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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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Are You Unwittingly Aiding the Rise of Superfungi?

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Wed, 01/17/2024 - 12:38

Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Unnecessary or incorrect use of topical antifungal medications is driving the spread of fungal infections like ringworm, which are becoming more difficult to treat, according to a January 11 study published in Morbidity and Mortality Weekly Report

If a patient’s condition is not caused by a fungus but is treated as such, treatment will be ineffective.

The authors strongly advise primary care clinicians to confirm ringworm diagnoses through lab testing before prescribing treatments such as clotrimazole or combinations of antifungals and corticosteroids. And because many topical treatments are also available over-the-counter, doctors should advise patients about how to use them correctly.

“In the last few years, there have been many antifungal resistant cases of tinea corporisand onychomycosisreported,” or ringworm and finger or toenail infections, respectively, said Shari Lipner, MD, PhD, a dermatologist at Weill Cornell Medicine in New York, and an author of the study.

Many of these cases originated in South Asia and have also been reported in Europe and Canada. In 2023, the first cases of a new strain of antifungal-resistant ringworm were reported in the United States. This species, Trichophyton indotineae, does not respond to topical medications, requiring oral treatment instead.

“It’s really a serious problem and a huge public health concern,” Dr. Lipner said. 

For the new study, Dr. Lipner and colleagues examined prescription patterns from 2021 Medicare Part D claims of topical antifungals. They report that 6.5 million topical antifungal prescriptions were filled that year, some of which included steroids in the formulation. Primary care clinicians wrote 40% of these prescriptions, the most for any clinician group. The estimate is almost certainly an undercount of topical antifungal use because the database did not include over-the-counter purchases or data from other insurance payers.

The number of prescriptions equate to 1 in every 8 Medicare Part D beneficiary receiving an antifungal, the researchers reported. 

“If I think about the patients that come into my office, I’m certainly not giving an antifungal to 1 in 8 of them, and I see a lot of fungal infections,” Dr. Lipner said. The findings suggest to Dr. Lipner that some clinicians are diagnosing ringworm by eyesight alone rather than confirming the diagnosis with techniques such as microscopy, fungal culture testing, or polymerase chain reaction testing. 

Sometimes what looks like ringworm may actually be eczema, in which case, the topical antifungal would not be appropriate, according to Avrom Caplan, MD, a dermatologist at NYU Langone Health in New York.

“If you’re prescribing something to somebody that they don’t need, you’re basically exposing them to the side effects without the benefit,” Dr. Caplan, who was not part of the study, said. 

Dr. Caplan, who reported the first cases of ringworm that only responded to oral medications in the United States, stressed that topical treatments work fine for many ringworm cases today. But if indiscriminate prescribing spurs the development of more resilient fungi, more situations may arise in which only oral medications work in the future, Dr. Caplan said. In addition, oral medications are inherently more demanding on a patient than something they can rub on their skin, Dr. Caplan added.

“We hope that physicians will really think hard about this study and change their practices if they’re not confirming the diagnosis,” Dr. Lipner said.

Dr. Lipner and Dr. Caplan report no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Left-Handed Med Students Still ‘Left Out’ in Surgery

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Wed, 01/17/2024 - 14:40

Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

  • Anxiety about laterality
  • Lack of mentoring on lateral preference
  • Difficulty handling traditional instruments
  • Difficulty with minimally invasive instruments
  • Inconvenience while assisting a right-handed person
  • Pressure to change lateral preference
  • Possible disadvantages with certain procedures
  • Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

  • Disorienting advice from faculty or residents
  • Discouraging right-handed pressures and left-handed stigmatization
  • Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

 

 

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

 

 

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

  • Anxiety about laterality
  • Lack of mentoring on lateral preference
  • Difficulty handling traditional instruments
  • Difficulty with minimally invasive instruments
  • Inconvenience while assisting a right-handed person
  • Pressure to change lateral preference
  • Possible disadvantages with certain procedures
  • Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

  • Disorienting advice from faculty or residents
  • Discouraging right-handed pressures and left-handed stigmatization
  • Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

 

 

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

 

 

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

  • Anxiety about laterality
  • Lack of mentoring on lateral preference
  • Difficulty handling traditional instruments
  • Difficulty with minimally invasive instruments
  • Inconvenience while assisting a right-handed person
  • Pressure to change lateral preference
  • Possible disadvantages with certain procedures
  • Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

  • Disorienting advice from faculty or residents
  • Discouraging right-handed pressures and left-handed stigmatization
  • Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

 

 

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

 

 

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

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CMS Okays Payment for Novel AI Prostate Test

Article Type
Changed
Tue, 01/16/2024 - 16:20

Medicare will now cover the use of an AI-based test for prostate cancer that can predict which men will benefit from potentially disabling androgen deprivation therapy.

The Centers for Medicare & Medicare Services (CMS) on January 1 approved the payment rate for ArteraAI as a clinical diagnostic laboratory test. The test is the first that can both predict therapeutic benefit and prognosticate long-term outcomes in localized prostate cancer. 

Daniel Spratt, MD, chair of radiation oncology at UH Seidman Cancer Center in Cleveland, who has been involved in researching ArteraAI, told this news organization that the test improves risk stratification or prognostication over standard clinical and pathologic tools, such as prostate-specific antigen, Gleason score, and T-stage, or risk groupings such as those from the National Comprehensive Cancer Network (NCCN).

“Medicare approval allows this test to reach more patients without the financial burden of covering the test out of pocket. The test is found among other tests in NCCN guidelines as a tool to improve risk stratification and personalization of treatment,” said Dr. Spratt, who serves on the network’s prostate cancer panel.

ArteraAI combines a patient’s standard clinical and pathologic information into an algorithm, alongside a digitized image analysis of the patients’ prostate biopsy. The result is a score that estimates a patient’s risk of developing metastasis or dying from prostate cancer.

Dr. Spratt was the lead author of article last June in NEJM Evidence that validated ArteraAI. He said ArteraAI is 80% accurate as a prognostic test compared with 65% accuracy using NCCN stratification systems. 

The AI test spares about two thirds of men with intermediate-risk prostate cancer who are starting radiation therapy from androgen deprivation and its side effects, such as weight gain, breast enlargement, hot flashes, heart disease, and brain problems, Dr. Spratt added. 

Andre Esteva, CEO and co-founder of San Francisco-based ArteraAI, said, “After someone is diagnosed with localized prostate cancer, deciding on a treatment can feel very overwhelming as there are so many factors to consider. During this time, knowledge is power, and having detailed, personalized information can increase confidence when making these challenging decisions. The ArteraAI Prostate Test was developed with this in mind and can predict whether a patient will benefit from hormone therapy and estimate long-term outcomes.”

Bruno Barrey is one of Dr. Spratt’s patients. Barrey, a robotics engineer from suburban Detroit who was transitioning from active surveillance with Gleason 3+4 intermediate-risk prostate cancer to radiation therapy, said, “I was concerned about the side effects from androgen-deprivation therapy. I was relieved that the AI test allowed me to avoid hormone therapy.”

Dr. Spratt reported working with NRG Oncology, a clinical trials group funded by the National Cancer Institute, and as an academic collaborator with ArteraAI. 

A version of this article appeared on Medscape.com.

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Medicare will now cover the use of an AI-based test for prostate cancer that can predict which men will benefit from potentially disabling androgen deprivation therapy.

The Centers for Medicare & Medicare Services (CMS) on January 1 approved the payment rate for ArteraAI as a clinical diagnostic laboratory test. The test is the first that can both predict therapeutic benefit and prognosticate long-term outcomes in localized prostate cancer. 

Daniel Spratt, MD, chair of radiation oncology at UH Seidman Cancer Center in Cleveland, who has been involved in researching ArteraAI, told this news organization that the test improves risk stratification or prognostication over standard clinical and pathologic tools, such as prostate-specific antigen, Gleason score, and T-stage, or risk groupings such as those from the National Comprehensive Cancer Network (NCCN).

“Medicare approval allows this test to reach more patients without the financial burden of covering the test out of pocket. The test is found among other tests in NCCN guidelines as a tool to improve risk stratification and personalization of treatment,” said Dr. Spratt, who serves on the network’s prostate cancer panel.

ArteraAI combines a patient’s standard clinical and pathologic information into an algorithm, alongside a digitized image analysis of the patients’ prostate biopsy. The result is a score that estimates a patient’s risk of developing metastasis or dying from prostate cancer.

