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Hairdressers have ‘excess risk’ of contact allergies

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When compared with the general population, hairdressers experience an excess risk of contact allergy linked to hair cosmetic ingredients, a systematic review suggests.

“Research has shown that up to 70% of hairdressers suffer from work-related skin damage, mostly hand dermatitis, at some point during their career,” write Wolfgang Uter of Friedrich-Alexander University Erlangen-Nürnberg and coauthors. In general, they write, occupational skin diseases such as hand dermatitis represent up to 35% of reported occupational diseases. The study was published online in Contact Dermatitis.

Wet work and skin contact with detergents and hairdressing chemicals are top risk factors for developing occupational skin disease in this population, according to the researchers.

To further understand the burden of occupational contact allergy in hairdressers, the investigators gathered evidence published since 2000 on contact allergies to hair cosmetic chemicals. They searched the literature for nine substances selected beforehand by experts and stakeholders. The researchers also examined the prevalence of sensitization between hairdressers and other individuals given skin patch tests.
 

Substance by substance

Common potentially sensitizing cosmetic ingredients reported across studies included p-phenylenediamine (PPD), persulfates (mostly ammonium persulfate [APS]), glyceryl thioglycolate (GMTG), and ammonium thioglycolate (ATG).

In a pooled analysis, the overall prevalence of contact allergy to PPD was 4.3% in consecutively patch-tested patients, but in hairdressers specifically, the overall prevalence of contact allergy to this ingredient was 28.6%, reviewers reported.

The pooled prevalence of contact allergy to APS was 5.5% in consumers and 17.2% in hairdressers. In other review studies, contact allergy risks to APS, GMTG, and ATG were also elevated in hairdressers compared with all controls.



The calculated relative risk (RR) of contact allergy to PPD was approximately 5.4 higher for hairdressers, while the RR for ATG sensitization was 3.4 in hairdressers compared with consumers.

Commenting on these findings, James A. Yiannias, MD, professor of dermatology at the Mayo Medical School, Phoenix, told this news organization in an email that many providers and patients are concerned only about hair dye molecules such as PPD and aminophenol, as well as permanent, wave, and straightening chemicals such as GMTG.

“Although these are common allergens in hairdressers, allergens such as fragrances and some preservatives found in daily hair care products such as shampoos, conditioners, and hair sprays are also common causes of contact dermatitis,” said Dr. Yiannias, who wasn’t involved in the research.

Consequences of exposure

Dr. Yiannias explained that progressive worsening of the dermatitis can occur with ongoing allergen exposure and, if not properly mitigated, can lead to bigger issues. “Initial nuisances of mild irritation and hyperkeratosis can evolve to a state of fissuring with the risk of bleeding and significant pain,” he said.

But once severe and untreated dermatitis occurs, Dr. Yiannias said that hairdressers “may need to change careers” or at least face short- or long-term unemployment.

The researchers suggest reducing exposure to the allergen is key for prevention of symptoms, adding that adequate guidance on the safe use of new products is needed. Also, the researchers suggested that vocational schools should more rigorously implement education for hairdressers that addresses how to protect the skin appropriately at work.

“Hairdressers are taught during their training to be cautious about allergen exposure by avoiding touching high-risk ingredients such as hair dyes,” Dr. Yiannias added. “However, in practice, this is very difficult since the wearing of gloves can impair the tactile sensations that hairdressers often feel is essential in performing their job.”

The study received no industry funding. Dr. Yiannias reports no relevant financial relationships.

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

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When compared with the general population, hairdressers experience an excess risk of contact allergy linked to hair cosmetic ingredients, a systematic review suggests.

“Research has shown that up to 70% of hairdressers suffer from work-related skin damage, mostly hand dermatitis, at some point during their career,” write Wolfgang Uter of Friedrich-Alexander University Erlangen-Nürnberg and coauthors. In general, they write, occupational skin diseases such as hand dermatitis represent up to 35% of reported occupational diseases. The study was published online in Contact Dermatitis.

Wet work and skin contact with detergents and hairdressing chemicals are top risk factors for developing occupational skin disease in this population, according to the researchers.

To further understand the burden of occupational contact allergy in hairdressers, the investigators gathered evidence published since 2000 on contact allergies to hair cosmetic chemicals. They searched the literature for nine substances selected beforehand by experts and stakeholders. The researchers also examined the prevalence of sensitization between hairdressers and other individuals given skin patch tests.
 

Substance by substance

Common potentially sensitizing cosmetic ingredients reported across studies included p-phenylenediamine (PPD), persulfates (mostly ammonium persulfate [APS]), glyceryl thioglycolate (GMTG), and ammonium thioglycolate (ATG).

In a pooled analysis, the overall prevalence of contact allergy to PPD was 4.3% in consecutively patch-tested patients, but in hairdressers specifically, the overall prevalence of contact allergy to this ingredient was 28.6%, reviewers reported.

The pooled prevalence of contact allergy to APS was 5.5% in consumers and 17.2% in hairdressers. In other review studies, contact allergy risks to APS, GMTG, and ATG were also elevated in hairdressers compared with all controls.



The calculated relative risk (RR) of contact allergy to PPD was approximately 5.4 higher for hairdressers, while the RR for ATG sensitization was 3.4 in hairdressers compared with consumers.

Commenting on these findings, James A. Yiannias, MD, professor of dermatology at the Mayo Medical School, Phoenix, told this news organization in an email that many providers and patients are concerned only about hair dye molecules such as PPD and aminophenol, as well as permanent, wave, and straightening chemicals such as GMTG.

“Although these are common allergens in hairdressers, allergens such as fragrances and some preservatives found in daily hair care products such as shampoos, conditioners, and hair sprays are also common causes of contact dermatitis,” said Dr. Yiannias, who wasn’t involved in the research.

Consequences of exposure

Dr. Yiannias explained that progressive worsening of the dermatitis can occur with ongoing allergen exposure and, if not properly mitigated, can lead to bigger issues. “Initial nuisances of mild irritation and hyperkeratosis can evolve to a state of fissuring with the risk of bleeding and significant pain,” he said.

But once severe and untreated dermatitis occurs, Dr. Yiannias said that hairdressers “may need to change careers” or at least face short- or long-term unemployment.

The researchers suggest reducing exposure to the allergen is key for prevention of symptoms, adding that adequate guidance on the safe use of new products is needed. Also, the researchers suggested that vocational schools should more rigorously implement education for hairdressers that addresses how to protect the skin appropriately at work.

“Hairdressers are taught during their training to be cautious about allergen exposure by avoiding touching high-risk ingredients such as hair dyes,” Dr. Yiannias added. “However, in practice, this is very difficult since the wearing of gloves can impair the tactile sensations that hairdressers often feel is essential in performing their job.”

The study received no industry funding. Dr. Yiannias reports no relevant financial relationships.

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

When compared with the general population, hairdressers experience an excess risk of contact allergy linked to hair cosmetic ingredients, a systematic review suggests.

“Research has shown that up to 70% of hairdressers suffer from work-related skin damage, mostly hand dermatitis, at some point during their career,” write Wolfgang Uter of Friedrich-Alexander University Erlangen-Nürnberg and coauthors. In general, they write, occupational skin diseases such as hand dermatitis represent up to 35% of reported occupational diseases. The study was published online in Contact Dermatitis.

Wet work and skin contact with detergents and hairdressing chemicals are top risk factors for developing occupational skin disease in this population, according to the researchers.

To further understand the burden of occupational contact allergy in hairdressers, the investigators gathered evidence published since 2000 on contact allergies to hair cosmetic chemicals. They searched the literature for nine substances selected beforehand by experts and stakeholders. The researchers also examined the prevalence of sensitization between hairdressers and other individuals given skin patch tests.
 

Substance by substance

Common potentially sensitizing cosmetic ingredients reported across studies included p-phenylenediamine (PPD), persulfates (mostly ammonium persulfate [APS]), glyceryl thioglycolate (GMTG), and ammonium thioglycolate (ATG).

In a pooled analysis, the overall prevalence of contact allergy to PPD was 4.3% in consecutively patch-tested patients, but in hairdressers specifically, the overall prevalence of contact allergy to this ingredient was 28.6%, reviewers reported.

The pooled prevalence of contact allergy to APS was 5.5% in consumers and 17.2% in hairdressers. In other review studies, contact allergy risks to APS, GMTG, and ATG were also elevated in hairdressers compared with all controls.



The calculated relative risk (RR) of contact allergy to PPD was approximately 5.4 higher for hairdressers, while the RR for ATG sensitization was 3.4 in hairdressers compared with consumers.

Commenting on these findings, James A. Yiannias, MD, professor of dermatology at the Mayo Medical School, Phoenix, told this news organization in an email that many providers and patients are concerned only about hair dye molecules such as PPD and aminophenol, as well as permanent, wave, and straightening chemicals such as GMTG.

“Although these are common allergens in hairdressers, allergens such as fragrances and some preservatives found in daily hair care products such as shampoos, conditioners, and hair sprays are also common causes of contact dermatitis,” said Dr. Yiannias, who wasn’t involved in the research.

Consequences of exposure

Dr. Yiannias explained that progressive worsening of the dermatitis can occur with ongoing allergen exposure and, if not properly mitigated, can lead to bigger issues. “Initial nuisances of mild irritation and hyperkeratosis can evolve to a state of fissuring with the risk of bleeding and significant pain,” he said.

But once severe and untreated dermatitis occurs, Dr. Yiannias said that hairdressers “may need to change careers” or at least face short- or long-term unemployment.

The researchers suggest reducing exposure to the allergen is key for prevention of symptoms, adding that adequate guidance on the safe use of new products is needed. Also, the researchers suggested that vocational schools should more rigorously implement education for hairdressers that addresses how to protect the skin appropriately at work.

“Hairdressers are taught during their training to be cautious about allergen exposure by avoiding touching high-risk ingredients such as hair dyes,” Dr. Yiannias added. “However, in practice, this is very difficult since the wearing of gloves can impair the tactile sensations that hairdressers often feel is essential in performing their job.”

The study received no industry funding. Dr. Yiannias reports no relevant financial relationships.

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

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ACC/AHA issues updated guidance on aortic disease

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Fri, 11/04/2022 - 13:50

The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

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The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

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Working while sick: Why doctors don’t stay home when ill

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Fri, 11/04/2022 - 13:19

Before the pandemic, physicians came to work sick, as people do in many other professions. The reasons are likely as varied as, “you weren’t feeling bad enough to miss work,” “you couldn’t afford to miss pay,” “you had too many patients to see,” or “too much work to do.”

In Medscape’s Employed Physicians Report: Loving the Focus, Hating the Bureaucracy, 61% of physicians reported that they sometimes or often come to work sick. Only 2% of respondents said they never come to work unwell.

Medscape wanted to know more about how often you call in sick, how often you come to work feeling unwell, what symptoms you have, and the dogma of your workplace culture regarding sick days. Not to mention the brutal ethos that starts in medical school, in which calling in sick shows weakness or is unacceptable.

So, we polled 2,347 physicians in the United States and abroad and asked them about their sniffling, sneezing, cold, flu, and fever symptoms, and, of course, COVID. Results were split about 50-50 among male and female physicians. The poll ran from Sept. 28 through Oct. 11.
 

Coming to work sick

It’s no surprise that the majority of physicians who were polled (85%) have come to work sick in 2022. In the last prepandemic year (2019), about 70% came to work feeling sick one to five times, and 13% worked while sick six to ten times.

When asked about the symptoms that they’ve previously come to work with, 48% of U.S. physicians said multiple symptoms. They gave high marks for runny nose, cough, congestion, and sore throat. Only 27% have worked with a fever, 22% have worked with other symptoms, and 7% have worked with both strep throat and COVID.

“My workplace, especially in the COVID years, accommodates persons who honestly do not feel well enough to report. Sooner or later, everyone covers for someone else who has to be out,” says Kenneth Abbott, MD, an oncologist in Maryland.
 

The culture of working while sick

Why doctors come to work when they’re sick is complicated. The overwhelming majority of U.S. respondents cited professional obligations; 73% noted that they feel a professional obligation to their patients, and 72% feel a professional obligation to their co-workers. Half of the polled U.S. physicians said they didn’t feel bad enough to stay home, while 48% said they had too much work to do to stay home.

Some 45% said the expectation at their workplace is to come to work unless seriously ill; 43% had too many patients to see; and 18% didn’t think they were contagious when they headed to work sick. Unfortunately, 15% chose to work while sick because otherwise they would lose pay.

In light of these responses, it’s not surprising that 93% reported they’d seen other medical professionals working when sick.

“My schedule is almost always booked weeks in advance. If someone misses or has to cancel their appointment, they typically have 2-4 weeks to wait to get back in. If I was sick and a full day of patients (or God forbid more than a day) had to be canceled because I called in, it’s so much more work when I return,” says Caitlin Briggs, MD, a psychiatrist in Lexington, Ky.
 

