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As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

As family doctors, we often provide contraception care for our patients and they ask many questions about what is the best choice for them. There are many factors that may contribute to our discussion with our patients, a patient’s body weight being just one of them.

We all know that some contraception methods have been shown to be less effective in patients with a body mass index (BMI) over 30. Additionally, many hormonal therapies are known to contribute to weight gain.

 

In August 2024, the Society of Family Planning set forth guidelines regarding contraception and body weight. The authors suggest that BMI may not be the best measure to use to reflect body size but suggest that it is the best we have. They state that we should refrain using the classification names contained within the BMI system: “healthy weight,” “obese,” etc. They caution against stigmatizing patients and bringing our own biases into the discussion.

It should be noted that no contraceptive method is contraindicated based on a patient’s body size. However, physicians should use evidence-based information to reach a shared decision with the patient. This should include risks based on body weight/size and its effect on contraception.

Although oral contraceptive pills (OCPs) affect the way steroid hormones are processed, efficacy is thought to be the same in all patients regardless of weight. Most contraception failures in patients taking OCPs are the result of incorrect use of the medication. It is important to note that in women with BMIs greater than 30 the risk of venous thromboembolism is increased with combined hormonal contraceptives. 

It is suggested that women with BMIs greater than 30 avoid hormonal transdermal patches because of higher rates of contraception failure. Vaginal rings have not been adequately studied regarding their effectiveness in patients with BMIs greater than 30.

Contraceptive implants are another good choice for women with BMIs greater than 30. Despite the serum level of etonogestrel being lower than in women with BMIs under 30, most remained high enough to suppress ovulation. IUDs and depo medroxyprogesterone shots also appear to be effective in those with higher BMIs, although there is a slight increased risk of venous thromboembolism in those utilizing depo medroxyprogesterone shots.

It is important for us to be very familiar with all methods of contraception and we need to be comfortable discussing the options with our patients. If a patient desires contraception to avoid pregnancy, she must be informed when effectiveness may be reduced. We also need to be aware of the side effects and let our patients know what to expect. They need as much data as possible to make an informed decision about which method they choose. We may not agree with their decision, but if a patient is aware of what may happen, it is her choice to make.

Many women feel uncomfortable bringing up the discussion of contraception. We need to address this with women of child-bearing age. Often, broaching the topic will open the door to a whole host of concerns. Women with overweight may avoid seeking care because they were made uncomfortable in the medical setting or were made to feel stigmatized. We will never fix the obesity epidemic in the United States if our patients avoid coming into the office.

The guidelines also discuss contraception choices that may lead to weight gain. The medication alone may not be responsible but rather it is a combination of genetic, environmental, and lifestyle factors. Along with the warning about weight gain, we should be counseling our patients regarding their lifestyle choices, such as diet and exercise.

The authors of this guideline paper do a great job exploring each contraception method for women with BMI over 30. However, many factors go into deciding which choice is the best for an individual patient. A patient may do poorly at taking pills every day. Another may dislike the concept of inserting a vaginal ring. Each patient should be approached individually and all these factors need to be taken into consideration. Weight is an important factor to consider, but there are many others. If we fail to acknowledge the complexity of our patients, we can never do our best for them.

 

Dr. Girgis is a family medicine practitioner, South River, New Jersey, and clinical assistant professor of family medicine, Robert Wood Johnson Medical School, New Brunswick, New Jersey. She was paid by Pfizer as a consultant on Paxlovid and is the editor in chief of Physician’s Weekly.

LOS ANGELES — Only about 27% of patients newly diagnosed with focal epilepsy are seizure-free on initial anti-seizure medications (ASMs), new research suggested.

This is sobering information to pass on to patients with focal epilepsy who may have high expectations based on prior data. “Patients tend to expect things to happen quickly, said study investigator Sarah Barnard, MD, a research fellow at the School of Translational Medicine, Monash University, Melbourne, Australia.

The study was presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

An International Collaboration

The study is part of the International Human Epilepsy Project (HEP), which focuses on new-onset focal epilepsy, one of the most common forms of the disorder. The researchers are aiming to identify factors that influence treatment response in this population.

For example, they will investigate how specific medications and coexisting conditions affect treatment outcomes. Ultimately, the goal is to enable the development of individualized treatment plans for patients, leading to faster and more effective improvements or potential cures for the condition.

“The investigators wanted to focus in on focal epilepsy and exclude patients with more severe phenotypes, such as those with developmental delays or significant brain injury,” said Barnard. Individuals with focal epilepsy are generally healthy, she added.

In addition, previous studies may have used differing definitions of seizure freedom, said Barnard.

The study included 448 patients, median age about 33 years and 60% women, with focal epilepsy who were enrolled at 34 tertiary epilepsy centers in the United States, Europe, and Australia within 4 months of initiating ASM treatment.

Participants were followed for up to 6 years (the median was 3.13 years). The median age at seizure onset was 29 years, and the median age of treatment initiation was 32 years. The most common first-line ASMs were levetiracetam (56.9%) and lamotrigine (16.5%).

Researchers used updated International League Against Epilepsy definitions. Seizure freedom is defined as no seizures for 12 months or three times the longest pretreatment seizure-free interval, whichever is longer.

Results showed that only 27% of patients were seizure-free in the first year after diagnosis even accounting for a 2-month “medication adjustment” period.

 

Managing Expectations

Although the study excluded individuals with more severe types of epilepsy, “we still identified a substantial proportion of treatment-resistant cases, suggesting that much more complex factors are at play,” said Jacqueline French, MD, a study coinvestigator and professor at the NYU Langone’s Comprehensive Epilepsy Center in New York City.

“I don’t think we adequately prepare our patients for the challenges of the first year, which can be quite turbulent,” French said.

However, the seizure freedom rate in this study is lower than previous estimates. “It’s much less than what was predicted in other studies, some of which quote around 50%-55% seizure freedom on the first ASM,” said Barnard.

It’s not clear why there’s such a difference, although it may be related to a predominance in the HEP study of patients taking levetiracetam as the first-line ASM. “We didn’t directly look at the rate of treatment response or seizure freedom on levetiracetam,” which is something that will be addressed in a follow-up study, Barnard added.

The difference could be due to the study including only focal epilepsy patients, “who usually have a different treatment regime,” or it could be related to using updated definitions in this study, she said.

Results also showed that patients are at high risk during the first year of treatment, with two thirds experiencing ongoing or worsening seizures during this period. “People have ongoing seizures for the first year, even if they go on to become seizure-free,” Barnard noted.

Experiencing ongoing seizures has potential implications for driving and for employment, she added.

A self-reported history of a psychological disorder was a risk factor for increased treatment resistance. Upon enrollment, each participant completed the Mini International Neuropsychiatric Interview, which Barnard said is a diagnostic, rather than a screening, tool.

One of the team’s next research steps is to look more closely at the role of depression, anxiety, bipolar disorder, and suicidality on treatment response in this patient population, said Barnard.

 

Important for Patient Counseling

Commenting on the research, Patrick Kwan, MD, PhD, professor, Department of Neuroscience, Monash University, said the research is “very important” in terms of patient counseling.

“For someone newly diagnosed with epilepsy, starting the first medication can be both daunting and confusing, with many uncertainties,” said Kwan. “That’s why it’s valuable to know that nearly a third of patients may not respond to initial treatment.”

He noted that the patients in the study were recruited from major centers, which could attract a specific subset of individuals. “It’s possible that this patient population might represent more severe cases,” he explained.

Kwan also emphasized that the study did not examine the “patterns” of prescription drug choices, adding that he agreed this should be addressed in future analyses.

The researchers and Kwan reported no relevant disclosures.

 

A version of this article appeared on Medscape.com.

LOS ANGELES — Only about 27% of patients newly diagnosed with focal epilepsy are seizure-free on initial anti-seizure medications (ASMs), new research suggested.

This is sobering information to pass on to patients with focal epilepsy who may have high expectations based on prior data. “Patients tend to expect things to happen quickly, said study investigator Sarah Barnard, MD, a research fellow at the School of Translational Medicine, Monash University, Melbourne, Australia.