Dr. Spratt was the lead author of article last June in NEJM Evidence that validated ArteraAI. He said ArteraAI is 80% accurate as a prognostic test compared with 65% accuracy using NCCN stratification systems. 

The AI test spares about two thirds of men with intermediate-risk prostate cancer who are starting radiation therapy from androgen deprivation and its side effects, such as weight gain, breast enlargement, hot flashes, heart disease, and brain problems, Dr. Spratt added. 

Andre Esteva, CEO and co-founder of San Francisco-based ArteraAI, said, “After someone is diagnosed with localized prostate cancer, deciding on a treatment can feel very overwhelming as there are so many factors to consider. During this time, knowledge is power, and having detailed, personalized information can increase confidence when making these challenging decisions. The ArteraAI Prostate Test was developed with this in mind and can predict whether a patient will benefit from hormone therapy and estimate long-term outcomes.”

Bruno Barrey is one of Dr. Spratt’s patients. Barrey, a robotics engineer from suburban Detroit who was transitioning from active surveillance with Gleason 3+4 intermediate-risk prostate cancer to radiation therapy, said, “I was concerned about the side effects from androgen-deprivation therapy. I was relieved that the AI test allowed me to avoid hormone therapy.”

Dr. Spratt reported working with NRG Oncology, a clinical trials group funded by the National Cancer Institute, and as an academic collaborator with ArteraAI. 

A version of this article appeared on Medscape.com.

Medicare will now cover the use of an AI-based test for prostate cancer that can predict which men will benefit from potentially disabling androgen deprivation therapy.

The Centers for Medicare & Medicare Services (CMS) on January 1 approved the payment rate for ArteraAI as a clinical diagnostic laboratory test. The test is the first that can both predict therapeutic benefit and prognosticate long-term outcomes in localized prostate cancer. 

Daniel Spratt, MD, chair of radiation oncology at UH Seidman Cancer Center in Cleveland, who has been involved in researching ArteraAI, told this news organization that the test improves risk stratification or prognostication over standard clinical and pathologic tools, such as prostate-specific antigen, Gleason score, and T-stage, or risk groupings such as those from the National Comprehensive Cancer Network (NCCN).

“Medicare approval allows this test to reach more patients without the financial burden of covering the test out of pocket. The test is found among other tests in NCCN guidelines as a tool to improve risk stratification and personalization of treatment,” said Dr. Spratt, who serves on the network’s prostate cancer panel.

ArteraAI combines a patient’s standard clinical and pathologic information into an algorithm, alongside a digitized image analysis of the patients’ prostate biopsy. The result is a score that estimates a patient’s risk of developing metastasis or dying from prostate cancer.

Dr. Spratt was the lead author of article last June in NEJM Evidence that validated ArteraAI. He said ArteraAI is 80% accurate as a prognostic test compared with 65% accuracy using NCCN stratification systems. 

The AI test spares about two thirds of men with intermediate-risk prostate cancer who are starting radiation therapy from androgen deprivation and its side effects, such as weight gain, breast enlargement, hot flashes, heart disease, and brain problems, Dr. Spratt added. 

Andre Esteva, CEO and co-founder of San Francisco-based ArteraAI, said, “After someone is diagnosed with localized prostate cancer, deciding on a treatment can feel very overwhelming as there are so many factors to consider. During this time, knowledge is power, and having detailed, personalized information can increase confidence when making these challenging decisions. The ArteraAI Prostate Test was developed with this in mind and can predict whether a patient will benefit from hormone therapy and estimate long-term outcomes.”

Bruno Barrey is one of Dr. Spratt’s patients. Barrey, a robotics engineer from suburban Detroit who was transitioning from active surveillance with Gleason 3+4 intermediate-risk prostate cancer to radiation therapy, said, “I was concerned about the side effects from androgen-deprivation therapy. I was relieved that the AI test allowed me to avoid hormone therapy.”

Dr. Spratt reported working with NRG Oncology, a clinical trials group funded by the National Cancer Institute, and as an academic collaborator with ArteraAI. 

A version of this article appeared on Medscape.com.

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Testosterone Replacement Therapy and Prostate Cancer Risk

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Tue, 01/16/2024 - 15:59

 

TOPLINE:

Testosterone replacement therapy in middle-aged and older men with hypogonadism does not increase the risk for high-grade or any prostate cancer, new data confirmed.

METHODOLOGY:

  • The relationship between testosterone replacement therapy and prostate cancer risk remains unclear.
  • Epidemiologic studies have shown inconsistent findings, and clinical trials have not examined prostate safety. As a result, guidelines generally advise against testosterone replacement therapy in men with a history of or increased risk for prostate cancer.
  • The current placebo-controlled, double-blind, parallel-group randomized study included 5204 men, ages 45-80, who had two fasting testosterone concentrations < 300 ng/dL, one or more hypogonadal symptoms, and a history of cardiovascular disease or increased . Patients were randomly assigned 1:1 to receive either testosterone replacement therapy or placebo.
  • The primary prostate safety endpoint was incident high-grade prostate cancer (Gleason score 4 + 3 or higher).
  • Secondary endpoints included incidence of any prostate cancer, acute urinary retention, invasive procedure for , , and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

  • The incidence of high-grade prostate cancer did not differ significantly between groups. Over a mean follow-up of 33 months, only 0.19% (5 of 2596 participants) in the testosterone replacement therapy group and 0.12% (3 of 2602) in the placebo group were diagnosed with high-grade disease (hazard ratio [HR], 1.62; P = .51).
  • The rate of any prostate cancer also did not differ significantly between the testosterone vs placebo groups (0.46% vs 0.42%; HR, 1.07; P = .87).
  • The rates of acute urinary retention (0.77% vs 0.61%; HR, 1.25; P = .50), invasive procedures for benign prostatic hyperplasia (0.89% vs 0.46%; HR, 1.91; P = .07), prostate biopsy (0.62% vs 0.54%; HR, 1.13; P = .74), or new treatment for lower urinary tract symptoms (3.89% vs 3.34%; HR, 1.16; P = .32) did not differ significantly between the testosterone vs placebo groups.
  • Compared with placebo, testosterone therapy did increase prostate-specific antigen (PSA) levels, but the differences were small and did not increase after 12 months.

IN PRACTICE:

In a population of middle-aged and older men with hypogonadism, “the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men,” the authors concluded. “The study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

This study, led by Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, was published online in JAMA Network Open.

LIMITATIONS:

These study findings do not apply to men with known prostate cancer, higher PSA values, or those without confirmed hypogonadism. The study design did not include prostate imaging or other biomarker tests after PSA testing, which may have affected the decision to perform a biopsy. Also, the rates of treatment discontinuation and loss to follow-up were high.

 

 

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc., with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corporation, and Upsher-Smith Laboratories. Bhasin, Lincoff, and Khera reported receiving grants and consulting and personal fees from various sources. The remaining authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

Testosterone replacement therapy in middle-aged and older men with hypogonadism does not increase the risk for high-grade or any prostate cancer, new data confirmed.

METHODOLOGY:

  • The relationship between testosterone replacement therapy and prostate cancer risk remains unclear.
  • Epidemiologic studies have shown inconsistent findings, and clinical trials have not examined prostate safety. As a result, guidelines generally advise against testosterone replacement therapy in men with a history of or increased risk for prostate cancer.
  • The current placebo-controlled, double-blind, parallel-group randomized study included 5204 men, ages 45-80, who had two fasting testosterone concentrations < 300 ng/dL, one or more hypogonadal symptoms, and a history of cardiovascular disease or increased . Patients were randomly assigned 1:1 to receive either testosterone replacement therapy or placebo.
  • The primary prostate safety endpoint was incident high-grade prostate cancer (Gleason score 4 + 3 or higher).
  • Secondary endpoints included incidence of any prostate cancer, acute urinary retention, invasive procedure for , , and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

  • The incidence of high-grade prostate cancer did not differ significantly between groups. Over a mean follow-up of 33 months, only 0.19% (5 of 2596 participants) in the testosterone replacement therapy group and 0.12% (3 of 2602) in the placebo group were diagnosed with high-grade disease (hazard ratio [HR], 1.62; P = .51).
  • The rate of any prostate cancer also did not differ significantly between the testosterone vs placebo groups (0.46% vs 0.42%; HR, 1.07; P = .87).
  • The rates of acute urinary retention (0.77% vs 0.61%; HR, 1.25; P = .50), invasive procedures for benign prostatic hyperplasia (0.89% vs 0.46%; HR, 1.91; P = .07), prostate biopsy (0.62% vs 0.54%; HR, 1.13; P = .74), or new treatment for lower urinary tract symptoms (3.89% vs 3.34%; HR, 1.16; P = .32) did not differ significantly between the testosterone vs placebo groups.
  • Compared with placebo, testosterone therapy did increase prostate-specific antigen (PSA) levels, but the differences were small and did not increase after 12 months.