 

 

Doctors’ workplace sick day policy

Most employees’ benefits allow at least a few sick days, but doctors who treat society’s ill patients don’t seem to stay home from work when they’re suffering. So, we asked physicians, official policy aside, whether they thought going to work sick was expected in their workplace. The majority (76%) said yes, while 24% said no.

“Unless I’m dying or extremely contagious, I usually work. At least now, I have the telehealth option. Not saying any of this is right, but it’s the reality we deal with and the choice we must make,” says Dr. Briggs.

Additionally, 58% of polled physicians said their workplace did not have a clearly defined policy against coming to work sick, while 20% said theirs did, and 22% weren’t sure.

“The first thing I heard on the subject as a medical student was that sick people come to the hospital, so if you’re sick, then you come to the hospital too ... to work. If you can’t work, then you will be admitted. Another aphorism was from Churchill, that ‘most of the world’s work is done by people who don’t feel very well,’ ” says Paul Andreason, MD, a psychiatrist in Bethesda, Md.
 

Working in the time of COVID

Working while ill during ordinary times is one thing, but what about working in the time of COVID? Has the pandemic changed the culture of coming to work sick because medical facilities, such as doctor’s offices and hospitals, don’t want their staff coming in when they have COVID?

Surprisingly, when we asked physicians whether the pandemic has made it more or less acceptable to come to work sick, only 61% thought COVID has made it less acceptable to work while sick, while 16% thought it made it more acceptable, and 23% said there’s no change.

“I draw the line at fevers/chills, feeling like you’ve just been run over, or significant enteritis,” says Dr. Abbott. “Also, if I have to take palliative meds that interfere with alertness, I’m not doing my patients any favors.”

While a minority of physicians may call in sick, most still suffer through their sneezing, coughing, chills, and fever while seeing patients as usual.

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

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Before the pandemic, physicians came to work sick, as people do in many other professions. The reasons are likely as varied as, “you weren’t feeling bad enough to miss work,” “you couldn’t afford to miss pay,” “you had too many patients to see,” or “too much work to do.”

In Medscape’s Employed Physicians Report: Loving the Focus, Hating the Bureaucracy, 61% of physicians reported that they sometimes or often come to work sick. Only 2% of respondents said they never come to work unwell.

Medscape wanted to know more about how often you call in sick, how often you come to work feeling unwell, what symptoms you have, and the dogma of your workplace culture regarding sick days. Not to mention the brutal ethos that starts in medical school, in which calling in sick shows weakness or is unacceptable.

So, we polled 2,347 physicians in the United States and abroad and asked them about their sniffling, sneezing, cold, flu, and fever symptoms, and, of course, COVID. Results were split about 50-50 among male and female physicians. The poll ran from Sept. 28 through Oct. 11.
 

Coming to work sick

It’s no surprise that the majority of physicians who were polled (85%) have come to work sick in 2022. In the last prepandemic year (2019), about 70% came to work feeling sick one to five times, and 13% worked while sick six to ten times.

When asked about the symptoms that they’ve previously come to work with, 48% of U.S. physicians said multiple symptoms. They gave high marks for runny nose, cough, congestion, and sore throat. Only 27% have worked with a fever, 22% have worked with other symptoms, and 7% have worked with both strep throat and COVID.

“My workplace, especially in the COVID years, accommodates persons who honestly do not feel well enough to report. Sooner or later, everyone covers for someone else who has to be out,” says Kenneth Abbott, MD, an oncologist in Maryland.
 

The culture of working while sick

Why doctors come to work when they’re sick is complicated. The overwhelming majority of U.S. respondents cited professional obligations; 73% noted that they feel a professional obligation to their patients, and 72% feel a professional obligation to their co-workers. Half of the polled U.S. physicians said they didn’t feel bad enough to stay home, while 48% said they had too much work to do to stay home.

Some 45% said the expectation at their workplace is to come to work unless seriously ill; 43% had too many patients to see; and 18% didn’t think they were contagious when they headed to work sick. Unfortunately, 15% chose to work while sick because otherwise they would lose pay.

In light of these responses, it’s not surprising that 93% reported they’d seen other medical professionals working when sick.

“My schedule is almost always booked weeks in advance. If someone misses or has to cancel their appointment, they typically have 2-4 weeks to wait to get back in. If I was sick and a full day of patients (or God forbid more than a day) had to be canceled because I called in, it’s so much more work when I return,” says Caitlin Briggs, MD, a psychiatrist in Lexington, Ky.
 

 

 

Doctors’ workplace sick day policy

Most employees’ benefits allow at least a few sick days, but doctors who treat society’s ill patients don’t seem to stay home from work when they’re suffering. So, we asked physicians, official policy aside, whether they thought going to work sick was expected in their workplace. The majority (76%) said yes, while 24% said no.

“Unless I’m dying or extremely contagious, I usually work. At least now, I have the telehealth option. Not saying any of this is right, but it’s the reality we deal with and the choice we must make,” says Dr. Briggs.

Additionally, 58% of polled physicians said their workplace did not have a clearly defined policy against coming to work sick, while 20% said theirs did, and 22% weren’t sure.

“The first thing I heard on the subject as a medical student was that sick people come to the hospital, so if you’re sick, then you come to the hospital too ... to work. If you can’t work, then you will be admitted. Another aphorism was from Churchill, that ‘most of the world’s work is done by people who don’t feel very well,’ ” says Paul Andreason, MD, a psychiatrist in Bethesda, Md.
 

Working in the time of COVID

Working while ill during ordinary times is one thing, but what about working in the time of COVID? Has the pandemic changed the culture of coming to work sick because medical facilities, such as doctor’s offices and hospitals, don’t want their staff coming in when they have COVID?

Surprisingly, when we asked physicians whether the pandemic has made it more or less acceptable to come to work sick, only 61% thought COVID has made it less acceptable to work while sick, while 16% thought it made it more acceptable, and 23% said there’s no change.

“I draw the line at fevers/chills, feeling like you’ve just been run over, or significant enteritis,” says Dr. Abbott. “Also, if I have to take palliative meds that interfere with alertness, I’m not doing my patients any favors.”

While a minority of physicians may call in sick, most still suffer through their sneezing, coughing, chills, and fever while seeing patients as usual.

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

Before the pandemic, physicians came to work sick, as people do in many other professions. The reasons are likely as varied as, “you weren’t feeling bad enough to miss work,” “you couldn’t afford to miss pay,” “you had too many patients to see,” or “too much work to do.”

In Medscape’s Employed Physicians Report: Loving the Focus, Hating the Bureaucracy, 61% of physicians reported that they sometimes or often come to work sick. Only 2% of respondents said they never come to work unwell.

Medscape wanted to know more about how often you call in sick, how often you come to work feeling unwell, what symptoms you have, and the dogma of your workplace culture regarding sick days. Not to mention the brutal ethos that starts in medical school, in which calling in sick shows weakness or is unacceptable.

So, we polled 2,347 physicians in the United States and abroad and asked them about their sniffling, sneezing, cold, flu, and fever symptoms, and, of course, COVID. Results were split about 50-50 among male and female physicians. The poll ran from Sept. 28 through Oct. 11.
 

Coming to work sick

It’s no surprise that the majority of physicians who were polled (85%) have come to work sick in 2022. In the last prepandemic year (2019), about 70% came to work feeling sick one to five times, and 13% worked while sick six to ten times.

When asked about the symptoms that they’ve previously come to work with, 48% of U.S. physicians said multiple symptoms. They gave high marks for runny nose, cough, congestion, and sore throat. Only 27% have worked with a fever, 22% have worked with other symptoms, and 7% have worked with both strep throat and COVID.

“My workplace, especially in the COVID years, accommodates persons who honestly do not feel well enough to report. Sooner or later, everyone covers for someone else who has to be out,” says Kenneth Abbott, MD, an oncologist in Maryland.
 

The culture of working while sick

Why doctors come to work when they’re sick is complicated. The overwhelming majority of U.S. respondents cited professional obligations; 73% noted that they feel a professional obligation to their patients, and 72% feel a professional obligation to their co-workers. Half of the polled U.S. physicians said they didn’t feel bad enough to stay home, while 48% said they had too much work to do to stay home.

Some 45% said the expectation at their workplace is to come to work unless seriously ill; 43% had too many patients to see; and 18% didn’t think they were contagious when they headed to work sick. Unfortunately, 15% chose to work while sick because otherwise they would lose pay.

In light of these responses, it’s not surprising that 93% reported they’d seen other medical professionals working when sick.

“My schedule is almost always booked weeks in advance. If someone misses or has to cancel their appointment, they typically have 2-4 weeks to wait to get back in. If I was sick and a full day of patients (or God forbid more than a day) had to be canceled because I called in, it’s so much more work when I return,” says Caitlin Briggs, MD, a psychiatrist in Lexington, Ky.
 

 

 

Doctors’ workplace sick day policy

Most employees’ benefits allow at least a few sick days, but doctors who treat society’s ill patients don’t seem to stay home from work when they’re suffering. So, we asked physicians, official policy aside, whether they thought going to work sick was expected in their workplace. The majority (76%) said yes, while 24% said no.

“Unless I’m dying or extremely contagious, I usually work. At least now, I have the telehealth option. Not saying any of this is right, but it’s the reality we deal with and the choice we must make,” says Dr. Briggs.

Additionally, 58% of polled physicians said their workplace did not have a clearly defined policy against coming to work sick, while 20% said theirs did, and 22% weren’t sure.

“The first thing I heard on the subject as a medical student was that sick people come to the hospital, so if you’re sick, then you come to the hospital too ... to work. If you can’t work, then you will be admitted. Another aphorism was from Churchill, that ‘most of the world’s work is done by people who don’t feel very well,’ ” says Paul Andreason, MD, a psychiatrist in Bethesda, Md.
 

Working in the time of COVID

Working while ill during ordinary times is one thing, but what about working in the time of COVID? Has the pandemic changed the culture of coming to work sick because medical facilities, such as doctor’s offices and hospitals, don’t want their staff coming in when they have COVID?

Surprisingly, when we asked physicians whether the pandemic has made it more or less acceptable to come to work sick, only 61% thought COVID has made it less acceptable to work while sick, while 16% thought it made it more acceptable, and 23% said there’s no change.

“I draw the line at fevers/chills, feeling like you’ve just been run over, or significant enteritis,” says Dr. Abbott. “Also, if I have to take palliative meds that interfere with alertness, I’m not doing my patients any favors.”

While a minority of physicians may call in sick, most still suffer through their sneezing, coughing, chills, and fever while seeing patients as usual.

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

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Stroke risk rises with years of drinking in young adults

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Young adults who are moderate to heavy drinkers are at increased risk of suffering a stroke – and the risk goes up with more years of imbibing, a new study suggests.

“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.

“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.

The study was published online in Neurology.

Compounding effects

Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.

During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.

After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.

Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.

The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.

“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.

A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
 

Consistent evidence

“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.

This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.

“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.

The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.

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

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Young adults who are moderate to heavy drinkers are at increased risk of suffering a stroke – and the risk goes up with more years of imbibing, a new study suggests.

“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.

“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.

The study was published online in Neurology.

Compounding effects

Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.

During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.

After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.

Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.

The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.

“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.

A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
 

Consistent evidence

“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.

This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.

“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.

The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.

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

Young adults who are moderate to heavy drinkers are at increased risk of suffering a stroke – and the risk goes up with more years of imbibing, a new study suggests.

“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.

“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.

The study was published online in Neurology.

Compounding effects

Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.

During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.

After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.

Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.

The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.

“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.

A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
 

Consistent evidence

“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.

This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.

“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.

The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.

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

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New research confirms recommendations on COVID-19 boosters in MS

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New research confirms the importance of COVID-19 mRNA booster doses for patients with multiple sclerosis (MS) who are receiving the anti-CD20 monoclonal antibody ocrelizumab (Ocrevus), as currently recommended.

“We have shown that even MS patients whose B cells were depleted from circulation with ocrelizumab can mount immune responses to COVID-19 vaccines,” said lead study author Ilya Kister, MD, of NYU Langone’s Multiple Sclerosis Comprehensive Care Center in New York.

The findings were presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

VIOLA study

The data stem from VIOLA, an ongoing prospective study of humoral and cellular immune responses to COVID-19 vaccines in 60 patients with MS receiving ocrelizumab at MS care centers at NYU Langone and the University of Colorado Denver.

The mean age of participants was 38 years, 73% were women, all had been taking ocrelizumab for a mean of 1.7 years, and 45% had had COVID-19 prior to vaccination.

