease (GERD), although the intervention may be hard to follow, suggests a small U.S. study.

Twenty-five individuals with suspected GERD symptoms underwent 96-hour pH monitoring. They were asked to follow their normal diet for the first 48 hours; for the second 48 hours, they were asked to switch to a 16-hour fast, which was followed by an 8-hour eating window.

Just over a third of participants were fully compliant with the 16:8 intermittent fasting. But those who followed the regimen experienced a mild reduction in mean acid exposure time and self-reported GERD symptoms scores.

The research was published online by the Journal of Clinical Gastroenterology.
 

Costly condition

The prevalence of GERD in the United States is estimated at 18%-28%. Annual costs of the condition are more than $18 billion per year, largely through pharmacologic therapies and diagnostic testing, write lead author Yan Jiang, MD, division of gastrointestinal and liver D-diseases, Keck Medicine of University of Southern California, Los Angeles, and colleagues.

Proton pump inhibitor (PPI) therapy is one of the most prescribed classes of medications in the United States, the authors write. But concerns over the long-term safety of the drugs, as well as the fact that half of patients report breakthrough GERD symptoms, have generated interest in non-PPI treatments among patients and providers.

The role of diet in the management of GERD, however, remains poorly understood, despite the fact that obesity and weight gain have been linked to reflux.

The authors note that intermittent fasting has shown benefits in coronary artery disease, inflammatory disorders, obesity, and diabetes. Proposed mechanisms include anti-inflammatory effects, weight loss, and alterations in hormone secretion.
 

Intervention test in a 96-hour clinical evaluation for GERD

To investigate the effects of intermittent fasting in GERD, the researchers screened patients referred to the Stanford University gastrointestinal clinic for diagnostic 96-hour ambulatory wireless pH monitoring of suspected acid reflux symptoms.

They excluded patients younger than 18 years, pregnant women, those with insulin-dependent diabetes, and those who had used PPIs within the previous 7 days. There were other exclusion criteria as well.

The study was completed by 25 participants. The mean age of the patients was 43.5 years; 52% were women. Just under half (44%) were White, and the mean body mass index was 25.8 kg/m².

For the first 48 hours of the pH monitoring, the patients followed their baseline diet. For the second 48 hours, they were asked to follow an intermittent fasting regimen.

In that regimen, during a 24-hour period, there was an 8-hour caloric intake window and no caloric intake during the other 16 consecutive hours. Participants who fasted for at least 15 hours, as indicated on a self-report food log, were considered successful.

Only 36% of participants were fully adherent to the fasting regimen; 84% were partially compliant, defined as following the regimen for at least 1 of the 2 days of intermittent fasting.

On intermittent fasting days, the mean acid exposure time was 3.5%, compared with 4.3% on the baseline diet. The team calculated that adhering to the 16:8 intermittent fasting regimen reduced the mean acid exposure time by 0.64%.

Intermittent fasting was also associated with a reduction in total GERD symptom scores, at 9.9 following day 4 versus 14.3 following day 2. There were reductions in heartburn symptoms scores of 2.6 and in regurgitation scores of 1.8.

When the researchers compared individuals who were compliant with intermittent fasting with those who were only partially compliant, they found that there was still an improvement in GERD symptoms, with a reduction in scores of 3.2.
 

More acid, bigger benefits

There could be several explanations for the findings, Dr. Jiang said in an interview.

In the short-term study, fewer meals during intermittent fasting and more hours between the last meal and bedtime can help with the supine symptoms of GERD, Dr. Jiang said.

Over the longer term, he added, previous studies have suggested that fasting-induced alterations in inflammatory cytokines or cells could be a contributory mechanism, “but it’s not something that we can glean from our study.”

Participants with elevated acid exposure at baseline and who were more likely to have GERD diagnosed by the pH monitoring seemed to experience the greatest benefit from intermittent fasting, Dr. Jiang pointed out.

“This study looked at all comers with GERD symptoms,” he said. “But if you were to do another study with people with proven GERD, they might experience a bigger impact with intermittent fasting.”

Dr. Jiang added, “If a patient is willing to do intermittent fasting, and certainly if they have other reasons [for doing so], I think it doesn’t hurt, and it might actually help them a little bit in their current symptoms.”
 

Larger scale, longer follow-up studies needed

Luigi Bonavina, MD, department of biomedical sciences for health, University of Milan, IRCCS Policlinico San Donato, Italy, said in an interview that it was a “nice, original study.”

