Physician Compensation: Gains Small, Gaps Large

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Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.

“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”

Dr. Amit Phull



Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.

 

Compensation Lag May Impact Care

A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.

In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity. 

Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.

 

Narrowing the Gap for Primary Care?

Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.

“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”

Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.

 

The Specialties

This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.

By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.

The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.

The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.

 

Practice Setting and Location

Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.

The Gender Effect

With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.

Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.

Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.

According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News

Dr. Maria T. Abreu



The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.

Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?

Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.

Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”

In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.

Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.

Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”

Abreu reported no conflicts of interest in regard to her comments.

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Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.

“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”

Dr. Amit Phull



Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.

 

Compensation Lag May Impact Care

A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.

In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity. 

Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.

 

Narrowing the Gap for Primary Care?

Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.

“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”

Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.

 

The Specialties

This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.

By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.

The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.

The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.

 

Practice Setting and Location

Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.

The Gender Effect

With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.

Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.

Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.

According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News

Dr. Maria T. Abreu



The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.

Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?

Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.

Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”

In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.

Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.

Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”

Abreu reported no conflicts of interest in regard to her comments.

Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that more than three-quarters of physicians polled would still choose to enter their profession.

“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”

Dr. Amit Phull



Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.

 

Compensation Lag May Impact Care

A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.

In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity. 

Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.

 

Narrowing the Gap for Primary Care?

Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.

“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”

Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.

 

The Specialties

This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.

By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. Neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.

The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.

The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.

 

Practice Setting and Location

Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.

The Gender Effect

With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to its 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.

Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.

Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.

According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News

Dr. Maria T. Abreu



The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.

Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?

Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.

Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”

In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.

Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.

Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”

Abreu reported no conflicts of interest in regard to her comments.

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Supporting Exceptional Researchers

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Did you know that the AGA Research Foundation helped support 74 researchers this past May? At the AGA Research Foundation, it’s our purpose to help talented investigators achieve their research goals.

But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.

When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.

It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].







 

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Did you know that the AGA Research Foundation helped support 74 researchers this past May? At the AGA Research Foundation, it’s our purpose to help talented investigators achieve their research goals.

But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.

When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.

It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].







 

Did you know that the AGA Research Foundation helped support 74 researchers this past May? At the AGA Research Foundation, it’s our purpose to help talented investigators achieve their research goals.

But we can’t do it without you. We depend on the generosity of our supporters to make our vision for the future a reality.

When you donate to AGA Research Foundation, you don’t just give funds – you personally give our beneficiaries grant funding that will lead to new discoveries in GI. Your support goes directly towards funding GI research, helping us address immediate needs while building the foundation for long-term solutions. Plus, you’ll become part of a community full of passionate members like you.

It’s easy to make your mark on our efforts to support investigators. Simply visit our website or learn more ways to give here: [email protected] or contact us at [email protected].







 

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Racial, Ethnic Discrimination Tied to Psychosis Risk

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TOPLINE:

Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.

METHODOLOGY:

  • Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
  • The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
  • Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
  • They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.

TAKEAWAY:

  • All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
  • Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
  • The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
  • More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.

IN PRACTICE:

“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.

SOURCE:

The study was published online in PLOS Mental Health

LIMITATIONS:

The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.

DISCLOSURES:

The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.

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

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

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TOPLINE:

Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.

METHODOLOGY:

  • Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
  • The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
  • Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
  • They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.

TAKEAWAY:

  • All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
  • Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
  • The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
  • More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.

IN PRACTICE:

“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.

SOURCE:

The study was published online in PLOS Mental Health

LIMITATIONS:

The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.

DISCLOSURES:

The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.

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

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

TOPLINE:

Racial and ethnic discrimination was consistently associated with increased risk for psychosis in studies included in a new umbrella review, with odds nearly doubled for both psychotic symptoms and experiences.

METHODOLOGY:

  • Researchers searched 5 databases and then conducted an umbrella review of 7 systematic reviews, 4 of which included meta-analyses, published between 2003 and 2023.
  • The systematic reviews included 23 primary studies representing more than 40,000 participants from Europe and the US.
  • Investigators assessed the potential association between perceived racial or ethnic discrimination (mostly measured using self-reported questionnaires) and risk for psychosis (measured using established questionnaires).
  • They assessed the risk for bias using the 16-item A MeaSurement Tool to Assess systematic Reviews, version 2 (AMSTAR-2) checklist.

TAKEAWAY:

  • All reviews that included meta-analyses showed significant associations between perceived ethnic discrimination and psychotic symptoms (adjusted odds ratio [aOR], 1.78; 95% CI, 1.3-2.5) and psychotic experiences (pooled OR, 1.9; 95% CI, 1.4-2.7).
  • Perceived racial or ethnic discrimination was also strongly linked to delusional symptoms (OR, 2.5; 95% CI, 1.6-4.0) and hallucinatory symptoms (OR, 1.65; 95% CI, 1.3-2.1).
  • The largest of the included studies showed a dose-response relationship between higher levels of lifetime perceived racial or ethnic discrimination and greater likelihood of psychotic experiences.
  • More robust associations were found in nonclinical populations compared to clinical ones, but there were significant associations in both.

IN PRACTICE:

“Our review was only looking at the impact of a person directly perceiving racism or interpersonal racial or ethnic discrimination; it may be that systemic racism, which can go unseen but still have profound impacts, could further contribute to mental health disparities,” lead investigator India Francis-Crossley, University College London, London, UK, said in a press release.

SOURCE:

The study was published online in PLOS Mental Health

LIMITATIONS:

The evidence was primarily based on cross-sectional studies and was limited by high heterogeneity. The reviews included showed low or critically low AMSTAR-2 quality scores, which may have affected the robustness of the findings. More robust evidence was observed for psychotic outcomes in nonclinical populations compared to clinical samples. Additionally, the study potentially exacerbated errors or misreporting in the original reviews and did not include relevant structural factors such as income, education, housing, and poverty.

DISCLOSURES:

The study was funded by the University College London-Windsor Fellowship Research Opportunities scholarship, Wellcome Trust PhD Fellowship in Mental Health Science, Mental Health Mission Early Psychosis Workstream, and UK Research and Innovation funding for the Population Mental Health Consortium. The investigators reported having no relevant conflicts of interest.

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

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

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Mental Health Practitioners Continue to Decrease Despite Aging Vet Population

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This article has been updated with a response from the US Department of Veterans Affairs.

