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A Hard Look at Toxic Workplace Culture in Medicine

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Changed
Thu, 10/10/2024 - 15:07

While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

  • 38% said workplace culture is declining.
  • 70% don’t see a big commitment from employers for positive culture.
  • 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

 

 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

 

 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

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While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

  • 38% said workplace culture is declining.
  • 70% don’t see a big commitment from employers for positive culture.
  • 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

 

 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

 

 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

  • 38% said workplace culture is declining.
  • 70% don’t see a big commitment from employers for positive culture.
  • 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

 

 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

 

 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

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NY Nurse Practitioners Sue State Over Pay Equity, Alleged Gender Inequality

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Changed
Thu, 10/10/2024 - 14:46

 

A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

 

 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

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A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

 

 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

 

A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

 

 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

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Beyond Scope Creep: Why Physicians and PAs Should Come Together for Patients

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Thu, 10/10/2024 - 13:44

Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

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Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

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Lawsuit Targets Publishers: Is Peer Review Flawed?

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Wed, 10/09/2024 - 12:54

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

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The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

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How AI Is Revolutionizing Drug Repurposing for Faster, Broader Impact

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Changed
Tue, 10/08/2024 - 15:49

 

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise


To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

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Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise


To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

 

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise


To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

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Methotrexate in Preventing RA: Benefits in ACPA-Negative Patients, and Is It Cost Effective?

Article Type
Changed
Tue, 10/08/2024 - 15:11

A 1-year course of methotrexate (MTX) in clinically suspected arthralgia may prevent the development of rheumatoid arthritis (RA) in at-risk individuals who test negative for anti-citrullinated protein antibody (ACPA), according to 4-year results from the TREAT EARLIER study.

While 2-year data did not show a preventive effect, researchers risk-stratified patients in this most recent data. The previous study also grouped all individuals together, while this new analysis separated patients by seropositivity.

“Heterogeneity in risk of rheumatoid arthritis development in ACPA–negative participants with clinically suspect arthralgia might have concealed a treatment effect due to dilution,” wrote senior author Annette H. van der Helm-van Mil, MD, PhD, professor of rheumatology at Leiden University Medical Center, Leiden, the Netherlands, and colleagues. “Therefore, risk-stratified analyses are required to adequately assess the possibility of prevention of rheumatoid arthritis in people with clinically suspect arthralgia who are ACPA–negative.”

Leiden University
Dr. Annette van der Helm-van Mil

To qualify for the study, participants needed to have recent-onset joint pain that a treating rheumatologist suspected of progressing to RA. Second, participants had to have subclinical joint inflammation, detected via MRI.

These are “promising results” for a group where predicting risk for RA has been more difficult than for their ACPA–positive counterparts, said Kevin Deane, MD, PhD, a professor of medicine and rheumatologist at the University of Colorado School of Medicine, Aurora, who was not involved with the study. However, additional research is necessary to investigate these findings.

The clinical utility of this finding is also unclear, he noted, as it would be an “extensive process” for all ACPA–negative individuals with joint pain to undergo MRI screening, he continued.

“It’s hard to find people who would meet these criteria, and healthcare systems need to understand how ultimately this could be implemented in clinical care,” he said.
 

Adding Risk Stratification

The TREAT EARLIER trial included 236 participants; nearly two thirds were women, and 77% were ACPA–negative (specifically for anti-cyclic citrullinated peptide 2). Patients randomly assigned to active treatment received a single intramuscular glucocorticoid injection (methylprednisolone 120 mg) upon inclusion and then completed a 1-year course of MTX. The comparator group received a single placebo injection at the beginning of the trial and a 1-year course of placebo tablets. All trial screenings and visits were conducted at the Leiden University Medical Center.

At the 2-year mark, there was no difference in the development of RA between the treatment and placebo groups, although there was improvement in joint pain, physical functioning, and MRI-detected joint inflammation in all at-risk groups given MTX — ACPA–positive patients and those at high risk for clinical arthritis development.

MTX delayed the onset of RA, with a statistically significant difference between treatment and placebo at 6 and 12 months, but not at 24 months.

For this 4-year analysis, published in The Lancet Rheumatology, authors stratified patients at their time of enrollment according to their risk of developing RA based on a published model for predicting inflammatory arthritis. Predictors included ACPA positivity (2 points), rheumatoid factor positivity (1 point), more than two locations of subclinical inflammation on MRI (2 points), and presence of metacarpophalangeal extensor tenosynovitis on MRI (1 point).

Patients with at least 4 points were classified as “high-risk,” with a 70% or higher predicted risk of developing RA. Participants with 2-3 points were at “increased risk” — translating to a 25%-70% higher likelihood of developing the condition. Low-risk patients, with 0-1 points, had < 25% chance of developing RA.

Of the 182 ACPA–negative participants in the study, none were considered high risk, 66 (36%) were at increased risk, and 116 (64%) were at low risk.
 

 

 

Decreased Rates of RA Development

Of these ACPA–negative patients stratified as increased risk, 3 of 35 (9%) in the treatment group developed RA, compared with 9 of 31 (29%) in the placebo arm (hazard ratio [HR], 0.27; P = .034).

All 54 ACPA–positive patients enrolled in the study were classified as either increased risk or high risk, but the treatment showed no difference in the rate of RA development in this group, and more than half (56%) developed RA during 4 years of follow-up. However, Dr. van der Helm-van Mil noted that the 2-year data showed treatment improved the severity of subclinical inflammation and symptoms over time in these patients.

