Although the prevalence of migraine in the United States has remained stable over the past three decades, migraine-related disability has nearly doubled during that time, a new systematic review showed.

“The disability trend could reflect changes in reporting, study methodology, social, and societal changes, or changes in exacerbating or remediating factors that make migraine more disabling,” wrote lead investigator Fred Cohen, MD, of Center for Headache and Facial Pain, Department of Neurology, Icahn School of Medicine, Mount Sinai, New York City, and colleagues.

The study was published online in Headache.

Researchers conducted a systematic review of population-based US epidemiologic studies focusing on the prevalence and/or burden of migraine, all published before February 2022. Studies on migraine, episodic migraine, and/or chronic migraine were included.

The primary measure of disease burden was the Migraine Disability Assessment Scale (MIDAS), which measures days lost to migraine over a 3-month period in three domains and defines groups with moderate or severe disability (grades III and IV, respectively), using cut-scores.

Of 1609 studies initially reviewed, the researchers included 26 publications from 11 US population-based studies.

For the past 30 years, the prevalence of migraine in the population has remained largely stable, ranging from 12% to 15% in the overall population, from 17% to 19% in women, and from 6% to 7% in men.

In adults overall, chronic migraine prevalence is 0.91% (1.3% in women and 0.5% in men), while in adolescents, the prevalence is 0.8%.

Although prevalence remained roughly the same during the 30 years, the proportion of people with migraine and moderate to severe MIDAS disability (grades III-IV) has trended upward across studies during part of the study period, increasing from 22% in 2005 to 42% in 2018.

Throughout the years studied, a consistently higher proportion of women versus men were assigned MIDAS grades III-IV.

Although researchers said the exact reason for the increase is unknown, possible explanations include changes in study methodology from mailed questionnaires to web surveys or the decline in participation rate in web surveys. It is also possible that people with migraine may be more willing to report disability than they used to be, authors wrote.

Increased MIDAS scores may be attributable to some environmental risk factor that exacerbates migraine without modifying its prevalence, such as worsening air quality, an increase in natural disasters, or increased opioid use for migraine, they added.

The reason for increased moderate to severe disability in women may be attributable to the fact that migraine is “most common in mid-life, a period characterized by familial and work responsibilities, which may engender a higher risk of burden for working women,” authors wrote. The link between migraine attacks and menstrual cycles may also explain observed gender differences in disability.

In general, the most frequently reported burdens associated with migraine included missed work and school and family and social functioning.

It is “surprising that improvements in treatment have not been associated with reductions in disability,” researchers noted.

No financial support was provided for this study. Dr. Cohen serves as an assistant editor for Headache. He has received honoraria from Springer Nature and MedLink Neurology. Other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

Although the prevalence of migraine in the United States has remained stable over the past three decades, migraine-related disability has nearly doubled during that time, a new systematic review showed.

“The disability trend could reflect changes in reporting, study methodology, social, and societal changes, or changes in exacerbating or remediating factors that make migraine more disabling,” wrote lead investigator Fred Cohen, MD, of Center for Headache and Facial Pain, Department of Neurology, Icahn School of Medicine, Mount Sinai, New York City, and colleagues.

The study was published online in Headache.

Researchers conducted a systematic review of population-based US epidemiologic studies focusing on the prevalence and/or burden of migraine, all published before February 2022. Studies on migraine, episodic migraine, and/or chronic migraine were included.

The primary measure of disease burden was the Migraine Disability Assessment Scale (MIDAS), which measures days lost to migraine over a 3-month period in three domains and defines groups with moderate or severe disability (grades III and IV, respectively), using cut-scores.

Of 1609 studies initially reviewed, the researchers included 26 publications from 11 US population-based studies.

For the past 30 years, the prevalence of migraine in the population has remained largely stable, ranging from 12% to 15% in the overall population, from 17% to 19% in women, and from 6% to 7% in men.

In adults overall, chronic migraine prevalence is 0.91% (1.3% in women and 0.5% in men), while in adolescents, the prevalence is 0.8%.

Although prevalence remained roughly the same during the 30 years, the proportion of people with migraine and moderate to severe MIDAS disability (grades III-IV) has trended upward across studies during part of the study period, increasing from 22% in 2005 to 42% in 2018.

Throughout the years studied, a consistently higher proportion of women versus men were assigned MIDAS grades III-IV.

Although researchers said the exact reason for the increase is unknown, possible explanations include changes in study methodology from mailed questionnaires to web surveys or the decline in participation rate in web surveys. It is also possible that people with migraine may be more willing to report disability than they used to be, authors wrote.

Increased MIDAS scores may be attributable to some environmental risk factor that exacerbates migraine without modifying its prevalence, such as worsening air quality, an increase in natural disasters, or increased opioid use for migraine, they added.

The reason for increased moderate to severe disability in women may be attributable to the fact that migraine is “most common in mid-life, a period characterized by familial and work responsibilities, which may engender a higher risk of burden for working women,” authors wrote. The link between migraine attacks and menstrual cycles may also explain observed gender differences in disability.

In general, the most frequently reported burdens associated with migraine included missed work and school and family and social functioning.

It is “surprising that improvements in treatment have not been associated with reductions in disability,” researchers noted.

No financial support was provided for this study. Dr. Cohen serves as an assistant editor for Headache. He has received honoraria from Springer Nature and MedLink Neurology. Other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

Although the prevalence of migraine in the United States has remained stable over the past three decades, migraine-related disability has nearly doubled during that time, a new systematic review showed.

“The disability trend could reflect changes in reporting, study methodology, social, and societal changes, or changes in exacerbating or remediating factors that make migraine more disabling,” wrote lead investigator Fred Cohen, MD, of Center for Headache and Facial Pain, Department of Neurology, Icahn School of Medicine, Mount Sinai, New York City, and colleagues.