The number of US Department of Veterans Affairs (VA) geriatric mental health professionals is failing to keep pace with a growing population of older veterans: nearly 8 million are aged ≥ 65 years. VA psychologists may treat older veterans in primary care settings or community living centers, but many lack formal training in geropsychology.

Some psychologists with the proper training to treat this population are leaving the workforce; a survey by the VA Office of Inspector General found psychology was the most frequently reported severe clinical occupational staffing shortage and the most frequently reported Hybrid Title 38 severe shortage occupation, with 57% of 139 facilities reporting it as a shortage. According to the September Workforce Dashboard, the VA has lost > 200 psychologists in 2025.

Veterans aged 65 years have higher rates of combined medical and mental health diagnoses than younger veterans and older nonveterans. Nearly 1 of 5 older veterans enrolled in US Department of Veterans Affairs (VA) health care services have confirmed mental health diagnoses, and another 26% have documented mental health concerns without a formal diagnosis in their health record. 

Older veterans also tend to have more complex mental health issues than younger adults. Posttraumatic stress nearly doubles their risk of dementia, and their psychiatric diagnoses may be complicated by co-occurring delirium, social isolation/loneliness, and polypharmacy.

According to reporting by The War Horse, the VA has been instituting limits on one-on-one mental health therapy and transitioning veterans to lower levels of treatment after having been told to stop treating them for long, indeterminate periods prior to referring them to group therapy, primary care, or discharging them altogether. In a statement to Federal Practitioner, VA Press Secretary Pete Kasperowicz refuted the reporting from The War Horse.

"The War Horse story is false. VA does not put caps on one-on-one mental health sessions for veterans with clinical care needs," he told Federal Practitioner. "VA works with veterans over an initial eight to 15 mental health sessions, and collaboratively plans any needed follow-on care. As part of this process, veterans and their health care team decide together how to address ongoing needs, including whether to step down to other types of care and self-maintenance, or continue with VA therapy."

The smaller pool of qualified mental health practitioners also may be due to medical students not knowing enough about the category. A study of 136 medical students and 61 internal medicine residents at an academic health center evaluated their beliefs and attitudes regarding 25 content areas essential to the primary care of older adults. Students and residents expressed similar beliefs about the importance of content areas, and attitudes toward aging did not appreciably differ. However, students rated lower in knowledge in areas surrounding general primary care, such as chronic conditions and medications. Residents reported larger gap scores in areas that reflected specialists’ expertise (eg, driving risk, cognition, and psychiatric symptoms).

VA does have channels for filling the gap in geriatric health care. Established in 1975, Geriatric Research, Education, and Clinical Centers (GRECCs), are the department’s centers of excellence focused on aging. Currently, there are 20 GRECCs across the country, each connected with a major research university. Studies focus on aging, for example, examining the effects of Alzheimer’s disease or traumatic brain injuries. 

Geriatric Scholars 

To specifically fill the gap in mental health care, the Geriatric Scholars Program (GSP) was developed in 2008. Initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists, the program later expanded to include other disciplines, including psychiatrists. In 2013, the GSP–Psychology Track (GSP-P) was developed because there were no commercially available training in geropsychology for licensed psychologists. GSP-P is based on an evidence-based educational model for the VA primary care workforce and includes a stepwise curriculum design, pilot implementation, and program evaluation. 

A recent survey that assessed the track’s effectiveness found respondents “strongly agreed” that participation in the program improved their geropsychology knowledge and skills. That positive reaction led to shifts in practice that had a positive impact on VA organizational goals. Several GSP-P graduates have become board certified in geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows.

Whether programs such as GSP-P can adequately address the dwindling number of VA mental health care professionals remains to be seen. More than 160 doctors, psychologists, nurses, and researchers sent a letter to VA Secretary Doug Collins, the VA inspector general, and congressional leaders on Sept. 24 warning that workforce reductions and moves to outsource care will harm veterans.

“We have witnessed these ongoing harms and can provide evidence and testimony of their impacts,” the letter read. By the next day, the number of signees had increased to 350. 

Though these shortages may impact their mental health care, older veterans could have an edge in mental resilience. While research in younger adults has found positive linear associations between physical health difficulties and severity of psychiatric symptoms, older veterans may benefit from what researchers have called an “aging paradox,” in which mental health improves later in life despite declining physical and cognitive function. A 2021 study suggests that prevention and treatment strategies designed to foster attachment security, mindfulness, and purpose in life may help enhance psychological resilience to physical health difficulties in older veterans.

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This article has been updated with a response from the US Department of Veterans Affairs.

The number of US Department of Veterans Affairs (VA) geriatric mental health professionals is failing to keep pace with a growing population of older veterans: nearly 8 million are aged ≥ 65 years. VA psychologists may treat older veterans in primary care settings or community living centers, but many lack formal training in geropsychology.

Some psychologists with the proper training to treat this population are leaving the workforce; a survey by the VA Office of Inspector General found psychology was the most frequently reported severe clinical occupational staffing shortage and the most frequently reported Hybrid Title 38 severe shortage occupation, with 57% of 139 facilities reporting it as a shortage. According to the September Workforce Dashboard, the VA has lost > 200 psychologists in 2025.

Veterans aged 65 years have higher rates of combined medical and mental health diagnoses than younger veterans and older nonveterans. Nearly 1 of 5 older veterans enrolled in US Department of Veterans Affairs (VA) health care services have confirmed mental health diagnoses, and another 26% have documented mental health concerns without a formal diagnosis in their health record. 

Older veterans also tend to have more complex mental health issues than younger adults. Posttraumatic stress nearly doubles their risk of dementia, and their psychiatric diagnoses may be complicated by co-occurring delirium, social isolation/loneliness, and polypharmacy.

According to reporting by The War Horse, the VA has been instituting limits on one-on-one mental health therapy and transitioning veterans to lower levels of treatment after having been told to stop treating them for long, indeterminate periods prior to referring them to group therapy, primary care, or discharging them altogether. In a statement to Federal Practitioner, VA Press Secretary Pete Kasperowicz refuted the reporting from The War Horse.