The 5-year data from the trial, including physical function and other measures of disease burden, will be analyzed in 2025, she said, and will reveal whether ACPA–negative patients treated with MTX had sustained improvements in these measures.

Additional studies are needed to validate these findings, Dr. van der Helm-van Mil said, but the results indicate that ACPA–positive and ACPA–negative patients “are different populations, and we should evaluate them separately.”

Future RA prevention studies should also risk stratify patients before enrollment so that patients at low risk of developing the disease are not included in the interventions. “You can’t expect a treatment effect if there is no risk for disease,” she added.
 

Is It Cost-Effective?

In a separate analysis, published in Annals of the Rheumatic Diseases, Dr. van der Helm-van Mil and colleagues sought to investigate the cost-effectiveness of the TREAT EARLIER intervention at 2 years of follow-up.

“There is an ongoing debate whether people with arthralgia at risk for RA should be treated with DMARDs [disease-modifying antirheumatic drugs]; however, the economic effects of an intervention in the arthralgia at risk phase are unknown.”

The analysis calculated healthcare productivity and work productivity costs from enrollment to 2 years of follow-up. To demonstrate effect, they also calculated change in quality-adjusted life years (QALYs).

Over the course of 2 years, estimated costs for the treatment arm were €4809 lower (−$5304) than the placebo arm per patient. Lower productivity costs accounted for 97% of this difference.

The treatment arm also resulted in a small improvement (+0.041) in QALYs, compared with placebo.

“These data provide the first evidence that first-line treatment aiming at secondary prevention in arthralgia at-risk for RA is cost-effective,” the authors wrote.

Dr. van der Helm-van Mil emphasized that this cost analysis used only 2-year follow-up data (rather than the newly published 4-year data) and did not differentiate ACPA–negative patients. Despite including a greater heterogeneity of patients, the intervention was still cost-effective. A future analysis that includes 5-year follow-up data and stratifies patients by ACPA status and excludes low-risk individuals could demonstrate more cost benefits to a temporary MTX regimen, she said.

Considering the costs of these preventive interventions is important, added Dr. Deane, who agreed that future analyses should examine cost-effectiveness in groups at high risk of developing RA. (Dr. Deane noted that he had reviewed this article for publication.) However, this analysis did not include the costs of screening patients before enrollment in the study.

Richard Mark Kirkner/MDedge News
Dr. Kevin D. Deane


“Additional factors that need to be considered are costs to find individuals who would meet the criteria for treatment,” he said, which would include getting an MRI to detect subclinical joint inflammation.

However, Dr. van der Helm-van Mil noted that both placebo and treatment groups received MRI scans, which would therefore not affect cost differences between the groups.

Future studies should also focus on longer-term outcomes, both Dr. Deane and Dr. van der Helm-van Mil agreed.

“Since RA is a chronic disease for which part of the patients require expensive biologicals, future cost-effectiveness analyses should also consider a lifetime horizon,” Dr. van der Helm-van Mil and colleagues wrote.

The TREAT EARLIER trial was funded by the Dutch Research Council and the Dutch Arthritis Society. The cost analysis study was funded by ZonMw and the Dutch Arthritis Society. Dr. Deane is a member of an American College of Rheumatology/European Alliance of Associations for Rheumatology task force for risk stratification in RA. He has received payments as a speaker for Werfen and Thermo Fisher Scientific and low-cost biomarker assays for research from Werfen. He has also received grant funding from Thermo Fisher Scientific, Gilead, and Boehringer Ingelheim. Dr. van der Helm-van Mil reported no disclosures.
 

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

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A 1-year course of methotrexate (MTX) in clinically suspected arthralgia may prevent the development of rheumatoid arthritis (RA) in at-risk individuals who test negative for anti-citrullinated protein antibody (ACPA), according to 4-year results from the TREAT EARLIER study.

While 2-year data did not show a preventive effect, researchers risk-stratified patients in this most recent data. The previous study also grouped all individuals together, while this new analysis separated patients by seropositivity.

“Heterogeneity in risk of rheumatoid arthritis development in ACPA–negative participants with clinically suspect arthralgia might have concealed a treatment effect due to dilution,” wrote senior author Annette H. van der Helm-van Mil, MD, PhD, professor of rheumatology at Leiden University Medical Center, Leiden, the Netherlands, and colleagues. “Therefore, risk-stratified analyses are required to adequately assess the possibility of prevention of rheumatoid arthritis in people with clinically suspect arthralgia who are ACPA–negative.”

Leiden University
Dr. Annette van der Helm-van Mil

To qualify for the study, participants needed to have recent-onset joint pain that a treating rheumatologist suspected of progressing to RA. Second, participants had to have subclinical joint inflammation, detected via MRI.

These are “promising results” for a group where predicting risk for RA has been more difficult than for their ACPA–positive counterparts, said Kevin Deane, MD, PhD, a professor of medicine and rheumatologist at the University of Colorado School of Medicine, Aurora, who was not involved with the study. However, additional research is necessary to investigate these findings.

The clinical utility of this finding is also unclear, he noted, as it would be an “extensive process” for all ACPA–negative individuals with joint pain to undergo MRI screening, he continued.

“It’s hard to find people who would meet these criteria, and healthcare systems need to understand how ultimately this could be implemented in clinical care,” he said.
 

Adding Risk Stratification

The TREAT EARLIER trial included 236 participants; nearly two thirds were women, and 77% were ACPA–negative (specifically for anti-cyclic citrullinated peptide 2). Patients randomly assigned to active treatment received a single intramuscular glucocorticoid injection (methylprednisolone 120 mg) upon inclusion and then completed a 1-year course of MTX. The comparator group received a single placebo injection at the beginning of the trial and a 1-year course of placebo tablets. All trial screenings and visits were conducted at the Leiden University Medical Center.