The study was published online in Headache.

Researchers conducted a systematic review of population-based US epidemiologic studies focusing on the prevalence and/or burden of migraine, all published before February 2022. Studies on migraine, episodic migraine, and/or chronic migraine were included.

The primary measure of disease burden was the Migraine Disability Assessment Scale (MIDAS), which measures days lost to migraine over a 3-month period in three domains and defines groups with moderate or severe disability (grades III and IV, respectively), using cut-scores.

Of 1609 studies initially reviewed, the researchers included 26 publications from 11 US population-based studies.

For the past 30 years, the prevalence of migraine in the population has remained largely stable, ranging from 12% to 15% in the overall population, from 17% to 19% in women, and from 6% to 7% in men.

In adults overall, chronic migraine prevalence is 0.91% (1.3% in women and 0.5% in men), while in adolescents, the prevalence is 0.8%.

Although prevalence remained roughly the same during the 30 years, the proportion of people with migraine and moderate to severe MIDAS disability (grades III-IV) has trended upward across studies during part of the study period, increasing from 22% in 2005 to 42% in 2018.

Throughout the years studied, a consistently higher proportion of women versus men were assigned MIDAS grades III-IV.

Although researchers said the exact reason for the increase is unknown, possible explanations include changes in study methodology from mailed questionnaires to web surveys or the decline in participation rate in web surveys. It is also possible that people with migraine may be more willing to report disability than they used to be, authors wrote.

Increased MIDAS scores may be attributable to some environmental risk factor that exacerbates migraine without modifying its prevalence, such as worsening air quality, an increase in natural disasters, or increased opioid use for migraine, they added.

The reason for increased moderate to severe disability in women may be attributable to the fact that migraine is “most common in mid-life, a period characterized by familial and work responsibilities, which may engender a higher risk of burden for working women,” authors wrote. The link between migraine attacks and menstrual cycles may also explain observed gender differences in disability.

In general, the most frequently reported burdens associated with migraine included missed work and school and family and social functioning.

It is “surprising that improvements in treatment have not been associated with reductions in disability,” researchers noted.

No financial support was provided for this study. Dr. Cohen serves as an assistant editor for Headache. He has received honoraria from Springer Nature and MedLink Neurology. Other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

Most younger women diagnosed with nonmetastatic breast cancer will succeed if they attempt to become pregnant after treatment, according to new research.

The findings, presented May 23 in advance of the annual meeting of the American Society of Clinical Oncology (ASCO) represent the most comprehensive look to date at fertility outcomes following treatment for women diagnosed with breast cancer before age 40 (Abstract 1518).

Kimia Sorouri, MD, a research fellow at the Dana-Farber Cancer Center in Boston, Massachusetts, and her colleagues, looked at data from the Young Women’s Breast Cancer study, a multicenter longitudinal cohort study, for 1213 U.S. and Canadian women (74% non-Hispanic white) who were diagnosed with stages 0-III breast cancer between 2006 and 2016. None of the included patients had metastatic disease, prior hysterectomy, or prior oophorectomy at diagnosis.

During a median 11 years of follow up, 197 of the women reported attempting pregnancy. Of these, 73% reported becoming pregnant, and 65% delivered a live infant a median 4 years after cancer diagnosis. The median age at diagnosis was 32 years, and 28% opted for egg or embryo freezing to preserve fertility. Importantly, 68% received chemotherapy, which can impair fertility, with only a small percentage undergoing ovarian suppression during chemotherapy treatment.

Key predictors of pregnancy or live birth in this study were “financial comfort,” a self-reported measure defined as having money left over to spend after bills are paid (odds ratio [OR], 2.04; 95% CI 1.01-4.12; P = .047); younger age at the time of diagnosis; and undergoing fertility preservation interventions at diagnosis (OR, 2.78; 95% CI 1.29-6.00; P = .009). Chemotherapy and other treatment factors were not seen to be associated with pregnancy or birth outcomes.

“Current research that informs our understanding of the impact of breast cancer treatment on pregnancy and live birth rates is fairly limited,” Dr. Sorouri said during an online press conference announcing the findings. Quality data on fertility outcomes has been limited to studies in certain subgroups, such as women with estrogen receptor–positive breast cancers, she noted, while other studies “have short-term follow-up and critically lack prospective assessment of attempt at conception.”

The new findings show, Dr. Sorouri said, “that in this modern cohort with a heightened awareness of fertility, access to fertility preservation can help to mitigate a portion of the damage from chemotherapy and other agents. Importantly, this highlights the need for increased accessibility of fertility preservation services for women newly diagnosed with breast cancer who are interested in a future pregnancy.”

Commenting on Dr. Sorouri and colleagues’ findings, Julie Gralow, MD, a breast cancer researcher and ASCO’s chief medical officer, stressed that, while younger age at diagnosis and financial comfort were two factors outside the scope of clinical oncology practice, “we can impact fertility preservation prior to treatment.”

She called it “critical” that every patient be informed of the impact of a breast cancer diagnosis and treatment on future fertility, and that all young patients interested in future fertility be offered fertility preservation prior to beginning treatment.

Ann Partridge, MD, of Dana-Farber, said in an interview that the findings reflected a decades’ long change in approach. “Twenty years ago when we first started this cohort, people would tell women ‘you can’t get pregnant. It’s too dangerous. You won’t be able to.’ And some indeed aren’t able to, but the majority who are attempting are succeeding, especially if they preserve their eggs or embryos. So even if chemo puts you into menopause or made you subfertile, if you’ve preserved eggs or embryos, we now can mitigate that distressing effect that many cancer patients have suffered from historically. That’s the good news here.”