The study was presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

An International Collaboration

The study is part of the International Human Epilepsy Project (HEP), which focuses on new-onset focal epilepsy, one of the most common forms of the disorder. The researchers are aiming to identify factors that influence treatment response in this population.

For example, they will investigate how specific medications and coexisting conditions affect treatment outcomes. Ultimately, the goal is to enable the development of individualized treatment plans for patients, leading to faster and more effective improvements or potential cures for the condition.

“The investigators wanted to focus in on focal epilepsy and exclude patients with more severe phenotypes, such as those with developmental delays or significant brain injury,” said Barnard. Individuals with focal epilepsy are generally healthy, she added.

In addition, previous studies may have used differing definitions of seizure freedom, said Barnard.

The study included 448 patients, median age about 33 years and 60% women, with focal epilepsy who were enrolled at 34 tertiary epilepsy centers in the United States, Europe, and Australia within 4 months of initiating ASM treatment.

Participants were followed for up to 6 years (the median was 3.13 years). The median age at seizure onset was 29 years, and the median age of treatment initiation was 32 years. The most common first-line ASMs were levetiracetam (56.9%) and lamotrigine (16.5%).

Researchers used updated International League Against Epilepsy definitions. Seizure freedom is defined as no seizures for 12 months or three times the longest pretreatment seizure-free interval, whichever is longer.

Results showed that only 27% of patients were seizure-free in the first year after diagnosis even accounting for a 2-month “medication adjustment” period.

 

Managing Expectations

Although the study excluded individuals with more severe types of epilepsy, “we still identified a substantial proportion of treatment-resistant cases, suggesting that much more complex factors are at play,” said Jacqueline French, MD, a study coinvestigator and professor at the NYU Langone’s Comprehensive Epilepsy Center in New York City.

“I don’t think we adequately prepare our patients for the challenges of the first year, which can be quite turbulent,” French said.

However, the seizure freedom rate in this study is lower than previous estimates. “It’s much less than what was predicted in other studies, some of which quote around 50%-55% seizure freedom on the first ASM,” said Barnard.

It’s not clear why there’s such a difference, although it may be related to a predominance in the HEP study of patients taking levetiracetam as the first-line ASM. “We didn’t directly look at the rate of treatment response or seizure freedom on levetiracetam,” which is something that will be addressed in a follow-up study, Barnard added.

The difference could be due to the study including only focal epilepsy patients, “who usually have a different treatment regime,” or it could be related to using updated definitions in this study, she said.

Results also showed that patients are at high risk during the first year of treatment, with two thirds experiencing ongoing or worsening seizures during this period. “People have ongoing seizures for the first year, even if they go on to become seizure-free,” Barnard noted.

Experiencing ongoing seizures has potential implications for driving and for employment, she added.

A self-reported history of a psychological disorder was a risk factor for increased treatment resistance. Upon enrollment, each participant completed the Mini International Neuropsychiatric Interview, which Barnard said is a diagnostic, rather than a screening, tool.

One of the team’s next research steps is to look more closely at the role of depression, anxiety, bipolar disorder, and suicidality on treatment response in this patient population, said Barnard.

 

Important for Patient Counseling

Commenting on the research, Patrick Kwan, MD, PhD, professor, Department of Neuroscience, Monash University, said the research is “very important” in terms of patient counseling.

“For someone newly diagnosed with epilepsy, starting the first medication can be both daunting and confusing, with many uncertainties,” said Kwan. “That’s why it’s valuable to know that nearly a third of patients may not respond to initial treatment.”

He noted that the patients in the study were recruited from major centers, which could attract a specific subset of individuals. “It’s possible that this patient population might represent more severe cases,” he explained.

Kwan also emphasized that the study did not examine the “patterns” of prescription drug choices, adding that he agreed this should be addressed in future analyses.

The researchers and Kwan reported no relevant disclosures.

 

A version of this article appeared on Medscape.com.

LOS ANGELES — Only about 27% of patients newly diagnosed with focal epilepsy are seizure-free on initial anti-seizure medications (ASMs), new research suggested.

This is sobering information to pass on to patients with focal epilepsy who may have high expectations based on prior data. “Patients tend to expect things to happen quickly, said study investigator Sarah Barnard, MD, a research fellow at the School of Translational Medicine, Monash University, Melbourne, Australia.

The study was presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

 

An International Collaboration

The study is part of the International Human Epilepsy Project (HEP), which focuses on new-onset focal epilepsy, one of the most common forms of the disorder. The researchers are aiming to identify factors that influence treatment response in this population.

For example, they will investigate how specific medications and coexisting conditions affect treatment outcomes. Ultimately, the goal is to enable the development of individualized treatment plans for patients, leading to faster and more effective improvements or potential cures for the condition.

“The investigators wanted to focus in on focal epilepsy and exclude patients with more severe phenotypes, such as those with developmental delays or significant brain injury,” said Barnard. Individuals with focal epilepsy are generally healthy, she added.

In addition, previous studies may have used differing definitions of seizure freedom, said Barnard.

The study included 448 patients, median age about 33 years and 60% women, with focal epilepsy who were enrolled at 34 tertiary epilepsy centers in the United States, Europe, and Australia within 4 months of initiating ASM treatment.

Participants were followed for up to 6 years (the median was 3.13 years). The median age at seizure onset was 29 years, and the median age of treatment initiation was 32 years. The most common first-line ASMs were levetiracetam (56.9%) and lamotrigine (16.5%).

Researchers used updated International League Against Epilepsy definitions. Seizure freedom is defined as no seizures for 12 months or three times the longest pretreatment seizure-free interval, whichever is longer.

Results showed that only 27% of patients were seizure-free in the first year after diagnosis even accounting for a 2-month “medication adjustment” period.

 

Managing Expectations

Although the study excluded individuals with more severe types of epilepsy, “we still identified a substantial proportion of treatment-resistant cases, suggesting that much more complex factors are at play,” said Jacqueline French, MD, a study coinvestigator and professor at the NYU Langone’s Comprehensive Epilepsy Center in New York City.

“I don’t think we adequately prepare our patients for the challenges of the first year, which can be quite turbulent,” French said.

However, the seizure freedom rate in this study is lower than previous estimates. “It’s much less than what was predicted in other studies, some of which quote around 50%-55% seizure freedom on the first ASM,” said Barnard.

It’s not clear why there’s such a difference, although it may be related to a predominance in the HEP study of patients taking levetiracetam as the first-line ASM. “We didn’t directly look at the rate of treatment response or seizure freedom on levetiracetam,” which is something that will be addressed in a follow-up study, Barnard added.

The difference could be due to the study including only focal epilepsy patients, “who usually have a different treatment regime,” or it could be related to using updated definitions in this study, she said.

Results also showed that patients are at high risk during the first year of treatment, with two thirds experiencing ongoing or worsening seizures during this period. “People have ongoing seizures for the first year, even if they go on to become seizure-free,” Barnard noted.

Experiencing ongoing seizures has potential implications for driving and for employment, she added.

A self-reported history of a psychological disorder was a risk factor for increased treatment resistance. Upon enrollment, each participant completed the Mini International Neuropsychiatric Interview, which Barnard said is a diagnostic, rather than a screening, tool.

One of the team’s next research steps is to look more closely at the role of depression, anxiety, bipolar disorder, and suicidality on treatment response in this patient population, said Barnard.

 

Important for Patient Counseling

Commenting on the research, Patrick Kwan, MD, PhD, professor, Department of Neuroscience, Monash University, said the research is “very important” in terms of patient counseling.

“For someone newly diagnosed with epilepsy, starting the first medication can be both daunting and confusing, with many uncertainties,” said Kwan. “That’s why it’s valuable to know that nearly a third of patients may not respond to initial treatment.”

He noted that the patients in the study were recruited from major centers, which could attract a specific subset of individuals. “It’s possible that this patient population might represent more severe cases,” he explained.

Kwan also emphasized that the study did not examine the “patterns” of prescription drug choices, adding that he agreed this should be addressed in future analyses.

The researchers and Kwan reported no relevant disclosures.

 

A version of this article appeared on Medscape.com.

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), bariatric surgery appears to carry a lower risk for mortality after 5 years than treatment with pharmacologic therapies such as glucagon-like peptide 1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors, new study results showed.

