Federal Practitioner

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

A new study finds that racial disparities in male breast cancer are persisting in the United States.

From 2000 to 2019, Black men were diagnosed at later ages than White males (median ages, 69 and 63 years, respectively) and were more likely to die from the disease (22.4% vs. 16.8%, respectively). Male breast cancer (MBC) was more likely to kill Black men in rural vs. urban areas (hazard ratio = 1.4; 95% confidence interval, 1.0-2.1; P less than .05). Among White males, in contrast, there was no difference on that front, according to the research, which was presented in a poster (Abstract No. 87P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

It’s not clear why the disparities exist, said lead author Lekha Yadukumar, MBBS, an internal medicine resident at the Wright Center for Graduate Medical Education in Scranton, Penn., in an interview.

“Several potential factors may contribute to the higher rate of breast cancer diagnosis in older [Black] men, including the pathology of the disease, limited awareness about breast cancer, and potential barriers to accessibility,” she said. “The increased mortality among [Black men] may be linked to variations in tumor pathology and molecular biology. Social factors may also potentially impact survival rates, including [having] limited access to health care in rural areas and inadequate social support.”

Male breast cancer is rare, accounting for less than 1% of all breast cancer cases in the United States, according to the Breast Cancer Research Foundation. An estimated 2,700 men are diagnosed each year, and about 530 will die. Previous research has suggested Black men have worse outcomes than White men, but the data covered earlier years than the new study.
 

Methods and results

Dr. Yadukumar and colleagues retrospectively analyzed statistics from the Surveillance, Epidemiology, and End Results database for patients diagnosed with primary male breast cancer from 2000 to 2019 (n = 8,373; Black men, 1,111 [13.26%]; White men, 6,817 [81.41%]).

Median income didn’t affect mortality, whereas men in both racial groups were less likely to die if they were married vs. single/divorced (hazard ratio = 0.6; P less than .05).

Other studies have shown that “[Black American] men diagnosed with breast cancer experience longer time intervals before receiving treatment, encounter more severe disease manifestations, and exhibit lower rates of survivorship,” Dr. Yadukumar said. “Despite these findings, there remains a scarcity of genetic studies aimed at comprehending the underlying causes of these disparities. Moreover, there is a dearth of research investigating other factors that may influence survival outcomes among men with breast cancer.”
 

Findings reflect the disparities in female breast cancer

In an interview, Duke University, Durham, N.C., oncologist Arif Kamal, MD, MBA, MHS, the chief patient officer at the American Cancer Society, said the study is impressive since the number of patients is large for a rare cancer and the population is diverse. Plus, the findings reflect the disparities in female breast cancer, he noted.

“We know that Black women’s mortality is worse vs. White women in breast cancer, and we believe that most of that has nothing to do with cancer screening,” said Dr. Kamal, who was not involved in the new study. “When the clock starts from diagnosis onwards, you start to see less introduction to clinical trials and standard care medications and more time to treatment, surgery, and radiation,” he said.

“You see similar disparities as related to mortality in Black vs. White men,” he noted.

The new findings about higher death rates for Black men, especially in rural areas, suggest that “distance matters, and race matters,” he said. In rural areas, it can be hard to access pathologists, radiologists, and surgeons with more experience with breast cancer, he said.

But, he noted, the study finds that income doesn’t appear to be a factor.

In the big picture, he said, the results suggest that when it comes to barriers to better outcomes, “things that are systemic don’t make exceptions because you are a man vs. a woman.”

No study funding was reported. The study authors and Dr. Kamal have no relevant financial disclosures.
 

SAN FRANCISCO – Only 11% of eating disorder apps protect the privacy of users as is mandated by the Health Insurance Portability and Accountability Act, according to the results of a new study.

Federal laws require those handling sensitive health information to have policies and security safeguards in place to protect such information, whether it’s stored on paper or electronically.

“As it stands right now, there’s not enough evidence to support using these apps as an adjunct to clinical care,” study author Theodora O’Leary, a 4th-year medical student at Tufts University, Boston, said in an interview. “We need more research on the efficacy of these apps because right now not enough of them meet HIPAA [standards] and don’t have privacy and security measures.”

Pauline Anderson

The findings were presented at the annual meeting of the American Psychiatric Association.

Eating disorders (EDs) are a common mental health condition affecting almost 1 in 10 Americans over their lifetime. Yet only about a third of patients with an eating disorder receive adequate treatment.

The pandemic saw a rise in eating disorders and in the use of mental health apps “to kind of fill the gap because people couldn’t be seen in person,” said Ms. O’Leary.
 

Inexpensive and accessible

Smartphone apps have a lot of advantages for patients with an ED. For one thing, they’re relatively inexpensive and accessible; most Americans already own one or more devices on which these apps can be used.

They’re also a feasible means of delivering psychological interventions, which are often recommended for EDs. Among these interventions, cognitive-behavioral therapy (CBT) has the largest evidence base for this condition.

Also, as many individuals with an ED may be reluctant to seek treatment because of stigma and shame, the anonymity afforded by an app could increase access to the help they seek.

But Ms. O’Leary warned the Food and Drug Administration does not regulate these apps, and people are sharing their personal health information on them.

The researchers conducted a review of commercially available eating disorder apps by searching the Apple and Google play stores using key phrases such as “eating disorder,” “anorexia,” and “binge eating disorder.”

They found 16 relevant apps that they added to the publicly available apps already in a database at Tufts, for a total of about 36 that were evaluated in the study (the number fluctuates as apps are deleted.)

They then reviewed the apps using the 105 questions based on the APA’s app evaluation model, which covers categories such as efficacy, privacy, accessibility, and clinical applicability. And they used filters to group apps by characteristics such as function, cost, and features.

The vast majority were self-help apps, which include things like journaling, meditation, and information on CBT. Others were reference apps that provide related definitions and sometimes include surveys to determine, for example, if the user has an eating disorder.

About 44% of the apps track mood, and 53% track symptoms. Some 56% include journaling, 42% mindfulness, 53% goal setting, and 42% psychoeducation.
 

Hybrid care

Only 5% of apps allow for “hybrid” care. This, explained Ms. O’Leary, is when clinicians use their own app to access patients’ apps, allowing them to track food restrictions and therapies, and make comments.

“The hybrid is viewed as the best form of app”, she said. “It’s almost like an adjunct to clinical care.”

Hybrid apps also tend to have patient safety features, she added. And these apps meet HIPAA standards, which only 11% of the apps in the study did.

Only 15% of apps advised patients to take steps in case of an emergency, and 11% had supporting studies. And where there was supporting research, much of it was funded by the app creators, said Ms. O’Leary.

For example, an app provided by Noom (the weight loss program that promises to help change habits and mindsets around food) “has a bunch of feasibility studies but they’re all funded by Noom”, which can introduce bias, she explained.

None of the apps were created by an accredited health care institution, she noted. “And I think only one app out of all the eating disorder apps we looked at was from a nonprofit.”

About 17% of the apps offer help with a “coach” or “expert”. However, these apps often fail to disclose the definition of a coach or state they’re not a replacement for medical care.
 

Coaching apps more expensive

Additionally, these coaching apps are often some of the most expensive, said Ms. O’Leary.

Daniel E. Gih, MD, associate professor at the University of Nebraska Medical Center, Omaha, helped start an eating disorders program at the University of Michigan and continues to treat patients with eating disorders. He said the increase in the use of eating disorder apps isn’t surprising as the incidence of these disorders increased in the wake of pandemic restrictions, especially among young people.

“Patients are likely doing more research on their medical conditions and trying to crowdsource information or self-treat,” Dr. Gih said.

It’s unclear whether “shame or just the general lack of specialized eating disorder professionals,” including physicians, is driving some of the interest in these apps, he added.

Dr. Gih stressed eating disorder apps should not only include screening for suicidality, but also explicitly tell patients to seek immediate attention if they show certain signs – for example, fainting, chest pain, or blood in emesis.

“The apps may be giving patients false hope or delaying medical care,” he said. “Apps are likely not sufficient enough to replace a multidisciplinary team with experience and expertise in eating disorders.”

Ms. O’Leary and Dr. Gih report no relevant financial relationships.