Nonetheless, Dr. Partridge, an oncologist and the last author of the study, noted, the results reflected success only for women actively attempting pregnancy. “Remember, we’re not including the people who didn’t attempt. There may be some who went into menopause who never banked eggs or embryos, and may never have tried because they went to a doctor who told them they’re not fertile.” Further, she said, not all insurances cover in vitro fertilization for women who have had breast cancer.

The fact that financial comfort was correlated with reproductive success, Dr. Partridge said, speaks to broader issues about access. “It may not be all about insurers. It may be to have the ability, to have the time, the education and the wherewithal to do this right — and about being with doctors who talk about it.”

Dr. Sorouri and colleagues’ study was sponsored by the Breast Cancer Research Foundation and Susan G. Komen. Several co-authors disclosed receiving speaking and/or consulting fees from pharmaceutical companies, and one reported being an employee of GlaxoSmithKline. Dr. Sorouri reported no industry funding, while Dr. Partridge reported research funding from Novartis.

TOPLINE:

US fentanyl seizures increased by more than 1700% between 2017 and 2023, new data showed. 

METHODOLOGY:

• Investigators analyzed data from the High Intensity Drug Trafficking Areas (HIDTA) program from 2017 through 2023.
• To assess trends in illicit fentanyl availability, investigators used eight indicators of potential shifts in illicit fentanyl supply, including total seizures, powder seizures, pill seizures, and the total weight of seizures.

TAKEAWAY:

• A total of 66,303 fentanyl seizures were identified. Of the total number of seizures, 67% were in powder form and 33% were pills.
• The total number of seizures during the study period increased by > 1700% — from 74,663 in 2017 to 115,221 in 2023.
• In 2023, the greatest number of fentanyl seizures was in Florida (n = 2,089), followed by Arizona (n = 1783) and California (n = 1440).Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).
• The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.
• Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).

The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.

IN PRACTICE:

“About half of seized fentanyl is now in pill form, suggesting that the illicit drug landscape has rapidly changed,” Joseph J. Palamar, PhD, MPH, of NYU Langone Health, New York, said in a press release. “The study’s findings underscore the evolving challenge of fentanyl in the illicit drug market, emphasizing the need for healthcare professionals to be vigilant in recognizing and responding to the risks associated with fentanyl, especially in pill form,” he added.

SOURCE:

Dr. Palamar led the study, which was published online on May 13, 2024, in the International Journal of Drug Policy. 

LIMITATIONS:

One limitation of the study is the inability to differentiate whether seizures were solely fentanyl, fentanyl combined with other drugs, or fentanyl analogs. Additionally, the reliance on HIDTA data may not fully represent the extent of illicit fentanyl availability.

DISCLOSURES:

Dr. Palamar reports a consulting or advisory relationship with the Washington Baltimore High Intensity Drug Trafficking Area. The study was supported by the National Institute on Drug Abuse.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

US fentanyl seizures increased by more than 1700% between 2017 and 2023, new data showed. 

METHODOLOGY:

• Investigators analyzed data from the High Intensity Drug Trafficking Areas (HIDTA) program from 2017 through 2023.
• To assess trends in illicit fentanyl availability, investigators used eight indicators of potential shifts in illicit fentanyl supply, including total seizures, powder seizures, pill seizures, and the total weight of seizures.

TAKEAWAY:

• A total of 66,303 fentanyl seizures were identified. Of the total number of seizures, 67% were in powder form and 33% were pills.
• The total number of seizures during the study period increased by > 1700% — from 74,663 in 2017 to 115,221 in 2023.
• In 2023, the greatest number of fentanyl seizures was in Florida (n = 2,089), followed by Arizona (n = 1783) and California (n = 1440).Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).
• The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.
• Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).

The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.

IN PRACTICE:

“About half of seized fentanyl is now in pill form, suggesting that the illicit drug landscape has rapidly changed,” Joseph J. Palamar, PhD, MPH, of NYU Langone Health, New York, said in a press release. “The study’s findings underscore the evolving challenge of fentanyl in the illicit drug market, emphasizing the need for healthcare professionals to be vigilant in recognizing and responding to the risks associated with fentanyl, especially in pill form,” he added.

SOURCE:

Dr. Palamar led the study, which was published online on May 13, 2024, in the International Journal of Drug Policy. 

LIMITATIONS:

One limitation of the study is the inability to differentiate whether seizures were solely fentanyl, fentanyl combined with other drugs, or fentanyl analogs. Additionally, the reliance on HIDTA data may not fully represent the extent of illicit fentanyl availability.

DISCLOSURES:

Dr. Palamar reports a consulting or advisory relationship with the Washington Baltimore High Intensity Drug Trafficking Area. The study was supported by the National Institute on Drug Abuse.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

US fentanyl seizures increased by more than 1700% between 2017 and 2023, new data showed. 

METHODOLOGY:

• Investigators analyzed data from the High Intensity Drug Trafficking Areas (HIDTA) program from 2017 through 2023.
• To assess trends in illicit fentanyl availability, investigators used eight indicators of potential shifts in illicit fentanyl supply, including total seizures, powder seizures, pill seizures, and the total weight of seizures.

TAKEAWAY:

• A total of 66,303 fentanyl seizures were identified. Of the total number of seizures, 67% were in powder form and 33% were pills.
• The total number of seizures during the study period increased by > 1700% — from 74,663 in 2017 to 115,221 in 2023.
• In 2023, the greatest number of fentanyl seizures was in Florida (n = 2,089), followed by Arizona (n = 1783) and California (n = 1440).Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).
• The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.
• Western United States experienced the greatest increase in seizures, particularly in pill form, suggesting a significant regional shift in fentanyl distribution. California had the greatest number of pills seized (n = 38.6 million) and also the greatest weight of powder seized (4315 kg).

The findings highlight the rapidly changing nature of the illicit fentanyl market, with an increasing prevalence of fentanyl pills.