It is “noteworthy that only one previous study explored the effect of Ramadan on GERD symptoms and found a small improvement of GERD symptoms,” Dr. Bonavina said. “Unfortunately, the magnitude of effect [in the current study] was not as one may have expected, due to small sample size and low compliance with intermittent fasting.”

Although the effect was “mild compared to that seen with PPIs,” it would “be interesting to see whether the results of this pilot, proof-of-concept study can be confirmed on a larger scale with longer follow-up to prove that reflux symptoms will not worsen over time,” he said.

“Intermittent fasting may be recommended, especially in overweight-obese patients with GERD symptoms who are poor responders to gastric acid inhibitors,” Dr. Bonavina added. “Reduction of inflammation, reduction of meal intake, and going to bed with an empty stomach may also work in patients with GERD.”

No funding for the study has been declared. The authors and Dr. Bonavina report no relevant financial relationships.

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

Intermittent fasting may reduce acid exposure time and improve symptoms for individuals with suspected gastroesophageal reflux disease (GERD), although the intervention may be hard to follow, suggests a small U.S. study.

Twenty-five individuals with suspected GERD symptoms underwent 96-hour pH monitoring. They were asked to follow their normal diet for the first 48 hours; for the second 48 hours, they were asked to switch to a 16-hour fast, which was followed by an 8-hour eating window.

Just over a third of participants were fully compliant with the 16:8 intermittent fasting. But those who followed the regimen experienced a mild reduction in mean acid exposure time and self-reported GERD symptoms scores.

The research was published online by the Journal of Clinical Gastroenterology.
 

Costly condition

The prevalence of GERD in the United States is estimated at 18%-28%. Annual costs of the condition are more than $18 billion per year, largely through pharmacologic therapies and diagnostic testing, write lead author Yan Jiang, MD, division of gastrointestinal and liver D-diseases, Keck Medicine of University of Southern California, Los Angeles, and colleagues.

Proton pump inhibitor (PPI) therapy is one of the most prescribed classes of medications in the United States, the authors write. But concerns over the long-term safety of the drugs, as well as the fact that half of patients report breakthrough GERD symptoms, have generated interest in non-PPI treatments among patients and providers.

The role of diet in the management of GERD, however, remains poorly understood, despite the fact that obesity and weight gain have been linked to reflux.

The authors note that intermittent fasting has shown benefits in coronary artery disease, inflammatory disorders, obesity, and diabetes. Proposed mechanisms include anti-inflammatory effects, weight loss, and alterations in hormone secretion.
 

Intervention test in a 96-hour clinical evaluation for GERD

To investigate the effects of intermittent fasting in GERD, the researchers screened patients referred to the Stanford University gastrointestinal clinic for diagnostic 96-hour ambulatory wireless pH monitoring of suspected acid reflux symptoms.

They excluded patients younger than 18 years, pregnant women, those with insulin-dependent diabetes, and those who had used PPIs within the previous 7 days. There were other exclusion criteria as well.

The study was completed by 25 participants. The mean age of the patients was 43.5 years; 52% were women. Just under half (44%) were White, and the mean body mass index was 25.8 kg/m².

For the first 48 hours of the pH monitoring, the patients followed their baseline diet. For the second 48 hours, they were asked to follow an intermittent fasting regimen.

In that regimen, during a 24-hour period, there was an 8-hour caloric intake window and no caloric intake during the other 16 consecutive hours. Participants who fasted for at least 15 hours, as indicated on a self-report food log, were considered successful.

Only 36% of participants were fully adherent to the fasting regimen; 84% were partially compliant, defined as following the regimen for at least 1 of the 2 days of intermittent fasting.

On intermittent fasting days, the mean acid exposure time was 3.5%, compared with 4.3% on the baseline diet. The team calculated that adhering to the 16:8 intermittent fasting regimen reduced the mean acid exposure time by 0.64%.

Intermittent fasting was also associated with a reduction in total GERD symptom scores, at 9.9 following day 4 versus 14.3 following day 2. There were reductions in heartburn symptoms scores of 2.6 and in regurgitation scores of 1.8.

When the researchers compared individuals who were compliant with intermittent fasting with those who were only partially compliant, they found that there was still an improvement in GERD symptoms, with a reduction in scores of 3.2.
 

More acid, bigger benefits

There could be several explanations for the findings, Dr. Jiang said in an interview.