In a separate analysis of data from the same study, researchers also found that bariatric surgery alone had lower risks for major adverse cardiovascular events (MACEs) than GLP-1 or SGLT2 inhibitor use or a combination of surgery and medications.

“While weight loss medications have demonstrated notable success, especially in managing diabetes and aiding weight loss, bariatric surgery offers more significant and varied benefits for weight and metabolic health, making it a better option for some patients,” said Leith Ghani, DO, an internal medicine resident at The University of Arizona College of Medicine – Phoenix.

Ghani presented the findings about mortality at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD). His co-author and fellow internal medicine resident Qumber Ali, DO, presented the findings about MACEs.

These findings highlight “the need for personalized treatment plans, allowing the decision between surgery and medication to be customized according to each patient’s specific situation and health goals,” Ghani said. “It also emphasizes the importance of a multidisciplinary approach to patient management.”

 

Comparing Bariatric Interventions and Pharmacologic Treatments

The retrospective, multicenter study of hospital admissions data from the Banner Health system in Phoenix included more than 8600 patients who had MASLD-related diagnostic codes and metabolic criteria. Patients were divided into four groups according to the treatment they received: Bariatric surgery alone (5.8%), GLP-1 medications (39.3%), SGLT2 inhibitor medications (23.4%), or a combination of surgery and medications (31.5%).

In the mortality analysis, Ghani and colleagues looked at data for patients who died between 12 and 60 months after surgery or starting medication. They found that patients who underwent bariatric surgery had a significantly higher chance of survival at 5 years.

When compared to bariatric surgery, the adjusted hazard ratio (aHR) for GLP-1 medications was 2.99, followed by an aHR of 2.96 for SGLT2 inhibitor medications, and an aHR of 1.78 for a combination of treatments.

In the MACE analysis, Ali and colleagues looked at data for patients who were followed for 12 months or more after intervention or initiation of treatment, identifying MACE diagnostic codes for coronary artery disease, cerebrovascular disease, and congestive heart failure. They found that patients who underwent bariatric surgery alone had a significantly lower rate of MACEs.

When compared to bariatric surgery, the aHR was 1.83 for GLP-1 medications, 1.72 for SGLT2 inhibitor medications, and 1.91 for a combination of treatments.

Regarding both analyses, patients taking GLP-1 or SGLT2 inhibitor medications may face higher risks for mortality or serious heart problems due to existing metabolic disorders or heart disease, Ali said.

Future studies could look at other risk factors that make these patients more vulnerable, he added. For instance, factors related to body mass index, glucose control, other medications, different clinical settings, and race/ethnicity can contribute to different treatment responses, as could the decision to take medication or undergo surgery in the first place.

“This emphasizes the need for additional, prospective randomized clinical trial research to explore why these differences exist,” Ali said. “While progress has been made, there is still much to learn about the optimal management of patients with metabolic and cardiovascular disorders.”

 

Considering a Multidisciplinary Approach to MASLD Treatment

Ghani and Ali also called for personalized treatment plans for metabolic-related disorders such as MASLD, as well as strong communication among specialists and with patients about the benefits and risks of choosing certain medications and procedures.

“Bariatric surgery is not a universal solution, and not all patients are suitable for surgery,” Ghani said. “We also can’t say at this point that drug treatments are worse than bariatric surgery. The effectiveness of these therapies can vary greatly depending on a patient’s health, lifestyle, and preferences.”

Looking ahead, MASLD studies should investigate long-term weight loss seen with bariatric surgery and different medications, said Katherine Schwenger, PhD, RD, a scientific associate at Toronto General Hospital in Toronto, Ontario, Canada.

“GLP-1s are a hot topic right now,” said Schwenger, who wasn’t involved with the study. But “we need to look at factors such as the longevity of weight loss. It’s hard to beat the success and sustainability of bariatric surgery.”

Ghani, Ali, and Schwenger reported no relevant disclosures.

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

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), bariatric surgery appears to carry a lower risk for mortality after 5 years than treatment with pharmacologic therapies such as glucagon-like peptide 1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors, new study results showed.

In a separate analysis of data from the same study, researchers also found that bariatric surgery alone had lower risks for major adverse cardiovascular events (MACEs) than GLP-1 or SGLT2 inhibitor use or a combination of surgery and medications.

“While weight loss medications have demonstrated notable success, especially in managing diabetes and aiding weight loss, bariatric surgery offers more significant and varied benefits for weight and metabolic health, making it a better option for some patients,” said Leith Ghani, DO, an internal medicine resident at The University of Arizona College of Medicine – Phoenix.

Ghani presented the findings about mortality at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD). His co-author and fellow internal medicine resident Qumber Ali, DO, presented the findings about MACEs.

These findings highlight “the need for personalized treatment plans, allowing the decision between surgery and medication to be customized according to each patient’s specific situation and health goals,” Ghani said. “It also emphasizes the importance of a multidisciplinary approach to patient management.”

 

Comparing Bariatric Interventions and Pharmacologic Treatments

The retrospective, multicenter study of hospital admissions data from the Banner Health system in Phoenix included more than 8600 patients who had MASLD-related diagnostic codes and metabolic criteria. Patients were divided into four groups according to the treatment they received: Bariatric surgery alone (5.8%), GLP-1 medications (39.3%), SGLT2 inhibitor medications (23.4%), or a combination of surgery and medications (31.5%).

In the mortality analysis, Ghani and colleagues looked at data for patients who died between 12 and 60 months after surgery or starting medication. They found that patients who underwent bariatric surgery had a significantly higher chance of survival at 5 years.

When compared to bariatric surgery, the adjusted hazard ratio (aHR) for GLP-1 medications was 2.99, followed by an aHR of 2.96 for SGLT2 inhibitor medications, and an aHR of 1.78 for a combination of treatments.

In the MACE analysis, Ali and colleagues looked at data for patients who were followed for 12 months or more after intervention or initiation of treatment, identifying MACE diagnostic codes for coronary artery disease, cerebrovascular disease, and congestive heart failure. They found that patients who underwent bariatric surgery alone had a significantly lower rate of MACEs.

When compared to bariatric surgery, the aHR was 1.83 for GLP-1 medications, 1.72 for SGLT2 inhibitor medications, and 1.91 for a combination of treatments.

Regarding both analyses, patients taking GLP-1 or SGLT2 inhibitor medications may face higher risks for mortality or serious heart problems due to existing metabolic disorders or heart disease, Ali said.

Future studies could look at other risk factors that make these patients more vulnerable, he added. For instance, factors related to body mass index, glucose control, other medications, different clinical settings, and race/ethnicity can contribute to different treatment responses, as could the decision to take medication or undergo surgery in the first place.

“This emphasizes the need for additional, prospective randomized clinical trial research to explore why these differences exist,” Ali said. “While progress has been made, there is still much to learn about the optimal management of patients with metabolic and cardiovascular disorders.”

 

Considering a Multidisciplinary Approach to MASLD Treatment

Ghani and Ali also called for personalized treatment plans for metabolic-related disorders such as MASLD, as well as strong communication among specialists and with patients about the benefits and risks of choosing certain medications and procedures.

“Bariatric surgery is not a universal solution, and not all patients are suitable for surgery,” Ghani said. “We also can’t say at this point that drug treatments are worse than bariatric surgery. The effectiveness of these therapies can vary greatly depending on a patient’s health, lifestyle, and preferences.”

Looking ahead, MASLD studies should investigate long-term weight loss seen with bariatric surgery and different medications, said Katherine Schwenger, PhD, RD, a scientific associate at Toronto General Hospital in Toronto, Ontario, Canada.

“GLP-1s are a hot topic right now,” said Schwenger, who wasn’t involved with the study. But “we need to look at factors such as the longevity of weight loss. It’s hard to beat the success and sustainability of bariatric surgery.”

Ghani, Ali, and Schwenger reported no relevant disclosures.

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

SAN DIEGO — In patients with metabolic dysfunction–associated steatotic liver disease (MASLD), bariatric surgery appears to carry a lower risk for mortality after 5 years than treatment with pharmacologic therapies such as glucagon-like peptide 1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors, new study results showed.

In a separate analysis of data from the same study, researchers also found that bariatric surgery alone had lower risks for major adverse cardiovascular events (MACEs) than GLP-1 or SGLT2 inhibitor use or a combination of surgery and medications.