The researchers examined antibody and cellular responses to the two-dose series of mRNA COVID-19 vaccine (80% received the Pfizer-BioNTech vaccine, 18% the Moderna vaccine, and 2% unknown) over 24 weeks. In addition, 57% of the participants received the third dose/booster.

Results showed that antibody and cellular responses to SARS-CoV-2 spike protein significantly increased after the two-dose mRNA COVID-19 vaccination, though antibody responses tended to peak between 4 and 12 weeks and declined thereafter. There was no significant decline in cellular responses at week 24.

“The third dose ‘booster’ again significantly increased antibody and cellular responses compared with the pre–third dose levels,” Dr. Kister said.

“Importantly, cellular responses remained elevated or even increased from 4 weeks to 12 weeks after third dose/booster. Overall, these data strongly support the need for a third dose in MS patients on ocrelizumab,” Dr. Kister added.

Participants with “hybrid immunity” (those who had been infected with SARS-CoV-2 and who had also been vaccinated for COVID) had markedly higher SARS-CoV-2–specific antibody and cellular responses than those of peers with vaccine-only immunity.
 

CDC recs

Looking ahead, Dr. Kister said the VIOLA investigators plan to present data on the durability of COVID-19 vaccines in ocrelizumab-treated patients up to 48 weeks after the third dose.

For immunocompromised patients, such as those taking ocrelizumab, the Centers for Disease Control and Prevention considers the third dose of mRNA vaccine not as a “booster” but as part of the regular vaccine series.

“In other words, all these patients should receive three doses as part of their ‘primary’ series,” Dr. Kister noted.

The CDC also recommends receiving the updated booster for COVID-19 that became available in September 2022 (the fourth dose of the vaccine).

“Our study did not evaluate the efficacy of this fourth dose; but based on our results, it is reasonable to suppose that the fourth dose would also lead to a further increase in immune defenses,” Dr. Kister said.

The VIOLA study is an investigator-initiated collaboration supported by F. Hoffmann-La Roche Ltd/Genentech Inc. Dr. Kister has reported no relevant financial relationships.

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

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New research confirms the importance of COVID-19 mRNA booster doses for patients with multiple sclerosis (MS) who are receiving the anti-CD20 monoclonal antibody ocrelizumab (Ocrevus), as currently recommended.

“We have shown that even MS patients whose B cells were depleted from circulation with ocrelizumab can mount immune responses to COVID-19 vaccines,” said lead study author Ilya Kister, MD, of NYU Langone’s Multiple Sclerosis Comprehensive Care Center in New York.

The findings were presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

VIOLA study

The data stem from VIOLA, an ongoing prospective study of humoral and cellular immune responses to COVID-19 vaccines in 60 patients with MS receiving ocrelizumab at MS care centers at NYU Langone and the University of Colorado Denver.

The mean age of participants was 38 years, 73% were women, all had been taking ocrelizumab for a mean of 1.7 years, and 45% had had COVID-19 prior to vaccination.

The researchers examined antibody and cellular responses to the two-dose series of mRNA COVID-19 vaccine (80% received the Pfizer-BioNTech vaccine, 18% the Moderna vaccine, and 2% unknown) over 24 weeks. In addition, 57% of the participants received the third dose/booster.

Results showed that antibody and cellular responses to SARS-CoV-2 spike protein significantly increased after the two-dose mRNA COVID-19 vaccination, though antibody responses tended to peak between 4 and 12 weeks and declined thereafter. There was no significant decline in cellular responses at week 24.

“The third dose ‘booster’ again significantly increased antibody and cellular responses compared with the pre–third dose levels,” Dr. Kister said.

“Importantly, cellular responses remained elevated or even increased from 4 weeks to 12 weeks after third dose/booster. Overall, these data strongly support the need for a third dose in MS patients on ocrelizumab,” Dr. Kister added.

Participants with “hybrid immunity” (those who had been infected with SARS-CoV-2 and who had also been vaccinated for COVID) had markedly higher SARS-CoV-2–specific antibody and cellular responses than those of peers with vaccine-only immunity.
 

CDC recs

Looking ahead, Dr. Kister said the VIOLA investigators plan to present data on the durability of COVID-19 vaccines in ocrelizumab-treated patients up to 48 weeks after the third dose.

For immunocompromised patients, such as those taking ocrelizumab, the Centers for Disease Control and Prevention considers the third dose of mRNA vaccine not as a “booster” but as part of the regular vaccine series.

“In other words, all these patients should receive three doses as part of their ‘primary’ series,” Dr. Kister noted.

The CDC also recommends receiving the updated booster for COVID-19 that became available in September 2022 (the fourth dose of the vaccine).

“Our study did not evaluate the efficacy of this fourth dose; but based on our results, it is reasonable to suppose that the fourth dose would also lead to a further increase in immune defenses,” Dr. Kister said.

The VIOLA study is an investigator-initiated collaboration supported by F. Hoffmann-La Roche Ltd/Genentech Inc. Dr. Kister has reported no relevant financial relationships.

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

New research confirms the importance of COVID-19 mRNA booster doses for patients with multiple sclerosis (MS) who are receiving the anti-CD20 monoclonal antibody ocrelizumab (Ocrevus), as currently recommended.

“We have shown that even MS patients whose B cells were depleted from circulation with ocrelizumab can mount immune responses to COVID-19 vaccines,” said lead study author Ilya Kister, MD, of NYU Langone’s Multiple Sclerosis Comprehensive Care Center in New York.

The findings were presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
 

VIOLA study

The data stem from VIOLA, an ongoing prospective study of humoral and cellular immune responses to COVID-19 vaccines in 60 patients with MS receiving ocrelizumab at MS care centers at NYU Langone and the University of Colorado Denver.

The mean age of participants was 38 years, 73% were women, all had been taking ocrelizumab for a mean of 1.7 years, and 45% had had COVID-19 prior to vaccination.

The researchers examined antibody and cellular responses to the two-dose series of mRNA COVID-19 vaccine (80% received the Pfizer-BioNTech vaccine, 18% the Moderna vaccine, and 2% unknown) over 24 weeks. In addition, 57% of the participants received the third dose/booster.

Results showed that antibody and cellular responses to SARS-CoV-2 spike protein significantly increased after the two-dose mRNA COVID-19 vaccination, though antibody responses tended to peak between 4 and 12 weeks and declined thereafter. There was no significant decline in cellular responses at week 24.

“The third dose ‘booster’ again significantly increased antibody and cellular responses compared with the pre–third dose levels,” Dr. Kister said.

“Importantly, cellular responses remained elevated or even increased from 4 weeks to 12 weeks after third dose/booster. Overall, these data strongly support the need for a third dose in MS patients on ocrelizumab,” Dr. Kister added.

Participants with “hybrid immunity” (those who had been infected with SARS-CoV-2 and who had also been vaccinated for COVID) had markedly higher SARS-CoV-2–specific antibody and cellular responses than those of peers with vaccine-only immunity.
 

CDC recs

Looking ahead, Dr. Kister said the VIOLA investigators plan to present data on the durability of COVID-19 vaccines in ocrelizumab-treated patients up to 48 weeks after the third dose.

For immunocompromised patients, such as those taking ocrelizumab, the Centers for Disease Control and Prevention considers the third dose of mRNA vaccine not as a “booster” but as part of the regular vaccine series.

“In other words, all these patients should receive three doses as part of their ‘primary’ series,” Dr. Kister noted.

The CDC also recommends receiving the updated booster for COVID-19 that became available in September 2022 (the fourth dose of the vaccine).

“Our study did not evaluate the efficacy of this fourth dose; but based on our results, it is reasonable to suppose that the fourth dose would also lead to a further increase in immune defenses,” Dr. Kister said.

The VIOLA study is an investigator-initiated collaboration supported by F. Hoffmann-La Roche Ltd/Genentech Inc. Dr. Kister has reported no relevant financial relationships.

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

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Testosterone ranges for young men could help classify deficiency

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Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.

It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.

“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.

Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”

A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
 

NHANES data provide norms

The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).

Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.

After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.

Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.

Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).

As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.

“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
 

 

 

Hormone levels and symptoms not correlated

These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.

“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”

Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.

Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.

“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”

However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
 

Value of tertile cutoffs questioned

Two independent experts challenged the methodology and conclusions of this study.

Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.

“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.

The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”

The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.

“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.

Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”

Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
 

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Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.

It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.

“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.

Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”

A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
 

NHANES data provide norms

The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).

Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.

After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.

Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.

Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).

As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.

“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
 

 

 

Hormone levels and symptoms not correlated

These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.

“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”

Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.

Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.

“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”

However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
 

Value of tertile cutoffs questioned

Two independent experts challenged the methodology and conclusions of this study.

Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.

“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.

The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”

The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.

“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.

Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”

Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
 

Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.

It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.

“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.

Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”

A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
 

NHANES data provide norms

The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).

Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.

After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.

Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.

Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).

As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.

“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
 

 

 

Hormone levels and symptoms not correlated

These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.

“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”

Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.

Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.

“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”

However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
 

Value of tertile cutoffs questioned

Two independent experts challenged the methodology and conclusions of this study.

Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.

“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.

The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”

The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.

“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.

Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”

Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
 

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Thyroid nodule volume reduction correlates with energy in ablation

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Fri, 11/04/2022 - 12:55

– In the treatment of thyroid nodules with radiofrequency ablation (RFA), the amount of energy delivered per unit volume of the nodule strongly correlates with the extent of nodule volume reduction after 6 and 12 months, suggesting an important indicator of treatment success.

The findings “provide an objective measure or goal energy input to achieve during the [RFA] procedure rather than relying only on the subjective judgment of sonographic changes, and in turn, produce more reliable outcomes for our patients,” first author Samantha A. Wolfe, MD, said in an interview.

Dr. Wolfe, of the department of otolaryngology – head and neck surgery at Johns Hopkins University, Baltimore, presented the findings at the American Thyroid Association annual meeting.

Commenting on the study, Insoo Suh, MD, an associate professor and associate vice chair of Surgical Innovation at New York University Langone Health, agreed that “an accounting of the total amount of energy delivered can be a useful additional data point for the operator when they are determining whether an ablation is successful.”

He noted, however, that the location of a nodule can be an important factor when deciding upon amounts of RF energy.

“Some target areas are too close for comfort to critical structures, such as the trachea or the recurrent laryngeal nerve, so sound judgment would dictate that the energy be dialed down in those areas, even if the price you pay is a slightly lower volume reduction,” he explained. 
 

Analysis of patients given RFA at Johns Hopkins

RFA utilizes RF energy for the reduction of nodule compression and aesthetic symptoms, avoiding the need for thyroid hormone replacement or surgery.

And while decisions regarding RFA treatment location and duration are commonly guided by the operator’s judgment of sonographic changes, those assessments can potentially result in inconsistent outcomes.

In observing a relationship between higher amounts of RF energy and nodule volume reduction, Dr. Wolfe and associates conducted their prospective study of nodules treated by two experienced endocrine surgeons at Johns Hopkins between June 2019 and May 2022 at 6 and 12 months in relation to the amount of total energy delivered during the treatment.

The analysis included 101 nodules, which had a median initial volume of 12.9 mL.

After 6 months, the median volume reduction ratio was 60%, and at 12 months, the median reduction was 64%.

In terms of the goal of achieving 50% or more volume reduction at 6 months, the median energy delivered was significantly higher for nodules that did reach that goal compared with those that had a volume reduction of less than 50% (2,317 vs. 1,912 J/mL, respectively; P = .01).

The figures were similar at 12 months (2,031 vs. 1254 J/mL; P < .01).

In a logistic regression analysis, the amount of energy delivered strongly increased the odds of obtaining a volume reduction ratio of at least 50% (odds ratio, 2.58; P = .048).

“Every twofold increase in energy delivered increases the odds of achieving a 50% volume ratio reduction by 2.58 times,” Dr. Wolfe explained.

Likewise, the same twofold increase in energy delivered also increased the odds of achieving a greater than 80% volume ratio reduction by 2.55 times (OR, 2.55; P = .038), she added.
 

 

 

Information may help to decide who needs multiple ablations

Of note, the effect was stronger with smaller nodules. Those with an initial volume of less than 20 mL had a significantly greater volume ratio reduction than nodules that were 20 mL or larger (61% vs. 48%, respectively; P = .05).

The initial volume of nodules that did, and did not, achieve a 50% volume ratio reduction at 6 months were 10.9 mL versus 19.1 mL, and the initial volumes of those that did, and did not, have at least a 50% reduction at 12 months were 10.5 mL and 41.5 mL.

“At 6 and 12 months, the successfully treated nodules had a significantly smaller immediate initial volume than those that did not,” Dr. Wolfe said.

“This information may aid in identifying patients with large nodules that are less likely to achieve a greater than 50% volume reduction ratio and may require multiple treatments,” she added.