In the short-term study, fewer meals during intermittent fasting and more hours between the last meal and bedtime can help with the supine symptoms of GERD, Dr. Jiang said.

Over the longer term, he added, previous studies have suggested that fasting-induced alterations in inflammatory cytokines or cells could be a contributory mechanism, “but it’s not something that we can glean from our study.”

Participants with elevated acid exposure at baseline and who were more likely to have GERD diagnosed by the pH monitoring seemed to experience the greatest benefit from intermittent fasting, Dr. Jiang pointed out.

“This study looked at all comers with GERD symptoms,” he said. “But if you were to do another study with people with proven GERD, they might experience a bigger impact with intermittent fasting.”

Dr. Jiang added, “If a patient is willing to do intermittent fasting, and certainly if they have other reasons [for doing so], I think it doesn’t hurt, and it might actually help them a little bit in their current symptoms.”
 

Larger scale, longer follow-up studies needed

Luigi Bonavina, MD, department of biomedical sciences for health, University of Milan, IRCCS Policlinico San Donato, Italy, said in an interview that it was a “nice, original study.”

It is “noteworthy that only one previous study explored the effect of Ramadan on GERD symptoms and found a small improvement of GERD symptoms,” Dr. Bonavina said. “Unfortunately, the magnitude of effect [in the current study] was not as one may have expected, due to small sample size and low compliance with intermittent fasting.”

Although the effect was “mild compared to that seen with PPIs,” it would “be interesting to see whether the results of this pilot, proof-of-concept study can be confirmed on a larger scale with longer follow-up to prove that reflux symptoms will not worsen over time,” he said.

“Intermittent fasting may be recommended, especially in overweight-obese patients with GERD symptoms who are poor responders to gastric acid inhibitors,” Dr. Bonavina added. “Reduction of inflammation, reduction of meal intake, and going to bed with an empty stomach may also work in patients with GERD.”

No funding for the study has been declared. The authors and Dr. Bonavina report no relevant financial relationships.

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

An increase in liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) may be predictive of poor clinical outcomes in patients with nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.

In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.

Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
 

Study findings

Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.

They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).

They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.

The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.

Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.

At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.

In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).

The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.

Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.

A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).

In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.

Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.

“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
 

Progression definition questioned

Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.

Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.

Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].

Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.

The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.

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

An increase in liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) may be predictive of poor clinical outcomes in patients with nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.

In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.

Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
 

Study findings

Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.

They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).

They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.

The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.

Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.

At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.

In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).

The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.

Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.

A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).

In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.

Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.

“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
 

Progression definition questioned

Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.

Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.

Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].

Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.

The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.

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

An increase in liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) may be predictive of poor clinical outcomes in patients with nonalcoholic fatty liver disease (NAFLD), according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
 

Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.

In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.

Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
 

Study findings

Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.

They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).

They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.

The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.

Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.

At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.

In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).

The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.

Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.

A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).

In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.

Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.

“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
 

Progression definition questioned

Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.

Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.

Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].

Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.

The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.

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

The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer-reviewed.

Key takeaway

• Acute atrial fibrillation (AF) is an independent predictor of severity of neurological deficits from early acute ischemic stroke and a high-probability predictor of death within 30 days after such strokes.

Why this matters

• A comprehensive understanding of the relationship between acute AF and risk for acute ischemic stroke and prognosis will help improve management and treatment of patients with acute ischemic stroke.

Study design

• The retrospective study included patients with acute ischemic stroke within the prior 24 hours; 12-lead electrocardiogram in the emergency department; and hospitalization and treatment at the hospital stroke center.
• The cohort of 706 patients admitted to a single center in Shanghai, China, from December 2019 to December 2021, included 142 with episodes of acute AF and 564 without such episodes.
• Patients with acute ischemic stroke and acute AF – including AF of new onset, paroxysmal, persistent, or permanent with symptoms such as palpitations or dizziness attributed to rapid ventricular rates – were identified.
• Neurological deficits were assessed using the 7-day National Institutes of Health Stroke Scale/Score (NIHSS). Patients with a 7-day NIHSS score of at least 16 were considered to have moderate to severe stroke.
• Associations between acute AF onset and the severity of early neurological deficits were assessed and related to all-cause mortality within 30 days of the stroke.