IN PRACTICE:

In a population of middle-aged and older men with hypogonadism, “the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men,” the authors concluded. “The study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

This study, led by Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, was published online in JAMA Network Open.

LIMITATIONS:

These study findings do not apply to men with known prostate cancer, higher PSA values, or those without confirmed hypogonadism. The study design did not include prostate imaging or other biomarker tests after PSA testing, which may have affected the decision to perform a biopsy. Also, the rates of treatment discontinuation and loss to follow-up were high.

 

 

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc., with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corporation, and Upsher-Smith Laboratories. Bhasin, Lincoff, and Khera reported receiving grants and consulting and personal fees from various sources. The remaining authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Testosterone replacement therapy in middle-aged and older men with hypogonadism does not increase the risk for high-grade or any prostate cancer, new data confirmed.

METHODOLOGY:

  • The relationship between testosterone replacement therapy and prostate cancer risk remains unclear.
  • Epidemiologic studies have shown inconsistent findings, and clinical trials have not examined prostate safety. As a result, guidelines generally advise against testosterone replacement therapy in men with a history of or increased risk for prostate cancer.
  • The current placebo-controlled, double-blind, parallel-group randomized study included 5204 men, ages 45-80, who had two fasting testosterone concentrations < 300 ng/dL, one or more hypogonadal symptoms, and a history of cardiovascular disease or increased . Patients were randomly assigned 1:1 to receive either testosterone replacement therapy or placebo.
  • The primary prostate safety endpoint was incident high-grade prostate cancer (Gleason score 4 + 3 or higher).
  • Secondary endpoints included incidence of any prostate cancer, acute urinary retention, invasive procedure for , , and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

  • The incidence of high-grade prostate cancer did not differ significantly between groups. Over a mean follow-up of 33 months, only 0.19% (5 of 2596 participants) in the testosterone replacement therapy group and 0.12% (3 of 2602) in the placebo group were diagnosed with high-grade disease (hazard ratio [HR], 1.62; P = .51).
  • The rate of any prostate cancer also did not differ significantly between the testosterone vs placebo groups (0.46% vs 0.42%; HR, 1.07; P = .87).
  • The rates of acute urinary retention (0.77% vs 0.61%; HR, 1.25; P = .50), invasive procedures for benign prostatic hyperplasia (0.89% vs 0.46%; HR, 1.91; P = .07), prostate biopsy (0.62% vs 0.54%; HR, 1.13; P = .74), or new treatment for lower urinary tract symptoms (3.89% vs 3.34%; HR, 1.16; P = .32) did not differ significantly between the testosterone vs placebo groups.
  • Compared with placebo, testosterone therapy did increase prostate-specific antigen (PSA) levels, but the differences were small and did not increase after 12 months.

IN PRACTICE:

In a population of middle-aged and older men with hypogonadism, “the incidences of high-grade or any prostate cancer and other prostate events were low and did not differ significantly between testosterone- and placebo-treated men,” the authors concluded. “The study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

This study, led by Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, was published online in JAMA Network Open.

LIMITATIONS:

These study findings do not apply to men with known prostate cancer, higher PSA values, or those without confirmed hypogonadism. The study design did not include prostate imaging or other biomarker tests after PSA testing, which may have affected the decision to perform a biopsy. Also, the rates of treatment discontinuation and loss to follow-up were high.

 

 

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc., with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corporation, and Upsher-Smith Laboratories. Bhasin, Lincoff, and Khera reported receiving grants and consulting and personal fees from various sources. The remaining authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

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Time Off Isn’t Really Off-Time for Most Physicians, Study Finds

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Changed
Fri, 01/19/2024 - 08:10

 

About 20% of US physicians took less than 1 week of vacation in the previous year, a new study found. When doctors did go on vacation, 70% reported working on their days off to handle patient-related tasks.

Burnout was more likely among doctors who worked more during vacations and lacked coverage in responding to electronic health messages from patients, according to the cross-sectional study, which was published on January 12, 2024, in JAMA Network Open.“It’s important to provide physicians with adequate time to disconnect from work and recharge,” said study coauthor Tait Shanafelt, MD, chief wellness officer at Stanford Medicine, in an interview.

The study’s conclusion that most US physicians work on their days off “is a marker of inadequate staffing, suboptimal teamwork, and poorly designed coverage systems,” he added. “Simply allocating people a number of vacation days is not enough.”

According to Dr. Shanafelt, there’s been little research into vacation’s impact on physician well-being. However, it is clear that work overload and exhaustion are major problems among American physicians. “Inadequate time off may magnify these challenges.”

Research suggests that physicians suffer more burnout than other US workers even after adjusting for confounders, he said. Extensive evidence shows that burnout in physicians contributes to medical errors and erodes quality of care and patient satisfaction, he added.

For the new study, researchers mailed surveys to 3671 members of the American Medical Association from 2020 to 2021, and 1162 (31.7%) responded. Another 6348 (7.1%) responded to an email survey sent to 90,000 physicians. An analysis suggested the respondents were representative of all US practicing physicians. 

Among 3024 respondents who responded to a subsurvey about vacations, about 40% took more than 15 days of vacation over the past year, about 40% took 6-15 days, and about 20% took 5 or fewer days. 

Fewer than half of physicians said their electronic health record (EHR) inboxes were fully covered by others while they were away. About 70% said they worked while on vacation, with nearly 15% working an hour or more each day.

Emergency physicians were the least likely and anesthesiologists were the most likely to take at least 15 days of vacation per year, according to the study. 

Women were more likely than men to work 30 or more minutes a day on vacation. Physicians aged 65 years and older were more likely to take 15 or more days of vacation per year than those under 35 years.

An adjusted analysis linked complete EHR inbox coverage to lower odds of taking time during vacation to work (odds ratio [OR], 0.68; 95% CI, 0.57-0.80).

“For many, difficulty finding clinical coverage, lack of EHR inbox coverage, and returning to an overwhelming backlog of EHR inbox work at were identified as barriers to taking vacation,” Dr. Shanafelt said.

Researchers linked lower rates of burnout to taking more than 3 weeks of vacation per year (OR, 0.59-0.66, depending on time spent; 95% CI, 0.40-0.98) vs none. They also linked less burnout to full EHR inbox coverage while on vacation (OR, 0.74; 95% CI, 0.63-0.88) and more burnout to spending 30 minutes or more on work while on a typical vacation day (OR, 1.58-1.97, depending on time spent; 95% CI, 1.22-2.77). 

Study limitations include the low participation rate and lack of insight into causation. It’s not clear how burnout and less vacation time are related and whether one causes the other, Shanafelt said. “It is possible there are a number of interacting factors rather than a simple, linear relationship.”

In an interview, Lazar J. Greenfield, Jr., MD, PhD, professor and chairman of neurology at UConn Health, Farmington, Connecticut, said his department encourages clinicians to plan vacations well ahead of time, and “we make a real strong effort to make sure that people are fully covered and someone has their Epic inbox.”

Dr. Greenfield, who wasn’t involved in the new study, recommended that physicians plan active vacations, so they have less downtime to catch up on work matters. But he acknowledged that stepping away from emails can be difficult, especially when physicians fear pileups of work upon their return or don’t want to annoy patients with tardy responses.

“They have a hard time disengaging from their moral obligations to patients,” he said. “Another issue, particularly in my field of neurology, is that there’s a lot of subspecialties. Finding somebody with the exact subspecialty and expertise to cover a very specific patient population they treat can be really hard.”

The Stanford WellMD Center, Mayo Clinic Department of Medicine Program on Physician Well-being, and American Medical Association funded the study.

Dr. Shanafelt discloses coinventing the Well-Being Index and its derivatives with another study author; Mayo Clinic licensed the Well-Being Index and pays them royalties outside the submitted work. Dr. Shanafelt also reported support for grand rounds, lectures, and advising for healthcare organizations outside the submitted work. Other authors reported personal fees from Marvin Behavioral Health and grants from the National Institute of Nursing Research, National Science Foundation, and Med Ed Solutions. 

Dr. Greenfield had no disclosures.

 

 

A version of this article appeared on Medscape.com

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About 20% of US physicians took less than 1 week of vacation in the previous year, a new study found. When doctors did go on vacation, 70% reported working on their days off to handle patient-related tasks.

