Interventional cardiologists (ICs) around the world are unhappy and burned out, and their well-being is compromised, a new international survey suggests.

“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.

“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.

The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.

Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.

“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”

The study was published online in JACC: Cardiovascular Interventions.
 

Too much paperwork

The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.

A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.

Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.

Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.  

Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.

As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.

Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.

Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).

Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).

Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.

For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.

Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.

Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.

Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.

Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.

Fellows rated insufficient income as the most significant contributor to burnout.

Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).

Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.

Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).

Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.

Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
 

Reforms needed

Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.

She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.

“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”

Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”

With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”

With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”

The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.

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

Interventional cardiologists (ICs) around the world are unhappy and burned out, and their well-being is compromised, a new international survey suggests.

“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.

“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.

The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.

Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.

“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”

The study was published online in JACC: Cardiovascular Interventions.
 

Too much paperwork

The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.

A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.

Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.

Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.  

Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.

As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.

Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.

Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).

Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).

Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.

For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.

Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.

Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.

Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.

Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.

Fellows rated insufficient income as the most significant contributor to burnout.

Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).

Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.

Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).

Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.

Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
 

Reforms needed

Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.

She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.

“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”

Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”

With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”

With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”

The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.

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

Interventional cardiologists (ICs) around the world are unhappy and burned out, and their well-being is compromised, a new international survey suggests.

“What surprised me was the magnitude of the findings,” Emmanouil S. Brilakis, MD, PhD of the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, said in an interview.

“I was expecting that some interventionalists would feel burned out, but not that 78% would feel they are working too hard, 64% are emotionally exhausted, and 41% considered quitting their job during the past year.

The survey, conducted in January, also showed that while 69% of respondents were affected by burnout, many were either not seeking mental health support or not willing to share whether they were under treatment.

Overall, 28% of interventional cardiologists were not happy with their lives, similar to the 29% reported in the Medscape Cardiologist Lifestyle, Happiness & Burnout Report 2022.

“Many institutions have formed task forces to better understand burnout and recommend solutions, but progress has been slow,” Dr. Brilakis said. “Barriers include financial constraints, understaffing, lack of understanding of the root causes of burnout in each practice, and perhaps underappreciation of the consequences of burnout.”

The study was published online in JACC: Cardiovascular Interventions.
 

Too much paperwork

The investigators conducted an international, online survey of IC attending physicians and fellows to assess their psychological well-being. The 78 survey questions prepared by the coauthors were shown to perform similarly to the validated Maslach Burnout Inventory.

A total of 1,159 attendings and 192 fellows completed the survey, representing 12% of U.S. IC attendings and 19% of U.S. IC fellows.

Half of attending physicians were from the United States, followed by the European Union (16%). Overall, 37% were from academic institutions; the median age was 41-45 years; 91% were men; and mean clinical work hours per week were 63.

Most (86%) had a partner with whom they lived. Yet most (84%) also felt lonely; 41% considered leaving their jobs during the past year; and 32% said they were currently considering leaving.  

Compared with the previous year, 12% had increased enthusiasm and 44% had decreased enthusiasm toward work. One-third (33%) felt overwhelmed and 20% doubted the significance of their work three or more times a week.

As noted, most (78%) felt they were “working too hard,” were emotionally exhausted (64%), and frustrated by work (58%). Almost one-third (30%) considered themselves physically unhealthy.

Unhappiness was highest (33%) among 51- to 60-year-olds, followed by 31- to 40-year-olds (31%); it was lowest (21%) among those over age 60.

Unhappiness was similar between men and women (27% vs. 30%) and was highest in North America (30%) and lower in Asia (26%).

Most (69%) respondents said that burnout impacted their life, with very little difference between men and women (68% vs. 73%).

Two-thirds (67%) said they had somebody they could share their mental health concerns with, yet only 37% reported having access to mental health support if needed through their hospital/practice.

For fellows, the median age was 31-35 years; 88% were men; 42% were from the United States and 22% from the European Union. Two-thirds were from academic institutions (67%) and the mean clinical work hours were 67 per week.

Two-thirds (67%) lived with a partner; half (48%) felt lonely, 29% considered leaving their jobs in the past year, and 15% were currently considering leaving.

Compared with the previous year, 27% had increased enthusiasm, and 32% had decreased enthusiasm toward work. More than one-quarter (29%) felt overwhelmed and 26% doubted the significance of their work three or more times per week.

Attendings rated excessive paperwork requirements, bureaucratic tasks, challenges in equipment acquisition, and excessive government regulations higher (in contributing to burnout) compared with fellows.

Non-U.S. attendings reported insufficient income and challenges with equipment acquisition as significant contributors to their burnout more than did their United States counterparts.

Fellows rated insufficient income as the most significant contributor to burnout.

Their main coping mechanisms were talking with family/friends (at 6.8 rated on a scale of 0-10), watching movies (6.4), and listening/playing music (6.0).

Attendings were more likely to use exercise as a coping skill, and fellows were more likely to cope by watching movies/series, sleeping, and eating junk food.

Asked what hospitals and practices can do to reduce burnout and improve well-being, attendings suggested removing rules/regulations that do not contribute to patient care, such as reforming prior authorization (mean rating, 8.1), better administrative support (8.0), and professional growth opportunities (7.9).

Non-U.S. attendings more often requested growth opportunities, increased compensation, availability of better hospital food, better hospital infrastructure, streamlined access to equipment, better on-call rooms, and access to mental health professionals to improve their well-being.

Overall, fellows were more likely than were attendings to request professional growth opportunities and were more likely to ask for availability of better food in the hospital, and better on-call rooms.
 

Reforms needed

Laxmi Mehta, MD, chief well-being leader, faculty director of the Gabbe Health and Well-Being Program, professor of medicine at The Ohio State University Wexner Medical Center in Columbus, and spokesperson for the American Heart Association, noted, “The burnout rates are much higher than our previously reported American College of Cardiology data, which found burnout rates at about 27%; however, that survey was conducted prepandemic,” she said. Dr. Mehta was the lead author of that 2019 report.

She said in an interview that she would have liked to see more breakdowns by gender, and whether there was an association between burnout and the number of procedures performed.

“Nevertheless,” she said, “the rates are very high for burnout, stress, and dissatisfaction, as well as mental health issues. Almost one half of the IC attendings considered leaving their job, which is also seen in other surveys, and is concerning given the projected shortages in the workforce.”

Changes need to be made in the profession of medicine as a whole, she said, though that is unlikely to happen any time soon. “Optimizing workflows and improving the work culture requires not only time, but also collaboration between administration and clinicians, along with an intent and strategic plan focused on well-being of the organization.”

With regard to prior authorization, she said, “medical organizations are advocating for reform at the state and national level. If meaningful reforms can occur, that can reduce some of the bureaucracy. However, there is much more [bureaucracy] in medicine.”

With respect to mental health, she added, “there is a lot that needs to be done to reduce the stigma of seeking help. Many physicians don’t seek help due to the shame, lack of time, and potential impact it can have on hospital credentialing and state medical licensing. Medical organizations and individuals are advocating for reforms in this space, as well, to normalize mental health.”

The Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr. Brilakis, study coauthors, and Dr. Mehta report no relevant financial relationships.

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

CHICAGO – ChatGPT and other artificial intelligence (AI)–driven natural language processing platforms are here to stay, so like them or not, physicians might as well figure out how to optimize their role in medicine and health care. That’s the takeaway from a three-expert panel session about the technology held at the annual Digestive Disease Week® (DDW).

The chatbot can help doctors to a certain extent by suggesting differential diagnoses, assisting with clinical note-taking, and producing rapid and easy-to-understand patient communication and educational materials, they noted. However, it can also make mistakes. And, unlike a medical trainee who might give a clinical answer and express some doubt, ChatGPT (Open AI/Microsoft) clearly states its findings as fact, even when it’s wrong.

Known as “hallucinating,” this problem of AI inaccuracy was displayed at the packed DDW session.

When asked when Leonardo da Vinci painted the Mona Lisa, for example, ChatGPT replied 1815. That’s off by about 300 years; the masterpiece was created sometime between 1503 and 1519. Asked for a fact about George Washington, ChatGPT said he invented the cotton gin. Also not true. (Eli Whitney patented the cotton gin.)

In an example more suited for gastroenterologists at DDW, ChatGPT correctly stated that Barrett esophagus can lead to adenocarcinoma of the esophagus in some cases. However, the technology also said that the condition could lead to prostate cancer.

So, if someone asked ChatGPT for a list of possible risks for Barrett’s esophagus, it would include prostate cancer. A person without medical knowledge “could take it at face value that it causes prostate cancer,” said panelist Sravanthi Parasa, MD, a gastroenterologist at Swedish Medical Center, Seattle.

“That is a lot of misinformation that is going to come our way,” she added at the session, which was sponsored by the American Society for Gastrointestinal Endoscopy.

The potential for inaccuracy is a downside to ChatGPT, agreed panelist Prateek Sharma, MD, a gastroenterologist at the University of Kansas Medical Center in Kansas City, Kansas.

“There is no quality control. You have to double check its answers,” said Dr. Sharma, who is president-elect of ASGE.

ChatGPT is not going to replace physicians in general or gastroenterologists doing endoscopies, said Ian Gralnek, MD, chief of the Institute of Gastroenterology and Hepatology at Emek Medical Center in Afula, Israel.

Even though the tool could play a role in medicine, “we need to be very careful as a society going forward ... and see where things are going,” Dr. Gralnek said.
 

How you ask makes a difference

Future iterations of ChatGPT are likely to produce fewer hallucinations, the experts said. In the meantime, users can lower the risk by paying attention to how they’re wording their queries, a practice known as “prompt engineering.”

It’s best to ask a question that has a firm answer to it. If you ask a vague question, you’ll likely get a vague answer, Dr. Sharma said.

ChatGPT is a large language model (LLM). GPT stands for “generative pretrained transformer” – specialized algorithms that find long-range patterns in sequences of data. LLMs can predict the next word in a sentence.

“That’s why this is also called generative AI,” Dr. Sharma said. “For example, if you put in ‘Where are we?’, it will predict for you that perhaps the next word is ‘going?’ ”

The current public version is ChatGPT 3.5, which was trained on open-source online information up until early 2022. It can gather information from open-access scientific journals and medical society guidelines, as well as from Twitter, Reddit, and other social media. It does not have access to private information, like electronic health records.

The use of ChatGPT has exploded in the past 6 months, Dr. Sharma said.

“ChatGPT has been the most-searched website or platform ever in history since it was launched in December of 2022,” he said.
 

What’s in it for doctors?

Although not specifically trained for health care–related tasks, the panelists noted that ChatGPT does have potential as a virtual medical assistant, chatbot, clinical decision-support tool, source of medical education, natural language processor for documentation, or medical note-taker.

ChatGPT can help physicians write a letter of support to a patient who, for example, was just diagnosed with stage IV colon cancer. It can do that in only 15 seconds, whereas it would take us much longer, Dr. Sharma said.

ChatGPT is the “next frontier” for generating patient education materials, Dr. Parasa said. It can help time-constrained health care providers, as long as the information is accurate.

ChatGPT 4.0, now available by subscription, can do “almost real-time note-taking during patient encounters,” she added.

Another reason to be familiar with the technology: “Many of your patients are using it, even if you don’t know about it,” Dr. Sharma said.
 

Questions abound

A conference attendee asked the panel what to do when a patient comes in with ChatGPT medical advice that does not align with official guidelines.

Dr. Gralnek said that he would explain to patients that medical information based on guidelines are not “black and white.” The panel likened it to how patients come to an appointment now armed with information from the Internet, which is not always correct, that must then be countered by doctors. The same would likely happen with ChatGPT.

Another attendee asked whether ChatGPT eventually will work in accordance with electronic health record systems.