Key results

• Patients with acute AF were older than those without acute AF (80.3 years vs. 71.0 years; P < .001).
• Baseline NIHSS scores averaged 16.09 for the stroke patients with acute AF and 8.65 for those without acute AF (P < .001).
• Significantly more patients with acute AF than without acute AF had a 7-day NIHSS score of at least 16 (45.1% vs. 14.4%; P < .001).
• More patients with than without acute AF underwent transcatheter thrombectomy (44.4% vs. 24.5%; P < .001) or received thrombolytic therapy (31.6% vs. 19.7%; P = .005).
• Patients aged 73 years or older showed baseline NIHSS score and acute AF as independent risk factors for early neurological deficits in stroke patients admitted to the emergency department.
• Mortality at 30 days was significantly higher in patients with acute AF than in those without acute AF (30.3% vs. 10.1%; P < .001).
• Baseline NIHSS had an adjusted odds ratio for 30-day mortality of 1.18 (95% confidence interval, 1.15-1.22; P < .001).  
• Other independent predictors included acute AF (1.87 [95% CI, 1.09-3.19; P = .022]) and age 73 or older (2.00 [95% CI, 1.18-3.37; P = .01]).

Limitations

• The study was retrospective and didn’t have access to some potentially relevant data, such as duration of AF.
• The single-center study with limited generalizability does not necessarily represent the broad population of stroke patients in China or elsewhere.

Disclosures

• This study was supported by the Cardiovascular Multidisciplinary Integrated Research Fund and Construction of Shanghai Municipal Health Commission.
• The authors report no relevant financial relationships.

This is a summary of a preprint research study, “Acute Atrial Fibrillation During Onset of Stroke Indicates Higher Probability of Post-Stroke Death Outcomes,” written by Yongxia Li, from the Shanghai Sixth People’s Hospital, and colleagues, on ResearchSquare.com. This study has not yet been peer reviewed. The full text of the study can be found on ResearchSquare.com.A version of this article first appeared on Medscape.com.

The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer-reviewed.

Key takeaway

• Acute atrial fibrillation (AF) is an independent predictor of severity of neurological deficits from early acute ischemic stroke and a high-probability predictor of death within 30 days after such strokes.

Why this matters

• A comprehensive understanding of the relationship between acute AF and risk for acute ischemic stroke and prognosis will help improve management and treatment of patients with acute ischemic stroke.

Study design

• The retrospective study included patients with acute ischemic stroke within the prior 24 hours; 12-lead electrocardiogram in the emergency department; and hospitalization and treatment at the hospital stroke center.
• The cohort of 706 patients admitted to a single center in Shanghai, China, from December 2019 to December 2021, included 142 with episodes of acute AF and 564 without such episodes.
• Patients with acute ischemic stroke and acute AF – including AF of new onset, paroxysmal, persistent, or permanent with symptoms such as palpitations or dizziness attributed to rapid ventricular rates – were identified.
• Neurological deficits were assessed using the 7-day National Institutes of Health Stroke Scale/Score (NIHSS). Patients with a 7-day NIHSS score of at least 16 were considered to have moderate to severe stroke.
• Associations between acute AF onset and the severity of early neurological deficits were assessed and related to all-cause mortality within 30 days of the stroke.

Key results

• Patients with acute AF were older than those without acute AF (80.3 years vs. 71.0 years; P < .001).
• Baseline NIHSS scores averaged 16.09 for the stroke patients with acute AF and 8.65 for those without acute AF (P < .001).
• Significantly more patients with acute AF than without acute AF had a 7-day NIHSS score of at least 16 (45.1% vs. 14.4%; P < .001).
• More patients with than without acute AF underwent transcatheter thrombectomy (44.4% vs. 24.5%; P < .001) or received thrombolytic therapy (31.6% vs. 19.7%; P = .005).
• Patients aged 73 years or older showed baseline NIHSS score and acute AF as independent risk factors for early neurological deficits in stroke patients admitted to the emergency department.
• Mortality at 30 days was significantly higher in patients with acute AF than in those without acute AF (30.3% vs. 10.1%; P < .001).
• Baseline NIHSS had an adjusted odds ratio for 30-day mortality of 1.18 (95% confidence interval, 1.15-1.22; P < .001).  
• Other independent predictors included acute AF (1.87 [95% CI, 1.09-3.19; P = .022]) and age 73 or older (2.00 [95% CI, 1.18-3.37; P = .01]).

Limitations

• The study was retrospective and didn’t have access to some potentially relevant data, such as duration of AF.
• The single-center study with limited generalizability does not necessarily represent the broad population of stroke patients in China or elsewhere.