IN PRACTICE:

“About half of seized fentanyl is now in pill form, suggesting that the illicit drug landscape has rapidly changed,” Joseph J. Palamar, PhD, MPH, of NYU Langone Health, New York, said in a press release. “The study’s findings underscore the evolving challenge of fentanyl in the illicit drug market, emphasizing the need for healthcare professionals to be vigilant in recognizing and responding to the risks associated with fentanyl, especially in pill form,” he added.

SOURCE:

Dr. Palamar led the study, which was published online on May 13, 2024, in the International Journal of Drug Policy. 

LIMITATIONS:

One limitation of the study is the inability to differentiate whether seizures were solely fentanyl, fentanyl combined with other drugs, or fentanyl analogs. Additionally, the reliance on HIDTA data may not fully represent the extent of illicit fentanyl availability.

DISCLOSURES:

Dr. Palamar reports a consulting or advisory relationship with the Washington Baltimore High Intensity Drug Trafficking Area. The study was supported by the National Institute on Drug Abuse.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

• Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
• Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
• Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
• Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
• Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
• Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

• Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
• Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
• Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
• Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
• Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
• Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

Sexual harassment, bullying, and gender bias are still very real occupational hazards for ob.gyn. trainees and practitioners alike — even in this female-dominated field, a systematic evidence review found.

Published in JAMA Network Open, by Ankita Gupta, MD, MPH, a urogynecology and reconstructive pelvic surgery specialist at the University of Louisville in Kentucky, and colleagues, the analysis found rates as high as 71% for sexual harassment, coercion, or unwanted advances. It also noted high rates of bullying, gender bias, and microaggressions. “We were struck by the continued high rates of harassment,” Dr. Gupta said in an interview. “Much of the literature within academic medicine has suggested the unequal distribution of women among medical specialties is the cause of sexual and gender harassment, but despite ob.gyns. being overwhelmingly female, we found that gender bias continues to occur at alarmingly high rates.”

Furthermore, among studies where this was reported, almost 25% of respondents had experienced sexual coercion. Not unexpectedly, this mistreatment often went unreported to institutional leadership out of fear of retaliation.

“We were also surprised to find a high rate of 51% for sexual harassment among male respondents as well, suggesting that both gender and power dynamics play a role in harassment,” Dr. Gupta said.

The primary perpetrators of unwanted behaviors were other doctors, overwhelmingly attending physicians, although residents and fellows were also identified as perpetrators, especially when harassment was reported by medical students, she added. “This once again points to the underreported abuse of professional power.” Women were rarely the perpetrators — just 10% — although they were the perpetrators in 57.7% of cases when the victim was male.

“Another interesting aspect of this is gender bias and microaggressions in the operating room,” she continued. While female surgeons often experience bias coming from OR staff, the review found that 94.4% of female ob.gyns. had been mistaken for non-physicians, 88.9% had pre-apologized for asking for something from a surgical technician or nurse, and 83.3% needed to make such requests multiple times. “These instances demonstrate gender bias in both male and female operating room staff toward female ob.gyns.”

Undermining and bullying behaviors are common in surgical specialties, Dr. Gupta explained, and the tantrums, swearing, and humiliation of trainees may be considered as much a rite of passage as the long hours. “As a trainee, you are taught to ignore such behavior as reporting it comes with fear of repercussions.”

This review bore this out, with only 8%-12% of respondents across studies reporting harassment and then predominantly to another trainee. “Sexual harassment and microaggressions can further lead to loss of career opportunities and burnout and I have come across many ob.gyns. who have chosen alternate paths owing to negative experiences,” Dr. Gupta said.

The Analysis

A joint effort by the Society of Gynecologic Surgeons and the and Society of Gynecologic Oncology, the analysis looked at existing literature from inception through June 2023.

A total of 10 eligible studies with 5852 participants addressed prevalence and 12 eligible studies in 2906 participants addressed interventions. Among the findings across different studies:

• Sexual harassment was noted by 250 of 907 physicians (27.6%) and 181 of 255 female gynecologic oncologists (70.9%).
• Workplace discrimination ranged from 142 of 249 female gynecologic oncologists (57.0%) to 354 of 527 female gynecologic oncologists (67.2%); among male gynecologic oncologists 138 of 358 (38.5%) reported discrimination.
• Bullying was reported by 131 of 248 female gynecologic oncologists (52.8%).
• Ob.gyn. trainees commonly experienced sexual harassment: 253 of 366 respondents (69.1%); this included gender harassment, unwanted sexual attention, and sexual coercion.
• Mistreatment of medical students during ob.gyn. rotation was indicated by 168 of 668 (25.1%).
• Perpetrators of harassment included physicians (30.1%), other trainees (13.1%), and OR staff (7.7%).

These findings are consistent with those of other recent investigations. A systematic review from 2022 found that 25% of ob.gyn., 32% of general surgery, and 21% of medical interns and students reported bullying .

In another 2022 review, in which ob.gyn. program directors were mainly women and department chairs mainly men, the prevalence of sexual harassment did not differ based on the gender of program directors and chairs.

A study from 2021 reported that 27% of academic surgical trainees, including ob.gyns., reported sexual harassment.

Going back to 2004, a study across multiple medical specialties found that ob.gyn. was second only to general surgery as the specialty associated with the highest rates of sexual harassment.

Despite institutional anti-discrimination policies, real-life interventions seem ineffective. “Disappointingly, we found that most interventions to address harassment had not been appropriately evaluated and did not show a decrease in sexual harassment,” Dr. Gupta said. “Interventions that were successful in reducing mistreatment of trainees required institutional buy-in at multiple levels, including leadership, management, and administration,” she said.