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

SAN FRANCISCO – Only 11% of eating disorder apps protect the privacy of users as is mandated by the Health Insurance Portability and Accountability Act, according to the results of a new study.

Federal laws require those handling sensitive health information to have policies and security safeguards in place to protect such information, whether it’s stored on paper or electronically.

“As it stands right now, there’s not enough evidence to support using these apps as an adjunct to clinical care,” study author Theodora O’Leary, a 4th-year medical student at Tufts University, Boston, said in an interview. “We need more research on the efficacy of these apps because right now not enough of them meet HIPAA [standards] and don’t have privacy and security measures.”

Pauline Anderson

The findings were presented at the annual meeting of the American Psychiatric Association.

Eating disorders (EDs) are a common mental health condition affecting almost 1 in 10 Americans over their lifetime. Yet only about a third of patients with an eating disorder receive adequate treatment.

The pandemic saw a rise in eating disorders and in the use of mental health apps “to kind of fill the gap because people couldn’t be seen in person,” said Ms. O’Leary.
 

Inexpensive and accessible

Smartphone apps have a lot of advantages for patients with an ED. For one thing, they’re relatively inexpensive and accessible; most Americans already own one or more devices on which these apps can be used.

They’re also a feasible means of delivering psychological interventions, which are often recommended for EDs. Among these interventions, cognitive-behavioral therapy (CBT) has the largest evidence base for this condition.

Also, as many individuals with an ED may be reluctant to seek treatment because of stigma and shame, the anonymity afforded by an app could increase access to the help they seek.

But Ms. O’Leary warned the Food and Drug Administration does not regulate these apps, and people are sharing their personal health information on them.

The researchers conducted a review of commercially available eating disorder apps by searching the Apple and Google play stores using key phrases such as “eating disorder,” “anorexia,” and “binge eating disorder.”

They found 16 relevant apps that they added to the publicly available apps already in a database at Tufts, for a total of about 36 that were evaluated in the study (the number fluctuates as apps are deleted.)

They then reviewed the apps using the 105 questions based on the APA’s app evaluation model, which covers categories such as efficacy, privacy, accessibility, and clinical applicability. And they used filters to group apps by characteristics such as function, cost, and features.

The vast majority were self-help apps, which include things like journaling, meditation, and information on CBT. Others were reference apps that provide related definitions and sometimes include surveys to determine, for example, if the user has an eating disorder.

About 44% of the apps track mood, and 53% track symptoms. Some 56% include journaling, 42% mindfulness, 53% goal setting, and 42% psychoeducation.
 

Hybrid care

Only 5% of apps allow for “hybrid” care. This, explained Ms. O’Leary, is when clinicians use their own app to access patients’ apps, allowing them to track food restrictions and therapies, and make comments.

“The hybrid is viewed as the best form of app”, she said. “It’s almost like an adjunct to clinical care.”

Hybrid apps also tend to have patient safety features, she added. And these apps meet HIPAA standards, which only 11% of the apps in the study did.

Only 15% of apps advised patients to take steps in case of an emergency, and 11% had supporting studies. And where there was supporting research, much of it was funded by the app creators, said Ms. O’Leary.

For example, an app provided by Noom (the weight loss program that promises to help change habits and mindsets around food) “has a bunch of feasibility studies but they’re all funded by Noom”, which can introduce bias, she explained.

None of the apps were created by an accredited health care institution, she noted. “And I think only one app out of all the eating disorder apps we looked at was from a nonprofit.”

About 17% of the apps offer help with a “coach” or “expert”. However, these apps often fail to disclose the definition of a coach or state they’re not a replacement for medical care.
 

Coaching apps more expensive

Additionally, these coaching apps are often some of the most expensive, said Ms. O’Leary.

Daniel E. Gih, MD, associate professor at the University of Nebraska Medical Center, Omaha, helped start an eating disorders program at the University of Michigan and continues to treat patients with eating disorders. He said the increase in the use of eating disorder apps isn’t surprising as the incidence of these disorders increased in the wake of pandemic restrictions, especially among young people.

“Patients are likely doing more research on their medical conditions and trying to crowdsource information or self-treat,” Dr. Gih said.

It’s unclear whether “shame or just the general lack of specialized eating disorder professionals,” including physicians, is driving some of the interest in these apps, he added.

Dr. Gih stressed eating disorder apps should not only include screening for suicidality, but also explicitly tell patients to seek immediate attention if they show certain signs – for example, fainting, chest pain, or blood in emesis.

“The apps may be giving patients false hope or delaying medical care,” he said. “Apps are likely not sufficient enough to replace a multidisciplinary team with experience and expertise in eating disorders.”

Ms. O’Leary and Dr. Gih report no relevant financial relationships.

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

SAN FRANCISCO – Only 11% of eating disorder apps protect the privacy of users as is mandated by the Health Insurance Portability and Accountability Act, according to the results of a new study.

Federal laws require those handling sensitive health information to have policies and security safeguards in place to protect such information, whether it’s stored on paper or electronically.

“As it stands right now, there’s not enough evidence to support using these apps as an adjunct to clinical care,” study author Theodora O’Leary, a 4th-year medical student at Tufts University, Boston, said in an interview. “We need more research on the efficacy of these apps because right now not enough of them meet HIPAA [standards] and don’t have privacy and security measures.”

Pauline Anderson

The findings were presented at the annual meeting of the American Psychiatric Association.

Eating disorders (EDs) are a common mental health condition affecting almost 1 in 10 Americans over their lifetime. Yet only about a third of patients with an eating disorder receive adequate treatment.

The pandemic saw a rise in eating disorders and in the use of mental health apps “to kind of fill the gap because people couldn’t be seen in person,” said Ms. O’Leary.
 

Inexpensive and accessible

Smartphone apps have a lot of advantages for patients with an ED. For one thing, they’re relatively inexpensive and accessible; most Americans already own one or more devices on which these apps can be used.

They’re also a feasible means of delivering psychological interventions, which are often recommended for EDs. Among these interventions, cognitive-behavioral therapy (CBT) has the largest evidence base for this condition.

Also, as many individuals with an ED may be reluctant to seek treatment because of stigma and shame, the anonymity afforded by an app could increase access to the help they seek.

But Ms. O’Leary warned the Food and Drug Administration does not regulate these apps, and people are sharing their personal health information on them.

The researchers conducted a review of commercially available eating disorder apps by searching the Apple and Google play stores using key phrases such as “eating disorder,” “anorexia,” and “binge eating disorder.”

They found 16 relevant apps that they added to the publicly available apps already in a database at Tufts, for a total of about 36 that were evaluated in the study (the number fluctuates as apps are deleted.)

They then reviewed the apps using the 105 questions based on the APA’s app evaluation model, which covers categories such as efficacy, privacy, accessibility, and clinical applicability. And they used filters to group apps by characteristics such as function, cost, and features.

The vast majority were self-help apps, which include things like journaling, meditation, and information on CBT. Others were reference apps that provide related definitions and sometimes include surveys to determine, for example, if the user has an eating disorder.

About 44% of the apps track mood, and 53% track symptoms. Some 56% include journaling, 42% mindfulness, 53% goal setting, and 42% psychoeducation.
 

Hybrid care

Only 5% of apps allow for “hybrid” care. This, explained Ms. O’Leary, is when clinicians use their own app to access patients’ apps, allowing them to track food restrictions and therapies, and make comments.

“The hybrid is viewed as the best form of app”, she said. “It’s almost like an adjunct to clinical care.”

Hybrid apps also tend to have patient safety features, she added. And these apps meet HIPAA standards, which only 11% of the apps in the study did.

Only 15% of apps advised patients to take steps in case of an emergency, and 11% had supporting studies. And where there was supporting research, much of it was funded by the app creators, said Ms. O’Leary.

For example, an app provided by Noom (the weight loss program that promises to help change habits and mindsets around food) “has a bunch of feasibility studies but they’re all funded by Noom”, which can introduce bias, she explained.

None of the apps were created by an accredited health care institution, she noted. “And I think only one app out of all the eating disorder apps we looked at was from a nonprofit.”

About 17% of the apps offer help with a “coach” or “expert”. However, these apps often fail to disclose the definition of a coach or state they’re not a replacement for medical care.
 

Coaching apps more expensive

Additionally, these coaching apps are often some of the most expensive, said Ms. O’Leary.