Disclosures

• This study was supported by the Cardiovascular Multidisciplinary Integrated Research Fund and Construction of Shanghai Municipal Health Commission.
• The authors report no relevant financial relationships.

This is a summary of a preprint research study, “Acute Atrial Fibrillation During Onset of Stroke Indicates Higher Probability of Post-Stroke Death Outcomes,” written by Yongxia Li, from the Shanghai Sixth People’s Hospital, and colleagues, on ResearchSquare.com. This study has not yet been peer reviewed. The full text of the study can be found on ResearchSquare.com.A version of this article first appeared on Medscape.com.

The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer-reviewed.

Key takeaway

• Acute atrial fibrillation (AF) is an independent predictor of severity of neurological deficits from early acute ischemic stroke and a high-probability predictor of death within 30 days after such strokes.

Why this matters

• A comprehensive understanding of the relationship between acute AF and risk for acute ischemic stroke and prognosis will help improve management and treatment of patients with acute ischemic stroke.

Study design

• The retrospective study included patients with acute ischemic stroke within the prior 24 hours; 12-lead electrocardiogram in the emergency department; and hospitalization and treatment at the hospital stroke center.
• The cohort of 706 patients admitted to a single center in Shanghai, China, from December 2019 to December 2021, included 142 with episodes of acute AF and 564 without such episodes.
• Patients with acute ischemic stroke and acute AF – including AF of new onset, paroxysmal, persistent, or permanent with symptoms such as palpitations or dizziness attributed to rapid ventricular rates – were identified.
• Neurological deficits were assessed using the 7-day National Institutes of Health Stroke Scale/Score (NIHSS). Patients with a 7-day NIHSS score of at least 16 were considered to have moderate to severe stroke.
• Associations between acute AF onset and the severity of early neurological deficits were assessed and related to all-cause mortality within 30 days of the stroke.

Key results

• Patients with acute AF were older than those without acute AF (80.3 years vs. 71.0 years; P < .001).
• Baseline NIHSS scores averaged 16.09 for the stroke patients with acute AF and 8.65 for those without acute AF (P < .001).
• Significantly more patients with acute AF than without acute AF had a 7-day NIHSS score of at least 16 (45.1% vs. 14.4%; P < .001).
• More patients with than without acute AF underwent transcatheter thrombectomy (44.4% vs. 24.5%; P < .001) or received thrombolytic therapy (31.6% vs. 19.7%; P = .005).
• Patients aged 73 years or older showed baseline NIHSS score and acute AF as independent risk factors for early neurological deficits in stroke patients admitted to the emergency department.
• Mortality at 30 days was significantly higher in patients with acute AF than in those without acute AF (30.3% vs. 10.1%; P < .001).
• Baseline NIHSS had an adjusted odds ratio for 30-day mortality of 1.18 (95% confidence interval, 1.15-1.22; P < .001).  
• Other independent predictors included acute AF (1.87 [95% CI, 1.09-3.19; P = .022]) and age 73 or older (2.00 [95% CI, 1.18-3.37; P = .01]).

Limitations

• The study was retrospective and didn’t have access to some potentially relevant data, such as duration of AF.
• The single-center study with limited generalizability does not necessarily represent the broad population of stroke patients in China or elsewhere.

Disclosures

• This study was supported by the Cardiovascular Multidisciplinary Integrated Research Fund and Construction of Shanghai Municipal Health Commission.
• The authors report no relevant financial relationships.

This is a summary of a preprint research study, “Acute Atrial Fibrillation During Onset of Stroke Indicates Higher Probability of Post-Stroke Death Outcomes,” written by Yongxia Li, from the Shanghai Sixth People’s Hospital, and colleagues, on ResearchSquare.com. This study has not yet been peer reviewed. The full text of the study can be found on ResearchSquare.com.A version of this article first appeared on Medscape.com.

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

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

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

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

After recovery from acute infection with SARS-CoV-2, major stressful life events such as the death of a loved one or financial insecurity can have a significant impact on the development of long COVID symptoms, new research suggests.

Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.

These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.

The findings were published online in the Journal of the Neurological Sciences.
 

Major stressful events common

Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points. 

Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.

In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8. 

The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.

Long-term sequelae of COVID are increasingly recognized as major public health issues. 

It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work. 
 

Holistic approach

Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”

She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”

Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.

She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.

“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.

“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.

The study had no commercial funding. The investigators reported no relevant financial relationships.