“Open AI and Microsoft are already working with Epic,” Dr. Parasa said.

A question arose about the reading level of information provided by ChatGPT. Dr. Parasa noted that it’s not standard. However, a person can prompt ChatGPT to provide an answer either at an eighth-grade reading level or for a well-trained physician.

Dr. Sharma offered a final warning: The technology learns over time.

“It knows what your habits are. It will learn what you’re doing,” Dr. Sharma said. “Everything else on your browsers that are open, it’s learning from that also. So be careful what websites you visit before you go to ChatGPT.”

Dr. Sharma is a stock shareholder in Microsoft. Dr. Parasa and Dr. Gralneck reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

CHICAGO – ChatGPT and other artificial intelligence (AI)–driven natural language processing platforms are here to stay, so like them or not, physicians might as well figure out how to optimize their role in medicine and health care. That’s the takeaway from a three-expert panel session about the technology held at the annual Digestive Disease Week® (DDW).

The chatbot can help doctors to a certain extent by suggesting differential diagnoses, assisting with clinical note-taking, and producing rapid and easy-to-understand patient communication and educational materials, they noted. However, it can also make mistakes. And, unlike a medical trainee who might give a clinical answer and express some doubt, ChatGPT (Open AI/Microsoft) clearly states its findings as fact, even when it’s wrong.

Known as “hallucinating,” this problem of AI inaccuracy was displayed at the packed DDW session.

When asked when Leonardo da Vinci painted the Mona Lisa, for example, ChatGPT replied 1815. That’s off by about 300 years; the masterpiece was created sometime between 1503 and 1519. Asked for a fact about George Washington, ChatGPT said he invented the cotton gin. Also not true. (Eli Whitney patented the cotton gin.)

In an example more suited for gastroenterologists at DDW, ChatGPT correctly stated that Barrett esophagus can lead to adenocarcinoma of the esophagus in some cases. However, the technology also said that the condition could lead to prostate cancer.

So, if someone asked ChatGPT for a list of possible risks for Barrett’s esophagus, it would include prostate cancer. A person without medical knowledge “could take it at face value that it causes prostate cancer,” said panelist Sravanthi Parasa, MD, a gastroenterologist at Swedish Medical Center, Seattle.

“That is a lot of misinformation that is going to come our way,” she added at the session, which was sponsored by the American Society for Gastrointestinal Endoscopy.

The potential for inaccuracy is a downside to ChatGPT, agreed panelist Prateek Sharma, MD, a gastroenterologist at the University of Kansas Medical Center in Kansas City, Kansas.

“There is no quality control. You have to double check its answers,” said Dr. Sharma, who is president-elect of ASGE.

ChatGPT is not going to replace physicians in general or gastroenterologists doing endoscopies, said Ian Gralnek, MD, chief of the Institute of Gastroenterology and Hepatology at Emek Medical Center in Afula, Israel.

Even though the tool could play a role in medicine, “we need to be very careful as a society going forward ... and see where things are going,” Dr. Gralnek said.
 

How you ask makes a difference

Future iterations of ChatGPT are likely to produce fewer hallucinations, the experts said. In the meantime, users can lower the risk by paying attention to how they’re wording their queries, a practice known as “prompt engineering.”

It’s best to ask a question that has a firm answer to it. If you ask a vague question, you’ll likely get a vague answer, Dr. Sharma said.

ChatGPT is a large language model (LLM). GPT stands for “generative pretrained transformer” – specialized algorithms that find long-range patterns in sequences of data. LLMs can predict the next word in a sentence.

“That’s why this is also called generative AI,” Dr. Sharma said. “For example, if you put in ‘Where are we?’, it will predict for you that perhaps the next word is ‘going?’ ”

The current public version is ChatGPT 3.5, which was trained on open-source online information up until early 2022. It can gather information from open-access scientific journals and medical society guidelines, as well as from Twitter, Reddit, and other social media. It does not have access to private information, like electronic health records.

The use of ChatGPT has exploded in the past 6 months, Dr. Sharma said.

“ChatGPT has been the most-searched website or platform ever in history since it was launched in December of 2022,” he said.
 

What’s in it for doctors?

Although not specifically trained for health care–related tasks, the panelists noted that ChatGPT does have potential as a virtual medical assistant, chatbot, clinical decision-support tool, source of medical education, natural language processor for documentation, or medical note-taker.

ChatGPT can help physicians write a letter of support to a patient who, for example, was just diagnosed with stage IV colon cancer. It can do that in only 15 seconds, whereas it would take us much longer, Dr. Sharma said.

ChatGPT is the “next frontier” for generating patient education materials, Dr. Parasa said. It can help time-constrained health care providers, as long as the information is accurate.

ChatGPT 4.0, now available by subscription, can do “almost real-time note-taking during patient encounters,” she added.

Another reason to be familiar with the technology: “Many of your patients are using it, even if you don’t know about it,” Dr. Sharma said.
 

Questions abound

A conference attendee asked the panel what to do when a patient comes in with ChatGPT medical advice that does not align with official guidelines.

Dr. Gralnek said that he would explain to patients that medical information based on guidelines are not “black and white.” The panel likened it to how patients come to an appointment now armed with information from the Internet, which is not always correct, that must then be countered by doctors. The same would likely happen with ChatGPT.

Another attendee asked whether ChatGPT eventually will work in accordance with electronic health record systems.

“Open AI and Microsoft are already working with Epic,” Dr. Parasa said.

A question arose about the reading level of information provided by ChatGPT. Dr. Parasa noted that it’s not standard. However, a person can prompt ChatGPT to provide an answer either at an eighth-grade reading level or for a well-trained physician.

Dr. Sharma offered a final warning: The technology learns over time.

“It knows what your habits are. It will learn what you’re doing,” Dr. Sharma said. “Everything else on your browsers that are open, it’s learning from that also. So be careful what websites you visit before you go to ChatGPT.”

Dr. Sharma is a stock shareholder in Microsoft. Dr. Parasa and Dr. Gralneck reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

CHICAGO – ChatGPT and other artificial intelligence (AI)–driven natural language processing platforms are here to stay, so like them or not, physicians might as well figure out how to optimize their role in medicine and health care. That’s the takeaway from a three-expert panel session about the technology held at the annual Digestive Disease Week® (DDW).

The chatbot can help doctors to a certain extent by suggesting differential diagnoses, assisting with clinical note-taking, and producing rapid and easy-to-understand patient communication and educational materials, they noted. However, it can also make mistakes. And, unlike a medical trainee who might give a clinical answer and express some doubt, ChatGPT (Open AI/Microsoft) clearly states its findings as fact, even when it’s wrong.

Known as “hallucinating,” this problem of AI inaccuracy was displayed at the packed DDW session.

When asked when Leonardo da Vinci painted the Mona Lisa, for example, ChatGPT replied 1815. That’s off by about 300 years; the masterpiece was created sometime between 1503 and 1519. Asked for a fact about George Washington, ChatGPT said he invented the cotton gin. Also not true. (Eli Whitney patented the cotton gin.)

In an example more suited for gastroenterologists at DDW, ChatGPT correctly stated that Barrett esophagus can lead to adenocarcinoma of the esophagus in some cases. However, the technology also said that the condition could lead to prostate cancer.

So, if someone asked ChatGPT for a list of possible risks for Barrett’s esophagus, it would include prostate cancer. A person without medical knowledge “could take it at face value that it causes prostate cancer,” said panelist Sravanthi Parasa, MD, a gastroenterologist at Swedish Medical Center, Seattle.

“That is a lot of misinformation that is going to come our way,” she added at the session, which was sponsored by the American Society for Gastrointestinal Endoscopy.

The potential for inaccuracy is a downside to ChatGPT, agreed panelist Prateek Sharma, MD, a gastroenterologist at the University of Kansas Medical Center in Kansas City, Kansas.

“There is no quality control. You have to double check its answers,” said Dr. Sharma, who is president-elect of ASGE.

ChatGPT is not going to replace physicians in general or gastroenterologists doing endoscopies, said Ian Gralnek, MD, chief of the Institute of Gastroenterology and Hepatology at Emek Medical Center in Afula, Israel.

Even though the tool could play a role in medicine, “we need to be very careful as a society going forward ... and see where things are going,” Dr. Gralnek said.
 

How you ask makes a difference

Future iterations of ChatGPT are likely to produce fewer hallucinations, the experts said. In the meantime, users can lower the risk by paying attention to how they’re wording their queries, a practice known as “prompt engineering.”

It’s best to ask a question that has a firm answer to it. If you ask a vague question, you’ll likely get a vague answer, Dr. Sharma said.

ChatGPT is a large language model (LLM). GPT stands for “generative pretrained transformer” – specialized algorithms that find long-range patterns in sequences of data. LLMs can predict the next word in a sentence.

“That’s why this is also called generative AI,” Dr. Sharma said. “For example, if you put in ‘Where are we?’, it will predict for you that perhaps the next word is ‘going?’ ”

The current public version is ChatGPT 3.5, which was trained on open-source online information up until early 2022. It can gather information from open-access scientific journals and medical society guidelines, as well as from Twitter, Reddit, and other social media. It does not have access to private information, like electronic health records.

The use of ChatGPT has exploded in the past 6 months, Dr. Sharma said.

“ChatGPT has been the most-searched website or platform ever in history since it was launched in December of 2022,” he said.
 

What’s in it for doctors?

Although not specifically trained for health care–related tasks, the panelists noted that ChatGPT does have potential as a virtual medical assistant, chatbot, clinical decision-support tool, source of medical education, natural language processor for documentation, or medical note-taker.

ChatGPT can help physicians write a letter of support to a patient who, for example, was just diagnosed with stage IV colon cancer. It can do that in only 15 seconds, whereas it would take us much longer, Dr. Sharma said.

ChatGPT is the “next frontier” for generating patient education materials, Dr. Parasa said. It can help time-constrained health care providers, as long as the information is accurate.

ChatGPT 4.0, now available by subscription, can do “almost real-time note-taking during patient encounters,” she added.

Another reason to be familiar with the technology: “Many of your patients are using it, even if you don’t know about it,” Dr. Sharma said.
 

Questions abound

A conference attendee asked the panel what to do when a patient comes in with ChatGPT medical advice that does not align with official guidelines.

Dr. Gralnek said that he would explain to patients that medical information based on guidelines are not “black and white.” The panel likened it to how patients come to an appointment now armed with information from the Internet, which is not always correct, that must then be countered by doctors. The same would likely happen with ChatGPT.

Another attendee asked whether ChatGPT eventually will work in accordance with electronic health record systems.

“Open AI and Microsoft are already working with Epic,” Dr. Parasa said.

A question arose about the reading level of information provided by ChatGPT. Dr. Parasa noted that it’s not standard. However, a person can prompt ChatGPT to provide an answer either at an eighth-grade reading level or for a well-trained physician.

Dr. Sharma offered a final warning: The technology learns over time.

“It knows what your habits are. It will learn what you’re doing,” Dr. Sharma said. “Everything else on your browsers that are open, it’s learning from that also. So be careful what websites you visit before you go to ChatGPT.”

Dr. Sharma is a stock shareholder in Microsoft. Dr. Parasa and Dr. Gralneck reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

CHICAGO – A new agent under consideration for approval by the Food and Drug Administration to treat moderately to severely active ulcerative colitis (UC) has an “acceptable” safety profile, new evidence reveals.

Etrasimod (Arena Pharma/Pfizer) is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. If approved by the FDA, etrasimod could become the second agent in the S1P class approved for ulcerative colitis in the United States. The other agent, ozanimod (Zeposia), received FDA approval for treating moderately to severely active UC in May 2021.