Multi-pronged strategies might include providing tools to educate healthcare staff about harassment and empowering bystanders to intervene when encountering such situations. “Further, independent offices where all complaints are evaluated by an intermediary third party and requiring professionalism to be a criterion for promotion criterion can be useful strategies,” she said.

She noted that residents may model harassing behavior perpetrated by senior attending physicians, thereby creating a cycle of mistreatment. “Equipping clinicians to be better surgical educators, providing clinical support, and modeling positive behavior may help disrupt the culture of harassment.” While the best solutions may be unclear, it is clear that much work remains to be done before the ob.gyn. working environment catches up to official institutional anti-discrimination policies.

This study was supported by the Society of Gynecologic Surgeons. Dr. Gupta disclosed no competing interests. Several coauthors disclosed relationships with multiple pharmaceutical or biomedical companies.

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

TOPLINE:

Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.

METHODOLOGY:

• Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
• Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
• Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.

TAKEAWAY:

• Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both. 
• Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
• No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
• In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).

IN PRACTICE:

“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.

Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.

SOURCE:

The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.

LIMITATIONS:

No limitations were discussed in the presentation.

DISCLOSURES:

Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.

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

BOSTON — Primary care clinicians caring for patients with intellectual and developmental disabilities often recommend guardianship, a responsibility with life-altering implications. 

But only approximately 30% of primary care residency programs in the United States provide training  on how to assess the ability of patients with disabilities to make decisions for themselves, and much of this training is optional, according to a recent study cited during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

Assessing the capacity of patients with disabilities involves navigating a maze of legal, ethical, and clinical considerations, according to Mary Thomas, MD, MPH, a clinical fellow in geriatrics at Yale University School of Medicine in New Haven, Connecticut, who co-moderated the workshop.

Guardianship, while sometimes necessary, can be overly restrictive and diminish patient autonomy, she said. The legal process — ultimately decided through the courts — gives a guardian permission to manage medical care and make decisions for someone who cannot make or communicate those decisions themselves.

Clinicians can assess patients through an evaluation of functional capacity, which allows them to observe a patient’s demeanor and administer a cognition test. Alternatives such as supported decision-making may be less restrictive and can better serve patients, she said. Supported decision-making allows for a person with disabilities to receive assistance from a supporter who can help a patient process medical conditions and treatment needs. The supporter helps empower capable patients to decide on their own.

Some states have introduced legislation that would legally recognize supported decision-making as a less restrictive alternative to guardianship or conservatorship, in which a court-appointed individual manages all aspects of a person’s life. 

Sara Mixter, MD, MPH, an assistant professor of medicine and pediatrics at the Johns Hopkins University School of Medicine in Baltimore and a co-moderator of the workshop, called the use of inclusive language in patient communication the “first step toward fostering an environment where patients feel respected and understood.”

Inclusive conversations can include person-first language and using words such as “caregiver” rather than “caretaker.” 

Dr. Thomas and Dr. Mixter also called for the directors of residency programs to provide more training on disabilities. They cited a 2023 survey of directors, many of whom said that educational boards do not require training in disability-specific care and that experts in the care of people with disabilities are few and far between.

“Education and awareness are key to overcoming the challenges we face,” Dr. Thomas said. “Improving our training programs means we can ensure that all patients receive the care and respect they deserve.”

Dr. Thomas and Dr. Mixter report no relevant disclosures.

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

BOSTON — Primary care clinicians caring for patients with intellectual and developmental disabilities often recommend guardianship, a responsibility with life-altering implications. 

But only approximately 30% of primary care residency programs in the United States provide training  on how to assess the ability of patients with disabilities to make decisions for themselves, and much of this training is optional, according to a recent study cited during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

Assessing the capacity of patients with disabilities involves navigating a maze of legal, ethical, and clinical considerations, according to Mary Thomas, MD, MPH, a clinical fellow in geriatrics at Yale University School of Medicine in New Haven, Connecticut, who co-moderated the workshop.

Guardianship, while sometimes necessary, can be overly restrictive and diminish patient autonomy, she said. The legal process — ultimately decided through the courts — gives a guardian permission to manage medical care and make decisions for someone who cannot make or communicate those decisions themselves.

Clinicians can assess patients through an evaluation of functional capacity, which allows them to observe a patient’s demeanor and administer a cognition test. Alternatives such as supported decision-making may be less restrictive and can better serve patients, she said. Supported decision-making allows for a person with disabilities to receive assistance from a supporter who can help a patient process medical conditions and treatment needs. The supporter helps empower capable patients to decide on their own.

Some states have introduced legislation that would legally recognize supported decision-making as a less restrictive alternative to guardianship or conservatorship, in which a court-appointed individual manages all aspects of a person’s life. 

Sara Mixter, MD, MPH, an assistant professor of medicine and pediatrics at the Johns Hopkins University School of Medicine in Baltimore and a co-moderator of the workshop, called the use of inclusive language in patient communication the “first step toward fostering an environment where patients feel respected and understood.”

Inclusive conversations can include person-first language and using words such as “caregiver” rather than “caretaker.” 

Dr. Thomas and Dr. Mixter also called for the directors of residency programs to provide more training on disabilities. They cited a 2023 survey of directors, many of whom said that educational boards do not require training in disability-specific care and that experts in the care of people with disabilities are few and far between.

“Education and awareness are key to overcoming the challenges we face,” Dr. Thomas said. “Improving our training programs means we can ensure that all patients receive the care and respect they deserve.”

Dr. Thomas and Dr. Mixter report no relevant disclosures.

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

BOSTON — Primary care clinicians caring for patients with intellectual and developmental disabilities often recommend guardianship, a responsibility with life-altering implications. 

But only approximately 30% of primary care residency programs in the United States provide training  on how to assess the ability of patients with disabilities to make decisions for themselves, and much of this training is optional, according to a recent study cited during a workshop at the 2024 annual meeting of the Society of General Internal Medicine.