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

On one of the first days of medical school, Adaira Landry, MD, applied her favorite dark shade of lipstick and headed to her orientation. She was eager to learn about program expectations and connect with fellow aspiring physicians. But when Dr. Landry got there, one of her brand-new peers turned to her and asked, “Why do you wear your lipstick like an angry Black woman?”

“Imagine hearing that,” Dr. Landry, now an emergency medical physician in Boston, says. “It was so hurtful.”

So, what is a “standard-issue doctor” expected to look like? Physicians manage their appearances in myriad ways: through clothes, accessories, hair style, makeup; through a social media presence or lack thereof; in the rhythms and nuances of their interactions with patients and colleagues. These things add up to a professional “persona” – the Latin word for “mask,” or the face on display for the world to see.

Professional personae exist across various industries, but some standards for professionalism in medicine reflect a particularly narrow view of what a physician can or should be. While the health care field itself is diversifying, its guidelines for professionalism appear slower to change, often excluding or frowning upon expressions of individual personality or identity.

“Medicine is run primarily by men. It’s an objective truth,” Dr. Landry says. “Currently and historically, the standard of professionalism, especially in the physical sense, was set by them. As we increase diversity and welcome people bringing their authentic self to work, the prior definitions of professionalism are obviously in need of change.”
 

Split social media personalities

In August 2020, the Journal of Vascular Surgery published a study on the “prevalence of unprofessional social media content among young vascular surgeons.” The content that was deemed “unprofessional” included opinions on political issues like abortion and gun control. Photos of physicians holding alcoholic drinks or wearing “inappropriate/offensive attire,” including underwear, “provocative Halloween costumes,” and “bikinis/swimwear” were also censured. Six men and one woman worked on the study, and three of the male researchers took on the task of seeking out the “unprofessional” photos on social media. The resulting paper was reviewed by an all-male editorial board.

The study sparked immediate backlash and prompted hundreds of health care professionals to post photos of themselves in bathing suits with the hashtag “#medbikini.” The journal then retracted the study and issued an apology on Twitter, recognizing “errors in the design of the study with regards to conscious and unconscious bias.”

The researchers’ original definition of professionalism suggests that physicians should manage their personae even outside of work hours. “I think medicine in general is a very conservative and hierarchical field of study and of work, to say the least,” says Sarah Fraser, MD, a family medicine physician in Nova Scotia, Canada. “There’s this view that we have to have completely separate personal and professional lives, like church and state.”

The #medbikini controversy inspired Dr. Fraser to write an op-ed for the British Medical Journal blog about the flaws of requiring physicians to keep their personal and professional selves separate. The piece referenced Robert Louis Stevenson’s 1886 Gothic novella “The Strange Case of Dr. Jekyll and Mr. Hyde,” in which the respected scientist Dr. Jekyll creates an alter ego so he can express his evil urges without experiencing guilt, punishment, or loss of livelihood. Dr. Fraser likened this story to the pressure physicians feel to shrink or split themselves to squeeze into a narrow definition of professionalism.

But Dr. Landry points out that some elements of expression seen as unprofessional cannot be entirely separated from a physician’s fundamental identity. “For Black women, our daily behaviors and forms of expression that are deemed ‘unprofessional’ are much more subtle than being able to wear a bikini on social media,” she says. “The way we wear our hair, the tone of our voice, the color of our lipstick, the way we wear scrub caps are parts of us that are called into question.”
 

Keeping up appearances

The stereotype of what a doctor should look like starts to shape physicians’ professional personae in medical school. When Jennifer Caputo-Seidler, MD, started medical school in 2008, the dress code requirements for male students were simple: pants, a button-down shirt, a tie. But then there were the rules for women: Hair should be tied back. Minimal makeup. No flashy jewelry. Nothing without sleeves. Neutral colors. High necklines. Low hemlines. “The message I got was that we need to dress like the men in order to be taken seriously and to be seen as professional,” says Dr. Caputo-Seidler, now an assistant professor of medicine at the University of South Florida, Tampa, “and so that’s what I did.”

A 2018 analysis of 78 “draw-a-scientist” studies found that children have overwhelmingly associated scientific fields with men for the last 50 years. Overall, children drew 73% of scientists as men. The drawings grew more gender diverse over time, but even as more women entered scientific fields, both boys and girls continued to draw significantly more male than female scientists.