“While weight loss medications have demonstrated notable success, especially in managing diabetes and aiding weight loss, bariatric surgery offers more significant and varied benefits for weight and metabolic health, making it a better option for some patients,” said Leith Ghani, DO, an internal medicine resident at The University of Arizona College of Medicine – Phoenix.

Ghani presented the findings about mortality at The Liver Meeting 2024: American Association for the Study of Liver Diseases (AASLD). His co-author and fellow internal medicine resident Qumber Ali, DO, presented the findings about MACEs.

These findings highlight “the need for personalized treatment plans, allowing the decision between surgery and medication to be customized according to each patient’s specific situation and health goals,” Ghani said. “It also emphasizes the importance of a multidisciplinary approach to patient management.”

 

Comparing Bariatric Interventions and Pharmacologic Treatments

The retrospective, multicenter study of hospital admissions data from the Banner Health system in Phoenix included more than 8600 patients who had MASLD-related diagnostic codes and metabolic criteria. Patients were divided into four groups according to the treatment they received: Bariatric surgery alone (5.8%), GLP-1 medications (39.3%), SGLT2 inhibitor medications (23.4%), or a combination of surgery and medications (31.5%).

In the mortality analysis, Ghani and colleagues looked at data for patients who died between 12 and 60 months after surgery or starting medication. They found that patients who underwent bariatric surgery had a significantly higher chance of survival at 5 years.

When compared to bariatric surgery, the adjusted hazard ratio (aHR) for GLP-1 medications was 2.99, followed by an aHR of 2.96 for SGLT2 inhibitor medications, and an aHR of 1.78 for a combination of treatments.

In the MACE analysis, Ali and colleagues looked at data for patients who were followed for 12 months or more after intervention or initiation of treatment, identifying MACE diagnostic codes for coronary artery disease, cerebrovascular disease, and congestive heart failure. They found that patients who underwent bariatric surgery alone had a significantly lower rate of MACEs.

When compared to bariatric surgery, the aHR was 1.83 for GLP-1 medications, 1.72 for SGLT2 inhibitor medications, and 1.91 for a combination of treatments.

Regarding both analyses, patients taking GLP-1 or SGLT2 inhibitor medications may face higher risks for mortality or serious heart problems due to existing metabolic disorders or heart disease, Ali said.

Future studies could look at other risk factors that make these patients more vulnerable, he added. For instance, factors related to body mass index, glucose control, other medications, different clinical settings, and race/ethnicity can contribute to different treatment responses, as could the decision to take medication or undergo surgery in the first place.

“This emphasizes the need for additional, prospective randomized clinical trial research to explore why these differences exist,” Ali said. “While progress has been made, there is still much to learn about the optimal management of patients with metabolic and cardiovascular disorders.”

 

Considering a Multidisciplinary Approach to MASLD Treatment

Ghani and Ali also called for personalized treatment plans for metabolic-related disorders such as MASLD, as well as strong communication among specialists and with patients about the benefits and risks of choosing certain medications and procedures.

“Bariatric surgery is not a universal solution, and not all patients are suitable for surgery,” Ghani said. “We also can’t say at this point that drug treatments are worse than bariatric surgery. The effectiveness of these therapies can vary greatly depending on a patient’s health, lifestyle, and preferences.”

Looking ahead, MASLD studies should investigate long-term weight loss seen with bariatric surgery and different medications, said Katherine Schwenger, PhD, RD, a scientific associate at Toronto General Hospital in Toronto, Ontario, Canada.

“GLP-1s are a hot topic right now,” said Schwenger, who wasn’t involved with the study. But “we need to look at factors such as the longevity of weight loss. It’s hard to beat the success and sustainability of bariatric surgery.”

Ghani, Ali, and Schwenger reported no relevant disclosures.

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

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

There has been a lot of talk about polarization in America in the past year and how hard it can be to talk with someone with a different world view. It also seems that the COVID pandemic and a move to non–face-to-face communication has eroded social skills, increased disinformation, and made people irritable. As pediatric providers dealing with all kinds of people we have to increasingly deal with difficult communications.

We pediatric providers tend to be a friendly bunch with a mission of helping the health and well-being of children whose problems are no fault of their own. What’s not to like about us? Hence, one of the most difficult situations is a parent approaching us in anger. [All that follows also applies generally to adults, teens, and children but I here focus on parents.]

 

Health problems are often very frustrating. Parents mainly want their child’s problem fixed, yet that is not easy. Frustration with the health condition is compounded by having to wait, costs for care, life interruption, and confusing information. Anger and aggression are natural results of frustration (remember the Frustration-Aggression paradigm in animals?). Frustration is cumulative — a health problem may be the last straw, especially when social stressors or past trauma, also out of their control, were already present. Individuals with mental disorders or substance use are especially vulnerable to anger reactions.

 

Allaying Anger

As providers, we don’t know how anger may have been reinforced in the individual’s past. Anger may have scared others into giving in to them and thus became a familiar weapon. Sometimes angry outbursts get people to the front of the line. Expressing anger is also a kind of relief valve for emotions. Acknowledging that their situation is “very upsetting” and “frustrating” and that you will try to get a solution is the first step in effective communication.

Anger also comes from anxiety or fear. Anxiety is often a missed cause of childhood aggressive behavior. Parents are scared about poor short-and long-term outcomes of health problems in their child. Asking “What worries you the most about this illness?” or “What have you heard about this illness?” can elicit reports of fears you may be able to debunk or put in perspective. 

Keeping their child healthy and safe are parents’ top priorities, so feeling helpless and out of control when an illness or injury occurs is very disturbing. Being a good parent is partly driven by guilt, which may be unrealistic, or from omission (eg, did not bring the child in sooner), or commission (eg, shouldn’t have taken her to that birthday party where she caught it). This is where you may normalize their actions such as saying “a child really can’t grow up in a bubble” or “symptoms can mean many things. I usually tell parents they don’t need to call unless the temperature is over 101,” for example. If appropriate, you might clarify what actions they should take in the future and provide a handout or instructions for sources of reliable information (and perhaps what is unreliable, such as TikTok!) to give them more power. 

Feeling helpless may also evoke memories from the past when, as a child themselves, they were not able to help a loved one suffering from an accident or a health or mental health issue. They may have been helpless in the face of bullying, domestic violence, or racism. Even a hint of helplessness now can tap into the previous emotions, accelerating their reactivity. Promising to “work on this together” lends them your agency. 

Of course, the main thing angry parents need is to have their child’s issue resolved. But this may not be a quick fix, especially if they are too incensed to cooperate. But what we can always do is address their need to be heard — both in content and emotion — and to help them regain a sense of control.

 

Pacing Can Help

One strategy that may seem counterintuitive is called “pacing.” Instead of begging the parent to calm down, which denigrates their strong feelings, we can echo their concerns while mirroring their emotions (within limits) to demonstrate that we understand them. Mirroring emotions may include your physical posture, volume and speed of speech, as well as use of similar sensory modalities. As for the modality component, you may notice that people tend to use visual, auditory or kinesthetic (feeling or action) words. So, for example, for an angry parent “screaming that no one has looked at the lab results yet” we might posture as they do, increase our volume, and use visual words such as saying “You are upset because you don’t see anyone looking over the labs in all this time.” As you hear more, you can continue to paraphrase and summarize what they are saying including their examples or wording. You can then change your own tone and posture progressively downshifting, bringing them along, and establishing rapport as they can tell that you are understanding them. Validating their emotions does not mean you have to agree with what they are saying; it demonstrates that you hear them.

Other strategies to demonstrate listening that can be helpful include sitting down side by side, and taking notes they can see, asking if you are getting the details correct. Using open-ended questions to elicit answers other than yes/no conveys openness to hear their story and may also reveal some of the causes for the upset. Sitting side by side conveys collaboration, whereas face to face implies more confrontation. Keep your arms down and arms and legs uncrossed and your head nodding and tilted somewhat down. These positions and verbal techniques demonstrate that you are listening to both their content and feelings. 