"The War Horse story is false. VA does not put caps on one-on-one mental health sessions for veterans with clinical care needs," he told Federal Practitioner. "VA works with veterans over an initial eight to 15 mental health sessions, and collaboratively plans any needed follow-on care. As part of this process, veterans and their health care team decide together how to address ongoing needs, including whether to step down to other types of care and self-maintenance, or continue with VA therapy."

The smaller pool of qualified mental health practitioners also may be due to medical students not knowing enough about the category. A study of 136 medical students and 61 internal medicine residents at an academic health center evaluated their beliefs and attitudes regarding 25 content areas essential to the primary care of older adults. Students and residents expressed similar beliefs about the importance of content areas, and attitudes toward aging did not appreciably differ. However, students rated lower in knowledge in areas surrounding general primary care, such as chronic conditions and medications. Residents reported larger gap scores in areas that reflected specialists’ expertise (eg, driving risk, cognition, and psychiatric symptoms).

VA does have channels for filling the gap in geriatric health care. Established in 1975, Geriatric Research, Education, and Clinical Centers (GRECCs), are the department’s centers of excellence focused on aging. Currently, there are 20 GRECCs across the country, each connected with a major research university. Studies focus on aging, for example, examining the effects of Alzheimer’s disease or traumatic brain injuries. 

Geriatric Scholars 

To specifically fill the gap in mental health care, the Geriatric Scholars Program (GSP) was developed in 2008. Initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists, the program later expanded to include other disciplines, including psychiatrists. In 2013, the GSP–Psychology Track (GSP-P) was developed because there were no commercially available training in geropsychology for licensed psychologists. GSP-P is based on an evidence-based educational model for the VA primary care workforce and includes a stepwise curriculum design, pilot implementation, and program evaluation. 

A recent survey that assessed the track’s effectiveness found respondents “strongly agreed” that participation in the program improved their geropsychology knowledge and skills. That positive reaction led to shifts in practice that had a positive impact on VA organizational goals. Several GSP-P graduates have become board certified in geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows.

Whether programs such as GSP-P can adequately address the dwindling number of VA mental health care professionals remains to be seen. More than 160 doctors, psychologists, nurses, and researchers sent a letter to VA Secretary Doug Collins, the VA inspector general, and congressional leaders on Sept. 24 warning that workforce reductions and moves to outsource care will harm veterans.

“We have witnessed these ongoing harms and can provide evidence and testimony of their impacts,” the letter read. By the next day, the number of signees had increased to 350. 

Though these shortages may impact their mental health care, older veterans could have an edge in mental resilience. While research in younger adults has found positive linear associations between physical health difficulties and severity of psychiatric symptoms, older veterans may benefit from what researchers have called an “aging paradox,” in which mental health improves later in life despite declining physical and cognitive function. A 2021 study suggests that prevention and treatment strategies designed to foster attachment security, mindfulness, and purpose in life may help enhance psychological resilience to physical health difficulties in older veterans.

This article has been updated with a response from the US Department of Veterans Affairs.

The number of US Department of Veterans Affairs (VA) geriatric mental health professionals is failing to keep pace with a growing population of older veterans: nearly 8 million are aged ≥ 65 years. VA psychologists may treat older veterans in primary care settings or community living centers, but many lack formal training in geropsychology.

Some psychologists with the proper training to treat this population are leaving the workforce; a survey by the VA Office of Inspector General found psychology was the most frequently reported severe clinical occupational staffing shortage and the most frequently reported Hybrid Title 38 severe shortage occupation, with 57% of 139 facilities reporting it as a shortage. According to the September Workforce Dashboard, the VA has lost > 200 psychologists in 2025.

Veterans aged 65 years have higher rates of combined medical and mental health diagnoses than younger veterans and older nonveterans. Nearly 1 of 5 older veterans enrolled in US Department of Veterans Affairs (VA) health care services have confirmed mental health diagnoses, and another 26% have documented mental health concerns without a formal diagnosis in their health record. 

Older veterans also tend to have more complex mental health issues than younger adults. Posttraumatic stress nearly doubles their risk of dementia, and their psychiatric diagnoses may be complicated by co-occurring delirium, social isolation/loneliness, and polypharmacy.

According to reporting by The War Horse, the VA has been instituting limits on one-on-one mental health therapy and transitioning veterans to lower levels of treatment after having been told to stop treating them for long, indeterminate periods prior to referring them to group therapy, primary care, or discharging them altogether. In a statement to Federal Practitioner, VA Press Secretary Pete Kasperowicz refuted the reporting from The War Horse.

"The War Horse story is false. VA does not put caps on one-on-one mental health sessions for veterans with clinical care needs," he told Federal Practitioner. "VA works with veterans over an initial eight to 15 mental health sessions, and collaboratively plans any needed follow-on care. As part of this process, veterans and their health care team decide together how to address ongoing needs, including whether to step down to other types of care and self-maintenance, or continue with VA therapy."

The smaller pool of qualified mental health practitioners also may be due to medical students not knowing enough about the category. A study of 136 medical students and 61 internal medicine residents at an academic health center evaluated their beliefs and attitudes regarding 25 content areas essential to the primary care of older adults. Students and residents expressed similar beliefs about the importance of content areas, and attitudes toward aging did not appreciably differ. However, students rated lower in knowledge in areas surrounding general primary care, such as chronic conditions and medications. Residents reported larger gap scores in areas that reflected specialists’ expertise (eg, driving risk, cognition, and psychiatric symptoms).

VA does have channels for filling the gap in geriatric health care. Established in 1975, Geriatric Research, Education, and Clinical Centers (GRECCs), are the department’s centers of excellence focused on aging. Currently, there are 20 GRECCs across the country, each connected with a major research university. Studies focus on aging, for example, examining the effects of Alzheimer’s disease or traumatic brain injuries. 

Geriatric Scholars 

To specifically fill the gap in mental health care, the Geriatric Scholars Program (GSP) was developed in 2008. Initially focused on primary care physicians, nurse practitioners, physician assistants, and pharmacists, the program later expanded to include other disciplines, including psychiatrists. In 2013, the GSP–Psychology Track (GSP-P) was developed because there were no commercially available training in geropsychology for licensed psychologists. GSP-P is based on an evidence-based educational model for the VA primary care workforce and includes a stepwise curriculum design, pilot implementation, and program evaluation. 