Not everyone at Dr. Caputo-Seidler’s medical school adhered to the environment’s gendered expectations. One resident she worked with often wore voluminous hairstyles, lipstick, and high heels. Dr. Caputo-Seidler overheard her peers as they gossiped behind the resident’s back, ridiculing the way she looked.

“She was good at her job,” Dr. Caputo-Seidler says. “She knew her patients. She had things down. She was, by all measures, very competent. But when people saw her dressing outside the norm and being forward with her femininity, there was definitely a lot of chatter about it.”

While expectations for a conservative appearance may disproportionately affect women, and particularly women of color, they also affect men who deviate from the norm. “As an LGBTQ+ person working as a ‘professional,’ I have countless stories and moments where I had my professionalism questioned,” Blair Peters, MD, a plastic surgeon and assistant professor at Oregon Health & Science University, Portland, wrote on Twitter. “Why is it ‘unprofessional’ to have colored hair? Why is it ‘unprofessional’ to have a visible tattoo? Why is it ‘unprofessional’ to wear bright colors and patterns?”

Dr. Fraser remembers a fellow medical student who had full-sleeve tattoos on both of his arms. A preceptor made a comment about it to Dr. Fraser, and then instructed the student to cover up his tattoos. “I think that there are scenarios when having tattoos or having different-colored hair or expressing your individual personality could help you even better bond with your patients,” Dr. Fraser says, “especially if you’re, for example, working with youth.”
 

Unmasking health care

Beyond the facets of dress codes and social media posts, the issue of professional personae speaks to the deeper issue of inclusion in medicine. As the field grows increasingly diverse, health care institutions and those they serve may need to expand their definitions of professionalism to include more truthful expressions of who contemporary health care professionals are as people.

Dr. Fraser suggests that the benefits of physicians embracing self-expression – rather than assimilating to an outdated model of professionalism – extend beyond the individual.

“Whether it comes to what you choose to wear to the clinic on a day-to-day basis, or what you choose to share on a social media account, as long as it’s not harming others, then I think that it’s a positive thing to be able to be yourself and express yourself,” she says. “I feel like doctors are expected to have a different personality when we’re at the clinic, and usually it’s more conservative or objective or aloof. But I think that by being open about who we are, we’ll actually help build a trusting relationship with both patients and society.”

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

Headlines over the past few weeks are ringing the alarm about earlier and more serious influenza (flu) and respiratory syncytial virus (RSV) outbreaks compared with previous years. Add COVID-19 to the mix and you have a dangerous mash of viruses that have many experts calling for caution and searching for explanations.

RSV and the flu “are certainly getting more attention, and they’re getting more attention for two reasons,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University, Nashville, Tenn.

“The first is that they’re both extraordinarily early. The second is that they’re both out there spreading very, very rapidly,” he told this news organization.

RSV usually follows a seasonal pattern with cases peaking in January and February. Both viruses tend to hit different regions of the country at different times, and that’s not the case in 2022.

“This is particularly striking for RSV, which usually doesn’t affect the entire country simultaneously,” Dr. Schaffner said.

“Yes, RSV is causing many more hospitalizations and earlier than any previously recorded season in the U.S.,” according to figures from the Centers for Disease Control and Prevention on RSV hospitalizations, said Kevin Messacar, MD, PhD, associate professor at the University of Colorado at Denver, Aurora, and a pediatric infectious disease specialist at Children’s Hospital Colorado in Aurora.

Although there could be some increase in diagnoses because of increased awareness, the jump in RSV and flu cases “is a real phenomenon for multiple reasons,” said Peter Chin-Hong, MD, professor in the division of infectious diseases at the University of California, San Francisco.

With fewer COVID-related restrictions, people are moving around more. Also, during fall and winter, people tend to gather indoors. Colder temperatures and lower humidity contribute as well, Dr. Chin-Hong said, because “the droplets are just simply lighter.

“I think those are all factors,” he told this news organization.

Paul Auwaerter, MD, agreed that there are likely multiple causes for the unusual timing and severity of RSV and flu this year.

“Change in behaviors is a leading cause,” said the clinical director for the division of infectious diseases at the Johns Hopkins University, Baltimore. More people returning to the workplace and children going to school without masks are examples, he added.

Less exposure to these three viruses also means there was less immune boosting among existing populations, he said. This can lead to “larger susceptible populations, especially infants and younger children, due to the relative absence of circulating virus in past years.”
 

A leading theory

Are we paying a price now for people following the edicts from officials to mask up, stand apart, and take other personal and public health precautions during the COVID-19 pandemic?