Other factors – including the probe tip size and total energy delivered – did not significantly correlate with volume ratio reduction at 6 or 12 months.

There was also no significant difference in terms of thyroid-stimulating hormone levels among nodules that achieved at least a 50% volume reduction and those that did not.

Nodules that did not have a satisfactory volume reduction at 12 months had a relatively large median total energy value delivered during ablation (103,463 J, compared with 25,969 J among those achieving more than 50% volume ratio reduction), which Dr. Wolfe said likely reflects that those nodules had a large initial volume.

“This speaks to the importance of describing the energy utilized per unit of nodule volume rather than just a gross measurement,” she said during her presentation.

Dr. Wolfe added that in terms of strategies for getting more energy into the nodule, a key approach is time.

“Sometimes you will see sonographic changes very quickly in the nodule, and it could be tempting to consider that area ablated and move on if you only rely on sonographic changes,” she said in an interview. “However, our research shows that, by spending more time, and thus inputting more energy into the nodule, we had better volume reduction.”

Dr. Wolfe and Dr. Suh reported no relevant financial relationships.

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

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– In the treatment of thyroid nodules with radiofrequency ablation (RFA), the amount of energy delivered per unit volume of the nodule strongly correlates with the extent of nodule volume reduction after 6 and 12 months, suggesting an important indicator of treatment success.

The findings “provide an objective measure or goal energy input to achieve during the [RFA] procedure rather than relying only on the subjective judgment of sonographic changes, and in turn, produce more reliable outcomes for our patients,” first author Samantha A. Wolfe, MD, said in an interview.

Dr. Wolfe, of the department of otolaryngology – head and neck surgery at Johns Hopkins University, Baltimore, presented the findings at the American Thyroid Association annual meeting.

Commenting on the study, Insoo Suh, MD, an associate professor and associate vice chair of Surgical Innovation at New York University Langone Health, agreed that “an accounting of the total amount of energy delivered can be a useful additional data point for the operator when they are determining whether an ablation is successful.”

He noted, however, that the location of a nodule can be an important factor when deciding upon amounts of RF energy.

“Some target areas are too close for comfort to critical structures, such as the trachea or the recurrent laryngeal nerve, so sound judgment would dictate that the energy be dialed down in those areas, even if the price you pay is a slightly lower volume reduction,” he explained. 
 

Analysis of patients given RFA at Johns Hopkins

RFA utilizes RF energy for the reduction of nodule compression and aesthetic symptoms, avoiding the need for thyroid hormone replacement or surgery.

And while decisions regarding RFA treatment location and duration are commonly guided by the operator’s judgment of sonographic changes, those assessments can potentially result in inconsistent outcomes.

In observing a relationship between higher amounts of RF energy and nodule volume reduction, Dr. Wolfe and associates conducted their prospective study of nodules treated by two experienced endocrine surgeons at Johns Hopkins between June 2019 and May 2022 at 6 and 12 months in relation to the amount of total energy delivered during the treatment.

The analysis included 101 nodules, which had a median initial volume of 12.9 mL.

After 6 months, the median volume reduction ratio was 60%, and at 12 months, the median reduction was 64%.

In terms of the goal of achieving 50% or more volume reduction at 6 months, the median energy delivered was significantly higher for nodules that did reach that goal compared with those that had a volume reduction of less than 50% (2,317 vs. 1,912 J/mL, respectively; P = .01).

The figures were similar at 12 months (2,031 vs. 1254 J/mL; P < .01).

In a logistic regression analysis, the amount of energy delivered strongly increased the odds of obtaining a volume reduction ratio of at least 50% (odds ratio, 2.58; P = .048).

“Every twofold increase in energy delivered increases the odds of achieving a 50% volume ratio reduction by 2.58 times,” Dr. Wolfe explained.

Likewise, the same twofold increase in energy delivered also increased the odds of achieving a greater than 80% volume ratio reduction by 2.55 times (OR, 2.55; P = .038), she added.
 

 

 

Information may help to decide who needs multiple ablations

Of note, the effect was stronger with smaller nodules. Those with an initial volume of less than 20 mL had a significantly greater volume ratio reduction than nodules that were 20 mL or larger (61% vs. 48%, respectively; P = .05).

The initial volume of nodules that did, and did not, achieve a 50% volume ratio reduction at 6 months were 10.9 mL versus 19.1 mL, and the initial volumes of those that did, and did not, have at least a 50% reduction at 12 months were 10.5 mL and 41.5 mL.

“At 6 and 12 months, the successfully treated nodules had a significantly smaller immediate initial volume than those that did not,” Dr. Wolfe said.

“This information may aid in identifying patients with large nodules that are less likely to achieve a greater than 50% volume reduction ratio and may require multiple treatments,” she added.

Other factors – including the probe tip size and total energy delivered – did not significantly correlate with volume ratio reduction at 6 or 12 months.

There was also no significant difference in terms of thyroid-stimulating hormone levels among nodules that achieved at least a 50% volume reduction and those that did not.

Nodules that did not have a satisfactory volume reduction at 12 months had a relatively large median total energy value delivered during ablation (103,463 J, compared with 25,969 J among those achieving more than 50% volume ratio reduction), which Dr. Wolfe said likely reflects that those nodules had a large initial volume.

“This speaks to the importance of describing the energy utilized per unit of nodule volume rather than just a gross measurement,” she said during her presentation.

Dr. Wolfe added that in terms of strategies for getting more energy into the nodule, a key approach is time.

“Sometimes you will see sonographic changes very quickly in the nodule, and it could be tempting to consider that area ablated and move on if you only rely on sonographic changes,” she said in an interview. “However, our research shows that, by spending more time, and thus inputting more energy into the nodule, we had better volume reduction.”

Dr. Wolfe and Dr. Suh reported no relevant financial relationships.

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

– In the treatment of thyroid nodules with radiofrequency ablation (RFA), the amount of energy delivered per unit volume of the nodule strongly correlates with the extent of nodule volume reduction after 6 and 12 months, suggesting an important indicator of treatment success.

The findings “provide an objective measure or goal energy input to achieve during the [RFA] procedure rather than relying only on the subjective judgment of sonographic changes, and in turn, produce more reliable outcomes for our patients,” first author Samantha A. Wolfe, MD, said in an interview.

Dr. Wolfe, of the department of otolaryngology – head and neck surgery at Johns Hopkins University, Baltimore, presented the findings at the American Thyroid Association annual meeting.

Commenting on the study, Insoo Suh, MD, an associate professor and associate vice chair of Surgical Innovation at New York University Langone Health, agreed that “an accounting of the total amount of energy delivered can be a useful additional data point for the operator when they are determining whether an ablation is successful.”

He noted, however, that the location of a nodule can be an important factor when deciding upon amounts of RF energy.

“Some target areas are too close for comfort to critical structures, such as the trachea or the recurrent laryngeal nerve, so sound judgment would dictate that the energy be dialed down in those areas, even if the price you pay is a slightly lower volume reduction,” he explained. 
 

Analysis of patients given RFA at Johns Hopkins

RFA utilizes RF energy for the reduction of nodule compression and aesthetic symptoms, avoiding the need for thyroid hormone replacement or surgery.

And while decisions regarding RFA treatment location and duration are commonly guided by the operator’s judgment of sonographic changes, those assessments can potentially result in inconsistent outcomes.

In observing a relationship between higher amounts of RF energy and nodule volume reduction, Dr. Wolfe and associates conducted their prospective study of nodules treated by two experienced endocrine surgeons at Johns Hopkins between June 2019 and May 2022 at 6 and 12 months in relation to the amount of total energy delivered during the treatment.

The analysis included 101 nodules, which had a median initial volume of 12.9 mL.

After 6 months, the median volume reduction ratio was 60%, and at 12 months, the median reduction was 64%.

In terms of the goal of achieving 50% or more volume reduction at 6 months, the median energy delivered was significantly higher for nodules that did reach that goal compared with those that had a volume reduction of less than 50% (2,317 vs. 1,912 J/mL, respectively; P = .01).

The figures were similar at 12 months (2,031 vs. 1254 J/mL; P < .01).

In a logistic regression analysis, the amount of energy delivered strongly increased the odds of obtaining a volume reduction ratio of at least 50% (odds ratio, 2.58; P = .048).

“Every twofold increase in energy delivered increases the odds of achieving a 50% volume ratio reduction by 2.58 times,” Dr. Wolfe explained.

Likewise, the same twofold increase in energy delivered also increased the odds of achieving a greater than 80% volume ratio reduction by 2.55 times (OR, 2.55; P = .038), she added.
 

 

 

Information may help to decide who needs multiple ablations

Of note, the effect was stronger with smaller nodules. Those with an initial volume of less than 20 mL had a significantly greater volume ratio reduction than nodules that were 20 mL or larger (61% vs. 48%, respectively; P = .05).

The initial volume of nodules that did, and did not, achieve a 50% volume ratio reduction at 6 months were 10.9 mL versus 19.1 mL, and the initial volumes of those that did, and did not, have at least a 50% reduction at 12 months were 10.5 mL and 41.5 mL.

“At 6 and 12 months, the successfully treated nodules had a significantly smaller immediate initial volume than those that did not,” Dr. Wolfe said.

“This information may aid in identifying patients with large nodules that are less likely to achieve a greater than 50% volume reduction ratio and may require multiple treatments,” she added.

Other factors – including the probe tip size and total energy delivered – did not significantly correlate with volume ratio reduction at 6 or 12 months.

There was also no significant difference in terms of thyroid-stimulating hormone levels among nodules that achieved at least a 50% volume reduction and those that did not.

Nodules that did not have a satisfactory volume reduction at 12 months had a relatively large median total energy value delivered during ablation (103,463 J, compared with 25,969 J among those achieving more than 50% volume ratio reduction), which Dr. Wolfe said likely reflects that those nodules had a large initial volume.

“This speaks to the importance of describing the energy utilized per unit of nodule volume rather than just a gross measurement,” she said during her presentation.

Dr. Wolfe added that in terms of strategies for getting more energy into the nodule, a key approach is time.

“Sometimes you will see sonographic changes very quickly in the nodule, and it could be tempting to consider that area ablated and move on if you only rely on sonographic changes,” she said in an interview. “However, our research shows that, by spending more time, and thus inputting more energy into the nodule, we had better volume reduction.”

Dr. Wolfe and Dr. Suh reported no relevant financial relationships.

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

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STEP TEENS: Semaglutide ‘gives hope’ to adolescents with obesity

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Attendees at ObesityWeek® 2022 listened with much excitement to the results of the STEP TEENS phase 3 trial of once-weekly subcutaneous semaglutide 2.4 mg (Wegovy) in adolescents aged 12 up to 18 years old with obesity.

When a session panel member said that clinical trials of weight-loss medications for adolescents with obesity should henceforth stop using placebo controls – implying that comparison with the once-weekly injection semaglutide would be more informative – the audience applauded.

The results were also simultaneously published in the New England Journal of Medicine to coincide with the presentation.  

The research “gives hope” to adolescents with obesity, their parents, and their doctors, the trial’s principal investigator, Daniel Weghuber, MD, said in an interview.

“Many of them have been struggling for such a long time – both the parents and the kids themselves,” said Dr. Weghuber, from the department of pediatrics, Paracelsus Medical University, Salzburg, Austria.

“It’s not an issue of lack of willpower,” he stressed. “That’s a major misunderstanding.”

“This drug [semaglutide] seems to enable people who are living with obesity to adhere to the recommendations that they may have been following for years and years but were [still] not able to achieve their goal,” he said. It “enables people to achieve their goals.”

Asked about any potential negative impact on normal growth, Dr. Weghuber pointed out that the average weight of study participants was 107 kg (236 lb). “I’m really not afraid of a 15-year-old with 107 kg losing 10%, 15%, 20%” of their weight, he said. There was no indication of a problem regarding normal growth or development in the study.

The research showed that “there is the combination of lifestyle plus in the future anti-obesity medications that will open up a new chapter” for treating adolescents with obesity, he summarized.

Senior study author, Silva Arslanian, MD, who holds the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh, agreed. “The results are amazing,” said Dr. Arslanian in a press release issued by the University of Pittsburgh. “For a person who is 5 foot, 5 inches tall and weighs 240 pounds, the average reduction in BMI equates to shedding about 40 pounds.”
 

‘Mind-blowing, awesome’ results

The session at ObesityWeek® 2022, the annual meeting of the Obesity Society, was chaired by Aaron S. Kelly, PhD, professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota, Minneapolis.

Dr. Kelly led the SCALE TEENS clinical trial of liraglutide (Saxenda), also a glucagon-like peptide (GLP-1) agonist like semaglutide, for adolescents aged 12 up to 18 years with obesity, which assigned 125 participants to the daily injectable liraglutide group and 126 to the placebo group. SCALE TEENS was presented and published in May 2020, leading to the approval of liraglutide for obesity in this age group, in December 2020.