Burnout was more likely among doctors who worked more during vacations and lacked coverage in responding to electronic health messages from patients, according to the cross-sectional study, which was published on January 12, 2024, in JAMA Network Open.“It’s important to provide physicians with adequate time to disconnect from work and recharge,” said study coauthor Tait Shanafelt, MD, chief wellness officer at Stanford Medicine, in an interview.

The study’s conclusion that most US physicians work on their days off “is a marker of inadequate staffing, suboptimal teamwork, and poorly designed coverage systems,” he added. “Simply allocating people a number of vacation days is not enough.”

According to Dr. Shanafelt, there’s been little research into vacation’s impact on physician well-being. However, it is clear that work overload and exhaustion are major problems among American physicians. “Inadequate time off may magnify these challenges.”

Research suggests that physicians suffer more burnout than other US workers even after adjusting for confounders, he said. Extensive evidence shows that burnout in physicians contributes to medical errors and erodes quality of care and patient satisfaction, he added.

For the new study, researchers mailed surveys to 3671 members of the American Medical Association from 2020 to 2021, and 1162 (31.7%) responded. Another 6348 (7.1%) responded to an email survey sent to 90,000 physicians. An analysis suggested the respondents were representative of all US practicing physicians. 

Among 3024 respondents who responded to a subsurvey about vacations, about 40% took more than 15 days of vacation over the past year, about 40% took 6-15 days, and about 20% took 5 or fewer days. 

Fewer than half of physicians said their electronic health record (EHR) inboxes were fully covered by others while they were away. About 70% said they worked while on vacation, with nearly 15% working an hour or more each day.

Emergency physicians were the least likely and anesthesiologists were the most likely to take at least 15 days of vacation per year, according to the study. 

Women were more likely than men to work 30 or more minutes a day on vacation. Physicians aged 65 years and older were more likely to take 15 or more days of vacation per year than those under 35 years.

An adjusted analysis linked complete EHR inbox coverage to lower odds of taking time during vacation to work (odds ratio [OR], 0.68; 95% CI, 0.57-0.80).

“For many, difficulty finding clinical coverage, lack of EHR inbox coverage, and returning to an overwhelming backlog of EHR inbox work at were identified as barriers to taking vacation,” Dr. Shanafelt said.

Researchers linked lower rates of burnout to taking more than 3 weeks of vacation per year (OR, 0.59-0.66, depending on time spent; 95% CI, 0.40-0.98) vs none. They also linked less burnout to full EHR inbox coverage while on vacation (OR, 0.74; 95% CI, 0.63-0.88) and more burnout to spending 30 minutes or more on work while on a typical vacation day (OR, 1.58-1.97, depending on time spent; 95% CI, 1.22-2.77). 

Study limitations include the low participation rate and lack of insight into causation. It’s not clear how burnout and less vacation time are related and whether one causes the other, Shanafelt said. “It is possible there are a number of interacting factors rather than a simple, linear relationship.”

In an interview, Lazar J. Greenfield, Jr., MD, PhD, professor and chairman of neurology at UConn Health, Farmington, Connecticut, said his department encourages clinicians to plan vacations well ahead of time, and “we make a real strong effort to make sure that people are fully covered and someone has their Epic inbox.”

Dr. Greenfield, who wasn’t involved in the new study, recommended that physicians plan active vacations, so they have less downtime to catch up on work matters. But he acknowledged that stepping away from emails can be difficult, especially when physicians fear pileups of work upon their return or don’t want to annoy patients with tardy responses.

“They have a hard time disengaging from their moral obligations to patients,” he said. “Another issue, particularly in my field of neurology, is that there’s a lot of subspecialties. Finding somebody with the exact subspecialty and expertise to cover a very specific patient population they treat can be really hard.”

The Stanford WellMD Center, Mayo Clinic Department of Medicine Program on Physician Well-being, and American Medical Association funded the study.

Dr. Shanafelt discloses coinventing the Well-Being Index and its derivatives with another study author; Mayo Clinic licensed the Well-Being Index and pays them royalties outside the submitted work. Dr. Shanafelt also reported support for grand rounds, lectures, and advising for healthcare organizations outside the submitted work. Other authors reported personal fees from Marvin Behavioral Health and grants from the National Institute of Nursing Research, National Science Foundation, and Med Ed Solutions. 

Dr. Greenfield had no disclosures.

 

 

A version of this article appeared on Medscape.com

 

About 20% of US physicians took less than 1 week of vacation in the previous year, a new study found. When doctors did go on vacation, 70% reported working on their days off to handle patient-related tasks.

Burnout was more likely among doctors who worked more during vacations and lacked coverage in responding to electronic health messages from patients, according to the cross-sectional study, which was published on January 12, 2024, in JAMA Network Open.“It’s important to provide physicians with adequate time to disconnect from work and recharge,” said study coauthor Tait Shanafelt, MD, chief wellness officer at Stanford Medicine, in an interview.

The study’s conclusion that most US physicians work on their days off “is a marker of inadequate staffing, suboptimal teamwork, and poorly designed coverage systems,” he added. “Simply allocating people a number of vacation days is not enough.”

According to Dr. Shanafelt, there’s been little research into vacation’s impact on physician well-being. However, it is clear that work overload and exhaustion are major problems among American physicians. “Inadequate time off may magnify these challenges.”

Research suggests that physicians suffer more burnout than other US workers even after adjusting for confounders, he said. Extensive evidence shows that burnout in physicians contributes to medical errors and erodes quality of care and patient satisfaction, he added.

For the new study, researchers mailed surveys to 3671 members of the American Medical Association from 2020 to 2021, and 1162 (31.7%) responded. Another 6348 (7.1%) responded to an email survey sent to 90,000 physicians. An analysis suggested the respondents were representative of all US practicing physicians. 

Among 3024 respondents who responded to a subsurvey about vacations, about 40% took more than 15 days of vacation over the past year, about 40% took 6-15 days, and about 20% took 5 or fewer days. 

Fewer than half of physicians said their electronic health record (EHR) inboxes were fully covered by others while they were away. About 70% said they worked while on vacation, with nearly 15% working an hour or more each day.

Emergency physicians were the least likely and anesthesiologists were the most likely to take at least 15 days of vacation per year, according to the study. 

Women were more likely than men to work 30 or more minutes a day on vacation. Physicians aged 65 years and older were more likely to take 15 or more days of vacation per year than those under 35 years.

An adjusted analysis linked complete EHR inbox coverage to lower odds of taking time during vacation to work (odds ratio [OR], 0.68; 95% CI, 0.57-0.80).

“For many, difficulty finding clinical coverage, lack of EHR inbox coverage, and returning to an overwhelming backlog of EHR inbox work at were identified as barriers to taking vacation,” Dr. Shanafelt said.

Researchers linked lower rates of burnout to taking more than 3 weeks of vacation per year (OR, 0.59-0.66, depending on time spent; 95% CI, 0.40-0.98) vs none. They also linked less burnout to full EHR inbox coverage while on vacation (OR, 0.74; 95% CI, 0.63-0.88) and more burnout to spending 30 minutes or more on work while on a typical vacation day (OR, 1.58-1.97, depending on time spent; 95% CI, 1.22-2.77). 

Study limitations include the low participation rate and lack of insight into causation. It’s not clear how burnout and less vacation time are related and whether one causes the other, Shanafelt said. “It is possible there are a number of interacting factors rather than a simple, linear relationship.”

In an interview, Lazar J. Greenfield, Jr., MD, PhD, professor and chairman of neurology at UConn Health, Farmington, Connecticut, said his department encourages clinicians to plan vacations well ahead of time, and “we make a real strong effort to make sure that people are fully covered and someone has their Epic inbox.”

Dr. Greenfield, who wasn’t involved in the new study, recommended that physicians plan active vacations, so they have less downtime to catch up on work matters. But he acknowledged that stepping away from emails can be difficult, especially when physicians fear pileups of work upon their return or don’t want to annoy patients with tardy responses.

“They have a hard time disengaging from their moral obligations to patients,” he said. “Another issue, particularly in my field of neurology, is that there’s a lot of subspecialties. Finding somebody with the exact subspecialty and expertise to cover a very specific patient population they treat can be really hard.”

The Stanford WellMD Center, Mayo Clinic Department of Medicine Program on Physician Well-being, and American Medical Association funded the study.