The updated safety profile of etrasimod, presented at the annual Digestive Disease Week® (DDW), is based on data from multiple clinical trials, including OASIS phase 2 and the ELEVATE phase 3, placebo-controlled trials, as well as an ongoing, open-label extension study.

“Etrasimod was well tolerated in patients with moderately to severely active UC and had an acceptable safety profile that did not appear to change with longer-term treatment up to 2.5 years,” said OASIS lead author Séverine Vermeire, MD, PhD, an expert on translational research in gastrointestinal disorders and professor of medicine at KU Leuven (Belgium), while presenting the findings at DDW.

Dr. Vermeire noted that data show an elevated risk for atrioventricular (AV) block or bradycardia in a minority of people treated with the agent during this time period. However, most of the heart-related risk was during induction, and the risks could be minimized by ordering an electrocardiogram before prescribing, she said.
 

Cumulative safety data

Researchers separated the trial participants into two cohorts. The all-UC cohort consisted of 956 patients who took at least one dose of etrasimod. The placebo-controlled cohort consisted of 629 patients taking etrasimod and 314 patients who took a placebo. Some patients participated in more than one study, the researchers noted.

In both cohorts, mean duration of disease was about 7 years, about 42% of all participants were female, and mean age was about 41 years.

The investigators looked at the frequency of adverse events and exposure-adjusted incidence rates from the OASIS phase 2 and the ELEVATE phase 3 placebo-controlled trials, as well as an ongoing, open-label extension study. They also assessed safety in placebo and 1 mg or 2 mg etrasimod in the phase 2 NCT02447302 or two phase 3 trials, NCT03945188 and NCT03996369, reported up until Jan. 31, 2022.

There were 770 patient-years of etrasimod exposure in the all-UC cohort, while exposure in the placebo-controlled cohort was 288 patient-years in the etrasimod group and 115 patient-years in the placebo group. Mean exposure to etrasimod was 42 weeks in the all-UC cohort. Mean exposure in the placebo-controlled cohort was 24 weeks in the etrasimod group and 19 weeks in the placebo group.

Because of the mechanism of action of etrasimod, Dr. Vermeire and colleagues focused on cardiovascular events, macular edema, severe or opportunistic infections, herpes zoster infections, and malignancies.

Eleven patients (1.8%) treated with etrasimod reported bradycardia or sinus bradycardia in the placebo-controlled research, and 9 of 11 were asymptomatic. No bradycardia was associated with taking a placebo. In the all-UC cohort, bradycardia or sinus bradycardia was reported in 14 patients (1.5%).

“Bradycardia is something you need to tell patients may occur,” Dr. Vermeire said. “Most of the bradycardia occurred on day one or day two, mostly on day one.”

Four people taking etrasimod in the placebo-controlled cohort and 7 people in the all-UC cohort had AV block of the first or second degree. No reports of AV block occurred in the placebo group.

“Other adverse events of special interest, including hypertension and macular edema, were all rare and similar between the treatment arms,” Dr. Vermeire said.

Herpes zoster infections were reported in two patients taking etrasimod and two taking placebo in the placebo-controlled cohort. Seven cases were reported in the all-UC cohort. Dr. Vermeire said she advocates vaccinating patients against herpes zoster soon after UC diagnosis, if possible.

In the placebo-controlled cohort, 11 patients taking etrasimod and two patients taking placebo experienced elevated ALT. This was fewer than 2% of patients. One patient taking etrasimod and one receiving placebo discontinued the study for this reason. In the all-UC cohort, 27 people experienced elevated ALT.

In the placebo-controlled cohort, 13 people treated with etrasimod and two taking placebo developed elevated gamma-glutamyltransferase. This adverse event was reported in 32 patients in the all-UC cohort.

There were no deaths reported in the placebo-controlled cohort of patients. One patient in the all-UC cohort developed a neuroendocrine tumor and died. The person received etrasimod 2 mg daily for about 6 months before the event’s onset. “This was assessed as unlikely related to the study treatment as judged by investigators,” Dr. Vermeire said.

Limitations of the study include a relatively short average duration of exposure to etrasimod.

“As the study continues, we will continue collecting and reporting the safety data,” Dr. Vermeire said.
 

A well-tolerated therapy

“The important take-home message is that patients tolerated therapy very well,” said session comoderator Jordan E. Axelrad, MD, MPH, when asked to comment.

There were very few adverse events, and of these, they were mostly minor, with patients being able to continue on therapy in large part, added Dr. Axelrad, a gastroenterologist at the Inflammatory Bowel Disease Center at NYU Langone Health, New York.

Physicians will “need to get comfortable” with ordering an ECG to screen patients before prescribing etrasimod, he noted.

“Once we can get past that hurdle [of ordering an ECG], we should be integrating it into our practice,” Dr. Axelrad said.

The study was funded by Arena Pharmaceuticals, which was acquired by Pfizer; Pfizer completed the acquisition in March 2022. Dr. Vermeire reported receiving consulting and speaking fees from Arena Pharmaceuticals and grant and research support from Pfizer. Dr. Axelrad reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

CHICAGO – A new agent under consideration for approval by the Food and Drug Administration to treat moderately to severely active ulcerative colitis (UC) has an “acceptable” safety profile, new evidence reveals.

Etrasimod (Arena Pharma/Pfizer) is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. If approved by the FDA, etrasimod could become the second agent in the S1P class approved for ulcerative colitis in the United States. The other agent, ozanimod (Zeposia), received FDA approval for treating moderately to severely active UC in May 2021.

The updated safety profile of etrasimod, presented at the annual Digestive Disease Week® (DDW), is based on data from multiple clinical trials, including OASIS phase 2 and the ELEVATE phase 3, placebo-controlled trials, as well as an ongoing, open-label extension study.

“Etrasimod was well tolerated in patients with moderately to severely active UC and had an acceptable safety profile that did not appear to change with longer-term treatment up to 2.5 years,” said OASIS lead author Séverine Vermeire, MD, PhD, an expert on translational research in gastrointestinal disorders and professor of medicine at KU Leuven (Belgium), while presenting the findings at DDW.

Dr. Vermeire noted that data show an elevated risk for atrioventricular (AV) block or bradycardia in a minority of people treated with the agent during this time period. However, most of the heart-related risk was during induction, and the risks could be minimized by ordering an electrocardiogram before prescribing, she said.
 

Cumulative safety data

Researchers separated the trial participants into two cohorts. The all-UC cohort consisted of 956 patients who took at least one dose of etrasimod. The placebo-controlled cohort consisted of 629 patients taking etrasimod and 314 patients who took a placebo. Some patients participated in more than one study, the researchers noted.

In both cohorts, mean duration of disease was about 7 years, about 42% of all participants were female, and mean age was about 41 years.

The investigators looked at the frequency of adverse events and exposure-adjusted incidence rates from the OASIS phase 2 and the ELEVATE phase 3 placebo-controlled trials, as well as an ongoing, open-label extension study. They also assessed safety in placebo and 1 mg or 2 mg etrasimod in the phase 2 NCT02447302 or two phase 3 trials, NCT03945188 and NCT03996369, reported up until Jan. 31, 2022.

There were 770 patient-years of etrasimod exposure in the all-UC cohort, while exposure in the placebo-controlled cohort was 288 patient-years in the etrasimod group and 115 patient-years in the placebo group. Mean exposure to etrasimod was 42 weeks in the all-UC cohort. Mean exposure in the placebo-controlled cohort was 24 weeks in the etrasimod group and 19 weeks in the placebo group.

Because of the mechanism of action of etrasimod, Dr. Vermeire and colleagues focused on cardiovascular events, macular edema, severe or opportunistic infections, herpes zoster infections, and malignancies.

Eleven patients (1.8%) treated with etrasimod reported bradycardia or sinus bradycardia in the placebo-controlled research, and 9 of 11 were asymptomatic. No bradycardia was associated with taking a placebo. In the all-UC cohort, bradycardia or sinus bradycardia was reported in 14 patients (1.5%).

“Bradycardia is something you need to tell patients may occur,” Dr. Vermeire said. “Most of the bradycardia occurred on day one or day two, mostly on day one.”

Four people taking etrasimod in the placebo-controlled cohort and 7 people in the all-UC cohort had AV block of the first or second degree. No reports of AV block occurred in the placebo group.

“Other adverse events of special interest, including hypertension and macular edema, were all rare and similar between the treatment arms,” Dr. Vermeire said.

Herpes zoster infections were reported in two patients taking etrasimod and two taking placebo in the placebo-controlled cohort. Seven cases were reported in the all-UC cohort. Dr. Vermeire said she advocates vaccinating patients against herpes zoster soon after UC diagnosis, if possible.

In the placebo-controlled cohort, 11 patients taking etrasimod and two patients taking placebo experienced elevated ALT. This was fewer than 2% of patients. One patient taking etrasimod and one receiving placebo discontinued the study for this reason. In the all-UC cohort, 27 people experienced elevated ALT.

In the placebo-controlled cohort, 13 people treated with etrasimod and two taking placebo developed elevated gamma-glutamyltransferase. This adverse event was reported in 32 patients in the all-UC cohort.

There were no deaths reported in the placebo-controlled cohort of patients. One patient in the all-UC cohort developed a neuroendocrine tumor and died. The person received etrasimod 2 mg daily for about 6 months before the event’s onset. “This was assessed as unlikely related to the study treatment as judged by investigators,” Dr. Vermeire said.

Limitations of the study include a relatively short average duration of exposure to etrasimod.

“As the study continues, we will continue collecting and reporting the safety data,” Dr. Vermeire said.
 

A well-tolerated therapy

“The important take-home message is that patients tolerated therapy very well,” said session comoderator Jordan E. Axelrad, MD, MPH, when asked to comment.

There were very few adverse events, and of these, they were mostly minor, with patients being able to continue on therapy in large part, added Dr. Axelrad, a gastroenterologist at the Inflammatory Bowel Disease Center at NYU Langone Health, New York.

Physicians will “need to get comfortable” with ordering an ECG to screen patients before prescribing etrasimod, he noted.

“Once we can get past that hurdle [of ordering an ECG], we should be integrating it into our practice,” Dr. Axelrad said.

The study was funded by Arena Pharmaceuticals, which was acquired by Pfizer; Pfizer completed the acquisition in March 2022. Dr. Vermeire reported receiving consulting and speaking fees from Arena Pharmaceuticals and grant and research support from Pfizer. Dr. Axelrad reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

CHICAGO – A new agent under consideration for approval by the Food and Drug Administration to treat moderately to severely active ulcerative colitis (UC) has an “acceptable” safety profile, new evidence reveals.

Etrasimod (Arena Pharma/Pfizer) is an oral sphingosine-1-phosphate (S1P) receptor that binds with high affinity to receptors 1, 4, and 5. If approved by the FDA, etrasimod could become the second agent in the S1P class approved for ulcerative colitis in the United States. The other agent, ozanimod (Zeposia), received FDA approval for treating moderately to severely active UC in May 2021.

The updated safety profile of etrasimod, presented at the annual Digestive Disease Week® (DDW), is based on data from multiple clinical trials, including OASIS phase 2 and the ELEVATE phase 3, placebo-controlled trials, as well as an ongoing, open-label extension study.

“Etrasimod was well tolerated in patients with moderately to severely active UC and had an acceptable safety profile that did not appear to change with longer-term treatment up to 2.5 years,” said OASIS lead author Séverine Vermeire, MD, PhD, an expert on translational research in gastrointestinal disorders and professor of medicine at KU Leuven (Belgium), while presenting the findings at DDW.

Dr. Vermeire noted that data show an elevated risk for atrioventricular (AV) block or bradycardia in a minority of people treated with the agent during this time period. However, most of the heart-related risk was during induction, and the risks could be minimized by ordering an electrocardiogram before prescribing, she said.
 