It’s possible, but that may not be the whole story.

“When it comes to RSV, I think that theory of isolation, social distancing, mask wearing, and not attending schools is a very valid one,” Dr. Schaffner said. “That’s everybody’s favorite [reason].”

He said he is confident that the jump in RSV cases is being driven by previous COVID public health protections. However, he’s “a little more cautious about influenza, in part because influenza is so variable.

“Like people in influenza say, if you’ve seen one influenza season, you’ve seen one influenza season,” Dr. Schaffner said.

“There’s a lot of debate,” he added. “Nobody can say definitively whether the immune deficit or debt is a consequence of not being stimulated and restimulated by the influenza virus over the past two seasons.”
 

‘A perfect storm’

“Now you kind of have the perfect storm,” Dr. Chin-Hong said. “It’s not a good situation for COVID with the variants that are emerging. For influenza, not having seen a lot of influenza the last 2 years, we’re probably more susceptible to getting infected.”

RSV cases rose during summer 2021, but now the weather is colder, and people are interacting more closely. “And it’s very, very transmissible,” he said.

Dr. Chin-Hong also predicted that “even though we don’t have a lot of COVID now, COVID will probably pick up.”

The rise in RSV was unexpected by some experts. “This early influenza is also a bit of a surprise and may be influenced by the fact that lots of us are going back and seeing each other again close-to-close, face-to-face in many enclosed environments,” Dr. Schaffner said.

He estimated the 2022-2023 flu season started 4-6 weeks early “and it’s taken off like a rocket. It started in the Southeast, quickly went to the Southwest and up the East Coast. Now it’s moving dramatically through the Midwest and will continue. It’s quite sure to hit the West Coast if it isn’t there already.”
 

A phenomenon by any other name

Some are calling the situation an “immunity debt,” while others dub it an “immunity pause” or an “immunity deficit.” Many physicians and immunologists have taken to social media to push back on the term “immunity debt,” saying it’s a mischaracterization that is being used to vilify COVID precautions, such as masking, social distancing, and other protective measures taken during the pandemic.

“I prefer the term ‘immunity gap’ ... which is more established in the epidemiology literature, especially given the politicization of the term ‘immunity debt’ by folks recently,” Dr. Messacar said.

“To me, the immunity gap is a scientific observation, not a political argument,” he added.

In a July 2022 publication in The Lancet, Dr. Messacar and his colleagues stated that “decreased exposure to endemic viruses created an immunity gap – a group of susceptible individuals who avoided infection and therefore lack pathogen-specific immunity to protect against future infection. Decreases in childhood vaccinations with pandemic disruptions to health care delivery contribute to this immunity gap for vaccine-preventable diseases, such as influenza,measles, and polio.”

The researchers noted that because of isolation during the pandemic, older children and newborns are being exposed to RSV for the first time. Returning to birthday parties, playing with friends, and going to school without masks means “children are being exposed to RSV, and that’s likely the reason that RSV is moving early and very, very substantially through this now expanded pool of susceptible children,” Dr. Schaffner said.
 

How likely are coinfections?

With peaks in RSV, flu, and COVID-19 cases each predicted in the coming months, how likely is it that someone could get sick with more than one infection at the same time?

Early in the pandemic, coinfection with COVID and the flu was reported in people at some centers on the West Coast, Dr. Auwaerter said. Now, however, “the unpredictable nature of the Omicron subvariants and the potential for further change, along with the never-before-seen significant lessening of influenza over 2 years, leave little for predictability.

“I do think it is less likely, given the extent of immunity now to SARS-CoV-2 in the population,” Dr. Auwaerter said.

“I most worry about viral coinfections ... in people with suppressed immune systems if we have high community rates of the SARS-CoV-2 and influenza circulating this fall and winter,” he added.

Studies during the pandemic suggest that coinfection with the SARS-CoV-2 virus and another respiratory virus were either rare or nonexistent.

Dr. Schaffner said these findings align with his experience at Vanderbilt University, which is part of a CDC-sponsored network that tracks laboratory-confirmed RSV, flu, and COVID cases among people in the hospital. “Coinfections are, at least to date, very unusual.”

There needs to be an asterisk next to that, Dr. Schaffner added. “Looking back over the last 2 years, we’ve had very little influenza, and we’ve had curtailed RSV seasons. So there hasn’t been a whole lot of opportunity for dual infections to occur.

“So this year may be more revelatory as we go forward,” he said.