Daniel E. Gih, MD, associate professor at the University of Nebraska Medical Center, Omaha, helped start an eating disorders program at the University of Michigan and continues to treat patients with eating disorders. He said the increase in the use of eating disorder apps isn’t surprising as the incidence of these disorders increased in the wake of pandemic restrictions, especially among young people.

“Patients are likely doing more research on their medical conditions and trying to crowdsource information or self-treat,” Dr. Gih said.

It’s unclear whether “shame or just the general lack of specialized eating disorder professionals,” including physicians, is driving some of the interest in these apps, he added.

Dr. Gih stressed eating disorder apps should not only include screening for suicidality, but also explicitly tell patients to seek immediate attention if they show certain signs – for example, fainting, chest pain, or blood in emesis.

“The apps may be giving patients false hope or delaying medical care,” he said. “Apps are likely not sufficient enough to replace a multidisciplinary team with experience and expertise in eating disorders.”

Ms. O’Leary and Dr. Gih report no relevant financial relationships.

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

DUBLIN – Changing the way food options and information is presented on food delivery apps, as well as default smaller portions, may encourage healthier selections, lowering the calorie intake by 4%-15%, show three new randomized trials from the United Kingdom.

The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.

“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”

Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York. 

Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”

She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.

“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
 

Three trials changing displays on simulated food delivery apps

“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.

So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.

“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.

The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).

The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.

For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.

The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.

Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.

“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”

Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.

The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.

“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.

“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
 

Qualitative think-aloud study explored views around food delivery apps

Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.

Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.

“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.

She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.

“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.   

The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).

“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
 

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

DUBLIN – Changing the way food options and information is presented on food delivery apps, as well as default smaller portions, may encourage healthier selections, lowering the calorie intake by 4%-15%, show three new randomized trials from the United Kingdom.

The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.

“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”

Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York. 

Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”

She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.

“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
 

Three trials changing displays on simulated food delivery apps

“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.

So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.

“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.

The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).

The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.

For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.

The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.

Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.

“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”

Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.

The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.

“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.

“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
 

Qualitative think-aloud study explored views around food delivery apps

Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.

Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.

“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.

She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.

“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.   

The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).

“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
 

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

DUBLIN – Changing the way food options and information is presented on food delivery apps, as well as default smaller portions, may encourage healthier selections, lowering the calorie intake by 4%-15%, show three new randomized trials from the United Kingdom.

The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.

“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”

Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York. 

Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”

She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.

“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
 

Three trials changing displays on simulated food delivery apps

“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.

So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.

“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.

The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).

The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.

For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.

The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.

Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.

“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”

Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.

The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.

“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.

“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
 

Qualitative think-aloud study explored views around food delivery apps

Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.

Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.

“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.

She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.

“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.   

The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).

“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
 

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

A new prospective, observational study from the Lupus Research Alliance (LRA) aims to enroll 3,500 patients in an effort to accelerate the development of personalized treatments for individuals living with systemic lupus erythematosus (SLE).

The LRA on May 23 announced the launch of the Lupus Landmark Study (LLS). The study will be conducted in partnership with Lupus Therapeutics, the clinical research affiliate of the LRA.

The study will be a key feature of the Lupus Nexus, a unique combination of lupus patient registry, biorepository, and portal for data sharing and analysis.

“The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities,” according to the LRA press release.

“SLE is a debilitating autoimmune disease that disproportionately impacts women and people from minority groups, but the cause of lupus is unknown, and no single laboratory test can definitively identify lupus,” lead investigator S. Sam Lim, MD, of Emory University, Atlanta, told this news organization.

“Nevertheless, early detection and treatment can often lessen the progression and severity of the disease. Although there are numerous contributing factors to the lag in research discoveries and new treatments for patients with lupus, limited access to standardized, high-quality biological samples and natural history data provides a significant roadblock to advancing lupus research,” Dr. Lim said.

“Existing registry and biorepository resources in the lupus field are largely siloed, mostly limited to relatively small or discrete patient populations, and frequently not designed for broad sharing across all stakeholders of the research community,” Dr. Lim said. The LRA and its affiliate Lupus Therapeutics are committed to developing Lupus Nexus, a first-of-its-kind registry and biorepository, to serve as a collaborative research platform for lupus and a leading source of prospective, longitudinal patient data and biological samples for the research community, Dr. Lim added.

“The Lupus Landmark Study will form the foundation of this registry and biorepository and will provide a critical resource to enable the understanding of lupus heterogeneity at the molecular level,” Dr. Lim said. The molecular data can be linked to clinical phenotypes, he explained, “while providing an opportunity to better understand the holistic experience of patients with lupus, thus helping patients address the daily life challenges they face.”

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was announced earlier this spring by the LRA. It represents a collaboration between the U.S. Food and Drug Administration and the lupus community to improve and accelerate the development of safer and more effective treatments for people with lupus, Dr. Lim said. “Data and other results from the LLS will inform this collaboration,” he said.

“The LLS will provide greater insight into the pathogenesis and evolution of the condition, providing much needed information and guidance to clinicians so that the disease can be detected and treated earlier and with better precision,” Dr. Lim said. “The partnership with patients will ensure that advances will not only be meaningful to clinicians but their patients and caregivers as well,” he added.

Individuals living with lupus were essential to the development of the Lupus Nexus, and patients will continue to be engaged through participation in the LLS, which will not only generate data to promote patient-centered treatments but will also give participants more insight into their health data, according to the LRA press release.

The clinical coordinating center and biorepository elements of the Lupus Nexus will be managed by Embleema and Azenta Life Sciences, respectively, according the LRA.

Biomarker analysis will be conducted by DxTerity Diagnostics via the company’s proprietary DxCollection MicroCollection Device and Modular Immune Profile platform.

The LLS is scheduled to begin enrolling patients through select academic medical centers in the Lupus Therapeutics Lupus Clinical Investigators Network later in 2023, with an expanded roll-out in 2024, according to the press release. More information about the Lupus Landmark Study is available from Lupus Nexus at LupusNexus@lupusresearch.org.

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

A new prospective, observational study from the Lupus Research Alliance (LRA) aims to enroll 3,500 patients in an effort to accelerate the development of personalized treatments for individuals living with systemic lupus erythematosus (SLE).

The LRA on May 23 announced the launch of the Lupus Landmark Study (LLS). The study will be conducted in partnership with Lupus Therapeutics, the clinical research affiliate of the LRA.

The study will be a key feature of the Lupus Nexus, a unique combination of lupus patient registry, biorepository, and portal for data sharing and analysis.

“The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities,” according to the LRA press release.

“SLE is a debilitating autoimmune disease that disproportionately impacts women and people from minority groups, but the cause of lupus is unknown, and no single laboratory test can definitively identify lupus,” lead investigator S. Sam Lim, MD, of Emory University, Atlanta, told this news organization.

“Nevertheless, early detection and treatment can often lessen the progression and severity of the disease. Although there are numerous contributing factors to the lag in research discoveries and new treatments for patients with lupus, limited access to standardized, high-quality biological samples and natural history data provides a significant roadblock to advancing lupus research,” Dr. Lim said.

“Existing registry and biorepository resources in the lupus field are largely siloed, mostly limited to relatively small or discrete patient populations, and frequently not designed for broad sharing across all stakeholders of the research community,” Dr. Lim said. The LRA and its affiliate Lupus Therapeutics are committed to developing Lupus Nexus, a first-of-its-kind registry and biorepository, to serve as a collaborative research platform for lupus and a leading source of prospective, longitudinal patient data and biological samples for the research community, Dr. Lim added.

“The Lupus Landmark Study will form the foundation of this registry and biorepository and will provide a critical resource to enable the understanding of lupus heterogeneity at the molecular level,” Dr. Lim said. The molecular data can be linked to clinical phenotypes, he explained, “while providing an opportunity to better understand the holistic experience of patients with lupus, thus helping patients address the daily life challenges they face.”

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was announced earlier this spring by the LRA. It represents a collaboration between the U.S. Food and Drug Administration and the lupus community to improve and accelerate the development of safer and more effective treatments for people with lupus, Dr. Lim said. “Data and other results from the LLS will inform this collaboration,” he said.