Dr. Kelly called on two experts who were not involved in the research to offer their comments, starting with Claudia K. Fox, MD, MPH.

“These results are mind-blowing,” said Dr. Fox, who is associate professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota.

“We are getting close to bariatric surgery results” in these adolescent patients with obesity, added Dr. Fox, who is an American Board of Obesity Medicine diplomate. To have 40% of patients attain normal weight, “that’s massive” and “life-changing,” she said. And improvement in quality of life is what families care most about. “I am super excited,” she commented.

Next, Dr. Kelly called on Sarah C. Armstrong, MD, director of the Duke Children’s Healthy Lifestyles Program, Duke University, Durham, N.C.

Dr. Armstrong is a member of the executive committee for the American Academy of Pediatrics Section on Obesity and a coauthor of the upcoming clinical practice guidelines that are being published.

Looking at more than 16,000 abstracts at the meeting shows that “watchful waiting is not effective,” Dr. Armstrong said.
 

 

 

200 teens with obesity, only 1 with overweight

Obesity affects almost one in five children and adolescents worldwide. The chronic disease is linked with decreased life expectancy and higher risk of developing serious health problems such as type 2 diabetes, heart disease, nonalcoholic fatty liver disease, sleep apnea, and certain cancers. Teenagers with obesity are also more likely to have depression, anxiety, poor self-esteem, and other psychological issues.

STEP TEENS enrolled 201 adolescents aged 12 up to 18 years with obesity (body mass index [BMI] ≥ 95th percentile) or overweight (BMI ≥ 85th percentile) plus at least one weight-related comorbidity.

Only one recruited patient fit the latter category; the rest had obesity.

Most patients (62%) were female. They had a mean age of 15.4 years, a mean BMI of 37 kg/m2, and a mean waist circumference of 110 cm (43 inches).

Patients were randomized 2:1 to receive a once-weekly 2.4-mg subcutaneous injection of semaglutide or placebo for 68 weeks, plus lifestyle intervention.

Dr. Weghuber noted that 89.6% of patients in the semaglutide group completed treatment.

The primary endpoint, mean change in BMI from baseline to week 68, was −16.1% with semaglutide and +0.6% with placebo (estimated difference, −16.7 percentage points; P < .001).

A second confirmatory endpoint, at least 5% weight loss at week 68, was met by 73% of patients in the semaglutide group versus 18% of patients in the placebo group (P < .001).

Reductions in body weight and improvements in waist circumference, A1c, lipids (except HDL cholesterol), and the liver enzyme alanine aminotransferase were greater with semaglutide than placebo.

The Impact of Weight on Quality of Life – Kids (IWQOL-Kids) questionnaire total score as well as scores for body esteem, family relation, physical comfort, and social life were better in the semaglutide group.

However, the incidence of gastrointestinal adverse events was greater with semaglutide than placebo (62% versus 42%).

Five participants (4%) in the semaglutide group and none in the placebo group developed gallstones (cholelithiasis).

Serious adverse events were reported in 11% of patients in the semaglutide group and 9% of patients in the placebo group.
 

‘Big change’ coming in guidelines for obesity in teens

Commenting on the upcoming new recommendations for adolescents, Dr. Armstrong noted “there’s going to be a strong recommendation” for therapy in the new guidelines for pediatric obesity. “That’s a big change,” she said.

In the lively question-and-answer session that followed, a clinician wanted to know what explained the very high rate of study completion during the COVID-19 pandemic (when STEP TEENS was conducted). “What can we learn?” he asked.

“The bottom line is the relationship” and “close communication” between study investigators and patients, Dr. Weghuber replied.

“The fast track is likely to lead to approval in adolescents,” another member of the audience noted. He wanted to know if the company is planning a trial of semaglutide in younger children.

They are, Dr. Weghuber replied, and one with liraglutide is already underway.

The SCALE KIDS clinical trial of liraglutide is randomizing 78 participants aged 6 up to 12 years for 56 weeks of treatment and 26 weeks of follow-up, with an estimated primary completion date of July 7, 2023.

The last words went to Dr. Fox. The current results “are indeed very awesome,” she said, yet “thousands of providers are hesitant” to prescribe medications for adolescents with obesity.

The trial was funded by Novo Nordisk. Dr. Weghuber has reported being a consultant for Novo Nordisk and member of the Global Pediatric Obesity Expert Panel for the company. Disclosures for the other authors are listed with the article. Dr. Kelly has reported receiving donated drugs from AstraZeneca and travel support from Novo Nordisk and serving as an unpaid consultant for Novo Nordisk, Orexigen Therapeutics, VIVUS, and WW (formerly Weight Watchers).

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

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Attendees at ObesityWeek® 2022 listened with much excitement to the results of the STEP TEENS phase 3 trial of once-weekly subcutaneous semaglutide 2.4 mg (Wegovy) in adolescents aged 12 up to 18 years old with obesity.

When a session panel member said that clinical trials of weight-loss medications for adolescents with obesity should henceforth stop using placebo controls – implying that comparison with the once-weekly injection semaglutide would be more informative – the audience applauded.

The results were also simultaneously published in the New England Journal of Medicine to coincide with the presentation.  

The research “gives hope” to adolescents with obesity, their parents, and their doctors, the trial’s principal investigator, Daniel Weghuber, MD, said in an interview.

“Many of them have been struggling for such a long time – both the parents and the kids themselves,” said Dr. Weghuber, from the department of pediatrics, Paracelsus Medical University, Salzburg, Austria.

“It’s not an issue of lack of willpower,” he stressed. “That’s a major misunderstanding.”

“This drug [semaglutide] seems to enable people who are living with obesity to adhere to the recommendations that they may have been following for years and years but were [still] not able to achieve their goal,” he said. It “enables people to achieve their goals.”

Asked about any potential negative impact on normal growth, Dr. Weghuber pointed out that the average weight of study participants was 107 kg (236 lb). “I’m really not afraid of a 15-year-old with 107 kg losing 10%, 15%, 20%” of their weight, he said. There was no indication of a problem regarding normal growth or development in the study.

The research showed that “there is the combination of lifestyle plus in the future anti-obesity medications that will open up a new chapter” for treating adolescents with obesity, he summarized.

Senior study author, Silva Arslanian, MD, who holds the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh, agreed. “The results are amazing,” said Dr. Arslanian in a press release issued by the University of Pittsburgh. “For a person who is 5 foot, 5 inches tall and weighs 240 pounds, the average reduction in BMI equates to shedding about 40 pounds.”
 

‘Mind-blowing, awesome’ results

The session at ObesityWeek® 2022, the annual meeting of the Obesity Society, was chaired by Aaron S. Kelly, PhD, professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota, Minneapolis.

Dr. Kelly led the SCALE TEENS clinical trial of liraglutide (Saxenda), also a glucagon-like peptide (GLP-1) agonist like semaglutide, for adolescents aged 12 up to 18 years with obesity, which assigned 125 participants to the daily injectable liraglutide group and 126 to the placebo group. SCALE TEENS was presented and published in May 2020, leading to the approval of liraglutide for obesity in this age group, in December 2020.

Dr. Kelly called on two experts who were not involved in the research to offer their comments, starting with Claudia K. Fox, MD, MPH.

“These results are mind-blowing,” said Dr. Fox, who is associate professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota.

“We are getting close to bariatric surgery results” in these adolescent patients with obesity, added Dr. Fox, who is an American Board of Obesity Medicine diplomate. To have 40% of patients attain normal weight, “that’s massive” and “life-changing,” she said. And improvement in quality of life is what families care most about. “I am super excited,” she commented.

Next, Dr. Kelly called on Sarah C. Armstrong, MD, director of the Duke Children’s Healthy Lifestyles Program, Duke University, Durham, N.C.

Dr. Armstrong is a member of the executive committee for the American Academy of Pediatrics Section on Obesity and a coauthor of the upcoming clinical practice guidelines that are being published.

Looking at more than 16,000 abstracts at the meeting shows that “watchful waiting is not effective,” Dr. Armstrong said.
 

 

 

200 teens with obesity, only 1 with overweight

Obesity affects almost one in five children and adolescents worldwide. The chronic disease is linked with decreased life expectancy and higher risk of developing serious health problems such as type 2 diabetes, heart disease, nonalcoholic fatty liver disease, sleep apnea, and certain cancers. Teenagers with obesity are also more likely to have depression, anxiety, poor self-esteem, and other psychological issues.

STEP TEENS enrolled 201 adolescents aged 12 up to 18 years with obesity (body mass index [BMI] ≥ 95th percentile) or overweight (BMI ≥ 85th percentile) plus at least one weight-related comorbidity.

Only one recruited patient fit the latter category; the rest had obesity.

Most patients (62%) were female. They had a mean age of 15.4 years, a mean BMI of 37 kg/m2, and a mean waist circumference of 110 cm (43 inches).

Patients were randomized 2:1 to receive a once-weekly 2.4-mg subcutaneous injection of semaglutide or placebo for 68 weeks, plus lifestyle intervention.

Dr. Weghuber noted that 89.6% of patients in the semaglutide group completed treatment.

The primary endpoint, mean change in BMI from baseline to week 68, was −16.1% with semaglutide and +0.6% with placebo (estimated difference, −16.7 percentage points; P < .001).

A second confirmatory endpoint, at least 5% weight loss at week 68, was met by 73% of patients in the semaglutide group versus 18% of patients in the placebo group (P < .001).

Reductions in body weight and improvements in waist circumference, A1c, lipids (except HDL cholesterol), and the liver enzyme alanine aminotransferase were greater with semaglutide than placebo.

The Impact of Weight on Quality of Life – Kids (IWQOL-Kids) questionnaire total score as well as scores for body esteem, family relation, physical comfort, and social life were better in the semaglutide group.

However, the incidence of gastrointestinal adverse events was greater with semaglutide than placebo (62% versus 42%).

Five participants (4%) in the semaglutide group and none in the placebo group developed gallstones (cholelithiasis).

Serious adverse events were reported in 11% of patients in the semaglutide group and 9% of patients in the placebo group.
 

‘Big change’ coming in guidelines for obesity in teens

Commenting on the upcoming new recommendations for adolescents, Dr. Armstrong noted “there’s going to be a strong recommendation” for therapy in the new guidelines for pediatric obesity. “That’s a big change,” she said.

In the lively question-and-answer session that followed, a clinician wanted to know what explained the very high rate of study completion during the COVID-19 pandemic (when STEP TEENS was conducted). “What can we learn?” he asked.

“The bottom line is the relationship” and “close communication” between study investigators and patients, Dr. Weghuber replied.

“The fast track is likely to lead to approval in adolescents,” another member of the audience noted. He wanted to know if the company is planning a trial of semaglutide in younger children.

They are, Dr. Weghuber replied, and one with liraglutide is already underway.

The SCALE KIDS clinical trial of liraglutide is randomizing 78 participants aged 6 up to 12 years for 56 weeks of treatment and 26 weeks of follow-up, with an estimated primary completion date of July 7, 2023.

The last words went to Dr. Fox. The current results “are indeed very awesome,” she said, yet “thousands of providers are hesitant” to prescribe medications for adolescents with obesity.

The trial was funded by Novo Nordisk. Dr. Weghuber has reported being a consultant for Novo Nordisk and member of the Global Pediatric Obesity Expert Panel for the company. Disclosures for the other authors are listed with the article. Dr. Kelly has reported receiving donated drugs from AstraZeneca and travel support from Novo Nordisk and serving as an unpaid consultant for Novo Nordisk, Orexigen Therapeutics, VIVUS, and WW (formerly Weight Watchers).

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

Attendees at ObesityWeek® 2022 listened with much excitement to the results of the STEP TEENS phase 3 trial of once-weekly subcutaneous semaglutide 2.4 mg (Wegovy) in adolescents aged 12 up to 18 years old with obesity.

When a session panel member said that clinical trials of weight-loss medications for adolescents with obesity should henceforth stop using placebo controls – implying that comparison with the once-weekly injection semaglutide would be more informative – the audience applauded.

The results were also simultaneously published in the New England Journal of Medicine to coincide with the presentation.  

The research “gives hope” to adolescents with obesity, their parents, and their doctors, the trial’s principal investigator, Daniel Weghuber, MD, said in an interview.

“Many of them have been struggling for such a long time – both the parents and the kids themselves,” said Dr. Weghuber, from the department of pediatrics, Paracelsus Medical University, Salzburg, Austria.

“It’s not an issue of lack of willpower,” he stressed. “That’s a major misunderstanding.”

“This drug [semaglutide] seems to enable people who are living with obesity to adhere to the recommendations that they may have been following for years and years but were [still] not able to achieve their goal,” he said. It “enables people to achieve their goals.”