Dr. Shanafelt discloses coinventing the Well-Being Index and its derivatives with another study author; Mayo Clinic licensed the Well-Being Index and pays them royalties outside the submitted work. Dr. Shanafelt also reported support for grand rounds, lectures, and advising for healthcare organizations outside the submitted work. Other authors reported personal fees from Marvin Behavioral Health and grants from the National Institute of Nursing Research, National Science Foundation, and Med Ed Solutions. 

Dr. Greenfield had no disclosures.

 

 

A version of this article appeared on Medscape.com

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SUDs rates highest in head, neck, and gastric cancer survivors

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Tue, 01/16/2024 - 16:09

Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

 

 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

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Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

 

 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

Nearly 10% of survivors of head, neck, esophageal, and gastric cancers experienced active substance use disorders, based on data from more than 6,000 individuals.

The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.

“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.

In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.

The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.

Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).

Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.

Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).

The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
 

Limitations and Implications

The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.

“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.

“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
 

 

 

Integrated care is needed

“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.

Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
 

Recognize risk factors

“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.

The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
 

Individualize risk assessment

“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.

As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.

The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.

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FDA Rejects GI Cancer Drug Over Manufacturing Issues

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Tue, 01/16/2024 - 16:10

The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has rejected approval of Astellas’s investigational gastric/gastroesophageal junction cancer agent zolbetuximab owing to manufacturing issues, the company announced January 8.

The monoclonal antibody was under priority review as the first agent specifically for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2-positive. Overexpression of claudin 18.2 in gastric cancer cells is associated with tumor growth and progression.

The FDA, however, could not approve zolbetuximab by the planned decision date of January 12, 2024, because of “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab,” according to the company press release

Astellas “is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve” the issues, the company said.

Astellas also clarified that the FDA isn’t asking for additional efficacy and safety data. In phase 3 testing, zolbetuximab improved median progression-free and overall survival by about 2-3 months over chemotherapy alone. 

If zolbetuximab is approved, “pathologists will have to be facile with claudin 18.2 testing as a companion diagnostic before [it] can be used,” Mark Lewis, MD, a gastrointestinal oncologist at Intermountain Healthcare in Murray, Utah, told this news organization.

The agent is also under review in Japan, Europe, and China.

A version of this article appeared on Medscape.com.

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Why GLP-1 Drugs Stop Working, and What to Do About It

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Wed, 01/17/2024 - 12:39

There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

 

 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

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There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

 

 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

There’s no question that glucagon-like peptide 1 (GLP-1) agonists represent a major advance in the treatment of obesity for patients with or without diabetes. In clinical trials, participants lost 15%-20% of their body weight, depending on the drug.

But studies also have shown that once people stop taking these drugs — either by choice, because of shortage, or lack of access — they regain most, if not all, the weight they lost.

Arguably more frustrating is the fact that those who continue on the drug eventually reach a plateau, at which point, the body seemingly stubbornly refuses to lose more weight. Essentially, it stabilizes at its set point, said Fatima Cody Stanford, MD, MPH, MPA, MBA, an obesity medicine physician at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston.
 

‘Tug of War’

Every study of weight loss drugs done over the past 40 years or so shows a plateau, Dr. Stanford told this news organization. “If you look at the phentermine/topiramate studies, there’s a plateau. If you look at the bupropion/naltrexone studies, there’s a plateau. Or if we look at bariatric surgery, there’s a plateau. And it’s the same for the newer GLP-1 drugs.”

The reason? “It really depends on where the body gets to,” Dr. Stanford said. “The body knows what it needs to do to maintain itself, and the brain knows where it’s supposed to be. And when you lose weight and reach what you feel is a lower set point, the body resists.”

When the body goes below its set point, the hunger hormone ghrelin, which is housed in the brain, gets reactivated and gradually starts to reemerge, she explained. GLP-1, which is housed in the distal portion of the small intestine and in the colon, also starts to reemerge over time.

“It becomes kind of a tug of war” between the body and whatever weight loss strategy is being implemented, from drugs to surgery to lifestyle changes, Dr. Stanford said. “The patient will start to notice changes in how their body is responding. Usually, they’ll say they don’t feel like the treatment is working the same. But the treatment is working the same as it’s always been working — except their body is now acclimated to it.”

Anne L. Peters, MD, CDE, professor and clinical scholar, Keck School of Medicine of the University of Southern California, and director, agreed that in the simplest terms, a plateau occurs because “the body becomes more and more used to” the weight loss intervention.

However, when you lose weight, you lose both fat mass and lean body mass, and lean body mass is the metabolically active part of your body, explained Dr. Peters. “That’s what burns and basically makes up your basal metabolic rate.”

With weight loss, the metabolism slows down, she said. If patients need 2000 calories a day to survive at a certain weight and then lose 50 pounds, they may then need only a 1000 calories a day. “With any obesity treatment, you reach a point at which your metabolic rate and your daily caloric requirements become equal, and you stop losing weight, even though your daily caloric requirement is less than it was when your weight was higher.”
 

 

 

Managing the Plateau

Several strategies can be used to help patients break through a plateau. One is to try multiple weight loss agents with different targets — something often done in the real world, Dr. Stanford said. “You don’t see this in the studies, which are focused on just one drug, but many of our patients are on combination therapy. They’re on a GLP-1 drug plus phentermine/topiramate plus metformin, and more. They’re usually on three, four, five drugs, similar to what we would see with resistant hypertension.”

If a patient plateaus on a GLP-1 drug, Dr. Stanford might add phentermine. When the patient reaches a plateau on phentermine, she would switch again to another agent. “The goal is to use agents that treat different receptors in the brain,” she said. “You would never use two GLP-1 agonists; you would use the GLP-1, and then something that treats norepinephrine, for example.”

At the same time, Dr. Peters noted, “try to get them off the drugs that cause weight gain, like insulin and sulfonylurea agents.”

Tapering the GLP-1 dose can also help, Dr. Peters said. However, she added, “If I’m using a GLP-1 drug for type 2 diabetes, it’s different than if I’m using it just for weight loss. With type 2 diabetes, if you taper too much, the blood sugar and weight will go back up, so you need to reach a balance.”

Dr. Peters has successfully tapered patients from a 2-mg dose down to 1 mg. She has also changed the strategy for some — ie, the patient takes the drug every other week instead of every week. “I even have a patient or two who just take it once a month and that seems to be enough,” she said. “You want to help them be at the dose that maintains their weight and keeps them healthy with the least possible medication.”

Emphasizing lifestyle changes is also important, she said. Although resistance training won’t necessarily help with weight loss, “it’s critical to maintaining lean body mass. If people keep losing and regaining weight, they’re going to lose more and more lean body mass and gain the weight back primarily as fat mass. So, their exercise should include about half aerobic activity and half resistance training.”
 

Long-term Journey

Setting appropriate expectations is a key part of helping patients accept and deal with a plateau. “This is long-term, lifelong journey,” Dr. Stanford said. “We need to think about obesity as a complex, multifactorial chronic disease, like we think about hypertension or type 2 diabetes or hyperlipidemia.”

Furthermore, and in keeping with that perspective, emerging evidence is demonstrating that GLP-1 drugs also have important nonglycemic benefits that can be achieved and maintained, Dr. Peters said. “Obviously weight loss matters, and weight loss is good for you if you’re overweight or obese. But now we know that GLP-1 drugs have wonderful benefits for the heart as well as renal function.” These are reasons to continue the drugs even in the face of a plateau.

One of Dr. Peters’ patients, a physician with type 2 diabetes, had “fought with her weight her whole life. She’s been on one or another GLP-1 drug for more than 15 years, and while none seem to impact her weight, she’s gone from having relatively poorly controlled to now beautifully controlled diabetes,” Dr. Peters said. “Even if she hasn’t lost, she’s maintained her weight, a benefit since people tend to gain weight as they get older, and she hasn’t gained.”

Another patient was disabled, on oxygen, and had recurrent pulmonary embolisms. “She weighed 420 pounds, and I put her on semaglutide because she was too sick to be considered for bariatric surgery.” When that didn’t work, Dr. Peters switched her to tirzepatide, gradually increasing the dose; the patient lost 80 pounds, her emboli are gone, she can walk down the street, and went back to work.

“Part of why she could do that is that she started exercising,” Dr. Peters noted. “She felt so much better from the drug-related weight loss that she began to do things that help enhance weight loss. She became happier because she was no longer homebound.”

This points to another element that can help patients break through a plateau over time, Dr. Peters said — namely, behavioral health. “The more people lose weight, the more they feel better about themselves, and that may mean that they take better care of themselves. The psychological part of this journey is as important as anything else. Not everyone has the same response to these agents, and there are all sorts of issues behind why people are overweight that physicians can’t ignore.