Assessing the capacity of patients with disabilities involves navigating a maze of legal, ethical, and clinical considerations, according to Mary Thomas, MD, MPH, a clinical fellow in geriatrics at Yale University School of Medicine in New Haven, Connecticut, who co-moderated the workshop.

Guardianship, while sometimes necessary, can be overly restrictive and diminish patient autonomy, she said. The legal process — ultimately decided through the courts — gives a guardian permission to manage medical care and make decisions for someone who cannot make or communicate those decisions themselves.

Clinicians can assess patients through an evaluation of functional capacity, which allows them to observe a patient’s demeanor and administer a cognition test. Alternatives such as supported decision-making may be less restrictive and can better serve patients, she said. Supported decision-making allows for a person with disabilities to receive assistance from a supporter who can help a patient process medical conditions and treatment needs. The supporter helps empower capable patients to decide on their own.

Some states have introduced legislation that would legally recognize supported decision-making as a less restrictive alternative to guardianship or conservatorship, in which a court-appointed individual manages all aspects of a person’s life. 

Sara Mixter, MD, MPH, an assistant professor of medicine and pediatrics at the Johns Hopkins University School of Medicine in Baltimore and a co-moderator of the workshop, called the use of inclusive language in patient communication the “first step toward fostering an environment where patients feel respected and understood.”

Inclusive conversations can include person-first language and using words such as “caregiver” rather than “caretaker.” 

Dr. Thomas and Dr. Mixter also called for the directors of residency programs to provide more training on disabilities. They cited a 2023 survey of directors, many of whom said that educational boards do not require training in disability-specific care and that experts in the care of people with disabilities are few and far between.

“Education and awareness are key to overcoming the challenges we face,” Dr. Thomas said. “Improving our training programs means we can ensure that all patients receive the care and respect they deserve.”

Dr. Thomas and Dr. Mixter report no relevant disclosures.

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

BOSTON — Online patient portals have shifted patient expectations of how quickly clinicians respond and provide timely care, which can lead to burnout. But asynchronous care can, in some cases, be compensated and increase physician productivity and enhance patient care, according to experts who led a workshop at the Society of General Internal Medicine (SGIM) 2024 Annual Meeting.

Patient portal visits have increased in popularity and use since the COVID-19 pandemic. For primary care clinicians especially, the amount of time spent and the span of requests, from messages with new health concerns to requests for prescription refills, can be daunting.

“Understanding the nuances of these relationships is pivotal in navigating the evolution toward asynchronous care,” said Jennifer Schmidt, MD, an assistant professor of medicine at the Washington University School of Medicine in St. Louis, who co-moderated the workshop.

But patient portals can give clinicians another tool to deliver care beyond conventional office visits or telemedicine appointments, Dr. Schmidt said.

Clinicians can bill insurance if their response to a patient question takes longer than 5 minutes to compose. Responses to messages related to scheduling appointments, refilling prescriptions, or visit follow-ups are not billable.

Some participants at the session said their employers do not have policies that allow compensation for their work in patient portals. Others said their health systems have reported that patients who use portals more frequently have higher satisfaction scores.

Asynchronous care holds promise for extending care beyond traditional constraints, according to Stephen Fuest, MD, an assistant professor of internal medicine at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, and a co-moderator of the workshop.

“By capitalizing on our experiences in designing and implementing systems for portal communication, we can find ways to optimize productivity and alleviate burnout,” Dr. Fuest said.

Dr. Fuest noted that while compensation rates for virtual care are lower than those for in-person, the lack of geographical barriers and time constraints allow clinicians to care for more patients. Asynchronous care also can limit losing patients to follow-up.

BOSTON — Online patient portals have shifted patient expectations of how quickly clinicians respond and provide timely care, which can lead to burnout. But asynchronous care can, in some cases, be compensated and increase physician productivity and enhance patient care, according to experts who led a workshop at the Society of General Internal Medicine (SGIM) 2024 Annual Meeting.

Patient portal visits have increased in popularity and use since the COVID-19 pandemic. For primary care clinicians especially, the amount of time spent and the span of requests, from messages with new health concerns to requests for prescription refills, can be daunting.

“Understanding the nuances of these relationships is pivotal in navigating the evolution toward asynchronous care,” said Jennifer Schmidt, MD, an assistant professor of medicine at the Washington University School of Medicine in St. Louis, who co-moderated the workshop.

But patient portals can give clinicians another tool to deliver care beyond conventional office visits or telemedicine appointments, Dr. Schmidt said.

Clinicians can bill insurance if their response to a patient question takes longer than 5 minutes to compose. Responses to messages related to scheduling appointments, refilling prescriptions, or visit follow-ups are not billable.

Some participants at the session said their employers do not have policies that allow compensation for their work in patient portals. Others said their health systems have reported that patients who use portals more frequently have higher satisfaction scores.

Asynchronous care holds promise for extending care beyond traditional constraints, according to Stephen Fuest, MD, an assistant professor of internal medicine at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, and a co-moderator of the workshop.

“By capitalizing on our experiences in designing and implementing systems for portal communication, we can find ways to optimize productivity and alleviate burnout,” Dr. Fuest said.

Dr. Fuest noted that while compensation rates for virtual care are lower than those for in-person, the lack of geographical barriers and time constraints allow clinicians to care for more patients. Asynchronous care also can limit losing patients to follow-up.

BOSTON — Online patient portals have shifted patient expectations of how quickly clinicians respond and provide timely care, which can lead to burnout. But asynchronous care can, in some cases, be compensated and increase physician productivity and enhance patient care, according to experts who led a workshop at the Society of General Internal Medicine (SGIM) 2024 Annual Meeting.