 

Next Steps

The other main component to communication with an angry parent is providing action on the issue, especially involving them in a way that gives them some sense of control. Once they can tell that you understand them, it is then key to stay focused on solutions, bringing the discussion back if it veers off. There may be things they can do or you can do together such as log in to their portal, get on the phone with a relevant staff person such as a referral coordinator, or set a time for a follow-up appointment or call. Any action step they can do, even asking that they record a temperature every 6 hours, reduces helplessness.

It is crucial to elicit the parents’ criteria for satisfaction of their complaint. You may try asking: “What would tell you that your child’s problem is being adequately addressed?” Write down these criteria as part of the overall plan, making sure they are detailed, measurable, feasible, time related, and relevant. Include actions for the parent to take, if possible. By setting criteria and times for follow-up you establish accountability that also gives them a sense of control. 

There are certain communications that can make things worse with an angry parent, some of which you may not even know occurred. Their anger may well have sparked a reaction in our staff, who are getting it full force before we even start our visit. Not only you but also your staff need to avoid making excuses for what happened (or didn’t happen) to the patient, blame the family for the child’s issue, imply that the parent’s feelings are invalid, or react as though their anger was a personal affront. 

 

Setting Boundaries

There are certainly times when a parent’s behavior is unacceptable or even dangerous. It is important to have policies about what action to take so that we can verbally refer to these, if needed. We should all avoid threatening expulsion from the practice or calling security. Instead, assertively state the boundaries and rules and tell them what will happen if the behavior continues or exceeds a limit, such as frightening other patients or damaging equipment. It is essential to use respectful language and address them by name and certainly not make comments about them personally or criticize them, as these raise defensiveness. Suggesting they or you “take a break,” give them “some space” for a few minutes in a safe private room, or leave and come back in 15 minutes allows the upset parent to save face and gather themselves. All these things also work with children and teens. 

Health care is stressful, especially with short staffing, and is often intensely personal and emotional. The human struggles we deal with may also be present in our own and our staff’s experiences. Mastering skills for interacting with angry parents can strengthen our relationships with them, our staff, and even our understanding of ourselves.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

Patients with BRCA mutations and a history of early-onset breast cancer benefited from risk-reducing surgeries, according to new data presented at the San Antonio Breast Cancer Symposium (SABCS) 2024.

Having a risk-reducing mastectomy or salpingo-oophorectomy was associated with significantly improved overall survival and disease-free survival in BRCA-mutation carriers who had been diagnosed with a first breast cancer at age ≤ 40 years.

“This global study provides the first evidence that risk-reducing surgeries improve survival outcomes among young BRCA-mutation carriers with a prior history of early-onset breast cancer,” study investigator Matteo Lambertini, MD, PhD, oncologist with the University of Genova–IRCCS Policlinico San Martino Hospital in Genoa, Italy, said in a statement from the SABCS, where he presented the findings. “Considering the unique traits and needs of this younger population, and their high risk for secondary malignancies, it is critical to understand how risk-reducing surgeries affect patient outcomes, so that the risks and benefits of these procedures can be carefully weighed.”

“We hope these findings may help to improve the counseling on cancer-risk management strategies for BRCA carriers with young-onset of breast cancer below the age of 40 years,” Lambertini added during a press briefing. 

Various risk-reducing strategies, including risk-reducing surgeries, are recommended for BRCA-mutation carriers without a prior history of cancer, but the impact of these surgeries among younger populations with a history of early-onset breast cancer has been less clear.

The new findings come from the BRCA BCY Collaboration, an international, multicenter, retrospective cohort study of 5290 patients with likely pathogenic/pathogenic germline BRCA1 and/or BRCA2 mutations who were diagnosed with stages I-III breast cancer at ≤ 40 years. The risk-reducing mastectomy analysis included 2910 patients (55%) who underwent the surgery less than 1 year from diagnosis and 2380 who opted not to have the surgery. 

Primary endpoint was overall survival, and disease-free survival and breast cancer-free interval were secondary endpoints. Overall survival models were adjusted for the development of distant recurrences or second primary malignancies.

During median follow-up of 5.1 years, patients who underwent risk-reducing mastectomy had a 35% lower risk of dying (adjusted hazard ratio [aHR], 0.65) as well as a significant improvement in both disease-free survival (aHR, 0.58) and breast cancer-free interval (aHR, 0.55). The improved outcomes were seen in both BRCA1 and BRCA2 carriers, Lambertini reported. 

The risk-reducing salpingo-oophorectomy analysis included 2782 patients who underwent this surgery a median of 3 years from diagnosis and 2508 who did not. 

During median follow up of 4.9 years, risk-reducing salpingo-oophorectomy was associated with a 42% lower risk for death (aHR, 0.58) as well as an improvement in both disease-free survival (aHR, 0.68) and breast cancer-free interval (aHR, 0.65).

For risk-reducing salpingo-oophorectomy, there was an interaction based on breast cancer subtype and BRCA mutation.

“Specifically, the benefit of risk-reducing salpingo-oophorectomy was greater for patients with BRCA1 pathogenic variants and for those with triple-negative disease, as compared to those with BRCA2 pathogenic variants or luminal disease,” Lambertini reported.

Overall survival results were similar in patients who underwent one or both surgeries.

Briefing moderator Kate Lathrop, MD, with the University of Texas Health Science Center at San Antonio, noted that this study provides valuable information for counseling younger patients. Having datasets like this helps us give patients “potentially our best estimate of the amount of reduction of risk you could have by having the surgery now.”

In an interview, Freya Schnabel, MD, director of breast surgery at NYU Langone Health’s Perlmutter Cancer Center, New York City, emphasized the importance of early, well-informed decision-making upfront at the time of diagnosis in this patient population.

The benefit of “risk-reducing oophorectomy cannot be overemphasized, even in the presence of a known breast cancer because, as my colleagues and I say — we don’t want to cure their breast cancer and then have them die of ovarian cancer,” said Schnabel, who was not involved in the study.

In terms of prophylactic contralateral mastectomy, Schnabel noted that BRCA-mutation carriers have a “very high” risk for a second primary breast cancer. In her experience, “that’s what drives patients frequently at the time of diagnosis to have bilateral mastectomy because who wants to go through this more than once?” 

This is especially true for BRCA1 carriers who have a higher risk for triple-negative breast cancer, which is associated with a worse prognosis and is harder to treat, Schnabel said. 

“For these patients, having surgery prevents the patient from getting into a situation where their second primary tumor winds up being biologically more aggressive and then affects their survival,” Schnabel said.

The study was supported by the Italian Association for Cancer Research and the European Society for Medical Oncology. Lambertini reported advisory roles for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, and Menarini. Lathrop consults for TeraSera Pharmaceuticals. Schnabel had no relevant disclosures.

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

WASHINGTON — When the American College of Rheumatology (ACR) released its updated guideline for management of lupus nephritis (LN) at its 2024 Annual Meeting, they included recommendations for managing pediatric LN for the first time. 

The pediatric recommendations use the same classification criteria, outcome measures, and treatments as in adults — including the first-line triple therapy recommendation — but there remain important differences between pediatric and adult LN, Mary Beth Son, MD, clinical chief of immunology and section chief of rheumatology at Boston Children’s Hospital in Massachusetts, and an associate professor of pediatrics at Harvard Medical School, also in Boston, told attendees. 

“In general, kids and adolescents with lupus are sicker,” Son said. They are more likely to have renal manifestations and neuropsychiatric lupus at diagnosis, compared with adults. Further, “although the disease is the same, it’s happening to kids and adolescents who are undergoing critical periods of growth and development.” 

Medication risk profiles also shift for younger patients, Son noted. 

“Importantly, they’re at risk for higher cumulative dosing of both glucocorticoids and cyclophosphamide,” Son said. “When we give an adolescent a course of cyclophosphamide, we have to be aware that this might be the first of a few courses over the course of the lifetime disease, and with increasing numbers of cyclophosphamide courses, you have increased risk for infertility and malignancy.” 

Son also acknowledged challenges of pediatric literature, including differences in definitions of pediatric lupus, very few randomized controlled trials, and fewer pediatric studies in general, with fewer participants. Given these research gaps, the guideline panels included pediatric rheumatologists and nephrologists, and the patient panel included several patients with childhood-onset disease.