Asked about any potential negative impact on normal growth, Dr. Weghuber pointed out that the average weight of study participants was 107 kg (236 lb). “I’m really not afraid of a 15-year-old with 107 kg losing 10%, 15%, 20%” of their weight, he said. There was no indication of a problem regarding normal growth or development in the study.

The research showed that “there is the combination of lifestyle plus in the future anti-obesity medications that will open up a new chapter” for treating adolescents with obesity, he summarized.

Senior study author, Silva Arslanian, MD, who holds the Richard L. Day Endowed Chair in Pediatrics at the University of Pittsburgh, agreed. “The results are amazing,” said Dr. Arslanian in a press release issued by the University of Pittsburgh. “For a person who is 5 foot, 5 inches tall and weighs 240 pounds, the average reduction in BMI equates to shedding about 40 pounds.”
 

‘Mind-blowing, awesome’ results

The session at ObesityWeek® 2022, the annual meeting of the Obesity Society, was chaired by Aaron S. Kelly, PhD, professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota, Minneapolis.

Dr. Kelly led the SCALE TEENS clinical trial of liraglutide (Saxenda), also a glucagon-like peptide (GLP-1) agonist like semaglutide, for adolescents aged 12 up to 18 years with obesity, which assigned 125 participants to the daily injectable liraglutide group and 126 to the placebo group. SCALE TEENS was presented and published in May 2020, leading to the approval of liraglutide for obesity in this age group, in December 2020.

Dr. Kelly called on two experts who were not involved in the research to offer their comments, starting with Claudia K. Fox, MD, MPH.

“These results are mind-blowing,” said Dr. Fox, who is associate professor of pediatrics and codirector of the center for pediatric obesity medicine at the University of Minnesota.

“We are getting close to bariatric surgery results” in these adolescent patients with obesity, added Dr. Fox, who is an American Board of Obesity Medicine diplomate. To have 40% of patients attain normal weight, “that’s massive” and “life-changing,” she said. And improvement in quality of life is what families care most about. “I am super excited,” she commented.

Next, Dr. Kelly called on Sarah C. Armstrong, MD, director of the Duke Children’s Healthy Lifestyles Program, Duke University, Durham, N.C.

Dr. Armstrong is a member of the executive committee for the American Academy of Pediatrics Section on Obesity and a coauthor of the upcoming clinical practice guidelines that are being published.

Looking at more than 16,000 abstracts at the meeting shows that “watchful waiting is not effective,” Dr. Armstrong said.
 

 

 

200 teens with obesity, only 1 with overweight

Obesity affects almost one in five children and adolescents worldwide. The chronic disease is linked with decreased life expectancy and higher risk of developing serious health problems such as type 2 diabetes, heart disease, nonalcoholic fatty liver disease, sleep apnea, and certain cancers. Teenagers with obesity are also more likely to have depression, anxiety, poor self-esteem, and other psychological issues.

STEP TEENS enrolled 201 adolescents aged 12 up to 18 years with obesity (body mass index [BMI] ≥ 95th percentile) or overweight (BMI ≥ 85th percentile) plus at least one weight-related comorbidity.

Only one recruited patient fit the latter category; the rest had obesity.

Most patients (62%) were female. They had a mean age of 15.4 years, a mean BMI of 37 kg/m2, and a mean waist circumference of 110 cm (43 inches).

Patients were randomized 2:1 to receive a once-weekly 2.4-mg subcutaneous injection of semaglutide or placebo for 68 weeks, plus lifestyle intervention.

Dr. Weghuber noted that 89.6% of patients in the semaglutide group completed treatment.

The primary endpoint, mean change in BMI from baseline to week 68, was −16.1% with semaglutide and +0.6% with placebo (estimated difference, −16.7 percentage points; P < .001).

A second confirmatory endpoint, at least 5% weight loss at week 68, was met by 73% of patients in the semaglutide group versus 18% of patients in the placebo group (P < .001).

Reductions in body weight and improvements in waist circumference, A1c, lipids (except HDL cholesterol), and the liver enzyme alanine aminotransferase were greater with semaglutide than placebo.

The Impact of Weight on Quality of Life – Kids (IWQOL-Kids) questionnaire total score as well as scores for body esteem, family relation, physical comfort, and social life were better in the semaglutide group.

However, the incidence of gastrointestinal adverse events was greater with semaglutide than placebo (62% versus 42%).

Five participants (4%) in the semaglutide group and none in the placebo group developed gallstones (cholelithiasis).

Serious adverse events were reported in 11% of patients in the semaglutide group and 9% of patients in the placebo group.
 

‘Big change’ coming in guidelines for obesity in teens

Commenting on the upcoming new recommendations for adolescents, Dr. Armstrong noted “there’s going to be a strong recommendation” for therapy in the new guidelines for pediatric obesity. “That’s a big change,” she said.

In the lively question-and-answer session that followed, a clinician wanted to know what explained the very high rate of study completion during the COVID-19 pandemic (when STEP TEENS was conducted). “What can we learn?” he asked.

“The bottom line is the relationship” and “close communication” between study investigators and patients, Dr. Weghuber replied.

“The fast track is likely to lead to approval in adolescents,” another member of the audience noted. He wanted to know if the company is planning a trial of semaglutide in younger children.

They are, Dr. Weghuber replied, and one with liraglutide is already underway.

The SCALE KIDS clinical trial of liraglutide is randomizing 78 participants aged 6 up to 12 years for 56 weeks of treatment and 26 weeks of follow-up, with an estimated primary completion date of July 7, 2023.

The last words went to Dr. Fox. The current results “are indeed very awesome,” she said, yet “thousands of providers are hesitant” to prescribe medications for adolescents with obesity.

The trial was funded by Novo Nordisk. Dr. Weghuber has reported being a consultant for Novo Nordisk and member of the Global Pediatric Obesity Expert Panel for the company. Disclosures for the other authors are listed with the article. Dr. Kelly has reported receiving donated drugs from AstraZeneca and travel support from Novo Nordisk and serving as an unpaid consultant for Novo Nordisk, Orexigen Therapeutics, VIVUS, and WW (formerly Weight Watchers).

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

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Uptake of high-sensitivity troponin assays lags in U.S. hospitals

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Most hospitals in the United States have yet to transition from conventional to high-sensitivity cardiac troponin (hs-cTn) assays, despite their greater sensitivity for myocardial injury, a new National Cardiovascular Data Registry (NCDR) registry study indicates.

hs-cTn assays have been used in routine clinical practice in Europe, Canada, and Australia since 2010, but the first such assay did not gain approval in the United States until 2017. Although single-center studies have examined their efficacy and potential downstream consequences, few data exist on hs-cTn implementation nationally, explained study author Cian McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston.

The results were published online in the Journal of the American College of Cardiology and will be presented Nov. 5 at the American Heart Association scientific sessions.

For the study, Dr. McCarthy and colleagues examined 550 hospitals participating in the NCDR Chest Pain-MI registry from January 2019 through September 2021.

Of the 251,000 patients included in the analysis (mean age, 64 years; 41.5% female), 155,049 had a non–ST-segment myocardial infarction (NSTEMI), 15,989 had unstable angina, and 79,962 had low-risk chest pain.

The hs-cTn assays included Roche Diagnostic’s Elecsys Gen5 STAT troponin T assay (23%); Abbott’s ARCHITECT STAT (17%); Beckman Coulter’s ACCESS (21%); and Siemens’ Atellica IM (18%), Dimension VISTA (14%), Dimension EXL (4%), and ADVIA Centaur (2%) troponin I assays.

During the study period, 11.5% of patients were evaluated with hs-cTn assays and the remainder were evaluated with conventional troponin assays. These patients were slightly older (65.0 vs. 64.0 years), more commonly White (83.1% vs. 79.9%), less likely to be of Hispanic or Latino ethnicity (8.9% vs. 10.0%), and less likely to be uninsured (6.8% vs. 8.3%; P for all < .001).

A slightly higher proportion of patients evaluated with hs-cTn assays were diagnosed with unstable angina (7.1% vs. 6.3%), a lower proportion with NSTEMI (61.1% vs. 61.9%), and a similar proportion with low-risk chest pain (31.8% vs. 31.9%) compared with those evaluated by conventional troponin assays.

Implementation, defined as at least 25% of patients evaluated by hs-cTn in each quarter, increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (P trend < .001).

Using higher implementation thresholds of at least 50% and 75% of patients evaluated by hs-cTn, the prevalence in 2021 was 28.9% and 24.7%, respectively.

“So still, the majority of the hospitals by the end of the third quarter 2021 were not using these assays,” Dr. McCarthy said.

Potential explanations for the slow uptake are that prospective comparative effectiveness trials of These assays have predominantly been in international populations and real-world data on U.S. implementation have been limited to integrated health networks at academic institutions.

Approval of several assays was also delayed and the study data cut off just before the October publication of the 2021 AHA/ACC Chest Pain guideline. “So, whether the chest pain guideline with the new class 1 recommendation for hs-cTn will lead to further uptake is something that will need to be looked at in the future,” he said.
 

Downstream testing

In adjusted analyses, hs-cTn use was associated with more echocardiography among patients with non-ST elevation–acute coronary syndrome (NSTE-ACS) (82.4% vs. 75.0%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.19-1.73), but not among those with low-risk chest pain (19.7% vs. 19.4%; OR, 0.93; 95% CI, 0.71-1.22) compared with conventional cTn assays.

Importantly, hs-cTn was not associated with a difference in stress testing or CT coronary angiography utilization.

Use of hs-cTn was associated with lower use of invasive coronary angiography among patients with low-risk chest pain (3.7% vs. 4.5%; OR, 0.73, 95% CI, 0.58-0.92) but similar use for NSTE-ACS (96.3% vs. 95.8%; OR, 0.99, 95% CI, 0.82-1.19).

Among patients with NSTE-ACS, there also was no difference in revascularization with percutaneous coronary intervention (PCI) (52.7% vs. 52.3%; OR, 0.99; 95% CI, 0.94-1.04) or coronary bypass graft surgery (9.4% vs. 9.1%; OR, 1.06; 95% CI, 0.94-1.18).

PCI (0.1% vs. 0.2%; P = .05) and bypass graft surgery (both 0.1%) were uncommon among patients with low-risk chest pain.

In-hospital mortality was similar among patients with low-risk chest pain evaluated using hs-cTn assays vs. conventional troponin assays (0% vs. 0.02%; P = .16) and among patients with NSTE-ACS (2.8% vs. 3.2%; OR, 0.98, 95% CI, 0.87-1.11).

Length of stay was slightly shorter with hs-cTn use for patients with low-risk chest pain (median, 5.8 vs. 6.2 hours; P < .001) and patients with NSTE-ACS (66.9 vs. 67.8 hours; P = .01).

“There was always a concern that maybe high-sensitivity cardiac troponin would dramatically increase testing and could even increase length of stay, but I think these data are reassuring, in that this study suggests high-sensitivity cardiac troponin is associated with a small reduction in length of stay and possibly more appropriate use of testing with echocardiography in STEMI and a reduction in invasive angiography in low-risk patients,” Dr. McCarthy said. “But the majority of hospitals haven’t implemented the assay.”

The authors pointed out that because registry entry of patients with low-risk chest pain and unstable angina is optional for participating sites, the percentage of patients with NSTEMI is higher than in typical chest pain analyses. This higher pretest probability for MI may thus affect post-test accuracy for a true positive result. “That stated, this is the exact scenario where higher sensitivity might be associated with favorable impact on utilization.”

Among other limitations: There was the potential for unmeasured confounders, the accuracy of diagnoses could not be confirmed, patients with type 2 MI were excluded from the registry, and post-discharge safety was not assessed.

“These data indicate further opportunities to more widely and effectively implement hs-cTn in the U.S. hospitals persist that could optimize care for patients with possible or definitive ACS,” Dr. McCarthy and colleagues concluded.

The study was funded by the American College of Cardiology’s National Cardiovascular Data Registry. Dr. McCarthy is supported by the National Heart, Lung, and Blood Institute and has received consulting income from Abbott Laboratories.

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

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Most hospitals in the United States have yet to transition from conventional to high-sensitivity cardiac troponin (hs-cTn) assays, despite their greater sensitivity for myocardial injury, a new National Cardiovascular Data Registry (NCDR) registry study indicates.

hs-cTn assays have been used in routine clinical practice in Europe, Canada, and Australia since 2010, but the first such assay did not gain approval in the United States until 2017. Although single-center studies have examined their efficacy and potential downstream consequences, few data exist on hs-cTn implementation nationally, explained study author Cian McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston.

The results were published online in the Journal of the American College of Cardiology and will be presented Nov. 5 at the American Heart Association scientific sessions.

