Feature

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

Since the European Alliance of Associations for Rheumatology (EULAR) published its 2019 recommendations, the range of therapeutic options in the management of psoriatic arthritis (PsA) has expanded significantly. Univadis France spoke to Laure Gossec, MD, PhD, a rheumatologist at Pitié-Salpêtrière Hospital and Sorbonne University in Paris, about the updates to these recommendations. 

What is the role of nonsteroidal anti-inflammatory drugs (NSAIDs) today?

NSAIDs remain the first-line treatment, but their place as monotherapy without background treatment has been mainly limited to patients with mild peripheral disease. For them, NSAIDs are recommended as monotherapy for a short duration, 2-4 weeks, while the clinician assesses and promptly introduces background treatment. We have a window of opportunity. Inflammation must be targeted quickly, especially if the patient has a form of disease associated with poor prognosis. Such patients include those with polyarticular forms or high C-reactive protein (CRP).

The two criteria of at least four swollen joints and/or a CRP greater than 5 mg/L should prompt the physician to introduce background treatment.

When prescribing NSAIDs, clinicians must rigorously evaluate the benefit-risk ratio because patients with PsA often have comorbidities. In France, one third of them have obesity, 20% have hypertension, and 20% have diabetes.
 

What is the recommended hierarchy for other treatments?

In the second phase of treatment, synthetic conventional treatments (like methotrexate, leflunomide, or sulfasalazine) are recommended. Methotrexate is by far the most used. This choice is based on efficacy, the efficacy-safety ratio, and cost.

A biologic therapy has no place as a first-line treatment because most PsA cases are moderate. In this regard, our European recommendations differ from American recommendations, which leave the choice between conventional or targeted therapies as a first-line treatment.

We have opted for a step-up approach. Although there is no study comparing a biologic therapy vs methotrexate as a first-line treatment, we have many data showing that more than half of patients will never need a biologic therapy.

We have a lot of experience with molecules like methotrexate. The benefit-risk ratio of this treatment as a first-line option is favorable, with efficacy for the skin. However, in axial forms, methotrexate is ineffective and calls for the use of biologic therapy.
 

Are there selection criteria for second-line biologic therapies?

Five classes of molecules are authorized and reimbursed in France: anti-TNF (tumor necrosis factor), anti–IL (interleukin)-17A, anti–IL-17A, -F, and -AF (bimekizumab), anti–IL-12/23 (ustekinumab), and anti–IL-23. All these treatments are effective in about two thirds of patients.

Unfortunately, we are not yet practicing personalized medicine to choose the most appropriate treatment for each patient, because we cannot predict this response. However, there are specific cases. Anti–IL-17 and anti–IL-23 can be favored in patients with bothersome skin involvement, either because it is extensive or located on the face or genital area. If a patient also has chronic inflammatory bowel disease, anti-TNF, anti–IL-23, or Janus kinase (JAK) inhibitors should be prioritized. In axial forms, anti-TNF or anti–IL-17 is recommended. But these cases concern only a minority of our patients. 

We have kept a place for JAK inhibitors in patients for whom biologic therapies are not suitable or effective. It is important to follow the recommendations of the European Medicines Agency, avoiding the use of JAK inhibitors after age 60 years, in smokers, or in those with cardiovascular risk. Oncologic monitoring is also important for patients treated with this therapeutic class.

Let’s also remember the role of apremilast, which is an alternative to biologic therapies in patients with moderate forms of the disease.

In the next 2 or 3 years, new modes of action or new molecules should be available, such as tyrosine kinase 2 (TYK2) inhibitors; izokibep, an oral nanomolecule targeting IL-17; or a new injectable anti–IL-17 with an affinity with interleukin that is incomparable to that of previous antibodies.
 

What message should be conveyed to the general practitioner?

PsA treatments are prescribed initially in hospitals, but rheumatologists will be able to prescribe them in the coming months. The general practitioner cannot initiate targeted treatment but has the role of starting methotrexate and referring the patient to specialized follow-up.

The most important thing to know is that in France, about half of patients will be on targeted treatment. The median maintenance of such therapy is only 3 years, which means that half of the patients will have replaced it with another therapy after 3 years. This switch could indicate a loss of efficacy or escape. It is therefore important for a specialist to follow the patient and to continue biologic monitoring every 2-6 months, as well as imaging every 2-5 years to check radiographic progression.

In cases of prolonged remission of more than 6 months, a gradual and cautious decrease in background treatments can be considered in a shared medical decision. However, treatment discontinuation leads to a systemic relapse in the short or long term, and a gradual decrease results in relapse in about half of the patients.
 

And in terms of monitoring?

The management of comorbidities is crucial. It is essential to keep vaccinations up to date, especially because of the increased risk for potential infections with targeted treatments. Regular screening for infections, including dental follow-up, is also recommended.

Preventive medicine is also important, especially regarding breast and colon cancer screening. General population recommendations apply.

Cardiovascular risk, which is doubled in patients with PsA compared with the general population due to chronic inflammation, should prompt monitoring of blood pressure and metabolic diseases. It should be noted that there is an 11% higher mortality rate after 8 years of follow-up, mainly due to cardiovascular and neoplastic risks.

Dr. Gossec reported receiving research grants from AbbVie, Biogen, Lilly, Novartis, and UCB and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Stada, and UCB.
 

This story was translated from Univadis France, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Since the European Alliance of Associations for Rheumatology (EULAR) published its 2019 recommendations, the range of therapeutic options in the management of psoriatic arthritis (PsA) has expanded significantly. Univadis France spoke to Laure Gossec, MD, PhD, a rheumatologist at Pitié-Salpêtrière Hospital and Sorbonne University in Paris, about the updates to these recommendations. 

What is the role of nonsteroidal anti-inflammatory drugs (NSAIDs) today?

NSAIDs remain the first-line treatment, but their place as monotherapy without background treatment has been mainly limited to patients with mild peripheral disease. For them, NSAIDs are recommended as monotherapy for a short duration, 2-4 weeks, while the clinician assesses and promptly introduces background treatment. We have a window of opportunity. Inflammation must be targeted quickly, especially if the patient has a form of disease associated with poor prognosis. Such patients include those with polyarticular forms or high C-reactive protein (CRP).

The two criteria of at least four swollen joints and/or a CRP greater than 5 mg/L should prompt the physician to introduce background treatment.