A recent survey that assessed the track’s effectiveness found respondents “strongly agreed” that participation in the program improved their geropsychology knowledge and skills. That positive reaction led to shifts in practice that had a positive impact on VA organizational goals. Several GSP-P graduates have become board certified in geropsychology and many proceed to supervise geropsychology-focused clinical rotations for psychology practicum students, predoctoral interns, and postdoctoral fellows.

Whether programs such as GSP-P can adequately address the dwindling number of VA mental health care professionals remains to be seen. More than 160 doctors, psychologists, nurses, and researchers sent a letter to VA Secretary Doug Collins, the VA inspector general, and congressional leaders on Sept. 24 warning that workforce reductions and moves to outsource care will harm veterans.

“We have witnessed these ongoing harms and can provide evidence and testimony of their impacts,” the letter read. By the next day, the number of signees had increased to 350. 

Though these shortages may impact their mental health care, older veterans could have an edge in mental resilience. While research in younger adults has found positive linear associations between physical health difficulties and severity of psychiatric symptoms, older veterans may benefit from what researchers have called an “aging paradox,” in which mental health improves later in life despite declining physical and cognitive function. A 2021 study suggests that prevention and treatment strategies designed to foster attachment security, mindfulness, and purpose in life may help enhance psychological resilience to physical health difficulties in older veterans.

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Parental Mental Disorders May Double Offspring Mortality Risk

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TOPLINE:

Offspring of parents with mental disorders had nearly double the risk for mortality, especially from unnatural causes, compared to those with parents did not have a mental disorder, a new Swedish cohort study showed. Additionally, mortality risk was highest when both parents had mental disorders but was not affected by the sex of the affected parent.

METHODOLOGY:

  • A nationwide register-based cohort study in Sweden included more than 3.5 million individuals born between 1973 and 2014 (51% men); 35% had a parent with a mental disorder (13% paternal, 16% maternal, and 6% both parents).
  • Mental disorder categories included alcohol or substance use, psychotic, mood, anxiety or stress-related, eating, and personality disorders and intellectual disability. Exposure timing was classified by offspring age (mean age, 15.8 years) at parental diagnosis.
  • Participants were followed up from birth until death, the death of either parent, emigration (up to 2014), either parent’s emigration, or the end of 2023, whichever came first (median follow-up duration, 20.1 years).
  • The main outcome was all-cause mortality; secondary outcomes were deaths from natural and unnatural causes, as well as deaths from cardiovascular disease, cancer, suicide, and unintentional injuries. Cousin comparison analyses were also conducted to account for confounding.

TAKEAWAY:

  • During the follow-up, offspring exposed to parental psychiatric disorders had higher overall mortality rates than unexposed offspring (7.9 vs 3.55 per 10,000 person-years). Mortality rates due to natural causes were 4.0 vs 2.4 per 10,000 person-years and were 3.95 vs 1.1 per 10,000 person-years for mortality due to unnatural causes.
  • Exposed offspring had an increased risk for mortality due to any cause (adjusted hazard ratio [aHR], 2.1), natural causes (aHR, 1.9), and unnatural causes (aHR, 2.45). Exposure was also associated with an increased risk for cardiovascular and cancer-related death, suicide, and death due to unintentional injuries. The associations remained significant, although slightly attenuated, in cousin comparison analyses.
  • The highest risks for mortality were in offspring exposed at ages 1-2 years to both parents having mental disorders (HR for natural causes, 4.5; HR for unnatural causes, 5.3).
  • The risk varied by the type of parental mental disorder, with HRs ranging from 1.6 for eating disorders to 2.2 for intellectual disability.

IN PRACTICE:

“Our findings highlight the need for improved surveillance, prevention, and early detection strategies to reduce the risk of premature mortality among offspring exposed to parental mental disorders. Whether additional support for families affected by mental disorders could mitigate the risk warrants further investigation,” the investigators wrote.

SOURCE:

This study was led by Hui Wang, PhD, Karolinska Institutet, Stockholm, Sweden. It was published online in JAMA Psychiatry.

LIMITATIONS:

Reliance on registry data may have led to the misclassification of parental mental disorders. The study lacked data on genetic factors, parenting quality, cohabitation, and social support, and its generalizability may have been limited. Immigration data after 2014 were unavailable, potentially leading to misclassifications of exposure and outcomes. The Patient Register did not distinguish between diagnoses made in general vs psychiatric hospital settings, and cousin comparisons remained susceptible to bias from unmeasured confounding and may have been limited in capturing temporal and familial heterogeneity.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare and the Heart and Lung Foundation. Wang reported having no relevant financial relationships. The other investigator reported receiving grants from Forte and the Heart and Lung Foundation.

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

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

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TOPLINE:

Offspring of parents with mental disorders had nearly double the risk for mortality, especially from unnatural causes, compared to those with parents did not have a mental disorder, a new Swedish cohort study showed. Additionally, mortality risk was highest when both parents had mental disorders but was not affected by the sex of the affected parent.

METHODOLOGY:

  • A nationwide register-based cohort study in Sweden included more than 3.5 million individuals born between 1973 and 2014 (51% men); 35% had a parent with a mental disorder (13% paternal, 16% maternal, and 6% both parents).
  • Mental disorder categories included alcohol or substance use, psychotic, mood, anxiety or stress-related, eating, and personality disorders and intellectual disability. Exposure timing was classified by offspring age (mean age, 15.8 years) at parental diagnosis.
  • Participants were followed up from birth until death, the death of either parent, emigration (up to 2014), either parent’s emigration, or the end of 2023, whichever came first (median follow-up duration, 20.1 years).
  • The main outcome was all-cause mortality; secondary outcomes were deaths from natural and unnatural causes, as well as deaths from cardiovascular disease, cancer, suicide, and unintentional injuries. Cousin comparison analyses were also conducted to account for confounding.