“So, in addition to managing the drugs and lifestyle, it’s important to make sure that people access the behavioral health help they need, and that once they break through a plateau, they don’t develop an eating disorder or go to the opposite extreme and become too thin, which has happened with some of my patients,” she said. “We need to remember that we’re not just giving patients a miraculous weight loss. We’re helping them to be healthier, mentally as well as physically.”

Dr. Stanford disclosed that she had been a consultant for Calibrate, GoodRx, Pfizer, Eli Lilly, Boehringer Ingelheim, Gelesis, Vida Health, Life Force, Ilant Health, Melli Cell, and Novo Nordisk. Dr. Peters disclosed that she had been a consultant for Vertex, Medscape Medical News, and Lilly; received funding from Abbott and Insulet; and had stock options in Omada Health.

A version of this article appeared on Medscape.com.

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Do Plant-based Psychedelics Offer a New Option for TBI Treatment?

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Fri, 01/12/2024 - 14:18

Oneirogens are substances that produce or enhance dreamlike states of consciousness—could one of those, ibogaine, be key to relieving the sequelae of traumatic brain injury (TBI) in veterans?

An extract from the root bark of Tabernanthe iboga, an African shrub, ibogaine has both pharmacological and psychological effects. Acting on opioid receptors and the serotonin and dopamine systems, it can relieve withdrawal symptoms and reduce drug cravings—reportedly, often, in just a few hours—and reduce the risk of regular use. The results can last for weeks, months, or sometimes longer.

In the US, ibogaine is a Schedule I drug. Few controlled studies of ibogaine are available; most data come from anecdotal reports and case studies. Clinical research into ibogaine stalled due to legal restrictions that come with a Schedule I drug, as well as concerns about possible cardiac consequences. For example, some reports have described QT interval prolongation, with instances of subsequent fatal arrhythmia.  

That may change now, with findings from the Magnesium–Ibogaine: the Stanford Traumatic Injury to the CNS protocol (MISTIC), which took place at a treatment center in Mexico. Researchers from Stanford School of Medicine and the Veterans Affairs Palo Alto Health Care System combined prophylactic intravenous magnesium with ibogaine, in hopes of mitigating the cardiac risks. Magnesium supplementation has been shown to protect against QT interval prolongation when coadministered with medications that ordinarily would have such an effect.

The researchers studied 30 male Special Operations Forces veterans (SOVs) who had predominantly mild TBI. Of those, 15 participants met the criteria for major depressive disorder, 14 for an anxiety disorder, and 23 for PTSD; 19 had past suicidal ideation and 7 had attempted suicide.

Special Operations Forces, the researchers note, are “deployed at a greater pace and to higher intensity combat than conventional military, exposing them to greater allostatic load and risk of injury, including from blast exposure.” This, they say, may result in a “unique pattern” of physical, cognitive, behavioral, psychiatric, and endocrine-related problems across several domains.

Participants received a mean (SD) of 12.1 (1.2) mg kg-1 of oral ibogaine. The researchers assessed changes in the World Health Organization Disability Assessment Schedule at baseline, immediately after treatment, and 1 month after treatment. They also assessed changes in posttraumatic stress disorder (PTSD), depression, and anxiety.

The treatment significantly improved functioning both immediately and at 1 month after treatment and PTSD, depression, and anxiety at 1 month after treatment. There were no unexpected or serious treatment-emergent adverse effects, nor were there instances of bradycardia, tachycardia, clinically meaningful QT prolongation, or hemodynamic instability. All participants experienced transient cerebellar signs, such as mild ataxia and intention tremor, that resolved within 24 hours. While experiencing oneirogenic effects, 12 participants were treated for headache, 7 for nausea, 3 for anxiety, 2 for hypertension, and 1 for insomnia. 

At 1 month, suicidal ideation had declined from 47% to 7%—a statistically significant change. “Given the alarming rates of suicide in veterans, as well as evidence that military-related TBI increases the risk of suicide,” the researchers say, “the substantial reduction in SI that we observed—which must be interpreted cautiously as an exploratory analysis—is noteworthy.” TBI also is associated with increased impulsivity, a well-known risk factor for suicide, they note. MISTIC resulted in a measurable improvement in cognitive inhibition.

Results of a neuropsychological battery indicated statistically significant improvements in processing speed and executive functioning (including inhibition, cognitive flexibility, problem-solving, phonemic fluency, and working memory), both immediately after treatment and at 1 month. No declines were noted across any performance domain.

Interestingly, mean performances on these tests moved from the average to the high average score range relative to same-age peers and, in all but one instance, phonemic fluency was high average at baseline and improved to the superior range relative to same-age peers at the 1-month follow-up. Learning and memory tests showed a significant improvement in visual memory and verbal memory. Sustained attention showed a significant improvement in accuracy (detection) and a weak but significant slowing of reaction time, consistent with a prioritization of accuracy over speed and reduced impulsivity.

In a Scientific American article, lead researcher Nolan Williams said he suspects the powerful effects of psychedelics have to do with their “profound ability to increase plasticity in the brain” by “bringing it back to a more juvenile state where reorganization can occur.” People often experience a life review that appears in their minds almost like a slideshow. “It somehow drives a particular sort of psychological phenomenon that you don’t achieve through guidance,” Williams said.

The data from the MISTIC trial in Mexico may spur more research in the US. The National Defense Authorization Act, signed by President Joe Biden last December, authorizes service members diagnosed with PTSD or TBI to take part in clinical studies of any “qualified plant-based alternative therapies.”

“It’s all really timely,” Williams said. “From my perspective, we should have some traction to make a strong argument that the risk-benefit is right.”

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Oneirogens are substances that produce or enhance dreamlike states of consciousness—could one of those, ibogaine, be key to relieving the sequelae of traumatic brain injury (TBI) in veterans?

An extract from the root bark of Tabernanthe iboga, an African shrub, ibogaine has both pharmacological and psychological effects. Acting on opioid receptors and the serotonin and dopamine systems, it can relieve withdrawal symptoms and reduce drug cravings—reportedly, often, in just a few hours—and reduce the risk of regular use. The results can last for weeks, months, or sometimes longer.

In the US, ibogaine is a Schedule I drug. Few controlled studies of ibogaine are available; most data come from anecdotal reports and case studies. Clinical research into ibogaine stalled due to legal restrictions that come with a Schedule I drug, as well as concerns about possible cardiac consequences. For example, some reports have described QT interval prolongation, with instances of subsequent fatal arrhythmia.  

That may change now, with findings from the Magnesium–Ibogaine: the Stanford Traumatic Injury to the CNS protocol (MISTIC), which took place at a treatment center in Mexico. Researchers from Stanford School of Medicine and the Veterans Affairs Palo Alto Health Care System combined prophylactic intravenous magnesium with ibogaine, in hopes of mitigating the cardiac risks. Magnesium supplementation has been shown to protect against QT interval prolongation when coadministered with medications that ordinarily would have such an effect.

The researchers studied 30 male Special Operations Forces veterans (SOVs) who had predominantly mild TBI. Of those, 15 participants met the criteria for major depressive disorder, 14 for an anxiety disorder, and 23 for PTSD; 19 had past suicidal ideation and 7 had attempted suicide.

Special Operations Forces, the researchers note, are “deployed at a greater pace and to higher intensity combat than conventional military, exposing them to greater allostatic load and risk of injury, including from blast exposure.” This, they say, may result in a “unique pattern” of physical, cognitive, behavioral, psychiatric, and endocrine-related problems across several domains.

Participants received a mean (SD) of 12.1 (1.2) mg kg-1 of oral ibogaine. The researchers assessed changes in the World Health Organization Disability Assessment Schedule at baseline, immediately after treatment, and 1 month after treatment. They also assessed changes in posttraumatic stress disorder (PTSD), depression, and anxiety.

The treatment significantly improved functioning both immediately and at 1 month after treatment and PTSD, depression, and anxiety at 1 month after treatment. There were no unexpected or serious treatment-emergent adverse effects, nor were there instances of bradycardia, tachycardia, clinically meaningful QT prolongation, or hemodynamic instability. All participants experienced transient cerebellar signs, such as mild ataxia and intention tremor, that resolved within 24 hours. While experiencing oneirogenic effects, 12 participants were treated for headache, 7 for nausea, 3 for anxiety, 2 for hypertension, and 1 for insomnia. 