When prescribing NSAIDs, clinicians must rigorously evaluate the benefit-risk ratio because patients with PsA often have comorbidities. In France, one third of them have obesity, 20% have hypertension, and 20% have diabetes.
 

What is the recommended hierarchy for other treatments?

In the second phase of treatment, synthetic conventional treatments (like methotrexate, leflunomide, or sulfasalazine) are recommended. Methotrexate is by far the most used. This choice is based on efficacy, the efficacy-safety ratio, and cost.

A biologic therapy has no place as a first-line treatment because most PsA cases are moderate. In this regard, our European recommendations differ from American recommendations, which leave the choice between conventional or targeted therapies as a first-line treatment.

We have opted for a step-up approach. Although there is no study comparing a biologic therapy vs methotrexate as a first-line treatment, we have many data showing that more than half of patients will never need a biologic therapy.

We have a lot of experience with molecules like methotrexate. The benefit-risk ratio of this treatment as a first-line option is favorable, with efficacy for the skin. However, in axial forms, methotrexate is ineffective and calls for the use of biologic therapy.
 

Are there selection criteria for second-line biologic therapies?

Five classes of molecules are authorized and reimbursed in France: anti-TNF (tumor necrosis factor), anti–IL (interleukin)-17A, anti–IL-17A, -F, and -AF (bimekizumab), anti–IL-12/23 (ustekinumab), and anti–IL-23. All these treatments are effective in about two thirds of patients.

Unfortunately, we are not yet practicing personalized medicine to choose the most appropriate treatment for each patient, because we cannot predict this response. However, there are specific cases. Anti–IL-17 and anti–IL-23 can be favored in patients with bothersome skin involvement, either because it is extensive or located on the face or genital area. If a patient also has chronic inflammatory bowel disease, anti-TNF, anti–IL-23, or Janus kinase (JAK) inhibitors should be prioritized. In axial forms, anti-TNF or anti–IL-17 is recommended. But these cases concern only a minority of our patients. 

We have kept a place for JAK inhibitors in patients for whom biologic therapies are not suitable or effective. It is important to follow the recommendations of the European Medicines Agency, avoiding the use of JAK inhibitors after age 60 years, in smokers, or in those with cardiovascular risk. Oncologic monitoring is also important for patients treated with this therapeutic class.

Let’s also remember the role of apremilast, which is an alternative to biologic therapies in patients with moderate forms of the disease.

In the next 2 or 3 years, new modes of action or new molecules should be available, such as tyrosine kinase 2 (TYK2) inhibitors; izokibep, an oral nanomolecule targeting IL-17; or a new injectable anti–IL-17 with an affinity with interleukin that is incomparable to that of previous antibodies.
 

What message should be conveyed to the general practitioner?

PsA treatments are prescribed initially in hospitals, but rheumatologists will be able to prescribe them in the coming months. The general practitioner cannot initiate targeted treatment but has the role of starting methotrexate and referring the patient to specialized follow-up.

The most important thing to know is that in France, about half of patients will be on targeted treatment. The median maintenance of such therapy is only 3 years, which means that half of the patients will have replaced it with another therapy after 3 years. This switch could indicate a loss of efficacy or escape. It is therefore important for a specialist to follow the patient and to continue biologic monitoring every 2-6 months, as well as imaging every 2-5 years to check radiographic progression.

In cases of prolonged remission of more than 6 months, a gradual and cautious decrease in background treatments can be considered in a shared medical decision. However, treatment discontinuation leads to a systemic relapse in the short or long term, and a gradual decrease results in relapse in about half of the patients.
 

And in terms of monitoring?

The management of comorbidities is crucial. It is essential to keep vaccinations up to date, especially because of the increased risk for potential infections with targeted treatments. Regular screening for infections, including dental follow-up, is also recommended.

Preventive medicine is also important, especially regarding breast and colon cancer screening. General population recommendations apply.

Cardiovascular risk, which is doubled in patients with PsA compared with the general population due to chronic inflammation, should prompt monitoring of blood pressure and metabolic diseases. It should be noted that there is an 11% higher mortality rate after 8 years of follow-up, mainly due to cardiovascular and neoplastic risks.

Dr. Gossec reported receiving research grants from AbbVie, Biogen, Lilly, Novartis, and UCB and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Stada, and UCB.
 

This story was translated from Univadis France, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Since the European Alliance of Associations for Rheumatology (EULAR) published its 2019 recommendations, the range of therapeutic options in the management of psoriatic arthritis (PsA) has expanded significantly. Univadis France spoke to Laure Gossec, MD, PhD, a rheumatologist at Pitié-Salpêtrière Hospital and Sorbonne University in Paris, about the updates to these recommendations. 

What is the role of nonsteroidal anti-inflammatory drugs (NSAIDs) today?

NSAIDs remain the first-line treatment, but their place as monotherapy without background treatment has been mainly limited to patients with mild peripheral disease. For them, NSAIDs are recommended as monotherapy for a short duration, 2-4 weeks, while the clinician assesses and promptly introduces background treatment. We have a window of opportunity. Inflammation must be targeted quickly, especially if the patient has a form of disease associated with poor prognosis. Such patients include those with polyarticular forms or high C-reactive protein (CRP).

The two criteria of at least four swollen joints and/or a CRP greater than 5 mg/L should prompt the physician to introduce background treatment.

When prescribing NSAIDs, clinicians must rigorously evaluate the benefit-risk ratio because patients with PsA often have comorbidities. In France, one third of them have obesity, 20% have hypertension, and 20% have diabetes.
 

What is the recommended hierarchy for other treatments?

In the second phase of treatment, synthetic conventional treatments (like methotrexate, leflunomide, or sulfasalazine) are recommended. Methotrexate is by far the most used. This choice is based on efficacy, the efficacy-safety ratio, and cost.

A biologic therapy has no place as a first-line treatment because most PsA cases are moderate. In this regard, our European recommendations differ from American recommendations, which leave the choice between conventional or targeted therapies as a first-line treatment.

We have opted for a step-up approach. Although there is no study comparing a biologic therapy vs methotrexate as a first-line treatment, we have many data showing that more than half of patients will never need a biologic therapy.

We have a lot of experience with molecules like methotrexate. The benefit-risk ratio of this treatment as a first-line option is favorable, with efficacy for the skin. However, in axial forms, methotrexate is ineffective and calls for the use of biologic therapy.
 