“The LLS will provide greater insight into the pathogenesis and evolution of the condition, providing much needed information and guidance to clinicians so that the disease can be detected and treated earlier and with better precision,” Dr. Lim said. “The partnership with patients will ensure that advances will not only be meaningful to clinicians but their patients and caregivers as well,” he added.

Individuals living with lupus were essential to the development of the Lupus Nexus, and patients will continue to be engaged through participation in the LLS, which will not only generate data to promote patient-centered treatments but will also give participants more insight into their health data, according to the LRA press release.

The clinical coordinating center and biorepository elements of the Lupus Nexus will be managed by Embleema and Azenta Life Sciences, respectively, according the LRA.

Biomarker analysis will be conducted by DxTerity Diagnostics via the company’s proprietary DxCollection MicroCollection Device and Modular Immune Profile platform.

The LLS is scheduled to begin enrolling patients through select academic medical centers in the Lupus Therapeutics Lupus Clinical Investigators Network later in 2023, with an expanded roll-out in 2024, according to the press release. More information about the Lupus Landmark Study is available from Lupus Nexus at LupusNexus@lupusresearch.org.

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

A new prospective, observational study from the Lupus Research Alliance (LRA) aims to enroll 3,500 patients in an effort to accelerate the development of personalized treatments for individuals living with systemic lupus erythematosus (SLE).

The LRA on May 23 announced the launch of the Lupus Landmark Study (LLS). The study will be conducted in partnership with Lupus Therapeutics, the clinical research affiliate of the LRA.

The study will be a key feature of the Lupus Nexus, a unique combination of lupus patient registry, biorepository, and portal for data sharing and analysis.

“The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities,” according to the LRA press release.

“SLE is a debilitating autoimmune disease that disproportionately impacts women and people from minority groups, but the cause of lupus is unknown, and no single laboratory test can definitively identify lupus,” lead investigator S. Sam Lim, MD, of Emory University, Atlanta, told this news organization.

“Nevertheless, early detection and treatment can often lessen the progression and severity of the disease. Although there are numerous contributing factors to the lag in research discoveries and new treatments for patients with lupus, limited access to standardized, high-quality biological samples and natural history data provides a significant roadblock to advancing lupus research,” Dr. Lim said.

“Existing registry and biorepository resources in the lupus field are largely siloed, mostly limited to relatively small or discrete patient populations, and frequently not designed for broad sharing across all stakeholders of the research community,” Dr. Lim said. The LRA and its affiliate Lupus Therapeutics are committed to developing Lupus Nexus, a first-of-its-kind registry and biorepository, to serve as a collaborative research platform for lupus and a leading source of prospective, longitudinal patient data and biological samples for the research community, Dr. Lim added.

“The Lupus Landmark Study will form the foundation of this registry and biorepository and will provide a critical resource to enable the understanding of lupus heterogeneity at the molecular level,” Dr. Lim said. The molecular data can be linked to clinical phenotypes, he explained, “while providing an opportunity to better understand the holistic experience of patients with lupus, thus helping patients address the daily life challenges they face.”

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was announced earlier this spring by the LRA. It represents a collaboration between the U.S. Food and Drug Administration and the lupus community to improve and accelerate the development of safer and more effective treatments for people with lupus, Dr. Lim said. “Data and other results from the LLS will inform this collaboration,” he said.

“The LLS will provide greater insight into the pathogenesis and evolution of the condition, providing much needed information and guidance to clinicians so that the disease can be detected and treated earlier and with better precision,” Dr. Lim said. “The partnership with patients will ensure that advances will not only be meaningful to clinicians but their patients and caregivers as well,” he added.

Individuals living with lupus were essential to the development of the Lupus Nexus, and patients will continue to be engaged through participation in the LLS, which will not only generate data to promote patient-centered treatments but will also give participants more insight into their health data, according to the LRA press release.

The clinical coordinating center and biorepository elements of the Lupus Nexus will be managed by Embleema and Azenta Life Sciences, respectively, according the LRA.

Biomarker analysis will be conducted by DxTerity Diagnostics via the company’s proprietary DxCollection MicroCollection Device and Modular Immune Profile platform.

The LLS is scheduled to begin enrolling patients through select academic medical centers in the Lupus Therapeutics Lupus Clinical Investigators Network later in 2023, with an expanded roll-out in 2024, according to the press release. More information about the Lupus Landmark Study is available from Lupus Nexus at LupusNexus@lupusresearch.org.

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

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

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

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

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

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

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

CHICAGO - The American Urological Association and the Society of Urologic Oncology (SUO) for the first time have taken a position on the type of biopsy men with prostate lesions should undergo, endorsing both transperineal and transrectal biopsy instead of choosing one over the other.

The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.

The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.

“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.

But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”

Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.

The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.

Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.

Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.

However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
 

Agents of death and destruction?

Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.

Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”

The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.

Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.

“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.

Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.

Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”

He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”

Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.

Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
 

Lack of training

The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.

Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.

“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”

The authors have disclosed no relevant financial relationships.
 

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

CHICAGO - The American Urological Association and the Society of Urologic Oncology (SUO) for the first time have taken a position on the type of biopsy men with prostate lesions should undergo, endorsing both transperineal and transrectal biopsy instead of choosing one over the other.

The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.

The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.

“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.

But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”

Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.

The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.

Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.

Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.

However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
 

Agents of death and destruction?

Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.

Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”

The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.

Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.

“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.

Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.

Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”

He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”

Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.

Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
 

Lack of training

The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.

Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.

“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”

The authors have disclosed no relevant financial relationships.
 

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

CHICAGO - The American Urological Association and the Society of Urologic Oncology (SUO) for the first time have taken a position on the type of biopsy men with prostate lesions should undergo, endorsing both transperineal and transrectal biopsy instead of choosing one over the other.

The new guidelines, issued at the annual meeting of the American Urological Association, contrast with 2021 recommendations from the European Association of Urologists (EAU), which regard the transperineal approach as superior to and safer than the transrectal approach.

The new guidelines state: “Clinicians may use either a transrectal or transperineal biopsy route when performing a biopsy. (Conditional Recommendation; Evidence Level: Grade C).” Grade C is the lowest grade of acceptance the guideline committee could issue, according to Daniel Lin, MD, vice-chair of the AUA guideline panel.

“The AUA looked at all the higher-level data comparing the two procedures. There was a lack of that data,” Dr. Lin, chief of urologic oncology at the University of Washington, Seattle, said in an interview. He said the literature consists mainly of systematic single-center reviews, rather than multicenter randomized trials.

But Hendrik Van Poppel, MD, policy chief for the EAU, said that in Europe, transrectal biopsies are now considered “medical malpractice.”

Philip Cornford, MD, associate professor of urology at the University of Liverpool, England, and chair of the prostate biopsy guidelines panel for the EAU, said the society in 2021 concluded that the transperineal approach is the preferred one.

The EAU stated that transperineal prostate biopsies should be performed “due to the lower risk of infectious complications.” The EAU described the evidence as strong: A meta-analysis of seven studies that included 1,330 patients showed that for patients undergoing transperineal biopsy, infectious complications were significantly reduced.

Dr. Cornford said in essence, the EAU made its decision out of concern about infections, whereas the AUA and SUO based their decision on the ability of the methods to detect cancer.

Advocates for transperineal procedures cite several studies that show that the rate of infection, including sepsis, with such biopsies is virtually zero.

However, Dr. Lin noted that the committee said existing data on infection did not support this position. He also cited a “a fairly compelling” single-center randomized study with 750 patients that showed no difference in infection rates. The study was presented at the AUA meeting.
 

Agents of death and destruction?

Badar Mian, MD, professor of surgery at Albany (N.Y.) Medical College, who led the study, told an AUA session that urology has been trapped in an “echo chamber” regarding the relative safety of biopsies.

Clinicians hear “loud proclamations, which get repeated and magnified, that there is a real zero risk of complications after transperineal biopsies as compared to the horrendous 5% to 10% or higher rate of transrectal biopsy complications and that you, with your transrectal biopsies, are the cause of death and destruction all around,” Dr. Mian said. “Well, if you step out of the echo chamber, what you’ll find is that the accurate complications amongst the two procedures are not that dramatically different, much less dramatic than what you’ve been told to believe.”