Cumulative safety data

Researchers separated the trial participants into two cohorts. The all-UC cohort consisted of 956 patients who took at least one dose of etrasimod. The placebo-controlled cohort consisted of 629 patients taking etrasimod and 314 patients who took a placebo. Some patients participated in more than one study, the researchers noted.

In both cohorts, mean duration of disease was about 7 years, about 42% of all participants were female, and mean age was about 41 years.

The investigators looked at the frequency of adverse events and exposure-adjusted incidence rates from the OASIS phase 2 and the ELEVATE phase 3 placebo-controlled trials, as well as an ongoing, open-label extension study. They also assessed safety in placebo and 1 mg or 2 mg etrasimod in the phase 2 NCT02447302 or two phase 3 trials, NCT03945188 and NCT03996369, reported up until Jan. 31, 2022.

There were 770 patient-years of etrasimod exposure in the all-UC cohort, while exposure in the placebo-controlled cohort was 288 patient-years in the etrasimod group and 115 patient-years in the placebo group. Mean exposure to etrasimod was 42 weeks in the all-UC cohort. Mean exposure in the placebo-controlled cohort was 24 weeks in the etrasimod group and 19 weeks in the placebo group.

Because of the mechanism of action of etrasimod, Dr. Vermeire and colleagues focused on cardiovascular events, macular edema, severe or opportunistic infections, herpes zoster infections, and malignancies.

Eleven patients (1.8%) treated with etrasimod reported bradycardia or sinus bradycardia in the placebo-controlled research, and 9 of 11 were asymptomatic. No bradycardia was associated with taking a placebo. In the all-UC cohort, bradycardia or sinus bradycardia was reported in 14 patients (1.5%).

“Bradycardia is something you need to tell patients may occur,” Dr. Vermeire said. “Most of the bradycardia occurred on day one or day two, mostly on day one.”

Four people taking etrasimod in the placebo-controlled cohort and 7 people in the all-UC cohort had AV block of the first or second degree. No reports of AV block occurred in the placebo group.

“Other adverse events of special interest, including hypertension and macular edema, were all rare and similar between the treatment arms,” Dr. Vermeire said.

Herpes zoster infections were reported in two patients taking etrasimod and two taking placebo in the placebo-controlled cohort. Seven cases were reported in the all-UC cohort. Dr. Vermeire said she advocates vaccinating patients against herpes zoster soon after UC diagnosis, if possible.

In the placebo-controlled cohort, 11 patients taking etrasimod and two patients taking placebo experienced elevated ALT. This was fewer than 2% of patients. One patient taking etrasimod and one receiving placebo discontinued the study for this reason. In the all-UC cohort, 27 people experienced elevated ALT.

In the placebo-controlled cohort, 13 people treated with etrasimod and two taking placebo developed elevated gamma-glutamyltransferase. This adverse event was reported in 32 patients in the all-UC cohort.

There were no deaths reported in the placebo-controlled cohort of patients. One patient in the all-UC cohort developed a neuroendocrine tumor and died. The person received etrasimod 2 mg daily for about 6 months before the event’s onset. “This was assessed as unlikely related to the study treatment as judged by investigators,” Dr. Vermeire said.

Limitations of the study include a relatively short average duration of exposure to etrasimod.

“As the study continues, we will continue collecting and reporting the safety data,” Dr. Vermeire said.
 

A well-tolerated therapy

“The important take-home message is that patients tolerated therapy very well,” said session comoderator Jordan E. Axelrad, MD, MPH, when asked to comment.

There were very few adverse events, and of these, they were mostly minor, with patients being able to continue on therapy in large part, added Dr. Axelrad, a gastroenterologist at the Inflammatory Bowel Disease Center at NYU Langone Health, New York.

Physicians will “need to get comfortable” with ordering an ECG to screen patients before prescribing etrasimod, he noted.

“Once we can get past that hurdle [of ordering an ECG], we should be integrating it into our practice,” Dr. Axelrad said.

The study was funded by Arena Pharmaceuticals, which was acquired by Pfizer; Pfizer completed the acquisition in March 2022. Dr. Vermeire reported receiving consulting and speaking fees from Arena Pharmaceuticals and grant and research support from Pfizer. Dr. Axelrad reported no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

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

In 2022, the most significant advances in the treatment of gynecologic cancers were achieved for patients with ovarian cancer. While ovarian cancer continues to carry the worst prognosis of all gynecologic cancers, 5-year relative survival has gradually increased, from 34.4% in 1975 to 52.4% in 2014.¹

In this Update, we highlight the recent advances in our understanding of targeted therapy in ovarian cancer. We review SORAYA, a trial that demonstrated that mirvetuximab soravtansine, an antibody-drug conjugate, has promising efficacy in platinum-resistant ovarian cancers that overexpress folate receptor α. We also spotlight progress in the treatment of low-grade serous ovarian cancer, another notoriously chemotherapy-resistant disease, in GOG 281/LOGS, a phase 2 study of the MEK inhibitor trametinib. Finally, we discuss emerging long-term follow-up data on poly(ADP-ribose) polymerase (PARP) inhibitors, which are helping to refine the role of these groundbreaking drugs.

New drug approved for platinum-resistant epithelial ovarian cancer—the first since 2014

Matulonis UA, Lorusso D, Oaknin A, et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. J Clin Oncol. 2023;41:2436-2445. doi:10.1200/JCO.22.01900.

While most patients diagnosed with advanced ovarian cancer will respond to platinum-based chemotherapy, those whose disease recurs eventually develop resistance to platinum agents. Treatment options for platinum-resistant ovarian cancer are limited and prognosis is poor. Most regimens have a response rate of only 10%. Since the approval of bevacizumab combined with chemotherapy in 2014, no new agents have been approved by the US Food and Drug Administration (FDA) for use in platinum-resistant ovarian cancer.

Efficacy shown with mirvetuximab

Recently, Matulonis and colleagues published results of the SORAYA study, a single-arm,phase 2 trial, that examined the efficacy and safety of mirvetuximab soravtansine-gynx among women with platinum-resistant ovarian cancer.² Mirvetuximab is an antibody-drug conjugate composed of an antibody directed at the folate receptor α attached to a cytotoxic microtubule inhibitor.

The study included 106 patients with platinum-resistant ovarian cancer whose tumors expressed folate receptor α at a high level—a feature of approximately 50% of patients screened for the study. Twenty-nine patients experienced a partial response and 5 had a complete response, corresponding to a remarkable objective response rate of 32.4%. The median progression-free survival was 4.3 months.

Like other antibody-drug conjugates, ocular toxicities, including blurred vision (41%) and keratopathy (29%), were common. However, toxicity was manageable and rarely led to drug discontinuation.

Continue to: A novel agent for recurrent low-grade serous ovarian carcinoma...

A novel agent for recurrent low-grade serous ovarian carcinoma

Gershenson DM, Miller A, Brady WE, et al. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022;399:541-553. doi:10.1016/S0140-6736(21)02175-9.

Low-grade serous carcinoma is a histologic subtype that makes up approximately 5% of all epithelial ovarian cancers.³ Patients with low-grade serous carcinoma are often younger and, because of the indolent nature of the histology, generally have a longer overall survival compared with patients with high-grade serous carcinoma. Unlike high-grade disease, however, low-grade serous carcinoma usually is resistant to chemotherapy, making treatment options limited for patients with advanced and recurrent disease.

Trametinib: A potential option

In an international, randomized, open-label trial (GOG 281/LOGS), Gershenson and colleagues investigated the efficacy of trametinib compared with standard-of-care chemotherapy in patients with recurrent low-grade serous ovarian cancer.⁴ Trametinib, a mitogen-activated protein kinase MEK inhibitor, is a targeted agent that is FDA approved for treatment in BRAF-mutated melanoma, lung, and thyroid cancers.

Patients with recurrent low-grade serous ovarian cancer were randomly assigned to trametinib (n = 130) or 1 of 5 standard-of-care treatment options (n = 130), including both chemotherapy and hormonal treatments. Those assigned to trametinib were significantly less likely to have disease progression (78% vs 89%), with a median progression-free survival of 13 months, compared with7.2 months in controls (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.36–0.64). Additionally, patients who had a radiographic response to trametinib experienced a longer duration of response compared with those who responded to standard-of-care treatment (13.6 months vs 5.9 months).

While there was no statistically significant difference in overall survival (HR, 0.76; 95% CI, 0.51–1.12), crossover to trametinib from the standard-of-care group was allowed and occurred among 68% of patients, which limits the study’s ability to measure differences in overall survival.

Trametinib was well tolerated by patients, but skin rash and anemia followed by hypertension were the most common adverse effects. In the standard-of-care group, the most common toxicities were abdominal pain, nausea, and anemia. A slightly higher proportion of patients in the trametinib group discontinued the drug due to toxicity compared with the standard-of-care group (36% vs 30%), but the there was no difference between the 2 groups in scores on quality-of-life assessments.

Continue to: PARP inhibitors benefit many women with ovarian cancer, but they may hurt others...

PARP inhibitors benefit many women with ovarian cancer, but they may hurt others

Monk BJ, Parkinson C, Lim MC, et al. A randomized, phase III trial to evaluate rucaparib monotherapy as maintenance treatment in patients with newly diagnosed ovarian cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022;40:3952-3964. doi:10.1200/JCO.22.01003.

Poly(ADP-ribose) polymerase (PARP) inhibitors are a class of oral anticancer agents that target DNA repair. Since the initial FDA approval in 2014 of olaparib for the treatment of patients with recurrent BRCA-mutated ovarian cancer, PARP inhibitors have been approved for maintenance in both the frontline setting and after platinum-sensitive recurrence, and as single-agenttreatment for ovarian cancer with BRCA mutations or evidence of homologous repair deficiency (HRD), a BRCA-like molecular phenotype.⁵ The expanding role for PARP inhibitors in ovarian cancer seemed inexorable.

Restricted prescribing advised

In 2022, we learned that in certain settings, PARP inhibitors may be the wrong choice. Several “Dear Health Care Provider” letters were issued by AstraZeneca, Clovis, and GSK to advise physicians to restrict the prescribing of olaparib, rucaparib, and niraparib.^6,7

AstraZeneca and Clovis issued letters spurred by the final analysis of ARIEL4 and SOLO3 studies, 2 randomized trials that investigated, respectively, rucaparib and olaparib monotherapy compared with chemotherapy in recurrent ovarian cancer.^8,9 In both cases patients randomized to PARP inhibitors may have experienced an overall survival decrement compared with those who received chemotherapy.

At the FDA’s request, Clovis has withdrawn rucaparib as a treatment for patients with recurrent BRCA-mutant ovarian cancer who had received 2 or more lines of chemotherapy, and AstraZeneca withdrew olaparib monotherapy in germline BRCA-mutant patients with recurrent ovarian cancer. Shortly after these withdrawals, GSK also withdrew its indication for niraparib as a treatment for women with HRD, platinum-sensitive ovarian cancer who have received 3 or more prior chemotherapies. Furthermore, based on the final overall survival analysis of the NOVA study, GSK also restricted its indication for niraparib maintenance for recurrent ovarian cancer to patients with germline BRCA mutations, due to evidence of an overall survival detriment in this setting.¹⁰

Positive study results

Fortunately, 2022 was not all bad news for PARP inhibitors in ovarian cancer. In June 2022, the ATHENA-MONO trial, a phase 3 double-blind randomized controlled trial, demonstrated that rucaparib maintenance in patients with newly diagnosed epithelial ovarian cancer was associated with a significantly longer progression-free survival compared with placebo.¹¹ The effect was most pronounced in the BRCA-mutant/HRD population, with a median progression-free survival of 28.7 months in the rucaparib group compared with 11.3 months in the placebo group (HR, 0.47; 95% CI, 0.31–0.72). Thus, rucaparib was added to the list of PARP inhibitors approved for upfront maintenance therapy in epithelial ovarian cancer.