For the study, Dr. McCarthy and colleagues examined 550 hospitals participating in the NCDR Chest Pain-MI registry from January 2019 through September 2021.

Of the 251,000 patients included in the analysis (mean age, 64 years; 41.5% female), 155,049 had a non–ST-segment myocardial infarction (NSTEMI), 15,989 had unstable angina, and 79,962 had low-risk chest pain.

The hs-cTn assays included Roche Diagnostic’s Elecsys Gen5 STAT troponin T assay (23%); Abbott’s ARCHITECT STAT (17%); Beckman Coulter’s ACCESS (21%); and Siemens’ Atellica IM (18%), Dimension VISTA (14%), Dimension EXL (4%), and ADVIA Centaur (2%) troponin I assays.

During the study period, 11.5% of patients were evaluated with hs-cTn assays and the remainder were evaluated with conventional troponin assays. These patients were slightly older (65.0 vs. 64.0 years), more commonly White (83.1% vs. 79.9%), less likely to be of Hispanic or Latino ethnicity (8.9% vs. 10.0%), and less likely to be uninsured (6.8% vs. 8.3%; P for all < .001).

A slightly higher proportion of patients evaluated with hs-cTn assays were diagnosed with unstable angina (7.1% vs. 6.3%), a lower proportion with NSTEMI (61.1% vs. 61.9%), and a similar proportion with low-risk chest pain (31.8% vs. 31.9%) compared with those evaluated by conventional troponin assays.

Implementation, defined as at least 25% of patients evaluated by hs-cTn in each quarter, increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (P trend < .001).

Using higher implementation thresholds of at least 50% and 75% of patients evaluated by hs-cTn, the prevalence in 2021 was 28.9% and 24.7%, respectively.

“So still, the majority of the hospitals by the end of the third quarter 2021 were not using these assays,” Dr. McCarthy said.

Potential explanations for the slow uptake are that prospective comparative effectiveness trials of These assays have predominantly been in international populations and real-world data on U.S. implementation have been limited to integrated health networks at academic institutions.

Approval of several assays was also delayed and the study data cut off just before the October publication of the 2021 AHA/ACC Chest Pain guideline. “So, whether the chest pain guideline with the new class 1 recommendation for hs-cTn will lead to further uptake is something that will need to be looked at in the future,” he said.
 

Downstream testing

In adjusted analyses, hs-cTn use was associated with more echocardiography among patients with non-ST elevation–acute coronary syndrome (NSTE-ACS) (82.4% vs. 75.0%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.19-1.73), but not among those with low-risk chest pain (19.7% vs. 19.4%; OR, 0.93; 95% CI, 0.71-1.22) compared with conventional cTn assays.

Importantly, hs-cTn was not associated with a difference in stress testing or CT coronary angiography utilization.

Use of hs-cTn was associated with lower use of invasive coronary angiography among patients with low-risk chest pain (3.7% vs. 4.5%; OR, 0.73, 95% CI, 0.58-0.92) but similar use for NSTE-ACS (96.3% vs. 95.8%; OR, 0.99, 95% CI, 0.82-1.19).

Among patients with NSTE-ACS, there also was no difference in revascularization with percutaneous coronary intervention (PCI) (52.7% vs. 52.3%; OR, 0.99; 95% CI, 0.94-1.04) or coronary bypass graft surgery (9.4% vs. 9.1%; OR, 1.06; 95% CI, 0.94-1.18).

PCI (0.1% vs. 0.2%; P = .05) and bypass graft surgery (both 0.1%) were uncommon among patients with low-risk chest pain.

In-hospital mortality was similar among patients with low-risk chest pain evaluated using hs-cTn assays vs. conventional troponin assays (0% vs. 0.02%; P = .16) and among patients with NSTE-ACS (2.8% vs. 3.2%; OR, 0.98, 95% CI, 0.87-1.11).

Length of stay was slightly shorter with hs-cTn use for patients with low-risk chest pain (median, 5.8 vs. 6.2 hours; P < .001) and patients with NSTE-ACS (66.9 vs. 67.8 hours; P = .01).

“There was always a concern that maybe high-sensitivity cardiac troponin would dramatically increase testing and could even increase length of stay, but I think these data are reassuring, in that this study suggests high-sensitivity cardiac troponin is associated with a small reduction in length of stay and possibly more appropriate use of testing with echocardiography in STEMI and a reduction in invasive angiography in low-risk patients,” Dr. McCarthy said. “But the majority of hospitals haven’t implemented the assay.”

The authors pointed out that because registry entry of patients with low-risk chest pain and unstable angina is optional for participating sites, the percentage of patients with NSTEMI is higher than in typical chest pain analyses. This higher pretest probability for MI may thus affect post-test accuracy for a true positive result. “That stated, this is the exact scenario where higher sensitivity might be associated with favorable impact on utilization.”

Among other limitations: There was the potential for unmeasured confounders, the accuracy of diagnoses could not be confirmed, patients with type 2 MI were excluded from the registry, and post-discharge safety was not assessed.

“These data indicate further opportunities to more widely and effectively implement hs-cTn in the U.S. hospitals persist that could optimize care for patients with possible or definitive ACS,” Dr. McCarthy and colleagues concluded.

The study was funded by the American College of Cardiology’s National Cardiovascular Data Registry. Dr. McCarthy is supported by the National Heart, Lung, and Blood Institute and has received consulting income from Abbott Laboratories.

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

Most hospitals in the United States have yet to transition from conventional to high-sensitivity cardiac troponin (hs-cTn) assays, despite their greater sensitivity for myocardial injury, a new National Cardiovascular Data Registry (NCDR) registry study indicates.

hs-cTn assays have been used in routine clinical practice in Europe, Canada, and Australia since 2010, but the first such assay did not gain approval in the United States until 2017. Although single-center studies have examined their efficacy and potential downstream consequences, few data exist on hs-cTn implementation nationally, explained study author Cian McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston.

The results were published online in the Journal of the American College of Cardiology and will be presented Nov. 5 at the American Heart Association scientific sessions.

For the study, Dr. McCarthy and colleagues examined 550 hospitals participating in the NCDR Chest Pain-MI registry from January 2019 through September 2021.

Of the 251,000 patients included in the analysis (mean age, 64 years; 41.5% female), 155,049 had a non–ST-segment myocardial infarction (NSTEMI), 15,989 had unstable angina, and 79,962 had low-risk chest pain.

The hs-cTn assays included Roche Diagnostic’s Elecsys Gen5 STAT troponin T assay (23%); Abbott’s ARCHITECT STAT (17%); Beckman Coulter’s ACCESS (21%); and Siemens’ Atellica IM (18%), Dimension VISTA (14%), Dimension EXL (4%), and ADVIA Centaur (2%) troponin I assays.

During the study period, 11.5% of patients were evaluated with hs-cTn assays and the remainder were evaluated with conventional troponin assays. These patients were slightly older (65.0 vs. 64.0 years), more commonly White (83.1% vs. 79.9%), less likely to be of Hispanic or Latino ethnicity (8.9% vs. 10.0%), and less likely to be uninsured (6.8% vs. 8.3%; P for all < .001).

A slightly higher proportion of patients evaluated with hs-cTn assays were diagnosed with unstable angina (7.1% vs. 6.3%), a lower proportion with NSTEMI (61.1% vs. 61.9%), and a similar proportion with low-risk chest pain (31.8% vs. 31.9%) compared with those evaluated by conventional troponin assays.

Implementation, defined as at least 25% of patients evaluated by hs-cTn in each quarter, increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (P trend < .001).

Using higher implementation thresholds of at least 50% and 75% of patients evaluated by hs-cTn, the prevalence in 2021 was 28.9% and 24.7%, respectively.

“So still, the majority of the hospitals by the end of the third quarter 2021 were not using these assays,” Dr. McCarthy said.

Potential explanations for the slow uptake are that prospective comparative effectiveness trials of These assays have predominantly been in international populations and real-world data on U.S. implementation have been limited to integrated health networks at academic institutions.

Approval of several assays was also delayed and the study data cut off just before the October publication of the 2021 AHA/ACC Chest Pain guideline. “So, whether the chest pain guideline with the new class 1 recommendation for hs-cTn will lead to further uptake is something that will need to be looked at in the future,” he said.
 

Downstream testing

In adjusted analyses, hs-cTn use was associated with more echocardiography among patients with non-ST elevation–acute coronary syndrome (NSTE-ACS) (82.4% vs. 75.0%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.19-1.73), but not among those with low-risk chest pain (19.7% vs. 19.4%; OR, 0.93; 95% CI, 0.71-1.22) compared with conventional cTn assays.

Importantly, hs-cTn was not associated with a difference in stress testing or CT coronary angiography utilization.

Use of hs-cTn was associated with lower use of invasive coronary angiography among patients with low-risk chest pain (3.7% vs. 4.5%; OR, 0.73, 95% CI, 0.58-0.92) but similar use for NSTE-ACS (96.3% vs. 95.8%; OR, 0.99, 95% CI, 0.82-1.19).

Among patients with NSTE-ACS, there also was no difference in revascularization with percutaneous coronary intervention (PCI) (52.7% vs. 52.3%; OR, 0.99; 95% CI, 0.94-1.04) or coronary bypass graft surgery (9.4% vs. 9.1%; OR, 1.06; 95% CI, 0.94-1.18).

PCI (0.1% vs. 0.2%; P = .05) and bypass graft surgery (both 0.1%) were uncommon among patients with low-risk chest pain.

In-hospital mortality was similar among patients with low-risk chest pain evaluated using hs-cTn assays vs. conventional troponin assays (0% vs. 0.02%; P = .16) and among patients with NSTE-ACS (2.8% vs. 3.2%; OR, 0.98, 95% CI, 0.87-1.11).

Length of stay was slightly shorter with hs-cTn use for patients with low-risk chest pain (median, 5.8 vs. 6.2 hours; P < .001) and patients with NSTE-ACS (66.9 vs. 67.8 hours; P = .01).

“There was always a concern that maybe high-sensitivity cardiac troponin would dramatically increase testing and could even increase length of stay, but I think these data are reassuring, in that this study suggests high-sensitivity cardiac troponin is associated with a small reduction in length of stay and possibly more appropriate use of testing with echocardiography in STEMI and a reduction in invasive angiography in low-risk patients,” Dr. McCarthy said. “But the majority of hospitals haven’t implemented the assay.”

The authors pointed out that because registry entry of patients with low-risk chest pain and unstable angina is optional for participating sites, the percentage of patients with NSTEMI is higher than in typical chest pain analyses. This higher pretest probability for MI may thus affect post-test accuracy for a true positive result. “That stated, this is the exact scenario where higher sensitivity might be associated with favorable impact on utilization.”

Among other limitations: There was the potential for unmeasured confounders, the accuracy of diagnoses could not be confirmed, patients with type 2 MI were excluded from the registry, and post-discharge safety was not assessed.

“These data indicate further opportunities to more widely and effectively implement hs-cTn in the U.S. hospitals persist that could optimize care for patients with possible or definitive ACS,” Dr. McCarthy and colleagues concluded.

The study was funded by the American College of Cardiology’s National Cardiovascular Data Registry. Dr. McCarthy is supported by the National Heart, Lung, and Blood Institute and has received consulting income from Abbott Laboratories.

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

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Marital stress tied to worse outcome in young MI patients

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Fri, 11/04/2022 - 11:32

Severe marital stress was associated with worse recovery after myocardial infarction in a large U.S. cohort of married/partnered patients aged 55 years or younger.

Compared with patients who reported no or mild marital stress a month after their MI, patients who reported severe marital stress had worse physical and mental health, worse generic and cardiovascular quality of life, more frequent angina symptoms, and a greater likelihood of having a hospital readmission a year later.

These findings held true after adjusting for gender, age, race/ethnicity, and baseline health status (model 1) and after further adjusting for education and income levels and employment and insurance status (model 2).

A greater percentage of women than men reported having severe marital stress (39% vs. 30%; P = .001).

Cenjing Zhu, MPhil, a PhD candidate at Yale University, New Haven, Conn., and colleagues will present this study at the American Heart Association scientific sessions.

The results show that “both patients and care providers should be aware that stress experienced in one’s everyday life, such as marital stress, can affect AMI [acute MI] recovery,” Ms. Zhu said in an email.

Health care providers should consider incorporating screening for everyday stress during follow-up patient visits to better spot people at high risk of a poor recovery and further hospitalizations, she added. When possible, they could guide patients to resources to help them manage and reduce their stress levels.

According to Ms. Zhu, the findings suggest that “managing personal stress may be as important as managing other clinical risk factors during the recovery process.”