The campaign to end transrectal biopsies in Europe started in 2018 with the death of a Norwegian man who experienced an infection after the procedure. Truls Bjerklund Johansen, MD, who’d performed the biopsy on the patient and who worked with the man’s daughter to change national practice, persuaded the EAU to look at the issue.

Advocates also say transperineal biopsies are better at detecting anterior and apical cancers.

“I would agree the data on cancer detection is less convincing, but that is not the basis of the EAU recommendation,” Dr. Cornford said.

Arvin George, MD, leads the transperineal biopsy program at the University of Michigan, Ann Arbor, and directs the transperineal training program at the AUA’s annual meeting. He said his course was sold out early and included about 60 trainees.

Dr. George said the new guideline statement “is not an unequivocal endorsement for transperineal biopsy as the preferred approach for diagnostic sampling but rather an acknowledgment of this approach as an alternative option.”

He said that although the new position statement should increase awareness of the transperineal approach in the United States, “without a strong recommendation, the guideline statement is unlikely to spark a large switch to the transperineal biopsy but rather supports the continued slow and steady adoption.”

Matthew Allaway, DO, founder of Perineologic, developer of the PrecisionPoint Transperineal Access System, said industry figures show that about 10% of the 1.5 million prostate biopsies performed in the United States annually are performed transperineally, a doubling in 2 years.

Jeremy Grummet, MD, clinical professor of urology at Monash University, Melbourne, and leader of the TREXIT (Transperineal Exit) movement to abandon transrectal procedures, said the AUA guidelines are biased toward “physician convenience.”
 

Lack of training

The AUA said another reason it did not endorse the transperineal approach was that currently, American urologists lack training and experience with transperineal procedures.

Dr. Grummet blamed major medical centers for any gap in the familiarity of clinicians with transperineal biopsies, which have been available for more than a decade.

“It is incumbent on the leaders of urology departments globally to ensure that their colleagues are trained in transperineal biopsy and have access to the appropriate equipment,” he said in an interview. “Lack of training didn’t seem to prevent the rapid uptake of robotic prostatectomy – a far more complex procedure.”

The authors have disclosed no relevant financial relationships.
 

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

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

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

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

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

A family physician whom a young patient’s mother accused of being impaired at work has won his lawsuit against a Kentucky hospital.
 

A jury on May 2 awarded John M. Farmer, MD, $3.7 million for emotional distress and contract damages against Baptist Health Madisonville and Baptist Health Medical Group for a series of actions they took against Dr. Farmer after the impairment complaint.

“It’s been the worst thing that I’ve ever gone through in my entire life,” Dr. Farmer said in an interview. “My career was disrupted, because I couldn’t finish residency on time, and I had difficulty finding full-time employment comparable to what I expected to obtain immediately following residency. It continues to significantly impact my life and my job, because I remain subject to random drug testing at any time and must check in every day to see whether I have to get drug tested.”

Dr. Farmer was in his third year of residency at the hospital when the mother of two young patients accused the doctor of being “on something” during a visit with her children, said Kathleen DeLaney, an Indianapolis-based attorney who represented Dr. Farmer in the case.

According to the lawsuit, the hospital violated its fitness for duty and drug testing policy by not immediately notifying Dr. Farmer of the complaint nor immediately testing him to prove whether or not there was a factual basis for the allegation. Repercussions from the unproven complaint damaged Dr. Farmer’s personal and professional reputation. It severely limited his job prospects and earning potential, the suit alleged.

Baptist Health spokeswoman Rebecca Towles Brown said Baptist Health is exploring its legal options after the jury’s decision. “We strongly disagree with the allegations made against Baptist Health in this case and are disappointed in the jury’s verdict. Baptist Health followed its medical staff policies and appropriately responded to concerns raised about Dr. Farmer’s well-being and behavior on the date in question. We are evaluating our postverdict options, as we believe the facts as they occurred do not support the verdict. Our primary focus remains providing high-quality care to our patients and families.”
 

What sparked the complaint?

On Nov. 4, 2019, Dr. Farmer worked a full day in the clinic at Baptist Health, visiting and treating patients and interacting with colleagues, according to court documents. In the late afternoon, he conducted a routine appointment with two children while their mother, her boyfriend, and a medical student were present.

Following the afternoon appointment, the mother issued a complaint to an office manager that Dr. Farmer was impaired, noting that he was “touching his nose a lot,” according to the lawsuit.

The next morning, hospital administrators met with Dr. Farmer and asked whether he was impaired the day before, to which he replied, “Absolutely not,” court documents state. Dr. Farmer asked to be given a urine drug screen immediately, but administrators allegedly said he needed to be tested at the Kentucky Physicians Health Foundation in Louisville.

Dr. Farmer immediately made the 3-hour drive to the facility, and Baptist Health placed him on leave, pending the evaluation. The health foundation sent Dr. Farmer to a third-party vendor to complete a urine drug screen, which returned a result of “dilute.” (A “dilute” result occurs when the urine concentration is weak because of too much water in the urine and testers are unable to detect whether alcohol or drugs are present.)

He was then instructed to go to a separate alcohol treatment facility for a 96-hour evaluation, where he was ultimately diagnosed with mild alcohol use disorder, according to Ms. DeLaney. The facility did not recommend that he receive any inpatient care.

Hospital administrators later sent a letter to the Kentucky Board of Medical Licensure alerting them of the patient’s complaint. The board opened an investigation, and Farmer was required to sign an interim order in which he agreed not to practice medicine until approved by the board, according to court documents. The order was reported to the National Practitioner’s Data Bank.

To maintain his employment and complete his residency, Dr. Farmer was ultimately required to sign a 2-year agreement with Kentucky Physicians Health Foundation, which included regular testing, monitoring, and therapy. The board later extended the agreement to 5 years and made Dr. Farmer’s compliance a condition of retaining his medical license, according to legal records.

Dr. Farmer sued Baptist Health Medical Group and Baptist Heath Madisonville in 2021, alleging breach of contract and tortious interference with prospective business advantage.

At trial, coworkers, including Farmer’s attending physicians, testified that Dr. Farmer was not impaired on the date in question, Ms. DeLaney said. A key fact highlighted at trial is that Dr. Farmer has ADHD.

“My client has ADHD, so he’s normally a twitchy person,” she said. “There was lots of testimony about how he moves a lot and that he’s fidgety and doesn’t stand still. The two attending doctors that were supervising him at clinic that afternoon both said 100% he was not impaired; he was his usual self. They told the residency director that right after the incident. They both testified at trial they thought that would be the end of the matter.”

Baptist Health would not comment about whether it followed its fitness for duty and drug testing policy or whether leaders spoke with other medical professionals who worked with Dr. Farmer on the day of the complaint.

Dr. Farmer said he feels vindicated by the verdict and grateful to the jury.

“I intend to continue practicing as a family medicine doctor and hope to continue to grow and advance in my career,” he said.
 

Have you been falsely accused? Here’s what to do

Dr. Farmer is not alone in fighting back against allegations by hospitals regarding conduct associated with impairment.

In 2020, an ob.gyn. who had been accused of being under the influence while working won $4.75 million in fraud and defamation damages against St. Vincent Carmel (Ind.) Hospital and St. Vincent Carmel Medical Group for its treatment following an impairment complaint by a nurse.

It’s unclear how prevalent such scenarios are because frequently, physicians are embarrassed and keep quiet about the situation and how they were treated, said Louise B. Andrew, MD, JD, an emergency physician/internist and attorney who consults on physician health and wellness, litigation stress, and disability discrimination.

“Physicians are unlikely to reveal that it’s happened to them unless they happen to have had a good outcome” she said. “All we know is that we’re hearing more and more about it, and that might be because people are becoming more open and outraged when it happens. It’s quite easy for anyone in a hospital environment or in an office environment, for a competitor, a coworker, or even a disgruntled patient to allege a physician has ‘glazed eyes’ or ‘alcohol on the breath,’ and that’s all it takes to start the ball rolling.”

If you are falsely accused of being impaired at work or are suddenly confronted with a complaint, the first step is to remain calm, said Kernan Manion, MD, executive director for the Center for Physician Rights, a nonprofit organization that assists physicians who have been subject to unfair medical board, health program, or peer review processes.

“The first thing is to keep your wits about you,” he said, “because often, docs get frightened or angry, and they overact. You have to gain your composure and ask for documentation about the nature of the allegation.”