At the 2-year mark, there was no difference in the development of RA between the treatment and placebo groups, although there was improvement in joint pain, physical functioning, and MRI-detected joint inflammation in all at-risk groups given MTX — ACPA–positive patients and those at high risk for clinical arthritis development.

MTX delayed the onset of RA, with a statistically significant difference between treatment and placebo at 6 and 12 months, but not at 24 months.

For this 4-year analysis, published in The Lancet Rheumatology, authors stratified patients at their time of enrollment according to their risk of developing RA based on a published model for predicting inflammatory arthritis. Predictors included ACPA positivity (2 points), rheumatoid factor positivity (1 point), more than two locations of subclinical inflammation on MRI (2 points), and presence of metacarpophalangeal extensor tenosynovitis on MRI (1 point).

Patients with at least 4 points were classified as “high-risk,” with a 70% or higher predicted risk of developing RA. Participants with 2-3 points were at “increased risk” — translating to a 25%-70% higher likelihood of developing the condition. Low-risk patients, with 0-1 points, had < 25% chance of developing RA.

Of the 182 ACPA–negative participants in the study, none were considered high risk, 66 (36%) were at increased risk, and 116 (64%) were at low risk.
 

 

 

Decreased Rates of RA Development

Of these ACPA–negative patients stratified as increased risk, 3 of 35 (9%) in the treatment group developed RA, compared with 9 of 31 (29%) in the placebo arm (hazard ratio [HR], 0.27; P = .034).

All 54 ACPA–positive patients enrolled in the study were classified as either increased risk or high risk, but the treatment showed no difference in the rate of RA development in this group, and more than half (56%) developed RA during 4 years of follow-up. However, Dr. van der Helm-van Mil noted that the 2-year data showed treatment improved the severity of subclinical inflammation and symptoms over time in these patients.

The 5-year data from the trial, including physical function and other measures of disease burden, will be analyzed in 2025, she said, and will reveal whether ACPA–negative patients treated with MTX had sustained improvements in these measures.

Additional studies are needed to validate these findings, Dr. van der Helm-van Mil said, but the results indicate that ACPA–positive and ACPA–negative patients “are different populations, and we should evaluate them separately.”

Future RA prevention studies should also risk stratify patients before enrollment so that patients at low risk of developing the disease are not included in the interventions. “You can’t expect a treatment effect if there is no risk for disease,” she added.
 

Is It Cost-Effective?

In a separate analysis, published in Annals of the Rheumatic Diseases, Dr. van der Helm-van Mil and colleagues sought to investigate the cost-effectiveness of the TREAT EARLIER intervention at 2 years of follow-up.

“There is an ongoing debate whether people with arthralgia at risk for RA should be treated with DMARDs [disease-modifying antirheumatic drugs]; however, the economic effects of an intervention in the arthralgia at risk phase are unknown.”

The analysis calculated healthcare productivity and work productivity costs from enrollment to 2 years of follow-up. To demonstrate effect, they also calculated change in quality-adjusted life years (QALYs).

Over the course of 2 years, estimated costs for the treatment arm were €4809 lower (−$5304) than the placebo arm per patient. Lower productivity costs accounted for 97% of this difference.

The treatment arm also resulted in a small improvement (+0.041) in QALYs, compared with placebo.

“These data provide the first evidence that first-line treatment aiming at secondary prevention in arthralgia at-risk for RA is cost-effective,” the authors wrote.

Dr. van der Helm-van Mil emphasized that this cost analysis used only 2-year follow-up data (rather than the newly published 4-year data) and did not differentiate ACPA–negative patients. Despite including a greater heterogeneity of patients, the intervention was still cost-effective. A future analysis that includes 5-year follow-up data and stratifies patients by ACPA status and excludes low-risk individuals could demonstrate more cost benefits to a temporary MTX regimen, she said.

Considering the costs of these preventive interventions is important, added Dr. Deane, who agreed that future analyses should examine cost-effectiveness in groups at high risk of developing RA. (Dr. Deane noted that he had reviewed this article for publication.) However, this analysis did not include the costs of screening patients before enrollment in the study.

Richard Mark Kirkner/MDedge News
Dr. Kevin D. Deane


“Additional factors that need to be considered are costs to find individuals who would meet the criteria for treatment,” he said, which would include getting an MRI to detect subclinical joint inflammation.

However, Dr. van der Helm-van Mil noted that both placebo and treatment groups received MRI scans, which would therefore not affect cost differences between the groups.

Future studies should also focus on longer-term outcomes, both Dr. Deane and Dr. van der Helm-van Mil agreed.

“Since RA is a chronic disease for which part of the patients require expensive biologicals, future cost-effectiveness analyses should also consider a lifetime horizon,” Dr. van der Helm-van Mil and colleagues wrote.

The TREAT EARLIER trial was funded by the Dutch Research Council and the Dutch Arthritis Society. The cost analysis study was funded by ZonMw and the Dutch Arthritis Society. Dr. Deane is a member of an American College of Rheumatology/European Alliance of Associations for Rheumatology task force for risk stratification in RA. He has received payments as a speaker for Werfen and Thermo Fisher Scientific and low-cost biomarker assays for research from Werfen. He has also received grant funding from Thermo Fisher Scientific, Gilead, and Boehringer Ingelheim. Dr. van der Helm-van Mil reported no disclosures.
 