Similarly, the long-term overall survival analysis from the upfront trials SOLO-1 and PAOLA-1 showed an overall survival advantage of PARP inhibitor, compared with placebo, maintenance in patients with BRCA mutations or HRD tumors.^12,13 ●

In 2022, the most significant advances in the treatment of gynecologic cancers were achieved for patients with ovarian cancer. While ovarian cancer continues to carry the worst prognosis of all gynecologic cancers, 5-year relative survival has gradually increased, from 34.4% in 1975 to 52.4% in 2014.¹

In this Update, we highlight the recent advances in our understanding of targeted therapy in ovarian cancer. We review SORAYA, a trial that demonstrated that mirvetuximab soravtansine, an antibody-drug conjugate, has promising efficacy in platinum-resistant ovarian cancers that overexpress folate receptor α. We also spotlight progress in the treatment of low-grade serous ovarian cancer, another notoriously chemotherapy-resistant disease, in GOG 281/LOGS, a phase 2 study of the MEK inhibitor trametinib. Finally, we discuss emerging long-term follow-up data on poly(ADP-ribose) polymerase (PARP) inhibitors, which are helping to refine the role of these groundbreaking drugs.

New drug approved for platinum-resistant epithelial ovarian cancer—the first since 2014

Matulonis UA, Lorusso D, Oaknin A, et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. J Clin Oncol. 2023;41:2436-2445. doi:10.1200/JCO.22.01900.

While most patients diagnosed with advanced ovarian cancer will respond to platinum-based chemotherapy, those whose disease recurs eventually develop resistance to platinum agents. Treatment options for platinum-resistant ovarian cancer are limited and prognosis is poor. Most regimens have a response rate of only 10%. Since the approval of bevacizumab combined with chemotherapy in 2014, no new agents have been approved by the US Food and Drug Administration (FDA) for use in platinum-resistant ovarian cancer.

Efficacy shown with mirvetuximab

Recently, Matulonis and colleagues published results of the SORAYA study, a single-arm,phase 2 trial, that examined the efficacy and safety of mirvetuximab soravtansine-gynx among women with platinum-resistant ovarian cancer.² Mirvetuximab is an antibody-drug conjugate composed of an antibody directed at the folate receptor α attached to a cytotoxic microtubule inhibitor.

The study included 106 patients with platinum-resistant ovarian cancer whose tumors expressed folate receptor α at a high level—a feature of approximately 50% of patients screened for the study. Twenty-nine patients experienced a partial response and 5 had a complete response, corresponding to a remarkable objective response rate of 32.4%. The median progression-free survival was 4.3 months.

Like other antibody-drug conjugates, ocular toxicities, including blurred vision (41%) and keratopathy (29%), were common. However, toxicity was manageable and rarely led to drug discontinuation.

Continue to: A novel agent for recurrent low-grade serous ovarian carcinoma...

A novel agent for recurrent low-grade serous ovarian carcinoma

Gershenson DM, Miller A, Brady WE, et al. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022;399:541-553. doi:10.1016/S0140-6736(21)02175-9.

Low-grade serous carcinoma is a histologic subtype that makes up approximately 5% of all epithelial ovarian cancers.³ Patients with low-grade serous carcinoma are often younger and, because of the indolent nature of the histology, generally have a longer overall survival compared with patients with high-grade serous carcinoma. Unlike high-grade disease, however, low-grade serous carcinoma usually is resistant to chemotherapy, making treatment options limited for patients with advanced and recurrent disease.

Trametinib: A potential option

In an international, randomized, open-label trial (GOG 281/LOGS), Gershenson and colleagues investigated the efficacy of trametinib compared with standard-of-care chemotherapy in patients with recurrent low-grade serous ovarian cancer.⁴ Trametinib, a mitogen-activated protein kinase MEK inhibitor, is a targeted agent that is FDA approved for treatment in BRAF-mutated melanoma, lung, and thyroid cancers.

Patients with recurrent low-grade serous ovarian cancer were randomly assigned to trametinib (n = 130) or 1 of 5 standard-of-care treatment options (n = 130), including both chemotherapy and hormonal treatments. Those assigned to trametinib were significantly less likely to have disease progression (78% vs 89%), with a median progression-free survival of 13 months, compared with7.2 months in controls (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.36–0.64). Additionally, patients who had a radiographic response to trametinib experienced a longer duration of response compared with those who responded to standard-of-care treatment (13.6 months vs 5.9 months).

While there was no statistically significant difference in overall survival (HR, 0.76; 95% CI, 0.51–1.12), crossover to trametinib from the standard-of-care group was allowed and occurred among 68% of patients, which limits the study’s ability to measure differences in overall survival.

Trametinib was well tolerated by patients, but skin rash and anemia followed by hypertension were the most common adverse effects. In the standard-of-care group, the most common toxicities were abdominal pain, nausea, and anemia. A slightly higher proportion of patients in the trametinib group discontinued the drug due to toxicity compared with the standard-of-care group (36% vs 30%), but the there was no difference between the 2 groups in scores on quality-of-life assessments.

Continue to: PARP inhibitors benefit many women with ovarian cancer, but they may hurt others...

PARP inhibitors benefit many women with ovarian cancer, but they may hurt others

Monk BJ, Parkinson C, Lim MC, et al. A randomized, phase III trial to evaluate rucaparib monotherapy as maintenance treatment in patients with newly diagnosed ovarian cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022;40:3952-3964. doi:10.1200/JCO.22.01003.

Poly(ADP-ribose) polymerase (PARP) inhibitors are a class of oral anticancer agents that target DNA repair. Since the initial FDA approval in 2014 of olaparib for the treatment of patients with recurrent BRCA-mutated ovarian cancer, PARP inhibitors have been approved for maintenance in both the frontline setting and after platinum-sensitive recurrence, and as single-agenttreatment for ovarian cancer with BRCA mutations or evidence of homologous repair deficiency (HRD), a BRCA-like molecular phenotype.⁵ The expanding role for PARP inhibitors in ovarian cancer seemed inexorable.

Restricted prescribing advised

In 2022, we learned that in certain settings, PARP inhibitors may be the wrong choice. Several “Dear Health Care Provider” letters were issued by AstraZeneca, Clovis, and GSK to advise physicians to restrict the prescribing of olaparib, rucaparib, and niraparib.^6,7

AstraZeneca and Clovis issued letters spurred by the final analysis of ARIEL4 and SOLO3 studies, 2 randomized trials that investigated, respectively, rucaparib and olaparib monotherapy compared with chemotherapy in recurrent ovarian cancer.^8,9 In both cases patients randomized to PARP inhibitors may have experienced an overall survival decrement compared with those who received chemotherapy.

At the FDA’s request, Clovis has withdrawn rucaparib as a treatment for patients with recurrent BRCA-mutant ovarian cancer who had received 2 or more lines of chemotherapy, and AstraZeneca withdrew olaparib monotherapy in germline BRCA-mutant patients with recurrent ovarian cancer. Shortly after these withdrawals, GSK also withdrew its indication for niraparib as a treatment for women with HRD, platinum-sensitive ovarian cancer who have received 3 or more prior chemotherapies. Furthermore, based on the final overall survival analysis of the NOVA study, GSK also restricted its indication for niraparib maintenance for recurrent ovarian cancer to patients with germline BRCA mutations, due to evidence of an overall survival detriment in this setting.¹⁰

Positive study results

Fortunately, 2022 was not all bad news for PARP inhibitors in ovarian cancer. In June 2022, the ATHENA-MONO trial, a phase 3 double-blind randomized controlled trial, demonstrated that rucaparib maintenance in patients with newly diagnosed epithelial ovarian cancer was associated with a significantly longer progression-free survival compared with placebo.¹¹ The effect was most pronounced in the BRCA-mutant/HRD population, with a median progression-free survival of 28.7 months in the rucaparib group compared with 11.3 months in the placebo group (HR, 0.47; 95% CI, 0.31–0.72). Thus, rucaparib was added to the list of PARP inhibitors approved for upfront maintenance therapy in epithelial ovarian cancer.

Similarly, the long-term overall survival analysis from the upfront trials SOLO-1 and PAOLA-1 showed an overall survival advantage of PARP inhibitor, compared with placebo, maintenance in patients with BRCA mutations or HRD tumors.^12,13 ●

In 2022, the most significant advances in the treatment of gynecologic cancers were achieved for patients with ovarian cancer. While ovarian cancer continues to carry the worst prognosis of all gynecologic cancers, 5-year relative survival has gradually increased, from 34.4% in 1975 to 52.4% in 2014.¹

In this Update, we highlight the recent advances in our understanding of targeted therapy in ovarian cancer. We review SORAYA, a trial that demonstrated that mirvetuximab soravtansine, an antibody-drug conjugate, has promising efficacy in platinum-resistant ovarian cancers that overexpress folate receptor α. We also spotlight progress in the treatment of low-grade serous ovarian cancer, another notoriously chemotherapy-resistant disease, in GOG 281/LOGS, a phase 2 study of the MEK inhibitor trametinib. Finally, we discuss emerging long-term follow-up data on poly(ADP-ribose) polymerase (PARP) inhibitors, which are helping to refine the role of these groundbreaking drugs.

New drug approved for platinum-resistant epithelial ovarian cancer—the first since 2014

Matulonis UA, Lorusso D, Oaknin A, et al. Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study. J Clin Oncol. 2023;41:2436-2445. doi:10.1200/JCO.22.01900.

While most patients diagnosed with advanced ovarian cancer will respond to platinum-based chemotherapy, those whose disease recurs eventually develop resistance to platinum agents. Treatment options for platinum-resistant ovarian cancer are limited and prognosis is poor. Most regimens have a response rate of only 10%. Since the approval of bevacizumab combined with chemotherapy in 2014, no new agents have been approved by the US Food and Drug Administration (FDA) for use in platinum-resistant ovarian cancer.

Efficacy shown with mirvetuximab

Recently, Matulonis and colleagues published results of the SORAYA study, a single-arm,phase 2 trial, that examined the efficacy and safety of mirvetuximab soravtansine-gynx among women with platinum-resistant ovarian cancer.² Mirvetuximab is an antibody-drug conjugate composed of an antibody directed at the folate receptor α attached to a cytotoxic microtubule inhibitor.

The study included 106 patients with platinum-resistant ovarian cancer whose tumors expressed folate receptor α at a high level—a feature of approximately 50% of patients screened for the study. Twenty-nine patients experienced a partial response and 5 had a complete response, corresponding to a remarkable objective response rate of 32.4%. The median progression-free survival was 4.3 months.

Like other antibody-drug conjugates, ocular toxicities, including blurred vision (41%) and keratopathy (29%), were common. However, toxicity was manageable and rarely led to drug discontinuation.

Continue to: A novel agent for recurrent low-grade serous ovarian carcinoma...

A novel agent for recurrent low-grade serous ovarian carcinoma

Gershenson DM, Miller A, Brady WE, et al. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022;399:541-553. doi:10.1016/S0140-6736(21)02175-9.

Low-grade serous carcinoma is a histologic subtype that makes up approximately 5% of all epithelial ovarian cancers.³ Patients with low-grade serous carcinoma are often younger and, because of the indolent nature of the histology, generally have a longer overall survival compared with patients with high-grade serous carcinoma. Unlike high-grade disease, however, low-grade serous carcinoma usually is resistant to chemotherapy, making treatment options limited for patients with advanced and recurrent disease.