Are there selection criteria for second-line biologic therapies?

Five classes of molecules are authorized and reimbursed in France: anti-TNF (tumor necrosis factor), anti–IL (interleukin)-17A, anti–IL-17A, -F, and -AF (bimekizumab), anti–IL-12/23 (ustekinumab), and anti–IL-23. All these treatments are effective in about two thirds of patients.

Unfortunately, we are not yet practicing personalized medicine to choose the most appropriate treatment for each patient, because we cannot predict this response. However, there are specific cases. Anti–IL-17 and anti–IL-23 can be favored in patients with bothersome skin involvement, either because it is extensive or located on the face or genital area. If a patient also has chronic inflammatory bowel disease, anti-TNF, anti–IL-23, or Janus kinase (JAK) inhibitors should be prioritized. In axial forms, anti-TNF or anti–IL-17 is recommended. But these cases concern only a minority of our patients. 

We have kept a place for JAK inhibitors in patients for whom biologic therapies are not suitable or effective. It is important to follow the recommendations of the European Medicines Agency, avoiding the use of JAK inhibitors after age 60 years, in smokers, or in those with cardiovascular risk. Oncologic monitoring is also important for patients treated with this therapeutic class.

Let’s also remember the role of apremilast, which is an alternative to biologic therapies in patients with moderate forms of the disease.

In the next 2 or 3 years, new modes of action or new molecules should be available, such as tyrosine kinase 2 (TYK2) inhibitors; izokibep, an oral nanomolecule targeting IL-17; or a new injectable anti–IL-17 with an affinity with interleukin that is incomparable to that of previous antibodies.
 

What message should be conveyed to the general practitioner?

PsA treatments are prescribed initially in hospitals, but rheumatologists will be able to prescribe them in the coming months. The general practitioner cannot initiate targeted treatment but has the role of starting methotrexate and referring the patient to specialized follow-up.

The most important thing to know is that in France, about half of patients will be on targeted treatment. The median maintenance of such therapy is only 3 years, which means that half of the patients will have replaced it with another therapy after 3 years. This switch could indicate a loss of efficacy or escape. It is therefore important for a specialist to follow the patient and to continue biologic monitoring every 2-6 months, as well as imaging every 2-5 years to check radiographic progression.

In cases of prolonged remission of more than 6 months, a gradual and cautious decrease in background treatments can be considered in a shared medical decision. However, treatment discontinuation leads to a systemic relapse in the short or long term, and a gradual decrease results in relapse in about half of the patients.
 

And in terms of monitoring?

The management of comorbidities is crucial. It is essential to keep vaccinations up to date, especially because of the increased risk for potential infections with targeted treatments. Regular screening for infections, including dental follow-up, is also recommended.

Preventive medicine is also important, especially regarding breast and colon cancer screening. General population recommendations apply.

Cardiovascular risk, which is doubled in patients with PsA compared with the general population due to chronic inflammation, should prompt monitoring of blood pressure and metabolic diseases. It should be noted that there is an 11% higher mortality rate after 8 years of follow-up, mainly due to cardiovascular and neoplastic risks.

Dr. Gossec reported receiving research grants from AbbVie, Biogen, Lilly, Novartis, and UCB and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Stada, and UCB.
 

This story was translated from Univadis France, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

Across the world, healthcare workers experience workplace violence, which can differ by gender, seniority, and the type of workplace, according to a recent study.

An analysis found that men were more likely to report physical violence, while women were more likely to face nonphysical violence, such as verbal abuse, sexual harassment, and bullying.

“Our study was sparked by the increasing research on workplace violence in healthcare settings. Yet, there’s less empirical data about workplace violence based on gender, its effects on individuals and the collective workforce, and its subsequent impact on patient care and healthcare organizations,” study author Basnama Ayaz, a PhD candidate in nursing at the University of Toronto, told this news organization.

“Workplace violence in healthcare settings is a critical issue that requires attention and action from all stakeholders, including individual providers, healthcare and other institutions, policymakers, and the community,” she said. “By recognizing the problem and implementing evidence-based solutions, we can create safer work environments that protect healthcare workers and improve quality care for patients and organizational effectiveness.”

The study was published online in PLOS Global Public Health.
 

Widespread and Severe

Although women represent most of the healthcare workforce worldwide, hierarchical structures tend to reflect traditional gender norms, where men hold leadership positions and women serve in front-line care roles, said Ms. Ayaz. Women are often marginalized, and their concerns dismissed, which can exacerbate their vulnerability to gender-based workplace violence, she added.

To better understand these imbalances on a global scale, the investigators conducted a scoping review of the prevalence of and risk factors for gender-based workplace violence in healthcare settings. Participants included physicians, nurses, and midwives, between 2010 and 2024. Although the authors acknowledged that gender-based workplace violence affects the full gender spectrum, only a handful of studies included information about nonbinary personnel, so the review focused on men and women.

Among 226 studies, half focused on physicians, 22% focused on nurses, and 28% included physicians, nurses, midwives, and other medical workers. About 64% of studies reported a higher prevalence of all forms of workplace violence for women, including sexual violence, verbal abuse, discrimination, bullying, and physical violence, while 17% reported a higher prevalence for men.

Overall, across most countries, men experienced more physical violence than did women, and women experienced more verbal abuse, sexual harassment, and bullying. Female nurses were particularly likely to experience violence.

Healthcare workers were also more likely to experience violence if they were younger, less experienced, had a lower professional status, or were part of a minority group based on ethnicity, nationality, culture, or language. These factors were sensitive to gender, “reflecting women’s structural disadvantages in the workplace,” wrote the authors.

As a result of workplace violence, women were more likely to report changes in mental health and social behaviors, as well as dissatisfaction, burnout, and changes in their career goals.

The research team identified various factors linked to violent episodes. In clinical settings where most perpetrators were patients and their relatives, abuse and violence could be related to overcrowding, waiting time, and heavy workloads for healthcare providers. When supervisors or colleagues were the perpetrators, workplace violence appeared to be more likely with long hours, night shifts, and certain clinical settings, such as emergency departments, psychiatric settings, operating rooms, and maternity wards, said Ms. Ayaz. Sexual or gender harassment toward women was more prevalent in male-dominated surgical specialties.