Obtain in writing any and all information that supports the allegation. Physicians who are asked to report to a physician health program should ask the reason they are being referred and whether it is for a medical evaluation or another type of evaluation, he said. If it’s a medical reason, the process needs to follow medical parameters in terms of confidentiality.

“The bottom line is that a doctor should not take everything at face value and follow the organization’s orders unquestioning,” Dr. Manion said. “They have a right to get their concerns addressed.”

Physicians who are accused of using substances on duty or being under the influence while working have to right to undergo testing immediately, Dr. Andrew said.

“If you’re told on the spot: ‘You need to submit to testing,’ then you should do it, but make sure it’s done properly,” she said. “Ensure that forensically, you give two samples and that they are sealed and the chain of evidence is maintained. The reason for that is if one of them is a false positive, the second one can be reviewed separately.”

If administrators do not allow for prompt testing, get yourself tested immediately on your own, she said.

As far as leaves of absence are concerned, ensure you know what type of leave is being executed, Dr. Manion said. Ask the nature of the leave and whether the leave counts as a suspension that will go against your medical license and be reportable to the NPDB. In such cases, the only reason to suspend a doctor’s privileges is because they are considered a danger to others, or, in other words, there’s been an allegation of unsafe care.

“If there is an allegation of unsafe care, the physician should ask for documentation of the patient safety issues in question and why they are being deemed unsafe to practice,” he said.

Ms. DeLaney recommended physicians not report to or communicate with any state medical association, physician health foundation, or licensing authority without first getting legal advice.

In addition, doctors will likely be tested for acute and long-term drug and alcohol use, so it’s a good idea to avoid any activity or substances that could result in a dilute sample or a positive result on a drug or alcohol test, she said.

As for broader solutions, it’s important that more physicians come out of the shadows and tell their stories when these injustices take place, said Dr. Andrew.

“Doctors need to be more open about this when it happens, which is not easy,” she said. “More need to be suing, which is certainly not cheap. Also, when they do come to settlements, they should not sign nondisclosure agreements so that they can talk about what happened and it can be publicized. This way, more doctors are aware of the types of tactics used against physicians and what other doctors have done that can help.”

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

In the first randomized clinical trial of remote pulmonary artery pressure–guided monitoring and management of chronic heart failure (HF) in Europe, the intervention “substantially” improved quality of life (QoL) and reduced HF hospitalizations, new data show.

The CardioMEMS-HF system (Abbot Laboratories) used in the trial, called MONITOR-HF, remotely monitors changes in pulmonary artery pressure and provides an early warning of worsening HF.

Jasper Brugts, MD, PhD, of Erasmus MC University Medical Centre, Rotterdam, the Netherlands, said in an interview, “The concordance on outcomes of the three CardioMEMS trials across different eras, evolving GDMT [guideline-directed medical therapy], different conditions (pandemic), and different health care systems is reassuring and supportive of technologies such as CardioMEMS to improve patient monitoring to prevent HF hospitalizations and improve QoL.”

Dr. Brugts presented the study at the Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2023 sessions.

The system “improved QoL in all six domains of the Kansas City Cardiomyopathy Questionnaire” and resulted in fewer HF-related hospitalizations (117 vs. 212) and fewer urgent visits (11 vs. 17), in comparison with standard of care, Dr. Brugts told meeting attendees.

Furthermore, CardioMEMS monitors hypervolemia as well as hypovolemia, enabling “fine-tuning of diuretics.”

The presentation drew such applause that one chairperson described it as “close to a standing ovation.” The study was published simultaneously in The Lancet.
 

Aggregate evidence

Early clinical evidence of the benefits of remote monitoring with the CardioMEMS-HF system was provided by the CHAMPION trial, which included patients with New York Heart Association (NYHA) class III heart failure.

Results of the subsequent GUIDE-HF trial, which aimed to test a broader population of patients with NYHA class II–IV heart failure and either increased N-terminal-pro-B-type natriuretic peptide (NT-proBNP) concentrations or hospitalization, were inconclusive.

However, a pre–COVID-19 impact analysis of GUIDE-HF indicated a possible benefit, which was primarily driven by a lower HF hospitalization rate, compared with the control group. That finding was the basis for an expanded indication for the system from the U.S. Food and Drug Administration.

The 2022 FDA indication permits the use of CardioMEMS for patients with NYHA class II HF and for those with worsening HF, as assessed by elevated natriuretic peptide levels.
 

From United States to Europe

Aware that most CardioMEMS data came from U.S. trials, the investigators embarked on the current trial, MONITOR-HF, an open-label, randomized trial in 25 centers in the Netherlands. Eligible patients had chronic NYHA class III HF, irrespective of ejection fraction, and had previously undergone hospitalization for HF.

A total of 348 patients were randomly assigned to either CardioMEMS-HF or standard of care (SoC) between 2019 and 2022.The median age of the patients was 69 years, and the median ejection fraction was 30%.

All patients were scheduled to be seen by their clinician at 3 months, 6 months, and every 6 months thereafter for up to 48 months.

The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score at 12 months

That difference between groups was 7.13 (+7.05 in the CardioMEMS group and –0.08 in the SoC group).

In the responder analysis, the odds ratio of an improvement of at least 5 points in the KCCQ overall summary score was 1.69 in the CardioMEMS group vs. the SoC group; the OR of a deterioration of at least 5 points was 0.45.

Subgroup analyses showed no relevant heterogeneity in the treatment effect on total HF hospitalizations and, notably, no significant interaction in patients with an EF below 40% and an EF above 40%.

There was a significant reduction in the median NT-proBNP change from baseline only in the remote monitoring group (800 pg/mL) and a smaller, nonsignificant difference with SoC.

Both groups received highly appropriate background guideline–directed medical therapy throughout the study. There were no significant between-group differences at 12 months.

Freedom from device-related or system-related complications and sensor failure were 97.7% and 98.8%, respectively.

Two sensor failures occurred during a mean follow-up 1.8 years. The percentage of failures was comparable to CHAMPION and GUIDE-HF trials.

The trial was not powered to assess a mortality benefit.
 

Pick the right patients

“As in the U.S. trials, there will be side effects, so select the right patients, because [remote monitoring] is not without risk,” Dr. Brugts told meeting attendees.

That point also was made by Christiane E. Angermann of University and University Hospital Würzburg, Germany, in a related editorial in The Lancet.

“To reproduce these results on a large scale in real-life health care, diligent patient selection should identify those at high risk of heart failure–related hospitalization who agree with the concept of daily data collection and are able and motivated to comply with treatment recommendations even if asymptomatic,” Dr. Angermann writes.

“Without direct interaction between health care providers and patients, and timely treatment modification triggered by abnormal monitoring results, the care cycle might break and the potential benefits from early detection of decompensation would be lost.”

Val Rakita, MD, assistant professor of medicine at Temple University, Philadelphia, a specialist in advanced heart failure and main implanter of the CardioMEMS device at Temple University Hospital, commented on the study for this article.

“This study confirms the previous data that the device is very safe and effective in preventing HF hospitalizations and improving patients’ quality of life, even in a different population with more modern background guideline-directed medical therapy.”

Nevertheless, he noted, “Studies have yet to confirm a mortality benefit, despite logic telling us that preventing heart failure hospitalizations should also improve patient survival. More studies are needed to see if a survival benefit can be proven over a longer follow-up period.”

Overall, he said, “Remote monitoring allows more precise management of medications, prevention of hospitalizations, and improvement in quality of life, and I am an advocate for it in my practice.”

Not everyone is an advocate, however. In a commentary published last year, John M. Mandrola, MD, a cardiac electrophysiologist at Baptist Medical Associates in Louisville, Ky., said the expanded FDA indication for the device is the result of “dubious trial analysis, spin, lax regulation, and the growth of low-value care.”

Others also have questioned the device’s value in the clinic.

But at least for now, as Dr. Angermann writes, “Scientific evidence supports the use of the CardioMEMS-HF system to enhance remote patient management in heart failure care. For more widespread application, technological advancements are desirable to provide more comfort for patients and reusable external device components, thereby improving care experience and saving resources.”