Patient portal visits have increased in popularity and use since the COVID-19 pandemic. For primary care clinicians especially, the amount of time spent and the span of requests, from messages with new health concerns to requests for prescription refills, can be daunting.

“Understanding the nuances of these relationships is pivotal in navigating the evolution toward asynchronous care,” said Jennifer Schmidt, MD, an assistant professor of medicine at the Washington University School of Medicine in St. Louis, who co-moderated the workshop.

But patient portals can give clinicians another tool to deliver care beyond conventional office visits or telemedicine appointments, Dr. Schmidt said.

Clinicians can bill insurance if their response to a patient question takes longer than 5 minutes to compose. Responses to messages related to scheduling appointments, refilling prescriptions, or visit follow-ups are not billable.

Some participants at the session said their employers do not have policies that allow compensation for their work in patient portals. Others said their health systems have reported that patients who use portals more frequently have higher satisfaction scores.

Asynchronous care holds promise for extending care beyond traditional constraints, according to Stephen Fuest, MD, an assistant professor of internal medicine at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, and a co-moderator of the workshop.

“By capitalizing on our experiences in designing and implementing systems for portal communication, we can find ways to optimize productivity and alleviate burnout,” Dr. Fuest said.

Dr. Fuest noted that while compensation rates for virtual care are lower than those for in-person, the lack of geographical barriers and time constraints allow clinicians to care for more patients. Asynchronous care also can limit losing patients to follow-up.

Artificial intelligence (AI) has drawn interest in ophthalmology for its potential to track disease trends in huge populations, such as the 38.4 million people in the United States with diabetes who are at risk for diabetic eye disease. However, a recent study using AI to detect diabetic retinopathy from retinal photo screenings has found wide disparities in the quality of data being fed into the algorithm.

And screening photos captured in nine primary care settings were three times more likely to be unusable than those obtained in two ophthalmology clinics, a study at Temple University in Philadelphia found. The results of the new research were reported at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual meeting.

“AI-assisted diabetic retinopathy screenings were more successful when completed in the ophthalmology clinic setting compared to the primary care setting,” study leader Madelyn Class, a medical student at Temple, told this news organization. One key difference, Ms. Class said, was that the specialty clinics used a photographer training in capturing ophthalmic images, while the primary care sites had medical assistants taking the photos.
 

Challenges of Screening in Primary Care

The American Diabetes Association acknowledged in a 2017 position statement that retinal photography has the potential to bring screening into settings where optometrists or ophthalmologists are unavailable. This study showed the potential may not yet be realized.

In the primary care setting, 42.5% of retinal photos were ungradable compared with 14.5% in the specialty settings.

The number of patients diagnosed with more-than-mild diabetic retinopathy also varied significantly between the two settings — 13% in primary care and 24% in ophthalmology — as did the rates of follow-up appointments: 58% and 80%, respectively.

“It seems user error played a role in the quality of photographs that were taken,” Ms. Class said. “Some of the images we received from the primary care settings were actually of the eyelid, or even the curtains on the wall, rather than the fundus.

“All the camera operators in the study received training on the imaging device,” Ms. Class added. “This suggests that some of the photographers were rushed, out of practice, or simply no longer interested in taking photos,” she said. “Apparently, we will have to continuously monitor the performance of each photographer to ensure that quality photos are being taken.”

The findings may also point to the need for using different equipment for screening in primary care, Ms. Class added. “Robotic as opposed to manual cameras may help eliminate some of the user error that was experienced with primary care screenings,” she said.

Need for Training ‘Fixable’

These findings demonstrate the challenges of capturing usable retinal images outside of an eye care professional’s office, according to Jennifer Lim, MD, director of the retina service at the University of Illinois Chicago.

“This study illustrates that implementation is the rub of AI,” Dr. Lim told this news organization. “Getting primary care doctors and clinics to want to adopt and figure out how to implement AI screening [for diabetic retinopathy] in a healthcare system is difficult, so I applaud the Temple University system for trying to integrate retinal photography-based AI screening into the primary care outpatient centers and comparing outcomes to the ophthalmology clinics.”

The study showed that photographers need not only initial training but also monitoring to avoid ungradable images, Dr. Lim added, a problem that is “fixable.”

“It’s going to take a lot of work to get the message out to the primary care practices that these autonomous, cloud-based systems are available and effective for detecting retinopathy,” she said.

But the effort is worth it, she added: “It doesn’t take much time to take these photos for diabetic retinopathy screening, and the potential benefits are huge because the earlier you diagnose diabetic retinopathy that’s more than mild, the more likely the patient can be sent for eye care in a timely fashion and thus prevent visual loss from diabetic retinopathy.”

Ms. Class had no relevant disclosures. Dr. Lim disclosed a past relationship with Eyenuk, the maker of retinal screening cameras.

A version of this article appeared on Medscape.com .

Artificial intelligence (AI) has drawn interest in ophthalmology for its potential to track disease trends in huge populations, such as the 38.4 million people in the United States with diabetes who are at risk for diabetic eye disease. However, a recent study using AI to detect diabetic retinopathy from retinal photo screenings has found wide disparities in the quality of data being fed into the algorithm.

And screening photos captured in nine primary care settings were three times more likely to be unusable than those obtained in two ophthalmology clinics, a study at Temple University in Philadelphia found. The results of the new research were reported at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual meeting.

“AI-assisted diabetic retinopathy screenings were more successful when completed in the ophthalmology clinic setting compared to the primary care setting,” study leader Madelyn Class, a medical student at Temple, told this news organization. One key difference, Ms. Class said, was that the specialty clinics used a photographer training in capturing ophthalmic images, while the primary care sites had medical assistants taking the photos.
 

Challenges of Screening in Primary Care

The American Diabetes Association acknowledged in a 2017 position statement that retinal photography has the potential to bring screening into settings where optometrists or ophthalmologists are unavailable. This study showed the potential may not yet be realized.