“We were surprised by the extent and severity of workplace violence that healthcare workers face around the globe based on gender,” she said. “One aspect that stood out was the significant role that organizational culture and support systems play either in mitigating or exacerbating these incidents, particularly the power structures between and within professions.”

For instance, trainees in lower hierarchical positions often face a higher risk for violence, especially gender-based harassment, she said. Many times, they feel they can’t report these incidents to trainers or managers, who may also be the perpetrators, she added.
 

Addressing Systemic Issues

In 2002, the World Health Organization, International Council of Nurses, and other major medical and labor groups worldwide launched a program focused on ways to eliminate workplace violence in healthcare settings. Since 2020, the call for a solution has grown louder as clinicians, nurses, and other health professionals faced more physical and verbal violence during the COVID-19 pandemic, often leading to burnout.

“Workplace violence is very important because it is more prevalent in healthcare workers than in many other settings and is on the rise,” said Karen Abrams, MD, assistant professor of psychiatry at the University of Toronto. Dr. Abrams, who wasn’t involved with this study, has researched physicians’ experiences of stalking by patients.

Workplace violence “can affect physical and mental health and lead to burnout, depression, anxiety, and symptoms of PTSD,” said Dr. Abrams. “It can affect one’s sleep and concentration and, therefore, ability to perform one’s job.”

Dr. Ayaz and colleagues suggested recommendations to improve gender-based workplace violence, noting the complex and multifaceted aspects of enhancing current policies, fortifying institutional capacities to respond, and implementing tailored interventions. Changes are needed at various levels, including at the healthcare system and provincial, territorial, and national levels, she said.

In Canada, for instance, lawmakers passed a bill in 2021 that amended the national criminal code to make intimidation or bullying a healthcare worker punishable by as many as 10 years in prison. The changes also required courts to consider more serious penalties for offenders who target healthcare workers aggressively.

But more needs to be done, medical professional groups say. The Canadian Nurses Association and Canadian Federation of Nurses Unions, as well as provincial groups, have called for a pan-Canadian violence-prevention framework, targeted funding for violence prevention infrastructure, and an update to the nation’s health human resources strategy to address severe staffing shortages across the country.

“Canada needs a bold vision for the future of our healthcare. Amid an ongoing staffing crisis, the cracks in our public healthcare systems have only grown deeper and wider, with too many going without the care they need when they need it,” Linda Silas, president of the Canadian Federation of Nurses Unions, told this news organization.

“Access to care relies on safe staffing. Years of unsafe working conditions and insufficient staffing are pushing nurses out of our public healthcare system,” she said. “Working collaboratively, we can make healthcare jobs the best jobs in our communities.”

The authors received no specific funding for the study. Ms. Ayaz, Dr. Abrams, and Ms. Silas reported no relevant financial relationships.

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

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

In the last 10 years, clinical outcomes have improved for patients with unresectable hepatocellular carcinoma (uHCC). The cancer generally comes with chronic liver inflammation, and liver cirrhosis is present in up to 80% of cases. The level of liver dysfunction helps determine the prognosis, but it also may affect the safety of delivering anticancer treatment.

Clinical trials that have tested systemic immunotherapies have excluded patients who don’t fall into the Child-Pugh class A criteria (CP-A) for liver disease, which is the least severe of the Child-Pugh classes A-C. Therefore, there has been much debate about whether patients who have more liver disease (moderate liver dysfunction) and fit under CP-B criteria, instead of CP-A, should be treated with immune checkpoint inhibitor (ICI) therapy or best supportive care (BSC).

A new study, led by Claudia Angela Maria Fulgenzi, MD, with the Department of Surgery and Cancer at the Imperial College London, England, published in JAMA Oncology on July 18, uses an alternative way to compare outcomes following two different paths of care for uHCC patients with moderate liver dysfunction.
 

How was the study done and what did the investigators find?

Researchers performed a retrospective, multicenter, international clinical case series of patients treated in routine practice in tertiary care centers across Europe, the United States, and Asia. They compared data from uHCC patients with CP-B who were receiving first-line ICI-based treatment regimens (n = 187) with a cohort of matched patients with CP-B receiving BSC (n = 156). The first-line immunotherapies were the monotherapy nivolumab or the combination (atezolizumab plus bevacizumab).

Immunotherapy was linked with significantly lower risk of death, compared with best supportive care.

ICI exposure was associated with a reduction of about 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001).
 

Is immunotherapy or best supportive care the superior treatment?

The authors wrote that the results point to “improved survival in association with ICI treatment, compared with BSC in patients with uHCC with CP-B liver dysfunction.”

According to the study’s senior author David Pinato, MD, PhD, “this is the first study to suggest that there might be an advantage [of treatment with immunotherapy] in a proportion of people with Child-Pugh B liver dysfunction and particularly so in those patients with more limited disease and portal vein tumor thrombosis.”
 

Will the findings of this study make treatment allocation for patients with uHCC and moderate liver dysfunction (CP-B) less controversial?

Because it is a retrospective study, Dr. Pinato said in an interview, that the findings are not definitive, but can be used to inform future randomized controlled trials.

Dr. Pinato, who is also with the Imperial College London, added that the findings may also introduce a new question.

Although the study was not powered to look at survival differences across the two immunotherapy options given to the patients, there did not seem to be a striking difference between using one immunotherapy (nivolumab) or a combination (atezolizumab plus bevacizumab), he said.

“This is quite important because we know that combinations are significantly superior to monotherapy in patients with normal liver function but based on our study we might say that this provides preliminary evidence that [superiority of combination therapy] might not be true if the liver function is worse.”
 

What do these findings add to the literature about how best to treat patients with uHCC and suboptimal liver function?

Without evidence of efficacy and safety for the group in previous studies, the widespread recommendation for those with moderate dysfunction has been BSC.

These findings “pave the way to select potential patient subgroups in clinical practice,” Dr. Pinato said. It also suggests that the safety level of immunotherapy treatments is acceptable in this patient population, so they are not necessarily disadvantaged compared to patients with more preserved liver function.

“This is the best level of evidence currently available to guide treatment decisions in patients with Child-Pugh B who have been universally excluded by prospective clinical trials and for whom there is no randomized comparison,” Dr. Pinato said.