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

A 1-year course of methotrexate (MTX) in clinically suspected arthralgia may prevent the development of rheumatoid arthritis (RA) in at-risk individuals who test negative for anti-citrullinated protein antibody (ACPA), according to 4-year results from the TREAT EARLIER study.

While 2-year data did not show a preventive effect, researchers risk-stratified patients in this most recent data. The previous study also grouped all individuals together, while this new analysis separated patients by seropositivity.

“Heterogeneity in risk of rheumatoid arthritis development in ACPA–negative participants with clinically suspect arthralgia might have concealed a treatment effect due to dilution,” wrote senior author Annette H. van der Helm-van Mil, MD, PhD, professor of rheumatology at Leiden University Medical Center, Leiden, the Netherlands, and colleagues. “Therefore, risk-stratified analyses are required to adequately assess the possibility of prevention of rheumatoid arthritis in people with clinically suspect arthralgia who are ACPA–negative.”

Leiden University
Dr. Annette van der Helm-van Mil

To qualify for the study, participants needed to have recent-onset joint pain that a treating rheumatologist suspected of progressing to RA. Second, participants had to have subclinical joint inflammation, detected via MRI.

These are “promising results” for a group where predicting risk for RA has been more difficult than for their ACPA–positive counterparts, said Kevin Deane, MD, PhD, a professor of medicine and rheumatologist at the University of Colorado School of Medicine, Aurora, who was not involved with the study. However, additional research is necessary to investigate these findings.

The clinical utility of this finding is also unclear, he noted, as it would be an “extensive process” for all ACPA–negative individuals with joint pain to undergo MRI screening, he continued.

“It’s hard to find people who would meet these criteria, and healthcare systems need to understand how ultimately this could be implemented in clinical care,” he said.
 

Adding Risk Stratification

The TREAT EARLIER trial included 236 participants; nearly two thirds were women, and 77% were ACPA–negative (specifically for anti-cyclic citrullinated peptide 2). Patients randomly assigned to active treatment received a single intramuscular glucocorticoid injection (methylprednisolone 120 mg) upon inclusion and then completed a 1-year course of MTX. The comparator group received a single placebo injection at the beginning of the trial and a 1-year course of placebo tablets. All trial screenings and visits were conducted at the Leiden University Medical Center.

At the 2-year mark, there was no difference in the development of RA between the treatment and placebo groups, although there was improvement in joint pain, physical functioning, and MRI-detected joint inflammation in all at-risk groups given MTX — ACPA–positive patients and those at high risk for clinical arthritis development.

MTX delayed the onset of RA, with a statistically significant difference between treatment and placebo at 6 and 12 months, but not at 24 months.

For this 4-year analysis, published in The Lancet Rheumatology, authors stratified patients at their time of enrollment according to their risk of developing RA based on a published model for predicting inflammatory arthritis. Predictors included ACPA positivity (2 points), rheumatoid factor positivity (1 point), more than two locations of subclinical inflammation on MRI (2 points), and presence of metacarpophalangeal extensor tenosynovitis on MRI (1 point).

Patients with at least 4 points were classified as “high-risk,” with a 70% or higher predicted risk of developing RA. Participants with 2-3 points were at “increased risk” — translating to a 25%-70% higher likelihood of developing the condition. Low-risk patients, with 0-1 points, had < 25% chance of developing RA.

Of the 182 ACPA–negative participants in the study, none were considered high risk, 66 (36%) were at increased risk, and 116 (64%) were at low risk.
 

 

 

Decreased Rates of RA Development

Of these ACPA–negative patients stratified as increased risk, 3 of 35 (9%) in the treatment group developed RA, compared with 9 of 31 (29%) in the placebo arm (hazard ratio [HR], 0.27; P = .034).

All 54 ACPA–positive patients enrolled in the study were classified as either increased risk or high risk, but the treatment showed no difference in the rate of RA development in this group, and more than half (56%) developed RA during 4 years of follow-up. However, Dr. van der Helm-van Mil noted that the 2-year data showed treatment improved the severity of subclinical inflammation and symptoms over time in these patients.

The 5-year data from the trial, including physical function and other measures of disease burden, will be analyzed in 2025, she said, and will reveal whether ACPA–negative patients treated with MTX had sustained improvements in these measures.

Additional studies are needed to validate these findings, Dr. van der Helm-van Mil said, but the results indicate that ACPA–positive and ACPA–negative patients “are different populations, and we should evaluate them separately.”

Future RA prevention studies should also risk stratify patients before enrollment so that patients at low risk of developing the disease are not included in the interventions. “You can’t expect a treatment effect if there is no risk for disease,” she added.
 

Is It Cost-Effective?

In a separate analysis, published in Annals of the Rheumatic Diseases, Dr. van der Helm-van Mil and colleagues sought to investigate the cost-effectiveness of the TREAT EARLIER intervention at 2 years of follow-up.

“There is an ongoing debate whether people with arthralgia at risk for RA should be treated with DMARDs [disease-modifying antirheumatic drugs]; however, the economic effects of an intervention in the arthralgia at risk phase are unknown.”

The analysis calculated healthcare productivity and work productivity costs from enrollment to 2 years of follow-up. To demonstrate effect, they also calculated change in quality-adjusted life years (QALYs).

Over the course of 2 years, estimated costs for the treatment arm were €4809 lower (−$5304) than the placebo arm per patient. Lower productivity costs accounted for 97% of this difference.

The treatment arm also resulted in a small improvement (+0.041) in QALYs, compared with placebo.

“These data provide the first evidence that first-line treatment aiming at secondary prevention in arthralgia at-risk for RA is cost-effective,” the authors wrote.