TAKEAWAY:

  • During the follow-up, offspring exposed to parental psychiatric disorders had higher overall mortality rates than unexposed offspring (7.9 vs 3.55 per 10,000 person-years). Mortality rates due to natural causes were 4.0 vs 2.4 per 10,000 person-years and were 3.95 vs 1.1 per 10,000 person-years for mortality due to unnatural causes.
  • Exposed offspring had an increased risk for mortality due to any cause (adjusted hazard ratio [aHR], 2.1), natural causes (aHR, 1.9), and unnatural causes (aHR, 2.45). Exposure was also associated with an increased risk for cardiovascular and cancer-related death, suicide, and death due to unintentional injuries. The associations remained significant, although slightly attenuated, in cousin comparison analyses.
  • The highest risks for mortality were in offspring exposed at ages 1-2 years to both parents having mental disorders (HR for natural causes, 4.5; HR for unnatural causes, 5.3).
  • The risk varied by the type of parental mental disorder, with HRs ranging from 1.6 for eating disorders to 2.2 for intellectual disability.

IN PRACTICE:

“Our findings highlight the need for improved surveillance, prevention, and early detection strategies to reduce the risk of premature mortality among offspring exposed to parental mental disorders. Whether additional support for families affected by mental disorders could mitigate the risk warrants further investigation,” the investigators wrote.

SOURCE:

This study was led by Hui Wang, PhD, Karolinska Institutet, Stockholm, Sweden. It was published online in JAMA Psychiatry.

LIMITATIONS:

Reliance on registry data may have led to the misclassification of parental mental disorders. The study lacked data on genetic factors, parenting quality, cohabitation, and social support, and its generalizability may have been limited. Immigration data after 2014 were unavailable, potentially leading to misclassifications of exposure and outcomes. The Patient Register did not distinguish between diagnoses made in general vs psychiatric hospital settings, and cousin comparisons remained susceptible to bias from unmeasured confounding and may have been limited in capturing temporal and familial heterogeneity.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare and the Heart and Lung Foundation. Wang reported having no relevant financial relationships. The other investigator reported receiving grants from Forte and the Heart and Lung Foundation.

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

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

TOPLINE:

Offspring of parents with mental disorders had nearly double the risk for mortality, especially from unnatural causes, compared to those with parents did not have a mental disorder, a new Swedish cohort study showed. Additionally, mortality risk was highest when both parents had mental disorders but was not affected by the sex of the affected parent.

METHODOLOGY:

  • A nationwide register-based cohort study in Sweden included more than 3.5 million individuals born between 1973 and 2014 (51% men); 35% had a parent with a mental disorder (13% paternal, 16% maternal, and 6% both parents).
  • Mental disorder categories included alcohol or substance use, psychotic, mood, anxiety or stress-related, eating, and personality disorders and intellectual disability. Exposure timing was classified by offspring age (mean age, 15.8 years) at parental diagnosis.
  • Participants were followed up from birth until death, the death of either parent, emigration (up to 2014), either parent’s emigration, or the end of 2023, whichever came first (median follow-up duration, 20.1 years).
  • The main outcome was all-cause mortality; secondary outcomes were deaths from natural and unnatural causes, as well as deaths from cardiovascular disease, cancer, suicide, and unintentional injuries. Cousin comparison analyses were also conducted to account for confounding.

TAKEAWAY:

  • During the follow-up, offspring exposed to parental psychiatric disorders had higher overall mortality rates than unexposed offspring (7.9 vs 3.55 per 10,000 person-years). Mortality rates due to natural causes were 4.0 vs 2.4 per 10,000 person-years and were 3.95 vs 1.1 per 10,000 person-years for mortality due to unnatural causes.
  • Exposed offspring had an increased risk for mortality due to any cause (adjusted hazard ratio [aHR], 2.1), natural causes (aHR, 1.9), and unnatural causes (aHR, 2.45). Exposure was also associated with an increased risk for cardiovascular and cancer-related death, suicide, and death due to unintentional injuries. The associations remained significant, although slightly attenuated, in cousin comparison analyses.
  • The highest risks for mortality were in offspring exposed at ages 1-2 years to both parents having mental disorders (HR for natural causes, 4.5; HR for unnatural causes, 5.3).
  • The risk varied by the type of parental mental disorder, with HRs ranging from 1.6 for eating disorders to 2.2 for intellectual disability.

IN PRACTICE:

“Our findings highlight the need for improved surveillance, prevention, and early detection strategies to reduce the risk of premature mortality among offspring exposed to parental mental disorders. Whether additional support for families affected by mental disorders could mitigate the risk warrants further investigation,” the investigators wrote.

SOURCE:

This study was led by Hui Wang, PhD, Karolinska Institutet, Stockholm, Sweden. It was published online in JAMA Psychiatry.

LIMITATIONS:

Reliance on registry data may have led to the misclassification of parental mental disorders. The study lacked data on genetic factors, parenting quality, cohabitation, and social support, and its generalizability may have been limited. Immigration data after 2014 were unavailable, potentially leading to misclassifications of exposure and outcomes. The Patient Register did not distinguish between diagnoses made in general vs psychiatric hospital settings, and cousin comparisons remained susceptible to bias from unmeasured confounding and may have been limited in capturing temporal and familial heterogeneity.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare and the Heart and Lung Foundation. Wang reported having no relevant financial relationships. The other investigator reported receiving grants from Forte and the Heart and Lung Foundation.

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

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

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MASLD/MASH Global Consensus Recommendations Address Guideline Discordance

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Global consensus recommendations were recently published for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH).

These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.

“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”

To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.

Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.

The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”

For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.

Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.

Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.

The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.

Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.

“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.

The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.







 

Body

The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.

Dr. Jaideep Behari

Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”



He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes. 



“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.



Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.” 



He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”



“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.

Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.

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The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.

Dr. Jaideep Behari

Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”



He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes. 



“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.



Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.” 



He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”



“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.

Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.

Body

The new consensus MASLD recommendations should help reconcile the “important differences” between guidelines from around the world, said Dr. Jaideep Behari, of the the University of Pittsburgh Medical Center.

Dr. Jaideep Behari

Behari highlighted several points that may be underappreciated in clinical practice. “While many clinicians associate MASLD with obesity and type 2 diabetes, approximately a fifth of people living with MASLD are lean,” he said. “It may also come as a surprise to non-liver specialists that cardiovascular disease is the most common cause of mortality in patients with MASLD.”



He underscored the consensus recommendation to screen patients with type 2 diabetes, those with obesity and at least one cardiometabolic risk factor, and individuals with persistently elevated liver enzymes. 



“Since many patients in the first two groups are mainly seen in primary care or endocrinology practices, physicians in these specialties need to be cognizant of these global consensus recommendations,” Behari said.