Dr. Pinato reported personal fees from Roche, AstraZeneca, Eisai, Mina Therapeutics, Starpharma, Lift Biosciences, Boston Scientific, and Avammune, and grants from GSK, MSD, and BMS outside the submitted work. Dr. Fulgenzi has no disclosures. Other authors of the new research have multiple ties with pharmaceutical companies. Complete disclosures are available with the full text of the journal article.

Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

An electronic health record (EHR)–based nudge intervention could reduce potentially unnecessary sentinel lymph node biopsies (SLNB) among older women with early-stage breast cancer, the authors of new research say.

Participating surgeons noted that the reminder system added minimal friction to their workflow, as it did not require additional clicks or actions on the day of the patient visit, reported lead author Neil Carleton, PhD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues in JAMA Surgery (JAMA Surg. 2024 Jul 17. doi: 10.1001/jamasurg.2024.2407).

This effort to reduce the rate of SLNB stems from the Choosing Wisely campaign, which recommends against axillary staging in women 70 years and older with early-stage, clinically node-negative (cN0), hormone receptor–positive (HR+) breast cancer, the investigators said.

“These recommendations were developed because axillary staging did not impact survival, and rates of SLN positivity were low because of the tumor’s biological phenotype,” they wrote. “Even in older patients with tumors that exhibit concerning clinicopathologic features, limited nodal involvement does not often alter receipt of chemotherapy independently from genomic testing. Despite these recommendations, most women still receive axillary surgery.”
 

How Did the Nudge System Aim to Reduce the Rate of SLNB?

The nudge intervention involved adding a new column to the Epic schedule view, which flagged eligible patients during their first outpatient surgical consultation. The flag appeared as a caution sign or red clipboard icon. When surgeons hovered over the icon, a text box appeared, reminding them to consider omitting SLNB after a detailed review of core biopsy pathology and ultrasonographic imaging.

The intervention was evaluated at eight outpatient clinics within an integrated healthcare system that included seven breast surgical oncologists.

The study began with a 12-month preintervention period to serve as a control, during which time SLNB rate was determined via 194 patients in the target demographic. SLNB rate was again collected during the 12-month intervention period, which involved 193 patients meeting enrollment criteria. Between these periods, the investigators conducted a brief session lasting less than 30 minutes to introduce the surgeons to the rationale and design of the nudge column.
 

How Effective Was the Nudge System?

The intervention reduced the SLNB rate from 46.9% to 23.8%, representing a 49.3% decrease in use of SLNB. Efficacy was further supported by a significant reduction in SLNB according to an interrupted time series model (adjusted odds ratio, 0.26; 95% confidence interval, 0.07 to 0.90; P = .03). Extended follow-up showed that this effect was durable beyond the intervention period, with a 6-month mean reduction in SLNB of 15.6%.

Omission of SLNB led to higher rates of pathological node positivity during the intervention period (15.2% vs 8.8%), with all positive cases staged as pN1. Adjuvant therapy recommendations were similar between groups and driven by genomic testing, not nodal status. The intervention period also saw a decrease in referrals for lymphedema evaluation (3.6% vs. 6.2%).

How Might the Nudge System Be Implemented in Other Practices?

Although the SLNB nudge system was effective in the present study, likelihood of uptake among practices could vary widely, according to Anne M. Wallace, MD, professor of clinical surgery at UC San Diego Health and director of the Moores Comprehensive Breast Health Program.

On a fundamental level, not all centers use Epic software, which could present issues with compatibility, Dr. Wallace said in an interview. More importantly, she added, many institutions already have EHR-based alerts and reminders in place, so it is not always feasible to add a new nudge for every possible clinical scenario.

“Already there are so many little icons that we have to go through now when we close a note,” she said. “That’s why electronic medical records are becoming one of the leading stressors in medicine.”

This presents a more complex challenge, Dr. Wallace said, particularly as potentially practice-changing data are becoming available, and physicians may not have time to learn about them and integrate them into routine practice. She suggested that the present system may be most appropriate for oncologists in solo practice, or in small group practices where it is more challenging to have routine conversations about changing standards of care.

What Are the Risks of Using the Nudge System?

One of those conversations may surround the validity of the recommendation implemented in the present study.

Although the Society of Surgical Oncology recommends against SLNB in the described demographic, other experts, including Dr. Wallace, take a more nuanced view of the decision.

She noted that some patients with a chronological age of 70 may have a lower biological age, casting doubt on the legitimacy of the age threshold, and those near the threshold may wish to make the decision about staging for themselves.

Beyond these concerns, Dr. Wallace described two potential risks involved in forgoing SLNB.

First, there’s the potential for underestimating the tumor’s severity, she said, as this could mean a trip back to the operating room. A tumor initially thought to be low-grade might later be found to be high-grade, necessitating further surgery. Some patients might refuse additional surgery, leaving the more aggressive tumor untreated.

Second, the nudge system could complicate radiation treatment decisions, Dr. Wallace said. Without full nodal status, some radiation oncologists might push for additional radiation therapy, which incurs a greater treatment burden than SNLB.
 

What Are Some Alternatives to the Nudge System?

After discussing the strengths and weaknesses of the present EHR-based nudge system, and others like it, Dr. Wallace returned to the importance of ongoing communication among colleagues managing complex cases.

At UC San Diego Health, where oncologists meet weekly for a 2-hour breast cancer conference, “we nudge each other,” she said.

This study was supported by the Shear Family Foundation, UPMC eRecord Ambulatory Decision Support and Analytics, UPMC Hillman Cancer Center Biostatistics Facility, and National Institutes of Health. The investigators disclosed relationships with Pfizer, Amgen, the Lewin Group, and Milestone Pennsylvania, and others.

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

An estimated two million people in England and Scotland were experiencing symptoms of long COVID as of March 2024, according to the Office for National Statistics. Of these, 1.5 million said the condition was adversely affecting their day-to-day activities.

As more research emerges about long COVID, some experts are noticing that its trigger factors, symptoms, and causative mechanisms overlap with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

ME/CFS is characterized by severe fatigue that does not improve with rest, in addition to pain and cognitive problems. One in four patients are bed- or house-bound with severe forms of the condition, sometimes experiencing atypical seizures, and speech and swallowing difficulties.

Despite affecting around 250,000 people in the UK and around 2 million people in the European Union (EU), it is a relatively poorly funded disease research area. Increased research into long COVID is thus providing a much-needed boost to ME/CFS research.