Dr. van der Helm-van Mil emphasized that this cost analysis used only 2-year follow-up data (rather than the newly published 4-year data) and did not differentiate ACPA–negative patients. Despite including a greater heterogeneity of patients, the intervention was still cost-effective. A future analysis that includes 5-year follow-up data and stratifies patients by ACPA status and excludes low-risk individuals could demonstrate more cost benefits to a temporary MTX regimen, she said.

Considering the costs of these preventive interventions is important, added Dr. Deane, who agreed that future analyses should examine cost-effectiveness in groups at high risk of developing RA. (Dr. Deane noted that he had reviewed this article for publication.) However, this analysis did not include the costs of screening patients before enrollment in the study.

Richard Mark Kirkner/MDedge News
Dr. Kevin D. Deane


“Additional factors that need to be considered are costs to find individuals who would meet the criteria for treatment,” he said, which would include getting an MRI to detect subclinical joint inflammation.

However, Dr. van der Helm-van Mil noted that both placebo and treatment groups received MRI scans, which would therefore not affect cost differences between the groups.

Future studies should also focus on longer-term outcomes, both Dr. Deane and Dr. van der Helm-van Mil agreed.

“Since RA is a chronic disease for which part of the patients require expensive biologicals, future cost-effectiveness analyses should also consider a lifetime horizon,” Dr. van der Helm-van Mil and colleagues wrote.

The TREAT EARLIER trial was funded by the Dutch Research Council and the Dutch Arthritis Society. The cost analysis study was funded by ZonMw and the Dutch Arthritis Society. Dr. Deane is a member of an American College of Rheumatology/European Alliance of Associations for Rheumatology task force for risk stratification in RA. He has received payments as a speaker for Werfen and Thermo Fisher Scientific and low-cost biomarker assays for research from Werfen. He has also received grant funding from Thermo Fisher Scientific, Gilead, and Boehringer Ingelheim. Dr. van der Helm-van Mil reported no disclosures.
 

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

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Frailty, Not Just Advanced Age, Affects ANCA Vasculitis Outcomes

Article Type
Changed
Tue, 10/08/2024 - 15:07

 

TOPLINE:

Older adults with antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis face a higher risk for end-stage renal disease or mortality and severe infections. However, frailty, more than age, predicts severe infections within 2 years of diagnosis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the Mass General Brigham ANCA-associated vasculitis cohort in the United States.
  • They included 234 individuals (median age, 75 years) with incident ANCA-associated vasculitis who were treated from January 2002 to December 2019.
  • Baseline frailty was measured using a claims-based frailty index, with data collected in the year before treatment initiation; individuals were categorized as those who were nonfrail, prefrail, mildly frail, and moderately to severely frail.
  • Frailty, either mild or moderate to severe, was noted in 44 of 118 individuals aged ≥ 75 years and in 25 of 116 individuals aged 65-74 years.
  • The outcomes of interest were the incidences of end-stage renal disease or death and severe infections within 2 years of diagnosis. The association of age and frailty with clinical outcomes was assessed in those aged 65-74 years and ≥ 75 years.

TAKEAWAY:

  • Frailty was a significant predictor of severe infections within 2 years of ANCA-associated vasculitis diagnosis (adjusted hazard ratio [aHR], 8.46; 95% CI, 3.95-18.14), showing a stronger association than seen for chronological age ≥ 75 years (aHR, 2.52; 95% CI, 1.26-5.04).
  • The incidence of severe infections was higher in those with vs without frailty in the age groups 65-74 years (38.9 vs 0.8 cases per 100 person-years) and ≥ 75 years (61.9 vs 12.3 cases per 100 person-years).
  • Older age (≥ 75 years) was associated with an increased risk for end-stage renal disease or death (aHR, 4.50; 95% CI, 1.83-11.09); however, frailty was not.
  • The effect of frailty on end-stage renal disease or death varied by age, with a larger difference observed in individuals aged 65-74 years (frail vs nonfrail, 7.5 vs 2.0 cases per 100 person-years) than in those aged ≥ 75 years (13.5 vs 16.0 cases per 100 person-years).

IN PRACTICE:

“Our results highlight the fact that assessment of frailty in the care of older adults with ANCA-associated vasculitis can distinguish a group of patients at increased risk of severe infections who might benefit from interventions to minimize infection risk and optimize outcomes,” the authors wrote.

“Incorporating frailty screening into the management of ANCA-associated vasculitis provides an opportunity to offer personalized, evidence-based care to frail older adults,” Alexandra Legge, MD, Dalhousie University, Halifax, Nova Scotia, Canada, wrote in an associated comment published online in The Lancet Rheumatology.
 

SOURCE:

This study was led by Sebastian E. Sattui, MD, Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh in Pennsylvania. It was published online on September 18, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study’s observational design and single-center setting limited the generalizability of the findings. Residual confounding may have been possible despite adjustments for relevant baseline factors. The requirement of at least one healthcare encounter before baseline may have underrepresented individuals without frailty. Differences in treatment patterns after the baseline period were not controlled for.

DISCLOSURES:

The study was supported by the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported receiving grants, research support, consulting fees, honoraria, or royalties or serving on advisory boards of pharmaceutical companies and other sources outside of the submitted work.