Trametinib: A potential option

In an international, randomized, open-label trial (GOG 281/LOGS), Gershenson and colleagues investigated the efficacy of trametinib compared with standard-of-care chemotherapy in patients with recurrent low-grade serous ovarian cancer.⁴ Trametinib, a mitogen-activated protein kinase MEK inhibitor, is a targeted agent that is FDA approved for treatment in BRAF-mutated melanoma, lung, and thyroid cancers.

Patients with recurrent low-grade serous ovarian cancer were randomly assigned to trametinib (n = 130) or 1 of 5 standard-of-care treatment options (n = 130), including both chemotherapy and hormonal treatments. Those assigned to trametinib were significantly less likely to have disease progression (78% vs 89%), with a median progression-free survival of 13 months, compared with7.2 months in controls (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.36–0.64). Additionally, patients who had a radiographic response to trametinib experienced a longer duration of response compared with those who responded to standard-of-care treatment (13.6 months vs 5.9 months).

While there was no statistically significant difference in overall survival (HR, 0.76; 95% CI, 0.51–1.12), crossover to trametinib from the standard-of-care group was allowed and occurred among 68% of patients, which limits the study’s ability to measure differences in overall survival.

Trametinib was well tolerated by patients, but skin rash and anemia followed by hypertension were the most common adverse effects. In the standard-of-care group, the most common toxicities were abdominal pain, nausea, and anemia. A slightly higher proportion of patients in the trametinib group discontinued the drug due to toxicity compared with the standard-of-care group (36% vs 30%), but the there was no difference between the 2 groups in scores on quality-of-life assessments.

Continue to: PARP inhibitors benefit many women with ovarian cancer, but they may hurt others...

PARP inhibitors benefit many women with ovarian cancer, but they may hurt others

Monk BJ, Parkinson C, Lim MC, et al. A randomized, phase III trial to evaluate rucaparib monotherapy as maintenance treatment in patients with newly diagnosed ovarian cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022;40:3952-3964. doi:10.1200/JCO.22.01003.

Poly(ADP-ribose) polymerase (PARP) inhibitors are a class of oral anticancer agents that target DNA repair. Since the initial FDA approval in 2014 of olaparib for the treatment of patients with recurrent BRCA-mutated ovarian cancer, PARP inhibitors have been approved for maintenance in both the frontline setting and after platinum-sensitive recurrence, and as single-agenttreatment for ovarian cancer with BRCA mutations or evidence of homologous repair deficiency (HRD), a BRCA-like molecular phenotype.⁵ The expanding role for PARP inhibitors in ovarian cancer seemed inexorable.

Restricted prescribing advised

In 2022, we learned that in certain settings, PARP inhibitors may be the wrong choice. Several “Dear Health Care Provider” letters were issued by AstraZeneca, Clovis, and GSK to advise physicians to restrict the prescribing of olaparib, rucaparib, and niraparib.^6,7

AstraZeneca and Clovis issued letters spurred by the final analysis of ARIEL4 and SOLO3 studies, 2 randomized trials that investigated, respectively, rucaparib and olaparib monotherapy compared with chemotherapy in recurrent ovarian cancer.^8,9 In both cases patients randomized to PARP inhibitors may have experienced an overall survival decrement compared with those who received chemotherapy.

At the FDA’s request, Clovis has withdrawn rucaparib as a treatment for patients with recurrent BRCA-mutant ovarian cancer who had received 2 or more lines of chemotherapy, and AstraZeneca withdrew olaparib monotherapy in germline BRCA-mutant patients with recurrent ovarian cancer. Shortly after these withdrawals, GSK also withdrew its indication for niraparib as a treatment for women with HRD, platinum-sensitive ovarian cancer who have received 3 or more prior chemotherapies. Furthermore, based on the final overall survival analysis of the NOVA study, GSK also restricted its indication for niraparib maintenance for recurrent ovarian cancer to patients with germline BRCA mutations, due to evidence of an overall survival detriment in this setting.¹⁰

Positive study results

Fortunately, 2022 was not all bad news for PARP inhibitors in ovarian cancer. In June 2022, the ATHENA-MONO trial, a phase 3 double-blind randomized controlled trial, demonstrated that rucaparib maintenance in patients with newly diagnosed epithelial ovarian cancer was associated with a significantly longer progression-free survival compared with placebo.¹¹ The effect was most pronounced in the BRCA-mutant/HRD population, with a median progression-free survival of 28.7 months in the rucaparib group compared with 11.3 months in the placebo group (HR, 0.47; 95% CI, 0.31–0.72). Thus, rucaparib was added to the list of PARP inhibitors approved for upfront maintenance therapy in epithelial ovarian cancer.

Similarly, the long-term overall survival analysis from the upfront trials SOLO-1 and PAOLA-1 showed an overall survival advantage of PARP inhibitor, compared with placebo, maintenance in patients with BRCA mutations or HRD tumors.^12,13 ●

A multicenter randomized controlled trial has provided more evidence that acupuncture and doxylamine-pyridoxine (Diclegis/Diclectin) are modestly effective for the nausea and vomiting of pregnancy (NVP). While the benefit of either agent was clinically small for moderate to severe symptoms, the combination showed numerically larger and potentially more meaningful benefit, according to a team led by Xiao-Ke Wu, MD, PhD, of the department of obstetrics and gynecology at First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital in Harbin, China.

The treatments found small reductions in symptoms of less than one point to 1.6 points on an emesis scale. Nevertheless, Dr. Wu’s group wrote online June 19 in Annals of Internal Medicine that the finding “is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

NVP affects as many as 85% of pregnant women, 80%-90% of whom have only mild symptoms, the authors noted. However, severe NVP and hyperemesis gravidarum, or HG, develop in about 10%. “Unfortunately, as many as 10% of wanted pregnancies with severe NVP or HG are terminated because of intolerable and untreatable symptoms and complications,” Dr. Wu told this news organization. And antiemetics may be underprescribed by general practitioners because of concerns about potential teratogenic effects, he said.

“Our findings suggest that either acupuncture or doxylamine-pyridoxine alone is a suitable for treating moderate to severe NVP, and a combination of both can be used to treat severe NVP and HG,” Dr. Wu said.

Commenting on the study but not involved in it, Catherine S. Stika, MD, a clinical professor of ob.gyn. at Northwestern University in Chicago, said the results suggest these two therapies are more suited to mild than severe symptoms. “But an RCT is important to do in order to support the use of these therapies since they’re not as widely accepted as they ought to be,” she said in an interview.

Design

The randomized, double-blind, placebo-controled 2x2 factorial trial was conducted at 13 tertiary-care hospitals in mainland China from June 2020 to February 2022. The researchers recruited 352 women in early pregnancy with moderate to severe NVP. The mean age of participants was about 29 years and the mean gestational age was about 9 weeks.

Participants were randomized into four 14-day treatment groups: active acupuncture for 30 minutes a day plus the antihistamine-vitamin B6 agent doxylamine-pyridoxine; sham acupuncture for 30 minutes daily plus doxylamine-pyridoxine; active acupuncture plus placebo; and sham acupuncture plus placebo.

The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at day 15 relative to baseline with a score of less than 6 indicating mild NVP, 6-12 indicating moderate NVP, and 13 or higher indicating severe NVP. Secondary outcomes ranged from quality of life and adverse events to maternal and perinatal complications. Acupuncture and combined treatment yielded larger though still small reductions in PUQE score, compared with control treatments. The mean differences were as follows: acupuncture, –.07; 95% confidence interval, 1.3-0.1); doxylamine-pyridoxine, –1.0: 95% CI, 1.6-0.4); combination of both, –1.6; 95% CI, 2.2-0.9). No significant interaction was detected between the interventions (P = .69).Compared with placebo treatments, pharmaceutical therapy resulted in more somnolence, while active acupuncture led to more frequent dyspnea, bruising, itching, and pain. A higher risk of babies born small for gestational age was observed in mothers who took doxylamine-pyridoxine versus placebo: odds ratio, 3.8; 95% CI, 1-14.1). Neither the placebo effects of the sham interventions nor the natural regression of symptoms experienced by many women were evaluated.
 

Suited to milder symptoms?

Dr. Stika called the study well-designed and well-written but cited several limitations, including the small cohort, the minor symptom improvement, and the lack of a comparator group receiving neither sham nor active treatment.

“Compared with sham combination treatments, the active combination arm was only about a point and a half better,” she said. “And would some women have got better over the 2 weeks anyway with no intervention at all? A large percentage of women with NVP do improve on their own.”

And in terms of acceptability to U.S. women, she cautioned, “The study cohort was entirely Chinese, and this is a population that already accepts acupuncture treatment.”

Countered Dr. Wu, “Medical care provided by licensed acupuncturists is approved in many countries. Certainly, it is ready to be prescribed by physicians when a pregnant patient is seeking NVP treatment.”

Dr. Stika stressed that these therapies are suited to milder NV, and would “barely take edge off severe symptoms,” for which a patient might have to “go up to a big gun like the antiemetic Zofran” (ondansetron). She is currently involved in a National Institutes of Health–funded clinical trial of the antidepressant mirtazapine (Remeron) for NVP.

Matthew Carroll, MD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, noted that doxylamine-pyridoxine is already an effective treatment for NVP, but in his experience it is often "not enough" to help patients deal with symptoms.

"Many patients are hesitant to take additional medications," he said. "If acupuncture can be safely done in pregnancy, then it seems a reasonable option as an adjuvant treatment for NVP. I think there is a cohort of pregnant people in the US who would be excited to try a complementary and nonpharmaceutical treatment option. Unfortunately, complementary therapies are rarely evaluated at a systems level for safety and so they are hard to recommend for obstetricians in the US," he added.

Dr. Carroll, who was not involved in the study. noted that "studies like this can help us counsel patients who may be seeking these treatments even if not approved or recommended by ACOG."

This study was funded by the National Key R&D Program of China and the Project of Heilongjiang Province “TouYan” Innovation Team. Support also came from the National Clinical Research Base of Chinese Medicine, the Heilongjiang Provincial Clinical Research Centre for Ovary Diseases, and the 2023 Capability Improvement Project for Evidence-based Assessment of Traditional Chinese Medicine.

Study coauthor Ben Willem J. Mol, MD, PhD, reported consulting fees from ObsEva and Merck and travel fees from Merck.

Dr. Stika and Dr. Carroll had no competing interests to disclose.

A multicenter randomized controlled trial has provided more evidence that acupuncture and doxylamine-pyridoxine (Diclegis/Diclectin) are modestly effective for the nausea and vomiting of pregnancy (NVP). While the benefit of either agent was clinically small for moderate to severe symptoms, the combination showed numerically larger and potentially more meaningful benefit, according to a team led by Xiao-Ke Wu, MD, PhD, of the department of obstetrics and gynecology at First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital in Harbin, China.

The treatments found small reductions in symptoms of less than one point to 1.6 points on an emesis scale. Nevertheless, Dr. Wu’s group wrote online June 19 in Annals of Internal Medicine that the finding “is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

NVP affects as many as 85% of pregnant women, 80%-90% of whom have only mild symptoms, the authors noted. However, severe NVP and hyperemesis gravidarum, or HG, develop in about 10%. “Unfortunately, as many as 10% of wanted pregnancies with severe NVP or HG are terminated because of intolerable and untreatable symptoms and complications,” Dr. Wu told this news organization. And antiemetics may be underprescribed by general practitioners because of concerns about potential teratogenic effects, he said.

“Our findings suggest that either acupuncture or doxylamine-pyridoxine alone is a suitable for treating moderate to severe NVP, and a combination of both can be used to treat severe NVP and HG,” Dr. Wu said.