“What we already know about the possible causation of ME/CFS is helping research into the causes of long COVID. At the same time, research into long COVID is opening up new avenues of research that may also be relevant to ME/CFS. It is becoming a two-way process,” Dr. Charles Shepherd, honorary medical adviser to the UK-based ME Association, told this news organization.

While funding remains an issue, promising research is currently underway in the UK to improve diagnosis, treatment, and understanding of the pathology of ME/CFS.
 

Viral Reactivation

Dr. David Newton is research director at ME Research UK. “Viral infection is commonly reported as a trigger for [ME/CFS, meaning that the disease] may be caused by reactivation of latent viruses, including human herpes viruses and enteroviruses,” he said.

Herpes viruses can lie dormant in their host’s immune system for long periods of time. They can be reactivated by factors including infections, stress, and a weakened immune system, and may cause temporary symptoms or persistent disease.

A 2021 pilot study found that people with ME/CFS have a higher concentration of human herpesvirus 6B (HHV-6B) DNA in their saliva, and that concentration correlates with symptom severity. HHV-6B is a common virus typically contracted during infancy and childhood.

A continuation of this research is now underway at Brunel University to improve understanding of HHV-6B’s role in the onset and progression of ME/CFS, and to support the development of diagnostic and prognostic markers, as well as therapeutics such as antiviral therapies.
 

Mitochondrial Dysfunction

Dr. Shepherd explained that there is now sound evidence demonstrating that biochemical abnormalities in ME/CFS affect how mitochondria produce energy after physical exertion. Research is thus underway to see if treating mitochondrial dysfunction improves ME/CFS symptoms.

A phase 2a placebo-controlled clinical trial from 2023 found that AXA1125, a drug that works by modulating energy metabolism, significantly improved symptoms of fatigue in patients with fatigue-dominant long COVID, although it did not improve mitochondrial respiration.

“[The findings suggest] that improving mitochondrial health may be one way to restore normal functioning among people with long COVID, and by extension CFS,” study author Betty Raman, associate professor of cardiovascular medicine at the University of Oxford, told this news organization. She noted, however, that plans for a phase III trial have stalled due to insufficient funding.

Meanwhile, researchers from the Quadram Institute in Norwich and the University of East Anglia are conducting a pilot study to see if red light therapy can relieve symptoms of ME/CFS. Red light can be absorbed by mitochondria and is used to boost energy production. The trial will monitor patients remotely from their homes and will assess cognitive function and physical activity levels.
 

Gut Dysbiosis

Many studies have found that people with ME/CFS have altered gut microbiota, which suggests that changes in gut bacteria may contribute to the condition. Researchers at the Quadram Institute will thus conduct a clinical trial called RESTORE-ME to see whether fecal microbiota transplants (FMT) can treat the condition.

Rik Haagmans is a research scientist and PhD candidate at the Quadram Institute. He told this news organization: “Our FMT studies, if effective, could provide a longer lasting or even permanent relief of ME/CFS, as restoring the gut microbial composition wouldn’t require continuous medication,” he said.
 

Biobank and Biomarkers

Europe’s first ME/CFS-specific biobank is in the UK and is called UKMEB. It now has more than 30,000 blood samples from patients with ME/CFS, multiple sclerosis, and healthy controls. Uniquely, it includes samples from people with ME/CFS who are house- and bed-bound. Caroline Kingdon, RN, MSc, a research fellow and biobank lead at the London School of Hygiene and Tropical Medicine, told this news organization that samples and data from the UKMEB have been provided to research groups all over the world and have contributed to widely cited literature.

One group making use of these samples is led by Fatima Labeed, PhD, senior lecturer in human biology at the University of Surrey. Dr. Labeed and her team are developing a diagnostic test for ME/CFS based on electrical properties in white blood cells.

“To date, studies of ME/CFS have focused on the biochemical behavior of cells: the amount and type of proteins that cells use. We have taken a different approach, studying the electrical properties,” she explained to this news organization.

Her research builds on initial observations from 2019 that found differences in the electrical impedance of white blood cells between people with ME/CFS and controls. While the biological implications remain unknown, the findings may represent a biomarker for the condition.

Using blood samples from the UKMEB, the researchers are now investigating this potential biomarker with improved techniques and a larger patient cohort, including those with mild/moderate and severe forms of ME/CFS. So far, they have received more than 100 blood samples and have analyzed the electrical properties of 42.

“Based on the results we have so far, we are very close to having a biomarker for diagnosis. Our results so far show a high degree of accuracy and are able to distinguish between ME/CFS and other diseases,” said Dr. Labeed.
 

Genetic Test

Another promising avenue for diagnostics comes from a research team at the University of Edinburgh led by Professor Chris Ponting at the university’s Institute of Genetics and Cancer. They are currently working on DecodeMe, a large genetic study of ME using data from more than 26,000 people.

“We are studying blood-based biomarkers that distinguish people with ME from population controls. We’ve found a large number — including some found previously in other studies — and are writing these results up for publication,” said Ponting. The results should be published in early 2025.
 

The Future

While research into ME/CFS has picked up pace in recent years, funding remains a key bottleneck.

“Over the last 10 years, only £8.05m has been spent on ME research,” Sonya Chowdhury, chief executive of UK charity Action for ME told this news organization. She believes this amount is not equitably comparable to research funding allocated to other diseases.

In 2022, the UK government announced its intention to develop a cross-government interim delivery plan on ME/CFS for England, however publication of the final plan has been delayed numerous times.

Dr. Shepherd agreed that increased funding is crucial for progress to be made. He said the biggest help to ME/CFS research would be to end the disparity in government research funding for the disease, and match what is given for many other disabling long-term conditions.

“It’s not fair to continue to rely on the charity sector to fund almost all of the biomedical research into ME/CFS here in the UK,” he said.

A version of this article appeared on Medscape.com.

An estimated two million people in England and Scotland were experiencing symptoms of long COVID as of March 2024, according to the Office for National Statistics. Of these, 1.5 million said the condition was adversely affecting their day-to-day activities.

As more research emerges about long COVID, some experts are noticing that its trigger factors, symptoms, and causative mechanisms overlap with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

ME/CFS is characterized by severe fatigue that does not improve with rest, in addition to pain and cognitive problems. One in four patients are bed- or house-bound with severe forms of the condition, sometimes experiencing atypical seizures, and speech and swallowing difficulties.