Son also addressed differences in pediatric drug development. Dosing studies also do not always directly translate from adults to children because children have larger drug volume distribution and differences in drug clearance, and they may need different formulations, she said. Children tend to tolerate medications better than adults because they usually have fewer comorbidities, but the assessment of a drug’s safety must take its impact on growth and development into consideration.

During a press conference after the session where the guideline was presented, Linda Hiraki, MD, ScD, a clinician-scientist in rheumatology at the Hospital for Sick Children, Toronto, Ontario, Canada, said the panel took into consideration that pediatric patients receive their diagnosis during a critical time of development, so considerations of medication risks include the fact that children “have much more life to live.”

 

Triple Therapy Recommended

As with adults, the pediatric LN guideline recommends a triple therapy approach: glucocorticoids plus mycophenolate mofetil and belimumab, in addition to the usual renin-angiotensin-aldosterone system inhibitors and hydroxychloroquine. But Son acknowledged limitations of applying the new guideline to children. For one, voclosporin has not been studied in or approved for pediatric patients, although there exists modest evidence for other calcineurin inhibitors, mainly tacrolimus, in children.

“The other important consideration is that the lower dose of prednisone that’s being offered by the guidelines of 40 mg per day as a starting dose has not been studied in pediatric lupus nephritis patients,” Son said. “However, I would offer that, given that we know that kids get higher doses and longer courses, it’s even more important to consider a lower dose to begin with in the setting of other immunosuppressants.”

 

Good Practice Statements for Pediatric LN

Son also reviewed three good practice statements for pediatric LN. First, “glucocorticoid regimens should use pediatric-appropriate doses for children, as reduction of human glucocorticoid dosing is critically important given the early age of pediatric lupus onset and attendant comorbidities,” she said.

That statement is based on both common sense and some literature, including awareness that children are more likely to receive higher doses of steroids and that children’s higher damage scores are driven in part by steroid-related toxicity, such as avascular necrosis and cataracts. In addition, glucocorticoids can have profound effects on body mass index, mood, and height attainment.

“This is during a period of emerging self-identity and struggles with appearance; steroids exacerbate that” as well as mood issues already associated with puberty, Son said.

The second good practice statement recommends that clinicians monitor patients “for delayed pubertal onset and decreased growth velocity that can result from disease activity and glucocorticoid treatment and consider referral to pediatric endocrinology if indicated.” The third states that “a structured, intentional transition from pediatric to adult rheumatology care is indicated to avoid poor outcomes during this vulnerable period.” 

During the press conference, Hiraki said that pediatric rheumatologists already recognize the need for discussions about transfer to adult care to begin very early, even years before patients are ready to transfer.

“The transition from being a pediatric patient to being an adult patient is very challenging for a number of reasons,” starting with loss of insurance coverage, added Bonnie Bermas, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas, Texas. When adult rheumatologists take on these patients, they may not have had care for 2 or 3 years, she said. 

Rebecca Sadun, MD, PhD, an associate professor of pediatrics in rheumatology at Duke University School of Medicine, Durham, North Carolina, and vice-chair of the Systemic Lupus Erythematosus Committee for the Childhood Arthritis and Rheumatology Research Alliance, was not involved in the guideline development process but reviewed the new guideline. 

“We appreciate that the ACR took care to involve pediatric rheumatologists, pediatric nephrologists, and patients with childhood-onset lupus in the development of the newest lupus nephritis treatment guidelines,” she said in an interview. She also noted, however, that “the dearth of pediatric-specific clinical trial data means that we continue to wonder when it is appropriate to extrapolate from adult data regarding the efficacy, safety, and dosing of certain medications, including steroids and voclosporin.” She also noted that voclosporin use can increase pill burden and therefore be difficult to use in pediatrics.

“Children, adolescents, and young adults are a unique population with unique challenges, including significant struggles with adherence to complex medication regimens,” she said. Sadun drew attention to two themes from the guideline that she found particularly applicable to management of pediatric LN.

“First, we must remain wary of the serious consequences of long-term, high-dose glucocorticoids, and we should continue to look towards steroid-sparing strategies that will reduce reliance on glucocorticoids,” Sadun said. “Second, we are likely to see better outcomes, including better renal response, when we take advantage of combination immunosuppression earlier in the disease course.”

Son, Bermas, and Sadun had no disclosures. Hiraki has consulted for Janssen. The guideline development did not involve outside funding.

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

WASHINGTON — When the American College of Rheumatology (ACR) released its updated guideline for management of lupus nephritis (LN) at its 2024 Annual Meeting, they included recommendations for managing pediatric LN for the first time. 

The pediatric recommendations use the same classification criteria, outcome measures, and treatments as in adults — including the first-line triple therapy recommendation — but there remain important differences between pediatric and adult LN, Mary Beth Son, MD, clinical chief of immunology and section chief of rheumatology at Boston Children’s Hospital in Massachusetts, and an associate professor of pediatrics at Harvard Medical School, also in Boston, told attendees. 

“In general, kids and adolescents with lupus are sicker,” Son said. They are more likely to have renal manifestations and neuropsychiatric lupus at diagnosis, compared with adults. Further, “although the disease is the same, it’s happening to kids and adolescents who are undergoing critical periods of growth and development.” 

Medication risk profiles also shift for younger patients, Son noted. 

“Importantly, they’re at risk for higher cumulative dosing of both glucocorticoids and cyclophosphamide,” Son said. “When we give an adolescent a course of cyclophosphamide, we have to be aware that this might be the first of a few courses over the course of the lifetime disease, and with increasing numbers of cyclophosphamide courses, you have increased risk for infertility and malignancy.” 

Son also acknowledged challenges of pediatric literature, including differences in definitions of pediatric lupus, very few randomized controlled trials, and fewer pediatric studies in general, with fewer participants. Given these research gaps, the guideline panels included pediatric rheumatologists and nephrologists, and the patient panel included several patients with childhood-onset disease.

Son also addressed differences in pediatric drug development. Dosing studies also do not always directly translate from adults to children because children have larger drug volume distribution and differences in drug clearance, and they may need different formulations, she said. Children tend to tolerate medications better than adults because they usually have fewer comorbidities, but the assessment of a drug’s safety must take its impact on growth and development into consideration.

During a press conference after the session where the guideline was presented, Linda Hiraki, MD, ScD, a clinician-scientist in rheumatology at the Hospital for Sick Children, Toronto, Ontario, Canada, said the panel took into consideration that pediatric patients receive their diagnosis during a critical time of development, so considerations of medication risks include the fact that children “have much more life to live.”

 

Triple Therapy Recommended

As with adults, the pediatric LN guideline recommends a triple therapy approach: glucocorticoids plus mycophenolate mofetil and belimumab, in addition to the usual renin-angiotensin-aldosterone system inhibitors and hydroxychloroquine. But Son acknowledged limitations of applying the new guideline to children. For one, voclosporin has not been studied in or approved for pediatric patients, although there exists modest evidence for other calcineurin inhibitors, mainly tacrolimus, in children.

“The other important consideration is that the lower dose of prednisone that’s being offered by the guidelines of 40 mg per day as a starting dose has not been studied in pediatric lupus nephritis patients,” Son said. “However, I would offer that, given that we know that kids get higher doses and longer courses, it’s even more important to consider a lower dose to begin with in the setting of other immunosuppressants.”

 

Good Practice Statements for Pediatric LN

Son also reviewed three good practice statements for pediatric LN. First, “glucocorticoid regimens should use pediatric-appropriate doses for children, as reduction of human glucocorticoid dosing is critically important given the early age of pediatric lupus onset and attendant comorbidities,” she said.

That statement is based on both common sense and some literature, including awareness that children are more likely to receive higher doses of steroids and that children’s higher damage scores are driven in part by steroid-related toxicity, such as avascular necrosis and cataracts. In addition, glucocorticoids can have profound effects on body mass index, mood, and height attainment.

“This is during a period of emerging self-identity and struggles with appearance; steroids exacerbate that” as well as mood issues already associated with puberty, Son said.

The second good practice statement recommends that clinicians monitor patients “for delayed pubertal onset and decreased growth velocity that can result from disease activity and glucocorticoid treatment and consider referral to pediatric endocrinology if indicated.” The third states that “a structured, intentional transition from pediatric to adult rheumatology care is indicated to avoid poor outcomes during this vulnerable period.” 