Turning to therapeutics, he described resmetirom as “a major milestone in the management of MASLD since it is the first drug approved in the US for treatment of MASH with F2 (moderate) or F3 (advanced) fibrosis.” 



He noted that treatment requires careful patient selection and monitoring, including VCTE in the 8–20 kPa range, followed by serial liver injury testing. Efficacy should be assessed at 12 months, he noted, since “resmetirom was found to be effective in approximately a quarter of all treated patients in the pivotal clinical trial.”



“These limitations highlight the gaps in the treatment of MASLD/MASH and the need to continue development of other therapies,” Behari said.

Jaideep Behari, MD, PhD, AGAF, is director of the liver steatosis and metabolic wellness program at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. He reported research grant support from AstraZeneca, Madrigal, and recently completed research grant support from Gilead and Pfizer.

Title
Reconciling Differences
Reconciling Differences

Global consensus recommendations were recently published for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH).

These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.

“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”

To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.

Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.

The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”

For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.

Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.

Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.

The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.

Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.

“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.

The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.







 

Global consensus recommendations were recently published for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH).

These recommendations aim to boost guideline adherence and disease awareness, which have lagged despite a surge of national and international guidance in recent years, lead author Zobair M. Younossi, MD, of the Global NASH/MASH Council, Washington, DC, and colleagues, reported.

“Although these documents are similar in many ways, there are important differences in their recommendations, which have created some confusion within the field,” the panel wrote in Gastroenterology. “Areas of discordance among guidelines can be partly responsible for their low rate of implementation and the suboptimal awareness about this liver disease. Furthermore, these guidelines can be long and complex, making it challenging for busy clinicians to access the appropriate information quickly and efficiently.”

To address these gaps, more than 40 experts from around the world collaborated on the consensus project. The team reviewed 61 eligible documents published between 2018 and January 2025. Each guideline was evaluated across eight domains: epidemiology; screening; risk stratification using noninvasive tests (NITs); lifestyle management; treatment with existing medications; treatment with future medications; hepatocellular carcinoma (HCC) and preventive guidance; and pregnancy and pediatric populations.

Areas of discordance were advanced to a Delphi process using iterative online surveys, with a supermajority threshold of 67% required for acceptance. Four Delphi rounds were conducted, and by the end, all statements had achieved more than 90% agreement. The final recommendations were then summarized into practical algorithms for clinical use.

The results cover the full spectrum of MASLD care. For screening and diagnosis, experts agreed that individuals with type 2 diabetes, obesity plus cardiometabolic risk factors, or persistently elevated aminotransferases should be considered high risk. Alcohol thresholds were standardized, clarifying when to classify disease as MASLD, alcohol-related liver disease, or the hybrid “Met-ALD.”

For risk stratification, the panel endorsed a two-step algorithm beginning with the Fibrosis-4 (FIB-4) index, followed by vibration-controlled transient elastography (VCTE) or other NITs in patients above the threshold. This approach, the authors noted, was designed to be feasible in both primary care and specialty settings.

Lifestyle intervention remains the cornerstone of treatment, with weight-loss goals of 5% to reduce steatosis, 7%–10% to reduce inflammation, and at least 10% to improve fibrosis. To this end, the panel recommended a Mediterranean-style diet, increased physical activity, and reductions in sedentary time.

Drug therapy recommendations prioritized glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with diabetes or obesity, though these were not considered MASH-specific agents. Pioglitazone was noted as an option for diabetes management but not as direct MASH therapy. The panel did not recommend vitamin E, ursodeoxycholic acid, or omega-3 fatty acids, citing insufficient evidence.

The document also provides structured guidance on resmetirom, the first FDA-approved therapy for MASH. Its use was endorsed in patients with F2–F3 fibrosis confirmed by NITs, with safety checks at 3, 6, and 12 months, and efficacy evaluation after 1 year. Treatment futility was defined as concordant worsening across two NITs.

Preventive recommendations included hepatitis A and B vaccination and HCC surveillance every 6 months in patients with cirrhosis. Surveillance in noncirrhotic MASH was left to clinician judgment, based on individualized risk factors. Special considerations were outlined for pediatric and pregnant populations, although the evidence base in these groups remains sparse.

“Further research is required to determine the effectiveness of this algorithm in raising awareness of MASLD and its treatment,” Dr. Younossi and colleagues concluded.

The study was supported by the Global NASH/MASH Council, Inova Health System, and an unrestricted educational grant from Madrigal Pharmaceuticals. The investigators disclosed relationships with Sanofi, Gilead, AstraZeneca, and others.







 

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Long-Term Data Support Reduced-Dose Maintenance in EoE

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Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

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Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

Biologic and corticosteroid maintenance therapies for eosinophilic esophagitis (EoE) are generally safe and effective, even at reduced doses, according to a recent meta-analysis of long-term data.

These findings support keeping patients on long-term maintenance therapy to prevent relapse, lead author Alberto Barchi, MD, of IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, reported.

Dr. Alberto Barchi



“Given the high relapse rate after treatment cessation, despite good initial response after induction, there is need for further information about long-term outcomes of maintenance treatments,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, few studies have focused on long-term effects of EoE therapies.”

In response, Dr. Barchi and colleagues conducted the present systematic review and meta-analysis, which included studies evaluating maintenance therapies for EoE with at least 48 weeks of follow-up. Eligible studies enrolled patients with confirmed EoE who had received an induction regimen and continued therapy long-term. The final dataset comprised 9 randomized controlled trials (RCTs) and 11 observational studies, with long-term outcomes were reported among 1,819 patients.

The primary outcome was histologic success, defined as fewer than 15 or 6 eosinophils per high-power field (HPF). Secondary outcomes included clinical and endoscopic response, treatment adherence, and safety events.

Random-effects meta-analyses were performed, with randomized trials and observational studies analyzed separately. Risk ratios for sustained remission versus placebo or induction therapy were calculated, and heterogeneity was assessed using the I² statistic. Safety outcomes included pooled rates of adverse events, severe adverse events, and treatment discontinuation.

Across 9 randomized controlled trials, swallowed topical corticosteroids (STCs) maintained histologic remission (less than 15 eosinophils/HPF) in 86% of patients, while biologics achieved a rate of 79%. At the stricter threshold of less than 6 eosinophils/HPF, remission rates for STCs and biologics were 59% and 70%, respectively.