In the primary care setting, 42.5% of retinal photos were ungradable compared with 14.5% in the specialty settings.

The number of patients diagnosed with more-than-mild diabetic retinopathy also varied significantly between the two settings — 13% in primary care and 24% in ophthalmology — as did the rates of follow-up appointments: 58% and 80%, respectively.

“It seems user error played a role in the quality of photographs that were taken,” Ms. Class said. “Some of the images we received from the primary care settings were actually of the eyelid, or even the curtains on the wall, rather than the fundus.

“All the camera operators in the study received training on the imaging device,” Ms. Class added. “This suggests that some of the photographers were rushed, out of practice, or simply no longer interested in taking photos,” she said. “Apparently, we will have to continuously monitor the performance of each photographer to ensure that quality photos are being taken.”

The findings may also point to the need for using different equipment for screening in primary care, Ms. Class added. “Robotic as opposed to manual cameras may help eliminate some of the user error that was experienced with primary care screenings,” she said.

Need for Training ‘Fixable’

These findings demonstrate the challenges of capturing usable retinal images outside of an eye care professional’s office, according to Jennifer Lim, MD, director of the retina service at the University of Illinois Chicago.

“This study illustrates that implementation is the rub of AI,” Dr. Lim told this news organization. “Getting primary care doctors and clinics to want to adopt and figure out how to implement AI screening [for diabetic retinopathy] in a healthcare system is difficult, so I applaud the Temple University system for trying to integrate retinal photography-based AI screening into the primary care outpatient centers and comparing outcomes to the ophthalmology clinics.”

The study showed that photographers need not only initial training but also monitoring to avoid ungradable images, Dr. Lim added, a problem that is “fixable.”

“It’s going to take a lot of work to get the message out to the primary care practices that these autonomous, cloud-based systems are available and effective for detecting retinopathy,” she said.

But the effort is worth it, she added: “It doesn’t take much time to take these photos for diabetic retinopathy screening, and the potential benefits are huge because the earlier you diagnose diabetic retinopathy that’s more than mild, the more likely the patient can be sent for eye care in a timely fashion and thus prevent visual loss from diabetic retinopathy.”

Ms. Class had no relevant disclosures. Dr. Lim disclosed a past relationship with Eyenuk, the maker of retinal screening cameras.

A version of this article appeared on Medscape.com .

Artificial intelligence (AI) has drawn interest in ophthalmology for its potential to track disease trends in huge populations, such as the 38.4 million people in the United States with diabetes who are at risk for diabetic eye disease. However, a recent study using AI to detect diabetic retinopathy from retinal photo screenings has found wide disparities in the quality of data being fed into the algorithm.

And screening photos captured in nine primary care settings were three times more likely to be unusable than those obtained in two ophthalmology clinics, a study at Temple University in Philadelphia found. The results of the new research were reported at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual meeting.

“AI-assisted diabetic retinopathy screenings were more successful when completed in the ophthalmology clinic setting compared to the primary care setting,” study leader Madelyn Class, a medical student at Temple, told this news organization. One key difference, Ms. Class said, was that the specialty clinics used a photographer training in capturing ophthalmic images, while the primary care sites had medical assistants taking the photos.
 

Challenges of Screening in Primary Care

The American Diabetes Association acknowledged in a 2017 position statement that retinal photography has the potential to bring screening into settings where optometrists or ophthalmologists are unavailable. This study showed the potential may not yet be realized.

In the primary care setting, 42.5% of retinal photos were ungradable compared with 14.5% in the specialty settings.

The number of patients diagnosed with more-than-mild diabetic retinopathy also varied significantly between the two settings — 13% in primary care and 24% in ophthalmology — as did the rates of follow-up appointments: 58% and 80%, respectively.

“It seems user error played a role in the quality of photographs that were taken,” Ms. Class said. “Some of the images we received from the primary care settings were actually of the eyelid, or even the curtains on the wall, rather than the fundus.

“All the camera operators in the study received training on the imaging device,” Ms. Class added. “This suggests that some of the photographers were rushed, out of practice, or simply no longer interested in taking photos,” she said. “Apparently, we will have to continuously monitor the performance of each photographer to ensure that quality photos are being taken.”

The findings may also point to the need for using different equipment for screening in primary care, Ms. Class added. “Robotic as opposed to manual cameras may help eliminate some of the user error that was experienced with primary care screenings,” she said.

Need for Training ‘Fixable’

These findings demonstrate the challenges of capturing usable retinal images outside of an eye care professional’s office, according to Jennifer Lim, MD, director of the retina service at the University of Illinois Chicago.

“This study illustrates that implementation is the rub of AI,” Dr. Lim told this news organization. “Getting primary care doctors and clinics to want to adopt and figure out how to implement AI screening [for diabetic retinopathy] in a healthcare system is difficult, so I applaud the Temple University system for trying to integrate retinal photography-based AI screening into the primary care outpatient centers and comparing outcomes to the ophthalmology clinics.”

The study showed that photographers need not only initial training but also monitoring to avoid ungradable images, Dr. Lim added, a problem that is “fixable.”

“It’s going to take a lot of work to get the message out to the primary care practices that these autonomous, cloud-based systems are available and effective for detecting retinopathy,” she said.

But the effort is worth it, she added: “It doesn’t take much time to take these photos for diabetic retinopathy screening, and the potential benefits are huge because the earlier you diagnose diabetic retinopathy that’s more than mild, the more likely the patient can be sent for eye care in a timely fashion and thus prevent visual loss from diabetic retinopathy.”

Ms. Class had no relevant disclosures. Dr. Lim disclosed a past relationship with Eyenuk, the maker of retinal screening cameras.

A version of this article appeared on Medscape.com .