At 1 month, suicidal ideation had declined from 47% to 7%—a statistically significant change. “Given the alarming rates of suicide in veterans, as well as evidence that military-related TBI increases the risk of suicide,” the researchers say, “the substantial reduction in SI that we observed—which must be interpreted cautiously as an exploratory analysis—is noteworthy.” TBI also is associated with increased impulsivity, a well-known risk factor for suicide, they note. MISTIC resulted in a measurable improvement in cognitive inhibition.

Results of a neuropsychological battery indicated statistically significant improvements in processing speed and executive functioning (including inhibition, cognitive flexibility, problem-solving, phonemic fluency, and working memory), both immediately after treatment and at 1 month. No declines were noted across any performance domain.

Interestingly, mean performances on these tests moved from the average to the high average score range relative to same-age peers and, in all but one instance, phonemic fluency was high average at baseline and improved to the superior range relative to same-age peers at the 1-month follow-up. Learning and memory tests showed a significant improvement in visual memory and verbal memory. Sustained attention showed a significant improvement in accuracy (detection) and a weak but significant slowing of reaction time, consistent with a prioritization of accuracy over speed and reduced impulsivity.

In a Scientific American article, lead researcher Nolan Williams said he suspects the powerful effects of psychedelics have to do with their “profound ability to increase plasticity in the brain” by “bringing it back to a more juvenile state where reorganization can occur.” People often experience a life review that appears in their minds almost like a slideshow. “It somehow drives a particular sort of psychological phenomenon that you don’t achieve through guidance,” Williams said.

The data from the MISTIC trial in Mexico may spur more research in the US. The National Defense Authorization Act, signed by President Joe Biden last December, authorizes service members diagnosed with PTSD or TBI to take part in clinical studies of any “qualified plant-based alternative therapies.”

“It’s all really timely,” Williams said. “From my perspective, we should have some traction to make a strong argument that the risk-benefit is right.”

Oneirogens are substances that produce or enhance dreamlike states of consciousness—could one of those, ibogaine, be key to relieving the sequelae of traumatic brain injury (TBI) in veterans?

An extract from the root bark of Tabernanthe iboga, an African shrub, ibogaine has both pharmacological and psychological effects. Acting on opioid receptors and the serotonin and dopamine systems, it can relieve withdrawal symptoms and reduce drug cravings—reportedly, often, in just a few hours—and reduce the risk of regular use. The results can last for weeks, months, or sometimes longer.

In the US, ibogaine is a Schedule I drug. Few controlled studies of ibogaine are available; most data come from anecdotal reports and case studies. Clinical research into ibogaine stalled due to legal restrictions that come with a Schedule I drug, as well as concerns about possible cardiac consequences. For example, some reports have described QT interval prolongation, with instances of subsequent fatal arrhythmia.  

That may change now, with findings from the Magnesium–Ibogaine: the Stanford Traumatic Injury to the CNS protocol (MISTIC), which took place at a treatment center in Mexico. Researchers from Stanford School of Medicine and the Veterans Affairs Palo Alto Health Care System combined prophylactic intravenous magnesium with ibogaine, in hopes of mitigating the cardiac risks. Magnesium supplementation has been shown to protect against QT interval prolongation when coadministered with medications that ordinarily would have such an effect.

The researchers studied 30 male Special Operations Forces veterans (SOVs) who had predominantly mild TBI. Of those, 15 participants met the criteria for major depressive disorder, 14 for an anxiety disorder, and 23 for PTSD; 19 had past suicidal ideation and 7 had attempted suicide.

Special Operations Forces, the researchers note, are “deployed at a greater pace and to higher intensity combat than conventional military, exposing them to greater allostatic load and risk of injury, including from blast exposure.” This, they say, may result in a “unique pattern” of physical, cognitive, behavioral, psychiatric, and endocrine-related problems across several domains.

Participants received a mean (SD) of 12.1 (1.2) mg kg-1 of oral ibogaine. The researchers assessed changes in the World Health Organization Disability Assessment Schedule at baseline, immediately after treatment, and 1 month after treatment. They also assessed changes in posttraumatic stress disorder (PTSD), depression, and anxiety.

The treatment significantly improved functioning both immediately and at 1 month after treatment and PTSD, depression, and anxiety at 1 month after treatment. There were no unexpected or serious treatment-emergent adverse effects, nor were there instances of bradycardia, tachycardia, clinically meaningful QT prolongation, or hemodynamic instability. All participants experienced transient cerebellar signs, such as mild ataxia and intention tremor, that resolved within 24 hours. While experiencing oneirogenic effects, 12 participants were treated for headache, 7 for nausea, 3 for anxiety, 2 for hypertension, and 1 for insomnia. 

At 1 month, suicidal ideation had declined from 47% to 7%—a statistically significant change. “Given the alarming rates of suicide in veterans, as well as evidence that military-related TBI increases the risk of suicide,” the researchers say, “the substantial reduction in SI that we observed—which must be interpreted cautiously as an exploratory analysis—is noteworthy.” TBI also is associated with increased impulsivity, a well-known risk factor for suicide, they note. MISTIC resulted in a measurable improvement in cognitive inhibition.

Results of a neuropsychological battery indicated statistically significant improvements in processing speed and executive functioning (including inhibition, cognitive flexibility, problem-solving, phonemic fluency, and working memory), both immediately after treatment and at 1 month. No declines were noted across any performance domain.

Interestingly, mean performances on these tests moved from the average to the high average score range relative to same-age peers and, in all but one instance, phonemic fluency was high average at baseline and improved to the superior range relative to same-age peers at the 1-month follow-up. Learning and memory tests showed a significant improvement in visual memory and verbal memory. Sustained attention showed a significant improvement in accuracy (detection) and a weak but significant slowing of reaction time, consistent with a prioritization of accuracy over speed and reduced impulsivity.

In a Scientific American article, lead researcher Nolan Williams said he suspects the powerful effects of psychedelics have to do with their “profound ability to increase plasticity in the brain” by “bringing it back to a more juvenile state where reorganization can occur.” People often experience a life review that appears in their minds almost like a slideshow. “It somehow drives a particular sort of psychological phenomenon that you don’t achieve through guidance,” Williams said.

The data from the MISTIC trial in Mexico may spur more research in the US. The National Defense Authorization Act, signed by President Joe Biden last December, authorizes service members diagnosed with PTSD or TBI to take part in clinical studies of any “qualified plant-based alternative therapies.”

“It’s all really timely,” Williams said. “From my perspective, we should have some traction to make a strong argument that the risk-benefit is right.”

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Analysis Finds Risk of Alopecia Areata After COVID-19 Infection

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Changed
Wed, 01/24/2024 - 12:39

Infection with COVID-19 conferred a nearly twofold risk of developing alopecia areata (AA), results from a large analysis of Korean patients demonstrated.

“There is a growing number of reports on new onset, exacerbation, and recurrence of AA after COVID-19,” corresponding author Jin Park, MD, PhD, of the department of dermatology at Jeonbuk National University Medical School, South Korea, and colleagues wrote in a research letter published online January 10, 2024, in JAMA Dermatology. “However, evidence supporting an association between COVID-19 and AA is limited.”

To investigate the association between COVID-19 and AA, the researchers used data from the Korea Disease Control and Prevention Agency–COVID-19–National Health Insurance Service cohort to conduct a propensity score–matched, nationwide, population-based cohort study from October 8, 2020, to September 30, 2021. They used Cox proportional hazards regression to calculate the incidence, prevalence, and adjusted hazard ratios (AHRs) for AA.

The cohort consisted of 259,369 patients with COVID-19 and 259,369 uninfected controls. The researchers observed an increased risk of telogen effluvium in patients with COVID-19 compared with the uninfected controls (AHR, 6.40; 95% CI, 4.92-8.33), while the incidence of epidermal cysts, benign skin tumors, and other negative control outcomes did not differ between groups.

Meanwhile, the incidence of AA in patients with COVID-19 was significantly higher compared with the uninfected controls (43.19 per 10,000 person-years [PY]), regardless of clinical subtype. This translated into an AHR of 1.82 (95% CI, 1.60-2.07). In other findings, the incidence of patchy AA and alopecia totalis and alopecia universalis (AT/AU) was 35.94 and 7.24 per 10,000 PY in patients with COVID-19 compared with 19.43 and 4.18 per 10,000 PY in uninfected controls, respectively.