Despite affecting around 250,000 people in the UK and around 2 million people in the European Union (EU), it is a relatively poorly funded disease research area. Increased research into long COVID is thus providing a much-needed boost to ME/CFS research.

“What we already know about the possible causation of ME/CFS is helping research into the causes of long COVID. At the same time, research into long COVID is opening up new avenues of research that may also be relevant to ME/CFS. It is becoming a two-way process,” Dr. Charles Shepherd, honorary medical adviser to the UK-based ME Association, told this news organization.

While funding remains an issue, promising research is currently underway in the UK to improve diagnosis, treatment, and understanding of the pathology of ME/CFS.
 

Viral Reactivation

Dr. David Newton is research director at ME Research UK. “Viral infection is commonly reported as a trigger for [ME/CFS, meaning that the disease] may be caused by reactivation of latent viruses, including human herpes viruses and enteroviruses,” he said.

Herpes viruses can lie dormant in their host’s immune system for long periods of time. They can be reactivated by factors including infections, stress, and a weakened immune system, and may cause temporary symptoms or persistent disease.

A 2021 pilot study found that people with ME/CFS have a higher concentration of human herpesvirus 6B (HHV-6B) DNA in their saliva, and that concentration correlates with symptom severity. HHV-6B is a common virus typically contracted during infancy and childhood.

A continuation of this research is now underway at Brunel University to improve understanding of HHV-6B’s role in the onset and progression of ME/CFS, and to support the development of diagnostic and prognostic markers, as well as therapeutics such as antiviral therapies.
 

Mitochondrial Dysfunction

Dr. Shepherd explained that there is now sound evidence demonstrating that biochemical abnormalities in ME/CFS affect how mitochondria produce energy after physical exertion. Research is thus underway to see if treating mitochondrial dysfunction improves ME/CFS symptoms.

A phase 2a placebo-controlled clinical trial from 2023 found that AXA1125, a drug that works by modulating energy metabolism, significantly improved symptoms of fatigue in patients with fatigue-dominant long COVID, although it did not improve mitochondrial respiration.

“[The findings suggest] that improving mitochondrial health may be one way to restore normal functioning among people with long COVID, and by extension CFS,” study author Betty Raman, associate professor of cardiovascular medicine at the University of Oxford, told this news organization. She noted, however, that plans for a phase III trial have stalled due to insufficient funding.

Meanwhile, researchers from the Quadram Institute in Norwich and the University of East Anglia are conducting a pilot study to see if red light therapy can relieve symptoms of ME/CFS. Red light can be absorbed by mitochondria and is used to boost energy production. The trial will monitor patients remotely from their homes and will assess cognitive function and physical activity levels.
 

Gut Dysbiosis

Many studies have found that people with ME/CFS have altered gut microbiota, which suggests that changes in gut bacteria may contribute to the condition. Researchers at the Quadram Institute will thus conduct a clinical trial called RESTORE-ME to see whether fecal microbiota transplants (FMT) can treat the condition.

Rik Haagmans is a research scientist and PhD candidate at the Quadram Institute. He told this news organization: “Our FMT studies, if effective, could provide a longer lasting or even permanent relief of ME/CFS, as restoring the gut microbial composition wouldn’t require continuous medication,” he said.
 

Biobank and Biomarkers

Europe’s first ME/CFS-specific biobank is in the UK and is called UKMEB. It now has more than 30,000 blood samples from patients with ME/CFS, multiple sclerosis, and healthy controls. Uniquely, it includes samples from people with ME/CFS who are house- and bed-bound. Caroline Kingdon, RN, MSc, a research fellow and biobank lead at the London School of Hygiene and Tropical Medicine, told this news organization that samples and data from the UKMEB have been provided to research groups all over the world and have contributed to widely cited literature.

One group making use of these samples is led by Fatima Labeed, PhD, senior lecturer in human biology at the University of Surrey. Dr. Labeed and her team are developing a diagnostic test for ME/CFS based on electrical properties in white blood cells.

“To date, studies of ME/CFS have focused on the biochemical behavior of cells: the amount and type of proteins that cells use. We have taken a different approach, studying the electrical properties,” she explained to this news organization.

Her research builds on initial observations from 2019 that found differences in the electrical impedance of white blood cells between people with ME/CFS and controls. While the biological implications remain unknown, the findings may represent a biomarker for the condition.

Using blood samples from the UKMEB, the researchers are now investigating this potential biomarker with improved techniques and a larger patient cohort, including those with mild/moderate and severe forms of ME/CFS. So far, they have received more than 100 blood samples and have analyzed the electrical properties of 42.

“Based on the results we have so far, we are very close to having a biomarker for diagnosis. Our results so far show a high degree of accuracy and are able to distinguish between ME/CFS and other diseases,” said Dr. Labeed.
 

Genetic Test

Another promising avenue for diagnostics comes from a research team at the University of Edinburgh led by Professor Chris Ponting at the university’s Institute of Genetics and Cancer. They are currently working on DecodeMe, a large genetic study of ME using data from more than 26,000 people.

“We are studying blood-based biomarkers that distinguish people with ME from population controls. We’ve found a large number — including some found previously in other studies — and are writing these results up for publication,” said Ponting. The results should be published in early 2025.
 

The Future

While research into ME/CFS has picked up pace in recent years, funding remains a key bottleneck.

“Over the last 10 years, only £8.05m has been spent on ME research,” Sonya Chowdhury, chief executive of UK charity Action for ME told this news organization. She believes this amount is not equitably comparable to research funding allocated to other diseases.

In 2022, the UK government announced its intention to develop a cross-government interim delivery plan on ME/CFS for England, however publication of the final plan has been delayed numerous times.

Dr. Shepherd agreed that increased funding is crucial for progress to be made. He said the biggest help to ME/CFS research would be to end the disparity in government research funding for the disease, and match what is given for many other disabling long-term conditions.

“It’s not fair to continue to rely on the charity sector to fund almost all of the biomedical research into ME/CFS here in the UK,” he said.

A version of this article appeared on Medscape.com.

An estimated two million people in England and Scotland were experiencing symptoms of long COVID as of March 2024, according to the Office for National Statistics. Of these, 1.5 million said the condition was adversely affecting their day-to-day activities.