Commenting on the study but not involved in it, Catherine S. Stika, MD, a clinical professor of ob.gyn. at Northwestern University in Chicago, said the results suggest these two therapies are more suited to mild than severe symptoms. “But an RCT is important to do in order to support the use of these therapies since they’re not as widely accepted as they ought to be,” she said in an interview.

Design

The randomized, double-blind, placebo-controled 2x2 factorial trial was conducted at 13 tertiary-care hospitals in mainland China from June 2020 to February 2022. The researchers recruited 352 women in early pregnancy with moderate to severe NVP. The mean age of participants was about 29 years and the mean gestational age was about 9 weeks.

Participants were randomized into four 14-day treatment groups: active acupuncture for 30 minutes a day plus the antihistamine-vitamin B6 agent doxylamine-pyridoxine; sham acupuncture for 30 minutes daily plus doxylamine-pyridoxine; active acupuncture plus placebo; and sham acupuncture plus placebo.

The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at day 15 relative to baseline with a score of less than 6 indicating mild NVP, 6-12 indicating moderate NVP, and 13 or higher indicating severe NVP. Secondary outcomes ranged from quality of life and adverse events to maternal and perinatal complications. Acupuncture and combined treatment yielded larger though still small reductions in PUQE score, compared with control treatments. The mean differences were as follows: acupuncture, –.07; 95% confidence interval, 1.3-0.1); doxylamine-pyridoxine, –1.0: 95% CI, 1.6-0.4); combination of both, –1.6; 95% CI, 2.2-0.9). No significant interaction was detected between the interventions (P = .69).Compared with placebo treatments, pharmaceutical therapy resulted in more somnolence, while active acupuncture led to more frequent dyspnea, bruising, itching, and pain. A higher risk of babies born small for gestational age was observed in mothers who took doxylamine-pyridoxine versus placebo: odds ratio, 3.8; 95% CI, 1-14.1). Neither the placebo effects of the sham interventions nor the natural regression of symptoms experienced by many women were evaluated.
 

Suited to milder symptoms?

Dr. Stika called the study well-designed and well-written but cited several limitations, including the small cohort, the minor symptom improvement, and the lack of a comparator group receiving neither sham nor active treatment.

“Compared with sham combination treatments, the active combination arm was only about a point and a half better,” she said. “And would some women have got better over the 2 weeks anyway with no intervention at all? A large percentage of women with NVP do improve on their own.”

And in terms of acceptability to U.S. women, she cautioned, “The study cohort was entirely Chinese, and this is a population that already accepts acupuncture treatment.”

Countered Dr. Wu, “Medical care provided by licensed acupuncturists is approved in many countries. Certainly, it is ready to be prescribed by physicians when a pregnant patient is seeking NVP treatment.”

Dr. Stika stressed that these therapies are suited to milder NV, and would “barely take edge off severe symptoms,” for which a patient might have to “go up to a big gun like the antiemetic Zofran” (ondansetron). She is currently involved in a National Institutes of Health–funded clinical trial of the antidepressant mirtazapine (Remeron) for NVP.

Matthew Carroll, MD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, noted that doxylamine-pyridoxine is already an effective treatment for NVP, but in his experience it is often "not enough" to help patients deal with symptoms.

"Many patients are hesitant to take additional medications," he said. "If acupuncture can be safely done in pregnancy, then it seems a reasonable option as an adjuvant treatment for NVP. I think there is a cohort of pregnant people in the US who would be excited to try a complementary and nonpharmaceutical treatment option. Unfortunately, complementary therapies are rarely evaluated at a systems level for safety and so they are hard to recommend for obstetricians in the US," he added.

Dr. Carroll, who was not involved in the study. noted that "studies like this can help us counsel patients who may be seeking these treatments even if not approved or recommended by ACOG."

This study was funded by the National Key R&D Program of China and the Project of Heilongjiang Province “TouYan” Innovation Team. Support also came from the National Clinical Research Base of Chinese Medicine, the Heilongjiang Provincial Clinical Research Centre for Ovary Diseases, and the 2023 Capability Improvement Project for Evidence-based Assessment of Traditional Chinese Medicine.

Study coauthor Ben Willem J. Mol, MD, PhD, reported consulting fees from ObsEva and Merck and travel fees from Merck.

Dr. Stika and Dr. Carroll had no competing interests to disclose.

A multicenter randomized controlled trial has provided more evidence that acupuncture and doxylamine-pyridoxine (Diclegis/Diclectin) are modestly effective for the nausea and vomiting of pregnancy (NVP). While the benefit of either agent was clinically small for moderate to severe symptoms, the combination showed numerically larger and potentially more meaningful benefit, according to a team led by Xiao-Ke Wu, MD, PhD, of the department of obstetrics and gynecology at First Affiliated Hospital, Heilongjiang University of Chinese Medicine, and Heilongjiang Provincial Hospital in Harbin, China.

The treatments found small reductions in symptoms of less than one point to 1.6 points on an emesis scale. Nevertheless, Dr. Wu’s group wrote online June 19 in Annals of Internal Medicine that the finding “is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

NVP affects as many as 85% of pregnant women, 80%-90% of whom have only mild symptoms, the authors noted. However, severe NVP and hyperemesis gravidarum, or HG, develop in about 10%. “Unfortunately, as many as 10% of wanted pregnancies with severe NVP or HG are terminated because of intolerable and untreatable symptoms and complications,” Dr. Wu told this news organization. And antiemetics may be underprescribed by general practitioners because of concerns about potential teratogenic effects, he said.

“Our findings suggest that either acupuncture or doxylamine-pyridoxine alone is a suitable for treating moderate to severe NVP, and a combination of both can be used to treat severe NVP and HG,” Dr. Wu said.

Commenting on the study but not involved in it, Catherine S. Stika, MD, a clinical professor of ob.gyn. at Northwestern University in Chicago, said the results suggest these two therapies are more suited to mild than severe symptoms. “But an RCT is important to do in order to support the use of these therapies since they’re not as widely accepted as they ought to be,” she said in an interview.

Design

The randomized, double-blind, placebo-controled 2x2 factorial trial was conducted at 13 tertiary-care hospitals in mainland China from June 2020 to February 2022. The researchers recruited 352 women in early pregnancy with moderate to severe NVP. The mean age of participants was about 29 years and the mean gestational age was about 9 weeks.

Participants were randomized into four 14-day treatment groups: active acupuncture for 30 minutes a day plus the antihistamine-vitamin B6 agent doxylamine-pyridoxine; sham acupuncture for 30 minutes daily plus doxylamine-pyridoxine; active acupuncture plus placebo; and sham acupuncture plus placebo.

The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at day 15 relative to baseline with a score of less than 6 indicating mild NVP, 6-12 indicating moderate NVP, and 13 or higher indicating severe NVP. Secondary outcomes ranged from quality of life and adverse events to maternal and perinatal complications. Acupuncture and combined treatment yielded larger though still small reductions in PUQE score, compared with control treatments. The mean differences were as follows: acupuncture, –.07; 95% confidence interval, 1.3-0.1); doxylamine-pyridoxine, –1.0: 95% CI, 1.6-0.4); combination of both, –1.6; 95% CI, 2.2-0.9). No significant interaction was detected between the interventions (P = .69).Compared with placebo treatments, pharmaceutical therapy resulted in more somnolence, while active acupuncture led to more frequent dyspnea, bruising, itching, and pain. A higher risk of babies born small for gestational age was observed in mothers who took doxylamine-pyridoxine versus placebo: odds ratio, 3.8; 95% CI, 1-14.1). Neither the placebo effects of the sham interventions nor the natural regression of symptoms experienced by many women were evaluated.
 

Suited to milder symptoms?

Dr. Stika called the study well-designed and well-written but cited several limitations, including the small cohort, the minor symptom improvement, and the lack of a comparator group receiving neither sham nor active treatment.

“Compared with sham combination treatments, the active combination arm was only about a point and a half better,” she said. “And would some women have got better over the 2 weeks anyway with no intervention at all? A large percentage of women with NVP do improve on their own.”

And in terms of acceptability to U.S. women, she cautioned, “The study cohort was entirely Chinese, and this is a population that already accepts acupuncture treatment.”

Countered Dr. Wu, “Medical care provided by licensed acupuncturists is approved in many countries. Certainly, it is ready to be prescribed by physicians when a pregnant patient is seeking NVP treatment.”

Dr. Stika stressed that these therapies are suited to milder NV, and would “barely take edge off severe symptoms,” for which a patient might have to “go up to a big gun like the antiemetic Zofran” (ondansetron). She is currently involved in a National Institutes of Health–funded clinical trial of the antidepressant mirtazapine (Remeron) for NVP.

Matthew Carroll, MD, a professor of obstetrics and gynecology at Baylor College of Medicine and Texas Children’s Hospital in Houston, noted that doxylamine-pyridoxine is already an effective treatment for NVP, but in his experience it is often "not enough" to help patients deal with symptoms.

"Many patients are hesitant to take additional medications," he said. "If acupuncture can be safely done in pregnancy, then it seems a reasonable option as an adjuvant treatment for NVP. I think there is a cohort of pregnant people in the US who would be excited to try a complementary and nonpharmaceutical treatment option. Unfortunately, complementary therapies are rarely evaluated at a systems level for safety and so they are hard to recommend for obstetricians in the US," he added.

Dr. Carroll, who was not involved in the study. noted that "studies like this can help us counsel patients who may be seeking these treatments even if not approved or recommended by ACOG."

This study was funded by the National Key R&D Program of China and the Project of Heilongjiang Province “TouYan” Innovation Team. Support also came from the National Clinical Research Base of Chinese Medicine, the Heilongjiang Provincial Clinical Research Centre for Ovary Diseases, and the 2023 Capability Improvement Project for Evidence-based Assessment of Traditional Chinese Medicine.

Study coauthor Ben Willem J. Mol, MD, PhD, reported consulting fees from ObsEva and Merck and travel fees from Merck.

Dr. Stika and Dr. Carroll had no competing interests to disclose.

Elephantiasis nostras verrucosa (ENV) is a chronic, uncommon and progressively disfiguring disease most commonly presenting on the bilateral lower extremities in the setting of chronic nonfilarial lymphedema resulting in secondary dermatologic sequelae.¹ Clinically, ENV presents as verrucous, hyperkeratotic, cobblestone-like patches, plaques, and nodules with associated nonpitting edema of the affected body area.¹ Secondary bacterial infections are common and often worsen the clinical course. The etiology of ENV involves chronic lymphatic obstruction and venous insufficiency, with additional risk factors including obesity, chronic lymphedema, bacterial infection, surgery or trauma, neoplasia, radiation, congestive heart failure, or scleroderma.^2,3 While most commonly presenting on the lower extremities, cases have been reported involving the abdomen, sacrum, ears, buttocks, and penoscrotal area.^1,2

Regardless of location, the pathogenesis of ENV remains the same. Chronic lymphatic obstruction results in accumulation and lymphostasis of protein-rich dermal fluid, which subsequently precipitates fibroblast proliferation and activation, suppression of the local immune response and development of recurrent lymphangitis, chronic inflammation, and potential secondary bacterial infection.^2,4

There is no standard of care for the treatment and management of ENV and recurrence is common. Interventions often involve those used for chronic lymphedema – including leg elevation, compression stockings or devices, skin hygiene, and lymphatic pumping.^2,3 Medical management with topical and oral retinoids has been reported, as well as emphasis on weight loss and infection control.^1,4 Surgical intervention is often reserved for refractory cases that fail to respond to more conservative management, or severe presentations resulting in extensive functional and aesthetic impairment. Less commonly reported treatment modalities include lymphaticovenular anastomosis and ablative carbon dioxide laser use, although this latter intervention demonstrated minimal improvement in this patient.^5,6

Penoscrotal ENV is a rare form of ENV affecting the genital region of males, often resulting in significant disfigurement, functional impairment, and psychosocial distress. Penoscrotal elephantiasis can be idiopathic, due to filarial infections, scleroinflammatory stricture of the urethra, Chlamydia trachomatis infection, and lymphostasis secondary to chronic inflammatory conditions such as streptococcal infections, radiotherapy, surgery, chronic venous stasis, or Kaposi sarcoma.⁷

In addition, hidradenitis suppurativa (HS) has been documented multiple times in the literature in association with the development of ENV, detailing lymphatic scarring secondary to chronic inguinal HS as the main pathogenic factor.^8,9

Surgery is the mainstay of treatment for penoscrotal ENV, which not only improves functionality and cosmesis, but also aids in prevention of rare malignant sequelae, such as lymphangiosarcoma.¹⁰ Such interventions can involve lymphangioplasty to aid in lymphatic drainage or excision of the mass and subcutaneous tissue with full-thickness skin grafting for reconstruction.⁷ Collaboration between urology, plastic surgery, and dermatology is often essential to obtain adequate care with satisfactory outcomes and minimal recurrence for patients with this uncommon condition.