“These findings support the possible role of COVID-19 in AA occurrence and exacerbation, although other environmental factors, such as psychological stress, may have also contributed to AA development during the pandemic,” the authors concluded. “Plausible mechanisms of AA following COVID-19 include antigenic molecular mimicry between SARS-CoV-2 and hair follicle autoantigens, cytokine shifting, and bystander activation.”

They acknowledged certain limitations of the analysis, including the potential for detection or misclassification bias and the fact that it did not evaluate causality between the two conditions.

Shari Lipner, MD, PhD, associate professor of dermatology at Weill Cornell Medicine, New York, who was asked to comment on the study, said that strengths of the study include the large sample size, and the use of positive and negative outcome controls, and that the incidence and prevalence of AA in Korea was stable during the prepandemic period. “A weakness of the study is that all alopecia areata cases may not have necessarily been confirmed,” Dr. Lipner told this news organization.

“Based on this study, dermatologists may consider AA in the differential diagnosis for a patient presenting with hair loss with recent COVID-19 diagnosis,” she added, noting that the potential for prevention of AA flares is also a reason to recommend COVID-19 vaccination for patients with a history of AA.

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to comment on the study, said that while the analysis suggests a definite epidemiologic association between COVID-19 and AA, “any causal relationship needs further study.” She added that she has no specific advice for patients who develop AA following a COVID-19 infection. “Any conversation about AA can be difficult because there is no way to prognosticate if someone will just have one small, localized area of hair loss,” or several small areas, versus loss of all hair on the head or even the body as well, Dr. Ko explained.

The study was supported with grants from the National Research Foundation of the Korean Government and the Ministry of Health and Welfare, Republic of Korea. The authors, as well as Dr. Lipner and Dr. Ko, reported having no relevant disclosures.

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Infection with COVID-19 conferred a nearly twofold risk of developing alopecia areata (AA), results from a large analysis of Korean patients demonstrated.

“There is a growing number of reports on new onset, exacerbation, and recurrence of AA after COVID-19,” corresponding author Jin Park, MD, PhD, of the department of dermatology at Jeonbuk National University Medical School, South Korea, and colleagues wrote in a research letter published online January 10, 2024, in JAMA Dermatology. “However, evidence supporting an association between COVID-19 and AA is limited.”

To investigate the association between COVID-19 and AA, the researchers used data from the Korea Disease Control and Prevention Agency–COVID-19–National Health Insurance Service cohort to conduct a propensity score–matched, nationwide, population-based cohort study from October 8, 2020, to September 30, 2021. They used Cox proportional hazards regression to calculate the incidence, prevalence, and adjusted hazard ratios (AHRs) for AA.

The cohort consisted of 259,369 patients with COVID-19 and 259,369 uninfected controls. The researchers observed an increased risk of telogen effluvium in patients with COVID-19 compared with the uninfected controls (AHR, 6.40; 95% CI, 4.92-8.33), while the incidence of epidermal cysts, benign skin tumors, and other negative control outcomes did not differ between groups.

Meanwhile, the incidence of AA in patients with COVID-19 was significantly higher compared with the uninfected controls (43.19 per 10,000 person-years [PY]), regardless of clinical subtype. This translated into an AHR of 1.82 (95% CI, 1.60-2.07). In other findings, the incidence of patchy AA and alopecia totalis and alopecia universalis (AT/AU) was 35.94 and 7.24 per 10,000 PY in patients with COVID-19 compared with 19.43 and 4.18 per 10,000 PY in uninfected controls, respectively.



“These findings support the possible role of COVID-19 in AA occurrence and exacerbation, although other environmental factors, such as psychological stress, may have also contributed to AA development during the pandemic,” the authors concluded. “Plausible mechanisms of AA following COVID-19 include antigenic molecular mimicry between SARS-CoV-2 and hair follicle autoantigens, cytokine shifting, and bystander activation.”

They acknowledged certain limitations of the analysis, including the potential for detection or misclassification bias and the fact that it did not evaluate causality between the two conditions.

Shari Lipner, MD, PhD, associate professor of dermatology at Weill Cornell Medicine, New York, who was asked to comment on the study, said that strengths of the study include the large sample size, and the use of positive and negative outcome controls, and that the incidence and prevalence of AA in Korea was stable during the prepandemic period. “A weakness of the study is that all alopecia areata cases may not have necessarily been confirmed,” Dr. Lipner told this news organization.

“Based on this study, dermatologists may consider AA in the differential diagnosis for a patient presenting with hair loss with recent COVID-19 diagnosis,” she added, noting that the potential for prevention of AA flares is also a reason to recommend COVID-19 vaccination for patients with a history of AA.

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to comment on the study, said that while the analysis suggests a definite epidemiologic association between COVID-19 and AA, “any causal relationship needs further study.” She added that she has no specific advice for patients who develop AA following a COVID-19 infection. “Any conversation about AA can be difficult because there is no way to prognosticate if someone will just have one small, localized area of hair loss,” or several small areas, versus loss of all hair on the head or even the body as well, Dr. Ko explained.

The study was supported with grants from the National Research Foundation of the Korean Government and the Ministry of Health and Welfare, Republic of Korea. The authors, as well as Dr. Lipner and Dr. Ko, reported having no relevant disclosures.

Infection with COVID-19 conferred a nearly twofold risk of developing alopecia areata (AA), results from a large analysis of Korean patients demonstrated.

“There is a growing number of reports on new onset, exacerbation, and recurrence of AA after COVID-19,” corresponding author Jin Park, MD, PhD, of the department of dermatology at Jeonbuk National University Medical School, South Korea, and colleagues wrote in a research letter published online January 10, 2024, in JAMA Dermatology. “However, evidence supporting an association between COVID-19 and AA is limited.”

To investigate the association between COVID-19 and AA, the researchers used data from the Korea Disease Control and Prevention Agency–COVID-19–National Health Insurance Service cohort to conduct a propensity score–matched, nationwide, population-based cohort study from October 8, 2020, to September 30, 2021. They used Cox proportional hazards regression to calculate the incidence, prevalence, and adjusted hazard ratios (AHRs) for AA.

The cohort consisted of 259,369 patients with COVID-19 and 259,369 uninfected controls. The researchers observed an increased risk of telogen effluvium in patients with COVID-19 compared with the uninfected controls (AHR, 6.40; 95% CI, 4.92-8.33), while the incidence of epidermal cysts, benign skin tumors, and other negative control outcomes did not differ between groups.

Meanwhile, the incidence of AA in patients with COVID-19 was significantly higher compared with the uninfected controls (43.19 per 10,000 person-years [PY]), regardless of clinical subtype. This translated into an AHR of 1.82 (95% CI, 1.60-2.07). In other findings, the incidence of patchy AA and alopecia totalis and alopecia universalis (AT/AU) was 35.94 and 7.24 per 10,000 PY in patients with COVID-19 compared with 19.43 and 4.18 per 10,000 PY in uninfected controls, respectively.



“These findings support the possible role of COVID-19 in AA occurrence and exacerbation, although other environmental factors, such as psychological stress, may have also contributed to AA development during the pandemic,” the authors concluded. “Plausible mechanisms of AA following COVID-19 include antigenic molecular mimicry between SARS-CoV-2 and hair follicle autoantigens, cytokine shifting, and bystander activation.”

They acknowledged certain limitations of the analysis, including the potential for detection or misclassification bias and the fact that it did not evaluate causality between the two conditions.

Shari Lipner, MD, PhD, associate professor of dermatology at Weill Cornell Medicine, New York, who was asked to comment on the study, said that strengths of the study include the large sample size, and the use of positive and negative outcome controls, and that the incidence and prevalence of AA in Korea was stable during the prepandemic period. “A weakness of the study is that all alopecia areata cases may not have necessarily been confirmed,” Dr. Lipner told this news organization.

“Based on this study, dermatologists may consider AA in the differential diagnosis for a patient presenting with hair loss with recent COVID-19 diagnosis,” she added, noting that the potential for prevention of AA flares is also a reason to recommend COVID-19 vaccination for patients with a history of AA.

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was also asked to comment on the study, said that while the analysis suggests a definite epidemiologic association between COVID-19 and AA, “any causal relationship needs further study.” She added that she has no specific advice for patients who develop AA following a COVID-19 infection. “Any conversation about AA can be difficult because there is no way to prognosticate if someone will just have one small, localized area of hair loss,” or several small areas, versus loss of all hair on the head or even the body as well, Dr. Ko explained.

The study was supported with grants from the National Research Foundation of the Korean Government and the Ministry of Health and Welfare, Republic of Korea. The authors, as well as Dr. Lipner and Dr. Ko, reported having no relevant disclosures.

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