During the press conference, Hiraki said that pediatric rheumatologists already recognize the need for discussions about transfer to adult care to begin very early, even years before patients are ready to transfer.

“The transition from being a pediatric patient to being an adult patient is very challenging for a number of reasons,” starting with loss of insurance coverage, added Bonnie Bermas, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas, Texas. When adult rheumatologists take on these patients, they may not have had care for 2 or 3 years, she said. 

Rebecca Sadun, MD, PhD, an associate professor of pediatrics in rheumatology at Duke University School of Medicine, Durham, North Carolina, and vice-chair of the Systemic Lupus Erythematosus Committee for the Childhood Arthritis and Rheumatology Research Alliance, was not involved in the guideline development process but reviewed the new guideline. 

“We appreciate that the ACR took care to involve pediatric rheumatologists, pediatric nephrologists, and patients with childhood-onset lupus in the development of the newest lupus nephritis treatment guidelines,” she said in an interview. She also noted, however, that “the dearth of pediatric-specific clinical trial data means that we continue to wonder when it is appropriate to extrapolate from adult data regarding the efficacy, safety, and dosing of certain medications, including steroids and voclosporin.” She also noted that voclosporin use can increase pill burden and therefore be difficult to use in pediatrics.

“Children, adolescents, and young adults are a unique population with unique challenges, including significant struggles with adherence to complex medication regimens,” she said. Sadun drew attention to two themes from the guideline that she found particularly applicable to management of pediatric LN.

“First, we must remain wary of the serious consequences of long-term, high-dose glucocorticoids, and we should continue to look towards steroid-sparing strategies that will reduce reliance on glucocorticoids,” Sadun said. “Second, we are likely to see better outcomes, including better renal response, when we take advantage of combination immunosuppression earlier in the disease course.”

Son, Bermas, and Sadun had no disclosures. Hiraki has consulted for Janssen. The guideline development did not involve outside funding.

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

WASHINGTON — When the American College of Rheumatology (ACR) released its updated guideline for management of lupus nephritis (LN) at its 2024 Annual Meeting, they included recommendations for managing pediatric LN for the first time. 

The pediatric recommendations use the same classification criteria, outcome measures, and treatments as in adults — including the first-line triple therapy recommendation — but there remain important differences between pediatric and adult LN, Mary Beth Son, MD, clinical chief of immunology and section chief of rheumatology at Boston Children’s Hospital in Massachusetts, and an associate professor of pediatrics at Harvard Medical School, also in Boston, told attendees. 

“In general, kids and adolescents with lupus are sicker,” Son said. They are more likely to have renal manifestations and neuropsychiatric lupus at diagnosis, compared with adults. Further, “although the disease is the same, it’s happening to kids and adolescents who are undergoing critical periods of growth and development.” 

Medication risk profiles also shift for younger patients, Son noted. 

“Importantly, they’re at risk for higher cumulative dosing of both glucocorticoids and cyclophosphamide,” Son said. “When we give an adolescent a course of cyclophosphamide, we have to be aware that this might be the first of a few courses over the course of the lifetime disease, and with increasing numbers of cyclophosphamide courses, you have increased risk for infertility and malignancy.” 

Son also acknowledged challenges of pediatric literature, including differences in definitions of pediatric lupus, very few randomized controlled trials, and fewer pediatric studies in general, with fewer participants. Given these research gaps, the guideline panels included pediatric rheumatologists and nephrologists, and the patient panel included several patients with childhood-onset disease.

Son also addressed differences in pediatric drug development. Dosing studies also do not always directly translate from adults to children because children have larger drug volume distribution and differences in drug clearance, and they may need different formulations, she said. Children tend to tolerate medications better than adults because they usually have fewer comorbidities, but the assessment of a drug’s safety must take its impact on growth and development into consideration.

During a press conference after the session where the guideline was presented, Linda Hiraki, MD, ScD, a clinician-scientist in rheumatology at the Hospital for Sick Children, Toronto, Ontario, Canada, said the panel took into consideration that pediatric patients receive their diagnosis during a critical time of development, so considerations of medication risks include the fact that children “have much more life to live.”

 

Triple Therapy Recommended

As with adults, the pediatric LN guideline recommends a triple therapy approach: glucocorticoids plus mycophenolate mofetil and belimumab, in addition to the usual renin-angiotensin-aldosterone system inhibitors and hydroxychloroquine. But Son acknowledged limitations of applying the new guideline to children. For one, voclosporin has not been studied in or approved for pediatric patients, although there exists modest evidence for other calcineurin inhibitors, mainly tacrolimus, in children.

“The other important consideration is that the lower dose of prednisone that’s being offered by the guidelines of 40 mg per day as a starting dose has not been studied in pediatric lupus nephritis patients,” Son said. “However, I would offer that, given that we know that kids get higher doses and longer courses, it’s even more important to consider a lower dose to begin with in the setting of other immunosuppressants.”

 

Good Practice Statements for Pediatric LN

Son also reviewed three good practice statements for pediatric LN. First, “glucocorticoid regimens should use pediatric-appropriate doses for children, as reduction of human glucocorticoid dosing is critically important given the early age of pediatric lupus onset and attendant comorbidities,” she said.

That statement is based on both common sense and some literature, including awareness that children are more likely to receive higher doses of steroids and that children’s higher damage scores are driven in part by steroid-related toxicity, such as avascular necrosis and cataracts. In addition, glucocorticoids can have profound effects on body mass index, mood, and height attainment.

“This is during a period of emerging self-identity and struggles with appearance; steroids exacerbate that” as well as mood issues already associated with puberty, Son said.

The second good practice statement recommends that clinicians monitor patients “for delayed pubertal onset and decreased growth velocity that can result from disease activity and glucocorticoid treatment and consider referral to pediatric endocrinology if indicated.” The third states that “a structured, intentional transition from pediatric to adult rheumatology care is indicated to avoid poor outcomes during this vulnerable period.” 

During the press conference, Hiraki said that pediatric rheumatologists already recognize the need for discussions about transfer to adult care to begin very early, even years before patients are ready to transfer.

“The transition from being a pediatric patient to being an adult patient is very challenging for a number of reasons,” starting with loss of insurance coverage, added Bonnie Bermas, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas, Texas. When adult rheumatologists take on these patients, they may not have had care for 2 or 3 years, she said. 

Rebecca Sadun, MD, PhD, an associate professor of pediatrics in rheumatology at Duke University School of Medicine, Durham, North Carolina, and vice-chair of the Systemic Lupus Erythematosus Committee for the Childhood Arthritis and Rheumatology Research Alliance, was not involved in the guideline development process but reviewed the new guideline. 

“We appreciate that the ACR took care to involve pediatric rheumatologists, pediatric nephrologists, and patients with childhood-onset lupus in the development of the newest lupus nephritis treatment guidelines,” she said in an interview. She also noted, however, that “the dearth of pediatric-specific clinical trial data means that we continue to wonder when it is appropriate to extrapolate from adult data regarding the efficacy, safety, and dosing of certain medications, including steroids and voclosporin.” She also noted that voclosporin use can increase pill burden and therefore be difficult to use in pediatrics.

“Children, adolescents, and young adults are a unique population with unique challenges, including significant struggles with adherence to complex medication regimens,” she said. Sadun drew attention to two themes from the guideline that she found particularly applicable to management of pediatric LN.

“First, we must remain wary of the serious consequences of long-term, high-dose glucocorticoids, and we should continue to look towards steroid-sparing strategies that will reduce reliance on glucocorticoids,” Sadun said. “Second, we are likely to see better outcomes, including better renal response, when we take advantage of combination immunosuppression earlier in the disease course.”

Son, Bermas, and Sadun had no disclosures. Hiraki has consulted for Janssen. The guideline development did not involve outside funding.

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

Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

Roshan Bransden didn’t count how many job offers she received during her recently completed training in family medicine. “It was pretty nonstop throughout all of my PGY-3 year,” she said.

Most of the job opportunities were different from the type of position she sought or where she wanted to work. Bransden graduated from residency at Montefiore Hospital in New York and accepted a position as a primary care doctor in Miami, close to where she grew up and where her family lives.