The MONITOR-HF trial is funded by the Dutch Ministry of Health and Health Care institute. Dr. Brugts has an independent research grant from Abbott (investigator-sponsored study) and has had speaker engagements or has participated in advisory boards for Abbott and other pharmaceutical companies. Dr. Angermann has received personal fees from Abbott for serving as chair of the steering committee for the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) and consulting fees, honoraria, and travel costs from Abbott. Dr. Rakita has disclosed no relevant financial relationships.

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

In the first randomized clinical trial of remote pulmonary artery pressure–guided monitoring and management of chronic heart failure (HF) in Europe, the intervention “substantially” improved quality of life (QoL) and reduced HF hospitalizations, new data show.

The CardioMEMS-HF system (Abbot Laboratories) used in the trial, called MONITOR-HF, remotely monitors changes in pulmonary artery pressure and provides an early warning of worsening HF.

Jasper Brugts, MD, PhD, of Erasmus MC University Medical Centre, Rotterdam, the Netherlands, said in an interview, “The concordance on outcomes of the three CardioMEMS trials across different eras, evolving GDMT [guideline-directed medical therapy], different conditions (pandemic), and different health care systems is reassuring and supportive of technologies such as CardioMEMS to improve patient monitoring to prevent HF hospitalizations and improve QoL.”

Dr. Brugts presented the study at the Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2023 sessions.

The system “improved QoL in all six domains of the Kansas City Cardiomyopathy Questionnaire” and resulted in fewer HF-related hospitalizations (117 vs. 212) and fewer urgent visits (11 vs. 17), in comparison with standard of care, Dr. Brugts told meeting attendees.

Furthermore, CardioMEMS monitors hypervolemia as well as hypovolemia, enabling “fine-tuning of diuretics.”

The presentation drew such applause that one chairperson described it as “close to a standing ovation.” The study was published simultaneously in The Lancet.
 

Aggregate evidence

Early clinical evidence of the benefits of remote monitoring with the CardioMEMS-HF system was provided by the CHAMPION trial, which included patients with New York Heart Association (NYHA) class III heart failure.

Results of the subsequent GUIDE-HF trial, which aimed to test a broader population of patients with NYHA class II–IV heart failure and either increased N-terminal-pro-B-type natriuretic peptide (NT-proBNP) concentrations or hospitalization, were inconclusive.

However, a pre–COVID-19 impact analysis of GUIDE-HF indicated a possible benefit, which was primarily driven by a lower HF hospitalization rate, compared with the control group. That finding was the basis for an expanded indication for the system from the U.S. Food and Drug Administration.

The 2022 FDA indication permits the use of CardioMEMS for patients with NYHA class II HF and for those with worsening HF, as assessed by elevated natriuretic peptide levels.
 

From United States to Europe

Aware that most CardioMEMS data came from U.S. trials, the investigators embarked on the current trial, MONITOR-HF, an open-label, randomized trial in 25 centers in the Netherlands. Eligible patients had chronic NYHA class III HF, irrespective of ejection fraction, and had previously undergone hospitalization for HF.

A total of 348 patients were randomly assigned to either CardioMEMS-HF or standard of care (SoC) between 2019 and 2022.The median age of the patients was 69 years, and the median ejection fraction was 30%.

All patients were scheduled to be seen by their clinician at 3 months, 6 months, and every 6 months thereafter for up to 48 months.

The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score at 12 months

That difference between groups was 7.13 (+7.05 in the CardioMEMS group and –0.08 in the SoC group).

In the responder analysis, the odds ratio of an improvement of at least 5 points in the KCCQ overall summary score was 1.69 in the CardioMEMS group vs. the SoC group; the OR of a deterioration of at least 5 points was 0.45.

Subgroup analyses showed no relevant heterogeneity in the treatment effect on total HF hospitalizations and, notably, no significant interaction in patients with an EF below 40% and an EF above 40%.

There was a significant reduction in the median NT-proBNP change from baseline only in the remote monitoring group (800 pg/mL) and a smaller, nonsignificant difference with SoC.

Both groups received highly appropriate background guideline–directed medical therapy throughout the study. There were no significant between-group differences at 12 months.

Freedom from device-related or system-related complications and sensor failure were 97.7% and 98.8%, respectively.

Two sensor failures occurred during a mean follow-up 1.8 years. The percentage of failures was comparable to CHAMPION and GUIDE-HF trials.

The trial was not powered to assess a mortality benefit.
 

Pick the right patients

“As in the U.S. trials, there will be side effects, so select the right patients, because [remote monitoring] is not without risk,” Dr. Brugts told meeting attendees.

That point also was made by Christiane E. Angermann of University and University Hospital Würzburg, Germany, in a related editorial in The Lancet.

“To reproduce these results on a large scale in real-life health care, diligent patient selection should identify those at high risk of heart failure–related hospitalization who agree with the concept of daily data collection and are able and motivated to comply with treatment recommendations even if asymptomatic,” Dr. Angermann writes.

“Without direct interaction between health care providers and patients, and timely treatment modification triggered by abnormal monitoring results, the care cycle might break and the potential benefits from early detection of decompensation would be lost.”

Val Rakita, MD, assistant professor of medicine at Temple University, Philadelphia, a specialist in advanced heart failure and main implanter of the CardioMEMS device at Temple University Hospital, commented on the study for this article.

“This study confirms the previous data that the device is very safe and effective in preventing HF hospitalizations and improving patients’ quality of life, even in a different population with more modern background guideline-directed medical therapy.”

Nevertheless, he noted, “Studies have yet to confirm a mortality benefit, despite logic telling us that preventing heart failure hospitalizations should also improve patient survival. More studies are needed to see if a survival benefit can be proven over a longer follow-up period.”

Overall, he said, “Remote monitoring allows more precise management of medications, prevention of hospitalizations, and improvement in quality of life, and I am an advocate for it in my practice.”

Not everyone is an advocate, however. In a commentary published last year, John M. Mandrola, MD, a cardiac electrophysiologist at Baptist Medical Associates in Louisville, Ky., said the expanded FDA indication for the device is the result of “dubious trial analysis, spin, lax regulation, and the growth of low-value care.”

Others also have questioned the device’s value in the clinic.

But at least for now, as Dr. Angermann writes, “Scientific evidence supports the use of the CardioMEMS-HF system to enhance remote patient management in heart failure care. For more widespread application, technological advancements are desirable to provide more comfort for patients and reusable external device components, thereby improving care experience and saving resources.”

The MONITOR-HF trial is funded by the Dutch Ministry of Health and Health Care institute. Dr. Brugts has an independent research grant from Abbott (investigator-sponsored study) and has had speaker engagements or has participated in advisory boards for Abbott and other pharmaceutical companies. Dr. Angermann has received personal fees from Abbott for serving as chair of the steering committee for the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) and consulting fees, honoraria, and travel costs from Abbott. Dr. Rakita has disclosed no relevant financial relationships.

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

In the first randomized clinical trial of remote pulmonary artery pressure–guided monitoring and management of chronic heart failure (HF) in Europe, the intervention “substantially” improved quality of life (QoL) and reduced HF hospitalizations, new data show.

The CardioMEMS-HF system (Abbot Laboratories) used in the trial, called MONITOR-HF, remotely monitors changes in pulmonary artery pressure and provides an early warning of worsening HF.

Jasper Brugts, MD, PhD, of Erasmus MC University Medical Centre, Rotterdam, the Netherlands, said in an interview, “The concordance on outcomes of the three CardioMEMS trials across different eras, evolving GDMT [guideline-directed medical therapy], different conditions (pandemic), and different health care systems is reassuring and supportive of technologies such as CardioMEMS to improve patient monitoring to prevent HF hospitalizations and improve QoL.”

Dr. Brugts presented the study at the Heart Failure Association of the European Society of Cardiology (HFA-ESC) 2023 sessions.

The system “improved QoL in all six domains of the Kansas City Cardiomyopathy Questionnaire” and resulted in fewer HF-related hospitalizations (117 vs. 212) and fewer urgent visits (11 vs. 17), in comparison with standard of care, Dr. Brugts told meeting attendees.

Furthermore, CardioMEMS monitors hypervolemia as well as hypovolemia, enabling “fine-tuning of diuretics.”

The presentation drew such applause that one chairperson described it as “close to a standing ovation.” The study was published simultaneously in The Lancet.
 