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:

Older adults with antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis face a higher risk for end-stage renal disease or mortality and severe infections. However, frailty, more than age, predicts severe infections within 2 years of diagnosis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the Mass General Brigham ANCA-associated vasculitis cohort in the United States.
  • They included 234 individuals (median age, 75 years) with incident ANCA-associated vasculitis who were treated from January 2002 to December 2019.
  • Baseline frailty was measured using a claims-based frailty index, with data collected in the year before treatment initiation; individuals were categorized as those who were nonfrail, prefrail, mildly frail, and moderately to severely frail.
  • Frailty, either mild or moderate to severe, was noted in 44 of 118 individuals aged ≥ 75 years and in 25 of 116 individuals aged 65-74 years.
  • The outcomes of interest were the incidences of end-stage renal disease or death and severe infections within 2 years of diagnosis. The association of age and frailty with clinical outcomes was assessed in those aged 65-74 years and ≥ 75 years.

TAKEAWAY:

  • Frailty was a significant predictor of severe infections within 2 years of ANCA-associated vasculitis diagnosis (adjusted hazard ratio [aHR], 8.46; 95% CI, 3.95-18.14), showing a stronger association than seen for chronological age ≥ 75 years (aHR, 2.52; 95% CI, 1.26-5.04).
  • The incidence of severe infections was higher in those with vs without frailty in the age groups 65-74 years (38.9 vs 0.8 cases per 100 person-years) and ≥ 75 years (61.9 vs 12.3 cases per 100 person-years).
  • Older age (≥ 75 years) was associated with an increased risk for end-stage renal disease or death (aHR, 4.50; 95% CI, 1.83-11.09); however, frailty was not.
  • The effect of frailty on end-stage renal disease or death varied by age, with a larger difference observed in individuals aged 65-74 years (frail vs nonfrail, 7.5 vs 2.0 cases per 100 person-years) than in those aged ≥ 75 years (13.5 vs 16.0 cases per 100 person-years).

IN PRACTICE:

“Our results highlight the fact that assessment of frailty in the care of older adults with ANCA-associated vasculitis can distinguish a group of patients at increased risk of severe infections who might benefit from interventions to minimize infection risk and optimize outcomes,” the authors wrote.

“Incorporating frailty screening into the management of ANCA-associated vasculitis provides an opportunity to offer personalized, evidence-based care to frail older adults,” Alexandra Legge, MD, Dalhousie University, Halifax, Nova Scotia, Canada, wrote in an associated comment published online in The Lancet Rheumatology.
 

SOURCE:

This study was led by Sebastian E. Sattui, MD, Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh in Pennsylvania. It was published online on September 18, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study’s observational design and single-center setting limited the generalizability of the findings. Residual confounding may have been possible despite adjustments for relevant baseline factors. The requirement of at least one healthcare encounter before baseline may have underrepresented individuals without frailty. Differences in treatment patterns after the baseline period were not controlled for.

DISCLOSURES:

The study was supported by the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported receiving grants, research support, consulting fees, honoraria, or royalties or serving on advisory boards of pharmaceutical companies and other sources outside of the submitted work.

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:

Older adults with antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis face a higher risk for end-stage renal disease or mortality and severe infections. However, frailty, more than age, predicts severe infections within 2 years of diagnosis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the Mass General Brigham ANCA-associated vasculitis cohort in the United States.
  • They included 234 individuals (median age, 75 years) with incident ANCA-associated vasculitis who were treated from January 2002 to December 2019.
  • Baseline frailty was measured using a claims-based frailty index, with data collected in the year before treatment initiation; individuals were categorized as those who were nonfrail, prefrail, mildly frail, and moderately to severely frail.
  • Frailty, either mild or moderate to severe, was noted in 44 of 118 individuals aged ≥ 75 years and in 25 of 116 individuals aged 65-74 years.
  • The outcomes of interest were the incidences of end-stage renal disease or death and severe infections within 2 years of diagnosis. The association of age and frailty with clinical outcomes was assessed in those aged 65-74 years and ≥ 75 years.

TAKEAWAY:

  • Frailty was a significant predictor of severe infections within 2 years of ANCA-associated vasculitis diagnosis (adjusted hazard ratio [aHR], 8.46; 95% CI, 3.95-18.14), showing a stronger association than seen for chronological age ≥ 75 years (aHR, 2.52; 95% CI, 1.26-5.04).
  • The incidence of severe infections was higher in those with vs without frailty in the age groups 65-74 years (38.9 vs 0.8 cases per 100 person-years) and ≥ 75 years (61.9 vs 12.3 cases per 100 person-years).
  • Older age (≥ 75 years) was associated with an increased risk for end-stage renal disease or death (aHR, 4.50; 95% CI, 1.83-11.09); however, frailty was not.
  • The effect of frailty on end-stage renal disease or death varied by age, with a larger difference observed in individuals aged 65-74 years (frail vs nonfrail, 7.5 vs 2.0 cases per 100 person-years) than in those aged ≥ 75 years (13.5 vs 16.0 cases per 100 person-years).

IN PRACTICE:

“Our results highlight the fact that assessment of frailty in the care of older adults with ANCA-associated vasculitis can distinguish a group of patients at increased risk of severe infections who might benefit from interventions to minimize infection risk and optimize outcomes,” the authors wrote.

“Incorporating frailty screening into the management of ANCA-associated vasculitis provides an opportunity to offer personalized, evidence-based care to frail older adults,” Alexandra Legge, MD, Dalhousie University, Halifax, Nova Scotia, Canada, wrote in an associated comment published online in The Lancet Rheumatology.
 

SOURCE:

This study was led by Sebastian E. Sattui, MD, Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh in Pennsylvania. It was published online on September 18, 2024, in The Lancet Rheumatology.

LIMITATIONS:

The study’s observational design and single-center setting limited the generalizability of the findings. Residual confounding may have been possible despite adjustments for relevant baseline factors. The requirement of at least one healthcare encounter before baseline may have underrepresented individuals without frailty. Differences in treatment patterns after the baseline period were not controlled for.