This case and photo were submitted by Marlee Hill, a medical student at the University of Oklahoma, Oklahoma City; and Michael Franzetti, MD, and Jeffrey McBride, MD, department of dermatology, University of Oklahoma Health Sciences Center. The column was edited by Donna Bilu Martin, MD.
 

Dr. Donna Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to d[email protected].

References

1. Hadian Y et al. Dermatol Online J. 2019 Dec 15;25(12):13030/qt6rn1s8ff.

2. Judge N and Kilic A. J Dermatol Case Rep. 2016 Nov 13;10(2):32-4.

3. Dean SM et al. J Am Acad Dermatol. 2011 Jun;64(6):1104-10.

4. Sisto K and Khachemoune A. Am J Clin Dermatol. 2008;9(3):141-6.

5. Motegi S et al. Dermatology. 2007;215(2):147-51.

6. Robinson CG et al. J Cutan Med Surg. 2018;22(6):611-3.

7. Koualla S et al. Ann Chir Plast Esthet. 2023 Apr 10;S0294-1260(23)00035-3.

8. Lelonek E et al. Acta Derm Venereol. 2021 Feb 11;101(2):adv00389.

9. Good LM et al. J Am Acad Dermatol. 2011 May;64(5):993-4.

10. Cerri A et al. Eur J Dermatol. 1998 Oct-Nov;8(7):511-4.

Elephantiasis nostras verrucosa (ENV) is a chronic, uncommon and progressively disfiguring disease most commonly presenting on the bilateral lower extremities in the setting of chronic nonfilarial lymphedema resulting in secondary dermatologic sequelae.¹ Clinically, ENV presents as verrucous, hyperkeratotic, cobblestone-like patches, plaques, and nodules with associated nonpitting edema of the affected body area.¹ Secondary bacterial infections are common and often worsen the clinical course. The etiology of ENV involves chronic lymphatic obstruction and venous insufficiency, with additional risk factors including obesity, chronic lymphedema, bacterial infection, surgery or trauma, neoplasia, radiation, congestive heart failure, or scleroderma.^2,3 While most commonly presenting on the lower extremities, cases have been reported involving the abdomen, sacrum, ears, buttocks, and penoscrotal area.^1,2

Regardless of location, the pathogenesis of ENV remains the same. Chronic lymphatic obstruction results in accumulation and lymphostasis of protein-rich dermal fluid, which subsequently precipitates fibroblast proliferation and activation, suppression of the local immune response and development of recurrent lymphangitis, chronic inflammation, and potential secondary bacterial infection.^2,4

There is no standard of care for the treatment and management of ENV and recurrence is common. Interventions often involve those used for chronic lymphedema – including leg elevation, compression stockings or devices, skin hygiene, and lymphatic pumping.^2,3 Medical management with topical and oral retinoids has been reported, as well as emphasis on weight loss and infection control.^1,4 Surgical intervention is often reserved for refractory cases that fail to respond to more conservative management, or severe presentations resulting in extensive functional and aesthetic impairment. Less commonly reported treatment modalities include lymphaticovenular anastomosis and ablative carbon dioxide laser use, although this latter intervention demonstrated minimal improvement in this patient.^5,6

Penoscrotal ENV is a rare form of ENV affecting the genital region of males, often resulting in significant disfigurement, functional impairment, and psychosocial distress. Penoscrotal elephantiasis can be idiopathic, due to filarial infections, scleroinflammatory stricture of the urethra, Chlamydia trachomatis infection, and lymphostasis secondary to chronic inflammatory conditions such as streptococcal infections, radiotherapy, surgery, chronic venous stasis, or Kaposi sarcoma.⁷

In addition, hidradenitis suppurativa (HS) has been documented multiple times in the literature in association with the development of ENV, detailing lymphatic scarring secondary to chronic inguinal HS as the main pathogenic factor.^8,9

Surgery is the mainstay of treatment for penoscrotal ENV, which not only improves functionality and cosmesis, but also aids in prevention of rare malignant sequelae, such as lymphangiosarcoma.¹⁰ Such interventions can involve lymphangioplasty to aid in lymphatic drainage or excision of the mass and subcutaneous tissue with full-thickness skin grafting for reconstruction.⁷ Collaboration between urology, plastic surgery, and dermatology is often essential to obtain adequate care with satisfactory outcomes and minimal recurrence for patients with this uncommon condition.

This case and photo were submitted by Marlee Hill, a medical student at the University of Oklahoma, Oklahoma City; and Michael Franzetti, MD, and Jeffrey McBride, MD, department of dermatology, University of Oklahoma Health Sciences Center. The column was edited by Donna Bilu Martin, MD.
 

Dr. Donna Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to d[email protected].

References

1. Hadian Y et al. Dermatol Online J. 2019 Dec 15;25(12):13030/qt6rn1s8ff.

2. Judge N and Kilic A. J Dermatol Case Rep. 2016 Nov 13;10(2):32-4.

3. Dean SM et al. J Am Acad Dermatol. 2011 Jun;64(6):1104-10.

4. Sisto K and Khachemoune A. Am J Clin Dermatol. 2008;9(3):141-6.

5. Motegi S et al. Dermatology. 2007;215(2):147-51.

6. Robinson CG et al. J Cutan Med Surg. 2018;22(6):611-3.

7. Koualla S et al. Ann Chir Plast Esthet. 2023 Apr 10;S0294-1260(23)00035-3.

8. Lelonek E et al. Acta Derm Venereol. 2021 Feb 11;101(2):adv00389.

9. Good LM et al. J Am Acad Dermatol. 2011 May;64(5):993-4.

10. Cerri A et al. Eur J Dermatol. 1998 Oct-Nov;8(7):511-4.

Elephantiasis nostras verrucosa (ENV) is a chronic, uncommon and progressively disfiguring disease most commonly presenting on the bilateral lower extremities in the setting of chronic nonfilarial lymphedema resulting in secondary dermatologic sequelae.¹ Clinically, ENV presents as verrucous, hyperkeratotic, cobblestone-like patches, plaques, and nodules with associated nonpitting edema of the affected body area.¹ Secondary bacterial infections are common and often worsen the clinical course. The etiology of ENV involves chronic lymphatic obstruction and venous insufficiency, with additional risk factors including obesity, chronic lymphedema, bacterial infection, surgery or trauma, neoplasia, radiation, congestive heart failure, or scleroderma.^2,3 While most commonly presenting on the lower extremities, cases have been reported involving the abdomen, sacrum, ears, buttocks, and penoscrotal area.^1,2

Regardless of location, the pathogenesis of ENV remains the same. Chronic lymphatic obstruction results in accumulation and lymphostasis of protein-rich dermal fluid, which subsequently precipitates fibroblast proliferation and activation, suppression of the local immune response and development of recurrent lymphangitis, chronic inflammation, and potential secondary bacterial infection.^2,4

There is no standard of care for the treatment and management of ENV and recurrence is common. Interventions often involve those used for chronic lymphedema – including leg elevation, compression stockings or devices, skin hygiene, and lymphatic pumping.^2,3 Medical management with topical and oral retinoids has been reported, as well as emphasis on weight loss and infection control.^1,4 Surgical intervention is often reserved for refractory cases that fail to respond to more conservative management, or severe presentations resulting in extensive functional and aesthetic impairment. Less commonly reported treatment modalities include lymphaticovenular anastomosis and ablative carbon dioxide laser use, although this latter intervention demonstrated minimal improvement in this patient.^5,6

Penoscrotal ENV is a rare form of ENV affecting the genital region of males, often resulting in significant disfigurement, functional impairment, and psychosocial distress. Penoscrotal elephantiasis can be idiopathic, due to filarial infections, scleroinflammatory stricture of the urethra, Chlamydia trachomatis infection, and lymphostasis secondary to chronic inflammatory conditions such as streptococcal infections, radiotherapy, surgery, chronic venous stasis, or Kaposi sarcoma.⁷

In addition, hidradenitis suppurativa (HS) has been documented multiple times in the literature in association with the development of ENV, detailing lymphatic scarring secondary to chronic inguinal HS as the main pathogenic factor.^8,9

Surgery is the mainstay of treatment for penoscrotal ENV, which not only improves functionality and cosmesis, but also aids in prevention of rare malignant sequelae, such as lymphangiosarcoma.¹⁰ Such interventions can involve lymphangioplasty to aid in lymphatic drainage or excision of the mass and subcutaneous tissue with full-thickness skin grafting for reconstruction.⁷ Collaboration between urology, plastic surgery, and dermatology is often essential to obtain adequate care with satisfactory outcomes and minimal recurrence for patients with this uncommon condition.

This case and photo were submitted by Marlee Hill, a medical student at the University of Oklahoma, Oklahoma City; and Michael Franzetti, MD, and Jeffrey McBride, MD, department of dermatology, University of Oklahoma Health Sciences Center. The column was edited by Donna Bilu Martin, MD.
 

Dr. Donna Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to d[email protected].

References

1. Hadian Y et al. Dermatol Online J. 2019 Dec 15;25(12):13030/qt6rn1s8ff.

2. Judge N and Kilic A. J Dermatol Case Rep. 2016 Nov 13;10(2):32-4.

3. Dean SM et al. J Am Acad Dermatol. 2011 Jun;64(6):1104-10.

4. Sisto K and Khachemoune A. Am J Clin Dermatol. 2008;9(3):141-6.

5. Motegi S et al. Dermatology. 2007;215(2):147-51.

6. Robinson CG et al. J Cutan Med Surg. 2018;22(6):611-3.

7. Koualla S et al. Ann Chir Plast Esthet. 2023 Apr 10;S0294-1260(23)00035-3.

8. Lelonek E et al. Acta Derm Venereol. 2021 Feb 11;101(2):adv00389.

9. Good LM et al. J Am Acad Dermatol. 2011 May;64(5):993-4.

10. Cerri A et al. Eur J Dermatol. 1998 Oct-Nov;8(7):511-4.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.

The results suggest that including fathers in conversations about breastfeeding and infant sleep practices could help improve adherence, the researchers said.

“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
 

Population-based survey results

Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.

In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).

Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.

Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).

The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.

“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
 

Educational efforts should recognize father’s contributions

In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”

The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.

While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”

To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.

“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.

While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”

Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.

Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.

It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.

“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.

In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.

This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.

A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.

Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.

The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.

This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.

According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.

Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.

Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.

In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.

Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].

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

A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.

Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.

The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.

This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.

According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.

Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.

Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.

In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.

Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].

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

A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.

Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.

The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.

This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.

According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.

Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.

Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.

In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.

Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].

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