Clinical remission rates were lower, at 58% for STCs and 59% for biologics. Endoscopic outcomes were less consistent-ly reported, but most trials showed stable or improved scores during long-term treatment.

In observational cohorts, proton pump inhibitors (PPIs) maintained histologic remission in 64% of patients and clinical remission in 80%. For STCs in the real-world setting, histologic and clinical remission rates were 49% and 51%, respectively.

Stepping down the dose of maintenance therapy—whether conventional or biologic—did not increase relapse risk (RR 1.04; 95% CI, 0.72–1.51). In contrast, treatment withdrawal was clearly associated with higher relapse rates: in pooled analyses, continuing therapy yielded nearly an 8-fold greater likelihood of sustained remission compared with discontinuation (RR 7.87; 95% CI, 4.19–14.77).

Safety signals were favorable. Severe adverse events occurred in 3% of patients in randomized trials and 5% in observational studies, while overall withdrawal rates were 10% and 4%, respectively. The most common adverse events with STCs were oropharyngeal candidiasis and reductions in morning cortisol, while biologics were mainly associated with injection-site reactions, headache, and nasopharyngitis.

“Results suggest that prolonging treatment is efficient in maintaining histologic and clinical remission, with overall drug-related safe profiles both in randomized trials and observational studies,” the investigators concluded, noting that more work is needed to determine if there is an optimal drug for maintenance therapy, and if certain patients can successfully discontinue treatment.

The investigators disclosed relationships with Pfizer, UCB Pharma, AstraZeneca, and others.
 

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Simpler Approach Increases Diagnostic Accuracy of Timed Barium Esophagram for Achalasia

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Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

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Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

Interpreting timed barium esophagram (TBE) results with a multimetric classification tree is more accurate for identifying disorders of achalasia than conventional interpretation, according to investigators.

The classification tree offers a practical alternative for evaluating esophagogastric junction (EGJ) outflow disorders when more advanced methods like high-resolution manometry (HRM) or functional lumen imaging probe (FLIP) panometry are unavailable, lead author Ofer Z. Fass, MD, of Northwestern University, Chicago, and colleagues reported.

“[T]here are limited data on normative TBE values,” the investigators wrote in Gastroenterology. “Furthermore, data supporting the accuracy of TBE as a screening test for esophageal motility disorders, as well as clinically relevant test thresholds, remains limited.”

TBE is conventionally interpreted using a handful of single measurements, most often the barium column height at 1, 2, or 5 minutes. Although these metrics are simple to obtain, variability in technique, cutoff values, and interpretation across centers limits reproducibility and weakens diagnostic accuracy, according to the investigators. The role of TBE has therefore been largely confined to adjudicating inconclusive manometry findings, but even in that setting, the absence of validated reference standards constrains its utility as a reliable screening tool.

To address this gap, Fass and colleagues conducted a prospective analysis of 290 patients who underwent TBE at Northwestern Memorial Hospital, Chicago, with HRM and FLIP panometry, interpreted according to the Chicago Classification version 4.0 (CCv4.0), serving as the diagnostic reference standards.

Patients were included if they had both TBE and manometry performed within a short interval, ensuring that the two tests could be meaningfully compared. The study population represented a broad spectrum of esophageal motility presentations, allowing the model to be trained on clinically relevant variation.

Beyond column height, the investigators measured barium height at multiple timepoints, maximal esophageal body width, maximum EGJ diameter, and tablet passage. These variables were incorporated into a recursive partitioning algorithm to build a multimetric classification tree aimed at distinguishing EGJ outflow obstruction from other motility disorders.

The optimal tree incorporated three sequential decision levels. At the top was maximum esophageal body width, followed by EGJ diameter and barium height at the second level, and tablet passage at the third. This stepwise structure allowed the model to refine diagnoses by combining simple, reproducible TBE metrics that are already collected in routine practice.

Among the 290 patients, 121 (42%) had EGJ outflow disorders, 151 (52%) had no outflow disorder, and 18 (6%) had inconclusive manometry findings. Using conventional interpretation with column height and tablet passage, TBE demonstrated a sensitivity of 77.8%, a specificity of 86.0%, and an accuracy of 82.2%. The multimetric classification tree improved diagnostic performance across all parameters, with a sensitivity of 84.2%, a specificity of 92.1%, and an accuracy of 88.3%.

The advantages of multimetric interpretation were most notable in patients with borderline column heights, which single-metric approaches often misclassify, underscoring the value of integrating multiple measurements into a unified model.

“[T]his study demonstrated that TBE can accurately identify achalasia when analyzed using multiple metrics in a classification tree model,” Fass and colleagues wrote. “Future studies should explore the use of TBE metrics and models to identify more specific esophageal motor disorders (such as esophageal spasm and absent contractility), as well as validation in a larger, multicenter cohort.”

 

Clinical Takeaways

Rishi Naik, MD, of the Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, Tennessee, said the study represents a step forward in how clinicians can use a widely accessible esophageal imaging test.

“This study is important in that it has updated the way we use a very common, readily available imaging test and compared it to the current gold standard of HRM and FLIP,” he told GI & Hepatology News. “This provides a practical, standardized framework for clinicians evaluating patients with suspected esophageal motility disorders.”

Naik noted that while HRM and FLIP provide highly detailed information, both carry drawbacks that limit their universal adoption.

“Practically, HRM is a transnasal test that can be cumbersome, and FLIP is performed during a sedated procedure,” he said. “From a comfort and cost perspective, the esophagram outcompetes. What the TBE lacked was adequate sensitivity and specificity when just looking at column height, which is how the authors overcame this by leveraging the comparisons using CCv4.0.”

Implementation, however, requires discipline.

“A timed barium esophagram is a protocol, not a single esophagram,” Naik said. “Without proper measurements, you can’t follow the decision tree.”

Still, he pointed to radiology’s increasing adoption of artificial intelligence (AI) as a promising way forward.

“AI has already transformed radiological reads, and I’m optimistic it will eventually allow us to incorporate not only width, height, and tablet clearance but also 3D [three-dimensional] reconstructions of bolus retention and pressure to enhance predictive modeling,” Naik said.

This study was supported by the Public Health Service.