DISCLOSURES:

The study was supported by the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported receiving grants, research support, consulting fees, honoraria, or royalties or serving on advisory boards of pharmaceutical companies and other sources outside of the submitted work.

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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Why Residents Are Joining Unions in Droves

Article Type
Changed
Tue, 10/08/2024 - 11:04

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

 

 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

 

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

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Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

 

 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

 

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

 

 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

 

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

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Crisugabalin Alleviates Postherpetic Neuralgia Symptoms in Phase 3 Study

Article Type
Changed
Tue, 10/08/2024 - 10:34

 

TOPLINE:

Crisugabalin — an oral calcium channel alpha 2 delta-1 subunit ligand — was safe and well-tolerated at doses of 40 mg/d and 80 mg/d and significantly reduced pain scores in patients with postherpetic neuralgia (PHN) over 12 weeks in a phase 3 study.

METHODOLOGY:

  • Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
  • Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
  • The primary efficacy endpoint was the change in ADPS from baseline at week 12.
  • Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.

TAKEAWAY:

  • At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
  • A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
  • Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
  • Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.

IN PRACTICE:

“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”

SOURCE:

The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.

LIMITATIONS:

The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.

DISCLOSURES:

The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.

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:

Crisugabalin — an oral calcium channel alpha 2 delta-1 subunit ligand — was safe and well-tolerated at doses of 40 mg/d and 80 mg/d and significantly reduced pain scores in patients with postherpetic neuralgia (PHN) over 12 weeks in a phase 3 study.

METHODOLOGY:

  • Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
  • Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
  • The primary efficacy endpoint was the change in ADPS from baseline at week 12.
  • Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.

TAKEAWAY:

  • At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
  • A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
  • Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
  • Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.

IN PRACTICE:

“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”

SOURCE:

The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.

LIMITATIONS:

The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.

DISCLOSURES:

The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.

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:

Crisugabalin — an oral calcium channel alpha 2 delta-1 subunit ligand — was safe and well-tolerated at doses of 40 mg/d and 80 mg/d and significantly reduced pain scores in patients with postherpetic neuralgia (PHN) over 12 weeks in a phase 3 study.

METHODOLOGY:

  • Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
  • Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
  • The primary efficacy endpoint was the change in ADPS from baseline at week 12.
  • Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.

TAKEAWAY:

  • At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
  • A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
  • Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
  • Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.

IN PRACTICE:

“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”

SOURCE:

The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.

LIMITATIONS:

The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.

DISCLOSURES:

The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.

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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Weight Loss After Anti-Obesity Medications Linked to Reduced Gout Risk

Article Type
Changed
Mon, 10/07/2024 - 15:03

 

TOPLINE:

A higher rate of weight loss within 1 year of initiating orlistat is associated with lower risks for incident gout and recurrent gout flares in individuals with body mass index (BMI) > 25, particularly if they have obesity or high baseline serum urate levels.

METHODOLOGY:

  • Researchers conducted a population-based cohort study using data from The Health Improvement Network in the United Kingdom to examine the association between weight loss rates after the initiation of anti-obesity medication (orlistat) and the risk for incident gout and recurrent gout flares in patients with overweight or obesity.
  • The risk for incident gout was analyzed in 131,000 patients with overweight or obesity (mean age, 45 years; 77.3% women; mean BMI, 37.2) who did not have gout before initiating orlistat.
  • The risk for recurrent gout flares was evaluated in 3847 individuals with overweight or obesity (mean age, 56.6 years; 29.4% women; mean BMI, 38.5), who had gout before initiating orlistat.
  • Participants were divided into four groups based on their rate of weight loss during the first year of orlistat use: Weight gain or stable (< 2%), slow (2% to < 5%), moderate (5% to < 10%), and fast (≥ 10%).
  • The primary outcome was incident gout, and the secondary outcome was the rate of recurrent gout flares during the 5-year follow-up period after initiating orlistat.

TAKEAWAY:

  • The 5-year risk for incident gout was the lowest among patients in the fast weight loss group (1.2%) and highest among those in the weight gain or stable weight group (1.6%).
  • The risk for incident gout was lower in the fast (hazard ratio [HR], 0.73; 95% CI, 0.62-0.86) and moderate (HR, 0.82; 95% CI, 0.72-0.92) weight loss groups than in the weight gain or stable weight group.
  • Similarly, faster weight loss rates were linked to lower rates of recurrent gout flares, with risk ratios of 0.71 (95% CI, 0.60-0.84) and 0.83 (95% CI, 0.71-0.96) in the fast and moderate weight loss groups, respectively.
  • This study found that weight loss after initiating orlistat was particularly beneficial for individuals with obesity and those with high baseline serum urate levels.

IN PRACTICE:

“Pharmacologic treatments, such as orlistat, present an alternative strategy for managing overweight and obesity. Our study provides empirical evidence of a dose-response effect of weight loss after initiating orlistat within 1 year lowers the risk of incident gout and recurrent gout flares,” the authors wrote.

SOURCE:

This study was led by Jie Wei, PhD, Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China, and was published online on September 19, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Despite adjustment for many variables, factors such as disease severity, exercise levels, and diet were not fully captured, which might have influenced the results. The lack of hospitalization data could have resulted in recurrent gout flares being underreported. The current study may have been subjected to bias due to potential exposure misclassification resulting from the timing of weight measurements and missing updated weight data.

DISCLOSURES:

This study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and other sources. No disclosures of interest were reported by the authors.