If the number of recruiting offers residents received last year is any indication, newly trained physicians will have no trouble finding work. More than half (56%) of all residents in AMN Healthcare’s 2023 Survey of Final-Year Medical Residents received 100 or more job solicitations during their training, the highest figure since the survey began more than 30 years ago, the staffing agency reported.

Employers are recruiting residents earlier, offering residency stipends of $1500 to $2500 up to 18 months before they finish their training if they commit to an employment contract, said Leah Grant, president of AMN Healthcare’s Physician Permanent Solutions division, specializing in doctor recruitment. She said that the company’s clients are already eyeing residents completing their training in 2026.

“The key for residents is not about finding a position but choosing the right one out of many.” Grant added that residents typically aren’t taught negotiation skills or how to evaluate job offers. They tend to choose a position based on location, but they should also consider work–life balance issues such as call schedules and whether incentives such as signing bonuses, relocation allowances, and student loan reimbursement offset the job’s time commitment.

“If you are a physician and you are willing to go anywhere, you will have hundreds of opportunities,” said Tibor Nagy, DO, an emergency medicine fellow who recently searched for jobs. “It depends on what they want out of their careers.”

 

Location Is a Key Consideration

Nagy said he had fewer options because he was limited by location, staying close to where his wife is finishing her internal medicine residency. He is completing his fellowship at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, and preparing to return to Prisma Health in Greenville, South Carolina, where he did his residency.

He said that the job search was easier than he anticipated considering the tight market following a job report from the American College of Emergency Physicians in 2021 that predicted an oversupply of 8000 emergency medicine physicians by 2030.

Halfway through Nagy’s residency, he sought a fellowship in emergency medical services (EMS) to be more competitive in the job market. After that, “Every door I knocked on was open to hiring. Maybe it’s a regional thing. They were happy to interview me.” 

In addition to location, Nagy’s top priorities when choosing a job were stability and being able to use his EMS fellowship to become a medical director of an EMS system, agency, or fire department. He wanted to work for a hospital system with an academic focus without much employee turnover.

 

Salary vs Benefits 

AMN Healthcare received the most physician searches for family medicine doctors, followed by OB/GYNs. The staffing agency reported that close to two thirds (63%) of its search engagements during the 2023-2024 review period were for specialists, reflecting the needs of an aging population.

The highest average starting salaries were for surgical and internal medicine subspecialties, according to AMN Healthcare’s 2024 Physician and Advanced Practitioner Recruiting Incentives. Orthopedic surgery averaged $633,000; urology, $540,000; gastroenterology, $506,000; and pulmonary medicine, $418,000. For comparison, the average starting salaries for primary care doctors were family medicine, $255,000; internal medicine, $255,000; and pediatrics, $233,000.

In addition to starting salaries, many physicians receive signing bonuses, relocation allowances, and continuing medical education (CME) allowances. According to the report, the average signing bonus for physicians was $31,473. The average relocation allowance for physicians was $11,284 and the average CME allowance was $3969.

Salary wasn’t Nagy’s top priority when choosing a job, though he admits that the ability to pay back thousands of dollars in medical school loans will be helpful. Instead of focusing on higher pay to offset student loans, Nagy said he sought nonprofit positions to help him qualify for public service loan forgiveness.

The federal program forgives loan balances after the recipient makes monthly payments for 10 years while working for a government or nonprofit organization. He also racked up 3 years of residency and his fellowship year at nonprofit hospitals toward that commitment.

He said jobs that pay more may require doctors to see more patients. “The hustle may be different. There are definitely tradeoffs,” he said.

Bransden said the position she begins in January will allow her to work part-time with full benefits, among other perks. “My employer is a membership-based practice, so I’ll be able to gift a few memberships to family and friends.” 

 

Going Solo

Mohammad Ibrahim, DO, is among a minority of new physicians who have chosen to set up their own practice.

Only 6% of residents in AMN Healthcare’s 2024 report indicated that a solo practice was among their top two choices, while 20% listed partnering with another physician.

Ibrahim is a sports medicine fellow at the University of Michigan Health-West in Wyoming, after finishing his family medicine residency at Trinity Health Livingston Hospital in Howell, Michigan.

After his fellowship ends, he said he plans to stay in Michigan, where his family lives.

Ibrahim said he began his medical education knowing he wanted to become a solo clinician in private practice. He sees it as a way to have more control over his decisions about patient care and business practices.

Working in a hospital often requires doctors to gain approval from several levels of authority for decisions such as ordering new equipment or forgiving part of a service payment. He also wanted to set his schedule to take Friday afternoons off for Muslim prayer.

Although he realizes the challenges of starting a private practice, Ibrahim said those who go through graduate medical education can figure out how to adapt and overcome any obstacles. “I think it’s more doable than we are led to believe.” 

He said that if more residents were exposed to private practice, they might pursue that path. During his training, Ibrahim did a rotation with a private practice physician. “It’s nice to see people proud of what they built, what they contributed.”

Most residents don’t choose private practice. In the AMN Healthcare survey, 68% of residents said that employment by a hospital was among their top two choices for a practice setting, 42% said employment by a single-specialty group, and 32%, employment by a multispecialty group.

Of the majority of job searches AMN Healthcare conducted, 28% were to fill positions in hospital settings, followed by 26% for medical groups, 22% for academic medical centers, 13% for urgent care centers and retail clinics, 6% for solo practices, partnerships, or concierge practice settings, and 5% for Federally Qualified Health Centers/Community Health Centers or Indian Health facilities.

Still, the report noted an increase in recruiting for independent medical practice ownership, which dwindled in recent years, with the majority of doctors today employed likely due to financial obstacles of starting a practice.

The increase in recruiting indicates possible renewed interest in these practice settings, particularly concierge medicine, which allows doctors to avoid the challenges of third-party payments, the report stated.

Grant said that despite the flexibility and financial autonomy of starting their own practice, new providers who choose this path face obstacles, such as competing with urgent care centers and retail health clinics, which have been on the rise in the past year.

Saddled with debt from medical training, most graduating residents will choose to work toward financial stability and then consider their own practice later in their career, she said.

 

Flexible Schedules

Work schedule/call hours or work-life balance was the biggest factor (36%) guiding residents’ choice of first post-residency positions compared with starting salary (19%), according to the Medscape Resident Salary & Debt Report 2024.

Grant said that larger practices and those closer to rural communities tend to offer more innovative work schedules, especially for certain specialists. Some solo practices that form partnerships could potentially allow flexible schedules such as 4-day work weeks or week-on-week-off arrangements, she added.

Physicians are also opting for the flexibility of temporary, locum tenens work to improve job conditions and address feelings of burnout. Dr. Kaydo, DO, as she’s known on Instagram, posts about her experiences as locum tenens. “I found that I could have more flexibility as a locum. I want to be able to take time off when I want and as long as I wanted,” said the full-time family medicine doctor who practices at an outpatient clinic in Philadelphia.

“Basically, I’m contract-working, and they pay me as much as I work, and I can also take more time off.” Her employer for the past year also allowed her to work 10 hours a day, 4 days a week instead of the more traditional 8-hour, 5-day schedule.

Dr. Kaydo said she believes many young doctors think contract employees don’t have a permanent job, are not guaranteed a certain salary, and could easily lose their jobs. “I’ve found that most places really need doctors and are willing to negotiate.”

She said primary care locum doctors are particularly in demand in rural clinics and urban underserved areas.

Nagy said he is considering being a nocturnist, an emergency medicine doctor who works nights, to have more control over his schedule, higher pay, and more flexible shifts. “I switch days and nights and that can be tiring.” 

Bransden said job flexibility was her primary job criterion. “I have a young child, so I wanted to work part-time with the potential for even more flexibility down the line. I am working 3 days a week, 8-hour days with a 1-hour break. A 3-day work week came with a pay cut, but for me, it works and is what I need right now.”

 

A version of this article appeared on Medscape.com.

Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

TOPLINE:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

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:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

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:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

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.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
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JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

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By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
By Douglas Tremblay, MD
JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

Current Management and Future Directions in the Treatment of Gallbladder Cancer
By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
By Douglas Tremblay, MD
JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

Current Management and Future Directions in the Treatment of Gallbladder Cancer
By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.