Dr. Nieca Goldberg

This study in younger patients with MI “shows that high levels of marital stress impair heart attack recovery, and women have greater impairment in their heart attack recovery compared to men,” AHA spokesperson Nieca Goldberg, MD, who was not involved with this research, told this news organization.

The study shows that “clinicians have to incorporate mental health as part of their assessment of all patients,” said Dr. Goldberg, a clinical associate professor of medicine at New York University and medical director of Atria New York City.

“Our mental health impacts our physical health,” she noted. “Questions about marital stress should be included as part of an overall assessment of mental health. This means assessing all patients for stress, anxiety, and depression.”

Patients who are experiencing marital stress should share the information with their doctor and discuss ways to be referred to therapists and cardiac rehabilitation providers, she said. “My final thought is, women have often been told that their cardiac symptoms are due to stress by doctors. Now we know stress impacts physical health and [is] no longer an excuse but a contributing factor to our physical health.”
 

Does marital stress affect young MI recovery?

Previous literature has linked psychological stress with worse cardiovascular outcomes, Ms. Zhu noted.

However, little is known about the prognostic impact of marital stress on 1-year health outcomes for younger people who survive an MI.

To investigate this, the researchers analyzed data from participants in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study.

The current study comprised 1,593 adults, including 1,020 female participants (64%), who were treated for MI at 103 hospitals in 30 U.S. states.

VIRGO enrolled participants in a 2:1 female-to-male ratio so as to enrich the inclusion of women, Ms. Zhu explained.

In the study, “partnered” participants were individuals who self-reported as “living as married/living with a partner.” There were 126 such patients (8%) in the current study.

The mean age of the patients was 47, and about 90% were 40-55 years old. Three quarters were White, 13% were Black, and 7% were Hispanic.

Marital stress was assessed on the basis of patients’ replies to 17 questions in the Stockholm Marital Stress Scale regarding the quality of their emotional and sexual relationships with their spouses/partners.

The researchers divided patients into three groups on the basis of their marital stress: mild or absent (lowest quartile), moderate (second quartile), and severe (upper two quartiles).

At 1 year after their MI, patients replied to questionnaires that assessed their health, quality of life, and depressive and angina symptoms. Hospital readmissions were determined on the basis of self-reports and medical records.

Compared to participants who reported no or mild marital stress, those who reported severe mental stress had significantly worse scores for physical and mental health and generic and cardiovascular quality of life, after adjusting for baseline health and demographics. They had worse scores for mental health and quality of life, after further adjusting for socioeconomic status.

In the fully adjusted model, patients who reported severe marital stress were significantly more likely to report more frequent chest pain/angina (odds ratio, 1.49; 95% confidence interval, 1.06-2.10; P = .023) and to have been readmitted to hospital for any cause (OR, 1.45; 95% CI, 1.04-2.00; P = .006), compared with the patients who reported no or mild marital stress.

Study limitations include the fact that the findings are based on self-reported questionnaire replies; they may not be generalizable to patients in other countries; and they do not extend beyond a period of 1 year.

The researchers call for further research “to understand this complex relationship and potential causal pathway associated with these findings.”

“Additional stressors beyond marital stress, such as financial strain or work stress, may also play a role in young adults’ recovery, and the interaction between these factors require further research,” Ms. Zhu noted in a press release from the AHA.

The study was funded by Canadian Institutes of Health Research. The VIRGO study was funded by the National Heart, Lung, and Blood Institute. Ms. Zhu and Dr. Goldberg have disclosed no relevant financial relationships.

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

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Severe marital stress was associated with worse recovery after myocardial infarction in a large U.S. cohort of married/partnered patients aged 55 years or younger.

Compared with patients who reported no or mild marital stress a month after their MI, patients who reported severe marital stress had worse physical and mental health, worse generic and cardiovascular quality of life, more frequent angina symptoms, and a greater likelihood of having a hospital readmission a year later.

These findings held true after adjusting for gender, age, race/ethnicity, and baseline health status (model 1) and after further adjusting for education and income levels and employment and insurance status (model 2).

A greater percentage of women than men reported having severe marital stress (39% vs. 30%; P = .001).

Cenjing Zhu, MPhil, a PhD candidate at Yale University, New Haven, Conn., and colleagues will present this study at the American Heart Association scientific sessions.

The results show that “both patients and care providers should be aware that stress experienced in one’s everyday life, such as marital stress, can affect AMI [acute MI] recovery,” Ms. Zhu said in an email.

Health care providers should consider incorporating screening for everyday stress during follow-up patient visits to better spot people at high risk of a poor recovery and further hospitalizations, she added. When possible, they could guide patients to resources to help them manage and reduce their stress levels.

According to Ms. Zhu, the findings suggest that “managing personal stress may be as important as managing other clinical risk factors during the recovery process.”

Dr. Nieca Goldberg

This study in younger patients with MI “shows that high levels of marital stress impair heart attack recovery, and women have greater impairment in their heart attack recovery compared to men,” AHA spokesperson Nieca Goldberg, MD, who was not involved with this research, told this news organization.

The study shows that “clinicians have to incorporate mental health as part of their assessment of all patients,” said Dr. Goldberg, a clinical associate professor of medicine at New York University and medical director of Atria New York City.

“Our mental health impacts our physical health,” she noted. “Questions about marital stress should be included as part of an overall assessment of mental health. This means assessing all patients for stress, anxiety, and depression.”

Patients who are experiencing marital stress should share the information with their doctor and discuss ways to be referred to therapists and cardiac rehabilitation providers, she said. “My final thought is, women have often been told that their cardiac symptoms are due to stress by doctors. Now we know stress impacts physical health and [is] no longer an excuse but a contributing factor to our physical health.”
 

Does marital stress affect young MI recovery?

Previous literature has linked psychological stress with worse cardiovascular outcomes, Ms. Zhu noted.

However, little is known about the prognostic impact of marital stress on 1-year health outcomes for younger people who survive an MI.

To investigate this, the researchers analyzed data from participants in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study.

The current study comprised 1,593 adults, including 1,020 female participants (64%), who were treated for MI at 103 hospitals in 30 U.S. states.

VIRGO enrolled participants in a 2:1 female-to-male ratio so as to enrich the inclusion of women, Ms. Zhu explained.

In the study, “partnered” participants were individuals who self-reported as “living as married/living with a partner.” There were 126 such patients (8%) in the current study.

The mean age of the patients was 47, and about 90% were 40-55 years old. Three quarters were White, 13% were Black, and 7% were Hispanic.

Marital stress was assessed on the basis of patients’ replies to 17 questions in the Stockholm Marital Stress Scale regarding the quality of their emotional and sexual relationships with their spouses/partners.

The researchers divided patients into three groups on the basis of their marital stress: mild or absent (lowest quartile), moderate (second quartile), and severe (upper two quartiles).

At 1 year after their MI, patients replied to questionnaires that assessed their health, quality of life, and depressive and angina symptoms. Hospital readmissions were determined on the basis of self-reports and medical records.

Compared to participants who reported no or mild marital stress, those who reported severe mental stress had significantly worse scores for physical and mental health and generic and cardiovascular quality of life, after adjusting for baseline health and demographics. They had worse scores for mental health and quality of life, after further adjusting for socioeconomic status.

In the fully adjusted model, patients who reported severe marital stress were significantly more likely to report more frequent chest pain/angina (odds ratio, 1.49; 95% confidence interval, 1.06-2.10; P = .023) and to have been readmitted to hospital for any cause (OR, 1.45; 95% CI, 1.04-2.00; P = .006), compared with the patients who reported no or mild marital stress.

Study limitations include the fact that the findings are based on self-reported questionnaire replies; they may not be generalizable to patients in other countries; and they do not extend beyond a period of 1 year.

The researchers call for further research “to understand this complex relationship and potential causal pathway associated with these findings.”

“Additional stressors beyond marital stress, such as financial strain or work stress, may also play a role in young adults’ recovery, and the interaction between these factors require further research,” Ms. Zhu noted in a press release from the AHA.

The study was funded by Canadian Institutes of Health Research. The VIRGO study was funded by the National Heart, Lung, and Blood Institute. Ms. Zhu and Dr. Goldberg have disclosed no relevant financial relationships.

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

Severe marital stress was associated with worse recovery after myocardial infarction in a large U.S. cohort of married/partnered patients aged 55 years or younger.

Compared with patients who reported no or mild marital stress a month after their MI, patients who reported severe marital stress had worse physical and mental health, worse generic and cardiovascular quality of life, more frequent angina symptoms, and a greater likelihood of having a hospital readmission a year later.

These findings held true after adjusting for gender, age, race/ethnicity, and baseline health status (model 1) and after further adjusting for education and income levels and employment and insurance status (model 2).

A greater percentage of women than men reported having severe marital stress (39% vs. 30%; P = .001).

Cenjing Zhu, MPhil, a PhD candidate at Yale University, New Haven, Conn., and colleagues will present this study at the American Heart Association scientific sessions.

The results show that “both patients and care providers should be aware that stress experienced in one’s everyday life, such as marital stress, can affect AMI [acute MI] recovery,” Ms. Zhu said in an email.

Health care providers should consider incorporating screening for everyday stress during follow-up patient visits to better spot people at high risk of a poor recovery and further hospitalizations, she added. When possible, they could guide patients to resources to help them manage and reduce their stress levels.

According to Ms. Zhu, the findings suggest that “managing personal stress may be as important as managing other clinical risk factors during the recovery process.”

Dr. Nieca Goldberg

This study in younger patients with MI “shows that high levels of marital stress impair heart attack recovery, and women have greater impairment in their heart attack recovery compared to men,” AHA spokesperson Nieca Goldberg, MD, who was not involved with this research, told this news organization.

The study shows that “clinicians have to incorporate mental health as part of their assessment of all patients,” said Dr. Goldberg, a clinical associate professor of medicine at New York University and medical director of Atria New York City.

“Our mental health impacts our physical health,” she noted. “Questions about marital stress should be included as part of an overall assessment of mental health. This means assessing all patients for stress, anxiety, and depression.”

Patients who are experiencing marital stress should share the information with their doctor and discuss ways to be referred to therapists and cardiac rehabilitation providers, she said. “My final thought is, women have often been told that their cardiac symptoms are due to stress by doctors. Now we know stress impacts physical health and [is] no longer an excuse but a contributing factor to our physical health.”
 

Does marital stress affect young MI recovery?

Previous literature has linked psychological stress with worse cardiovascular outcomes, Ms. Zhu noted.

However, little is known about the prognostic impact of marital stress on 1-year health outcomes for younger people who survive an MI.

To investigate this, the researchers analyzed data from participants in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study.

The current study comprised 1,593 adults, including 1,020 female participants (64%), who were treated for MI at 103 hospitals in 30 U.S. states.

VIRGO enrolled participants in a 2:1 female-to-male ratio so as to enrich the inclusion of women, Ms. Zhu explained.

In the study, “partnered” participants were individuals who self-reported as “living as married/living with a partner.” There were 126 such patients (8%) in the current study.

The mean age of the patients was 47, and about 90% were 40-55 years old. Three quarters were White, 13% were Black, and 7% were Hispanic.

Marital stress was assessed on the basis of patients’ replies to 17 questions in the Stockholm Marital Stress Scale regarding the quality of their emotional and sexual relationships with their spouses/partners.

The researchers divided patients into three groups on the basis of their marital stress: mild or absent (lowest quartile), moderate (second quartile), and severe (upper two quartiles).

At 1 year after their MI, patients replied to questionnaires that assessed their health, quality of life, and depressive and angina symptoms. Hospital readmissions were determined on the basis of self-reports and medical records.

Compared to participants who reported no or mild marital stress, those who reported severe mental stress had significantly worse scores for physical and mental health and generic and cardiovascular quality of life, after adjusting for baseline health and demographics. They had worse scores for mental health and quality of life, after further adjusting for socioeconomic status.

In the fully adjusted model, patients who reported severe marital stress were significantly more likely to report more frequent chest pain/angina (odds ratio, 1.49; 95% confidence interval, 1.06-2.10; P = .023) and to have been readmitted to hospital for any cause (OR, 1.45; 95% CI, 1.04-2.00; P = .006), compared with the patients who reported no or mild marital stress.

Study limitations include the fact that the findings are based on self-reported questionnaire replies; they may not be generalizable to patients in other countries; and they do not extend beyond a period of 1 year.

The researchers call for further research “to understand this complex relationship and potential causal pathway associated with these findings.”

“Additional stressors beyond marital stress, such as financial strain or work stress, may also play a role in young adults’ recovery, and the interaction between these factors require further research,” Ms. Zhu noted in a press release from the AHA.

The study was funded by Canadian Institutes of Health Research. The VIRGO study was funded by the National Heart, Lung, and Blood Institute. Ms. Zhu and Dr. Goldberg have disclosed no relevant financial relationships.

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

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