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:

A higher rate of weight loss within 1 year of initiating orlistat is associated with lower risks for incident gout and recurrent gout flares in individuals with body mass index (BMI) > 25, particularly if they have obesity or high baseline serum urate levels.

METHODOLOGY:

  • Researchers conducted a population-based cohort study using data from The Health Improvement Network in the United Kingdom to examine the association between weight loss rates after the initiation of anti-obesity medication (orlistat) and the risk for incident gout and recurrent gout flares in patients with overweight or obesity.
  • The risk for incident gout was analyzed in 131,000 patients with overweight or obesity (mean age, 45 years; 77.3% women; mean BMI, 37.2) who did not have gout before initiating orlistat.
  • The risk for recurrent gout flares was evaluated in 3847 individuals with overweight or obesity (mean age, 56.6 years; 29.4% women; mean BMI, 38.5), who had gout before initiating orlistat.
  • Participants were divided into four groups based on their rate of weight loss during the first year of orlistat use: Weight gain or stable (< 2%), slow (2% to < 5%), moderate (5% to < 10%), and fast (≥ 10%).
  • The primary outcome was incident gout, and the secondary outcome was the rate of recurrent gout flares during the 5-year follow-up period after initiating orlistat.

TAKEAWAY:

  • The 5-year risk for incident gout was the lowest among patients in the fast weight loss group (1.2%) and highest among those in the weight gain or stable weight group (1.6%).
  • The risk for incident gout was lower in the fast (hazard ratio [HR], 0.73; 95% CI, 0.62-0.86) and moderate (HR, 0.82; 95% CI, 0.72-0.92) weight loss groups than in the weight gain or stable weight group.
  • Similarly, faster weight loss rates were linked to lower rates of recurrent gout flares, with risk ratios of 0.71 (95% CI, 0.60-0.84) and 0.83 (95% CI, 0.71-0.96) in the fast and moderate weight loss groups, respectively.
  • This study found that weight loss after initiating orlistat was particularly beneficial for individuals with obesity and those with high baseline serum urate levels.

IN PRACTICE:

“Pharmacologic treatments, such as orlistat, present an alternative strategy for managing overweight and obesity. Our study provides empirical evidence of a dose-response effect of weight loss after initiating orlistat within 1 year lowers the risk of incident gout and recurrent gout flares,” the authors wrote.

SOURCE:

This study was led by Jie Wei, PhD, Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China, and was published online on September 19, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Despite adjustment for many variables, factors such as disease severity, exercise levels, and diet were not fully captured, which might have influenced the results. The lack of hospitalization data could have resulted in recurrent gout flares being underreported. The current study may have been subjected to bias due to potential exposure misclassification resulting from the timing of weight measurements and missing updated weight data.

DISCLOSURES:

This study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and other sources. No disclosures of interest were reported by the authors.

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:

A higher rate of weight loss within 1 year of initiating orlistat is associated with lower risks for incident gout and recurrent gout flares in individuals with body mass index (BMI) > 25, particularly if they have obesity or high baseline serum urate levels.

METHODOLOGY:

  • Researchers conducted a population-based cohort study using data from The Health Improvement Network in the United Kingdom to examine the association between weight loss rates after the initiation of anti-obesity medication (orlistat) and the risk for incident gout and recurrent gout flares in patients with overweight or obesity.
  • The risk for incident gout was analyzed in 131,000 patients with overweight or obesity (mean age, 45 years; 77.3% women; mean BMI, 37.2) who did not have gout before initiating orlistat.
  • The risk for recurrent gout flares was evaluated in 3847 individuals with overweight or obesity (mean age, 56.6 years; 29.4% women; mean BMI, 38.5), who had gout before initiating orlistat.
  • Participants were divided into four groups based on their rate of weight loss during the first year of orlistat use: Weight gain or stable (< 2%), slow (2% to < 5%), moderate (5% to < 10%), and fast (≥ 10%).
  • The primary outcome was incident gout, and the secondary outcome was the rate of recurrent gout flares during the 5-year follow-up period after initiating orlistat.

TAKEAWAY:

  • The 5-year risk for incident gout was the lowest among patients in the fast weight loss group (1.2%) and highest among those in the weight gain or stable weight group (1.6%).
  • The risk for incident gout was lower in the fast (hazard ratio [HR], 0.73; 95% CI, 0.62-0.86) and moderate (HR, 0.82; 95% CI, 0.72-0.92) weight loss groups than in the weight gain or stable weight group.
  • Similarly, faster weight loss rates were linked to lower rates of recurrent gout flares, with risk ratios of 0.71 (95% CI, 0.60-0.84) and 0.83 (95% CI, 0.71-0.96) in the fast and moderate weight loss groups, respectively.
  • This study found that weight loss after initiating orlistat was particularly beneficial for individuals with obesity and those with high baseline serum urate levels.

IN PRACTICE:

“Pharmacologic treatments, such as orlistat, present an alternative strategy for managing overweight and obesity. Our study provides empirical evidence of a dose-response effect of weight loss after initiating orlistat within 1 year lowers the risk of incident gout and recurrent gout flares,” the authors wrote.

SOURCE:

This study was led by Jie Wei, PhD, Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha, China, and was published online on September 19, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Despite adjustment for many variables, factors such as disease severity, exercise levels, and diet were not fully captured, which might have influenced the results. The lack of hospitalization data could have resulted in recurrent gout flares being underreported. The current study may have been subjected to bias due to potential exposure misclassification resulting from the timing of weight measurements and missing updated weight data.

DISCLOSURES:

This study was supported by the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and other sources. No disclosures of interest were reported by the authors.

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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