As more research emerges about long COVID, some experts are noticing that its trigger factors, symptoms, and causative mechanisms overlap with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

ME/CFS is characterized by severe fatigue that does not improve with rest, in addition to pain and cognitive problems. One in four patients are bed- or house-bound with severe forms of the condition, sometimes experiencing atypical seizures, and speech and swallowing difficulties.

Despite affecting around 250,000 people in the UK and around 2 million people in the European Union (EU), it is a relatively poorly funded disease research area. Increased research into long COVID is thus providing a much-needed boost to ME/CFS research.

“What we already know about the possible causation of ME/CFS is helping research into the causes of long COVID. At the same time, research into long COVID is opening up new avenues of research that may also be relevant to ME/CFS. It is becoming a two-way process,” Dr. Charles Shepherd, honorary medical adviser to the UK-based ME Association, told this news organization.

While funding remains an issue, promising research is currently underway in the UK to improve diagnosis, treatment, and understanding of the pathology of ME/CFS.
 

Viral Reactivation

Dr. David Newton is research director at ME Research UK. “Viral infection is commonly reported as a trigger for [ME/CFS, meaning that the disease] may be caused by reactivation of latent viruses, including human herpes viruses and enteroviruses,” he said.

Herpes viruses can lie dormant in their host’s immune system for long periods of time. They can be reactivated by factors including infections, stress, and a weakened immune system, and may cause temporary symptoms or persistent disease.

A 2021 pilot study found that people with ME/CFS have a higher concentration of human herpesvirus 6B (HHV-6B) DNA in their saliva, and that concentration correlates with symptom severity. HHV-6B is a common virus typically contracted during infancy and childhood.

A continuation of this research is now underway at Brunel University to improve understanding of HHV-6B’s role in the onset and progression of ME/CFS, and to support the development of diagnostic and prognostic markers, as well as therapeutics such as antiviral therapies.
 

Mitochondrial Dysfunction

Dr. Shepherd explained that there is now sound evidence demonstrating that biochemical abnormalities in ME/CFS affect how mitochondria produce energy after physical exertion. Research is thus underway to see if treating mitochondrial dysfunction improves ME/CFS symptoms.

A phase 2a placebo-controlled clinical trial from 2023 found that AXA1125, a drug that works by modulating energy metabolism, significantly improved symptoms of fatigue in patients with fatigue-dominant long COVID, although it did not improve mitochondrial respiration.

“[The findings suggest] that improving mitochondrial health may be one way to restore normal functioning among people with long COVID, and by extension CFS,” study author Betty Raman, associate professor of cardiovascular medicine at the University of Oxford, told this news organization. She noted, however, that plans for a phase III trial have stalled due to insufficient funding.

Meanwhile, researchers from the Quadram Institute in Norwich and the University of East Anglia are conducting a pilot study to see if red light therapy can relieve symptoms of ME/CFS. Red light can be absorbed by mitochondria and is used to boost energy production. The trial will monitor patients remotely from their homes and will assess cognitive function and physical activity levels.
 

Gut Dysbiosis

Many studies have found that people with ME/CFS have altered gut microbiota, which suggests that changes in gut bacteria may contribute to the condition. Researchers at the Quadram Institute will thus conduct a clinical trial called RESTORE-ME to see whether fecal microbiota transplants (FMT) can treat the condition.

Rik Haagmans is a research scientist and PhD candidate at the Quadram Institute. He told this news organization: “Our FMT studies, if effective, could provide a longer lasting or even permanent relief of ME/CFS, as restoring the gut microbial composition wouldn’t require continuous medication,” he said.
 

Biobank and Biomarkers

Europe’s first ME/CFS-specific biobank is in the UK and is called UKMEB. It now has more than 30,000 blood samples from patients with ME/CFS, multiple sclerosis, and healthy controls. Uniquely, it includes samples from people with ME/CFS who are house- and bed-bound. Caroline Kingdon, RN, MSc, a research fellow and biobank lead at the London School of Hygiene and Tropical Medicine, told this news organization that samples and data from the UKMEB have been provided to research groups all over the world and have contributed to widely cited literature.

One group making use of these samples is led by Fatima Labeed, PhD, senior lecturer in human biology at the University of Surrey. Dr. Labeed and her team are developing a diagnostic test for ME/CFS based on electrical properties in white blood cells.

“To date, studies of ME/CFS have focused on the biochemical behavior of cells: the amount and type of proteins that cells use. We have taken a different approach, studying the electrical properties,” she explained to this news organization.

Her research builds on initial observations from 2019 that found differences in the electrical impedance of white blood cells between people with ME/CFS and controls. While the biological implications remain unknown, the findings may represent a biomarker for the condition.

Using blood samples from the UKMEB, the researchers are now investigating this potential biomarker with improved techniques and a larger patient cohort, including those with mild/moderate and severe forms of ME/CFS. So far, they have received more than 100 blood samples and have analyzed the electrical properties of 42.

“Based on the results we have so far, we are very close to having a biomarker for diagnosis. Our results so far show a high degree of accuracy and are able to distinguish between ME/CFS and other diseases,” said Dr. Labeed.
 

Genetic Test

Another promising avenue for diagnostics comes from a research team at the University of Edinburgh led by Professor Chris Ponting at the university’s Institute of Genetics and Cancer. They are currently working on DecodeMe, a large genetic study of ME using data from more than 26,000 people.

“We are studying blood-based biomarkers that distinguish people with ME from population controls. We’ve found a large number — including some found previously in other studies — and are writing these results up for publication,” said Ponting. The results should be published in early 2025.
 

The Future

While research into ME/CFS has picked up pace in recent years, funding remains a key bottleneck.

“Over the last 10 years, only £8.05m has been spent on ME research,” Sonya Chowdhury, chief executive of UK charity Action for ME told this news organization. She believes this amount is not equitably comparable to research funding allocated to other diseases.

In 2022, the UK government announced its intention to develop a cross-government interim delivery plan on ME/CFS for England, however publication of the final plan has been delayed numerous times.

Dr. Shepherd agreed that increased funding is crucial for progress to be made. He said the biggest help to ME/CFS research would be to end the disparity in government research funding for the disease, and match what is given for many other disabling long-term conditions.

“It’s not fair to continue to rely on the charity sector to fund almost all of the biomedical research into ME/CFS here in the UK,” he said.

A version of this article appeared on Medscape.com.

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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