The investigators disclosed having relationships with Takeda, Phathom Pharmaceuticals, Medtronic, and others. Naik is a consultant for Sanofi/Regeneron, Eli Lilly and Company, and Renexxion.

A version of this article appeared on Medscape.com.

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GLP-1s Increase GERD Risk Over SGLT2 Inhibitors in T2D

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In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

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In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

In patients with type 2 diabetes (T2D), the risks for gastroesophageal reflux disease (GERD) and GERD-related complications were greater with GLP-1 receptor agonist (RA) use than with SGLT2 inhibitor use in a cohort study of new users.

Risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and patients with gastric comorbidities.

“The findings were not entirely surprising,” principal author Laurent Azoulay, PhD, of McGill University and Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada, told GI & Hepatology News. “There is a plausible biological mechanism through which GLP-1 RAs could increase the risk of GERD — namely, by delaying gastric emptying, which can lead to symptoms of reflux. Still, it’s always valuable to see whether the clinical data support what we suspect from a physiological standpoint.”

“As with any medication, it’s about balancing benefits and risks — and being proactive when side effects emerge,” he added.

The study was published online in Annals of Internal Medicine.

 

Duration of Use, Drug Action

Researchers designed an active comparator new-user cohort study emulating a target trial to estimate the effects of GLP-1 RAs compared with SGLT2 inhibitors on the risk for GERD and its complications among patients with T2D.

The study included 24,708 new users of GLP-1 RAs and 89,096 new users of SGLT2 inhibitors. Participants had a mean age of 56 years, and 55% were men. They initiated treatment with the drugs from January 2013 through December 2021, with follow-up through March 2022.

Three-year risk differences (RDs) and risk ratios (RRs) were estimated and weighted using propensity score fine stratification.

Overall, during follow-up, the incidence rate of GERD was 7.9 per 1000 person-years; 138 complications of GERD were observed, with over 90% of them being Barrett’s esophagus.

Over a median follow-up of 3 years, among GLP-1 RA users compared with SGLT2 inhibitor users, the RRs were 1.27 for GERD, with an RD of 0.7 per 100 patients, and 1.55 for complications, with an RD of 0.8 per 1000 patients.

Further analyses found that risks for GERD were higher overall for each GLP-1 RA type except lixisenatide, and risks for GERD complications were higher in ever-smokers, patients with obesity, and those with gastric comorbidities associated with gastric motility. The findings remained robust across sensitivity analyses addressing various types of biases.

The widening incidence curves with duration of use may indicate that mucosal injury and symptom severity correlate with reflux frequency and duration of esophageal acid exposure, the authors suggested.

GERD risk also was higher with long-acting GLP-1 RA use, suggesting that long-acting GLP-1 RAs (liraglutide, exenatide once weekly, dulaglutide, and semaglutide) may have more sustained delaying effects, they noted.

“These potential risks should be weighed against the established clinical benefits of this drug class, particularly in patients at high risk for gastroparesis and GERD,” the authors concluded.

“Given the mechanism through which these drugs may cause GERD, we can reasonably speculate that a similar effect might be observed in individuals without diabetes,” Azoulay added. “That said, a dedicated study would be needed to confirm that.”

 

Close Monitoring Advised

Caroline Collins, MD, assistant professor at Emory University School of Medicine in Atlanta, agreed with the findings and said the association between GLP-1s and GERD is consistent with what she has observed in her practice.

“I routinely counsel patients about the potential for GERD symptoms as well as other side effects before initiating GLP-1 therapy,” she told GI & Hepatology News. “Several patients on GLP-1s have reported new or worsening reflux symptoms after initiating therapy. Sometimes, we can lower the dose, and the GERD resolves. Other times initiating GERD treatment or discontinuing the medication is appropriate.”

“Patients with T2D are already at increased risk for delayed gastric emptying, which in itself is a contributor to GERD,” said Collins, who was not involved in the study. “Therefore, adding a GLP-1 RA, which further slows gastric motility, may compound this risk. I consider this when assessing which patients are the best candidates for these medications and often monitor more closely in patients with long-standing diabetes and other predisposing factors to GERD.”

Barrett’s esophagus and esophageal cancer generally occur over many years, she noted. “A median follow-up of 3 years may be insufficient to fully assess the long-term risks of serious complications.”

Chronic cough, a common but often overlooked manifestation of GERD, was not included in the outcome definitions,” she added. Including chronic cough “may have captured a broader picture of reflux-related symptoms.”

The study was funded by a Foundation Scheme grant from the Canadian Institutes of Health Research. Azoulay holds a Distinguished Research Scholar award from the Fonds de recherche du Quebec – Sante and is the recipient of a William Dawson Scholar award from McGill University.

A version of this article appeared on Medscape.com.

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Medicolegal Concerns in Contemporary Private GI Practice

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The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.

With expanded GI practice opportunities comes the need to raise awareness of medicolegal issues, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.

Erin Smith Aebel



“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.” 

Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.” 

Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”

Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.

From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).

Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”

These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.

 

Update Details

Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.

Stark Law on Self-Referrals

Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.

For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.

Ambulatory Surgery Centers

Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.

A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.

Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.

“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.

The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.

 

Private-Equity Investment

With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.

Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.

“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.

Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.

“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”

Dr. Camille Thélin



Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”

Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”

The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.

Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.

This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.

With expanded GI practice opportunities comes the need to raise awareness of medicolegal issues, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.

Erin Smith Aebel



“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.” 

Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.” 

Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”

Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.

From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).

Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”

These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.

 

Update Details

Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.

Stark Law on Self-Referrals

Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.

For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.

Ambulatory Surgery Centers

Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.

A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.

Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.

“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.

The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.

 

Private-Equity Investment

With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.

Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.

“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.

Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.

“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”

Dr. Camille Thélin



Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”

Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”

The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.

Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.

This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.

A version of this article appeared on Medscape.com.

The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.

With expanded GI practice opportunities comes the need to raise awareness of medicolegal issues, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.

Erin Smith Aebel



“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.” 

Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.” 

Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”

Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.

From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).

Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”

These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.

 

Update Details

Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.

Stark Law on Self-Referrals

Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.

For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.

Ambulatory Surgery Centers

Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.

A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.

Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.

“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.

The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.

 

Private-Equity Investment

With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.

Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.

“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.

Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.

“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”

Dr. Camille Thélin



Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”

Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”

The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.

Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.

This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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