Aggregate evidence

Early clinical evidence of the benefits of remote monitoring with the CardioMEMS-HF system was provided by the CHAMPION trial, which included patients with New York Heart Association (NYHA) class III heart failure.

Results of the subsequent GUIDE-HF trial, which aimed to test a broader population of patients with NYHA class II–IV heart failure and either increased N-terminal-pro-B-type natriuretic peptide (NT-proBNP) concentrations or hospitalization, were inconclusive.

However, a pre–COVID-19 impact analysis of GUIDE-HF indicated a possible benefit, which was primarily driven by a lower HF hospitalization rate, compared with the control group. That finding was the basis for an expanded indication for the system from the U.S. Food and Drug Administration.

The 2022 FDA indication permits the use of CardioMEMS for patients with NYHA class II HF and for those with worsening HF, as assessed by elevated natriuretic peptide levels.
 

From United States to Europe

Aware that most CardioMEMS data came from U.S. trials, the investigators embarked on the current trial, MONITOR-HF, an open-label, randomized trial in 25 centers in the Netherlands. Eligible patients had chronic NYHA class III HF, irrespective of ejection fraction, and had previously undergone hospitalization for HF.

A total of 348 patients were randomly assigned to either CardioMEMS-HF or standard of care (SoC) between 2019 and 2022.The median age of the patients was 69 years, and the median ejection fraction was 30%.

All patients were scheduled to be seen by their clinician at 3 months, 6 months, and every 6 months thereafter for up to 48 months.

The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score at 12 months

That difference between groups was 7.13 (+7.05 in the CardioMEMS group and –0.08 in the SoC group).

In the responder analysis, the odds ratio of an improvement of at least 5 points in the KCCQ overall summary score was 1.69 in the CardioMEMS group vs. the SoC group; the OR of a deterioration of at least 5 points was 0.45.

Subgroup analyses showed no relevant heterogeneity in the treatment effect on total HF hospitalizations and, notably, no significant interaction in patients with an EF below 40% and an EF above 40%.

There was a significant reduction in the median NT-proBNP change from baseline only in the remote monitoring group (800 pg/mL) and a smaller, nonsignificant difference with SoC.

Both groups received highly appropriate background guideline–directed medical therapy throughout the study. There were no significant between-group differences at 12 months.

Freedom from device-related or system-related complications and sensor failure were 97.7% and 98.8%, respectively.

Two sensor failures occurred during a mean follow-up 1.8 years. The percentage of failures was comparable to CHAMPION and GUIDE-HF trials.

The trial was not powered to assess a mortality benefit.
 

Pick the right patients

“As in the U.S. trials, there will be side effects, so select the right patients, because [remote monitoring] is not without risk,” Dr. Brugts told meeting attendees.

That point also was made by Christiane E. Angermann of University and University Hospital Würzburg, Germany, in a related editorial in The Lancet.

“To reproduce these results on a large scale in real-life health care, diligent patient selection should identify those at high risk of heart failure–related hospitalization who agree with the concept of daily data collection and are able and motivated to comply with treatment recommendations even if asymptomatic,” Dr. Angermann writes.

“Without direct interaction between health care providers and patients, and timely treatment modification triggered by abnormal monitoring results, the care cycle might break and the potential benefits from early detection of decompensation would be lost.”

Val Rakita, MD, assistant professor of medicine at Temple University, Philadelphia, a specialist in advanced heart failure and main implanter of the CardioMEMS device at Temple University Hospital, commented on the study for this article.

“This study confirms the previous data that the device is very safe and effective in preventing HF hospitalizations and improving patients’ quality of life, even in a different population with more modern background guideline-directed medical therapy.”

Nevertheless, he noted, “Studies have yet to confirm a mortality benefit, despite logic telling us that preventing heart failure hospitalizations should also improve patient survival. More studies are needed to see if a survival benefit can be proven over a longer follow-up period.”

Overall, he said, “Remote monitoring allows more precise management of medications, prevention of hospitalizations, and improvement in quality of life, and I am an advocate for it in my practice.”

Not everyone is an advocate, however. In a commentary published last year, John M. Mandrola, MD, a cardiac electrophysiologist at Baptist Medical Associates in Louisville, Ky., said the expanded FDA indication for the device is the result of “dubious trial analysis, spin, lax regulation, and the growth of low-value care.”

Others also have questioned the device’s value in the clinic.

But at least for now, as Dr. Angermann writes, “Scientific evidence supports the use of the CardioMEMS-HF system to enhance remote patient management in heart failure care. For more widespread application, technological advancements are desirable to provide more comfort for patients and reusable external device components, thereby improving care experience and saving resources.”

The MONITOR-HF trial is funded by the Dutch Ministry of Health and Health Care institute. Dr. Brugts has an independent research grant from Abbott (investigator-sponsored study) and has had speaker engagements or has participated in advisory boards for Abbott and other pharmaceutical companies. Dr. Angermann has received personal fees from Abbott for serving as chair of the steering committee for the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) and consulting fees, honoraria, and travel costs from Abbott. Dr. Rakita has disclosed no relevant financial relationships.

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

Weight loss before catheter ablation for atrial fibrillation (AFib) in patients who are initially overweight or obese can boost the procedure’s chances for abolishing the arrhythmia, at least in the short term, a new analysis suggests.

The finding comes from a small study that entered such patients with paroxysmal and especially persistent AFib who were candidates for ablation. Those shedding at least 3% of body weight in the months before the procedure while engaged in a structured risk-factor modification (RFM) program were “dramatically” more likely to be AFib-free 6 months later.

The improved ablation efficacy, compared with results in similar patients who didn’t lose as much weight, was most pronounced among those whose AFib had been the persistent form, reported investigators at the annual scientific sessions of the Heart Rhythm Society, held in New Orleans.

Of note, ablations in the study were consistently limited, as much as possible, to standard pulmonary-vein isolation (PVI).

Associations between AFib and obesity and other behavioral and lifestyle-related risk factors are well recognized, but the limited studies of their effect on AFib ablation success have been inconsistent. The current analysis, the group says, points specifically to preablation weight loss as means to improving AFib-ablation outcomes.

“Adjunctive therapy focused on weight loss should be incorporated in the treatment plan for obese patients undergoing ablation for atrial fibrillation,” Jeffrey J. Goldberger, MD, MBA, of the University of Miami, said when presenting the new results at the HRS sessions.

Such a plan is entirely consistent with recent guidelines and especially a 2020 American Heart Association (AHA) consensus statement, but is inconsistently and perhaps even seldom realized in clinical practice.
 

Dramatic increase in success

Even modest weight loss before ablation may help, proposed Dr. Goldberger, who directs his institution’s Center for Atrial Fibrillation. Decreases for the greater-weight-loss group actually averaged less than 6% of baseline body weight.

Yet it was apparently enough to improve ablation outcomes significantly: Eighty-eight percent were free of AFib 6 months after the procedure, compared with 61% for patients who lost less than 3% of their preablation weight.

For improving ablation success, he said, “We’re talking about a moderate amount of weight loss. These patients are not going from being obese to being thin. They’re still quite overweight.”

In an analysis limited to the four-fifths of patients with persistent AFib, “we saw the same pattern,” Dr. Goldberger said at a media presentation prior to his formal report at the HRS sessions.

Moreover, that subgroup’s benefit persisted out to 12 months, at which time 42% and 81% of patients with less and greater weight loss, respectively, were free of AFib. That represents, he said, “a really tremendous – dramatic, actually – increase in success of pulmonary vein isolation in those who lost weight.”

“We’ve known for a long time that weight loss is important for preventing atrial fibrillation or increasing the success rates of the different treatments we use,” Cynthia M. Tracy, MD, said in an interview. “Probably in some studies, weight loss has been as effective as antiarrhythmics.”

A loss of 3% body weight “is not a lot,” she said. In the current analysis, “It’s notable that it made that much difference with even a fairly modest amount of weight loss.”

Now when asked, “ ‘How much do I have to lose before you’ll consider doing my ablation?’ we have a bit more concrete data to give patients and doctors as to what amount might be beneficial,” said Dr. Tracy of George Washington University Hospital, Washington, who is not associated with the study.
 

Evolving view of AFib

The findings are emblematic of the profession’s evolving view of AFib and its management, Dr. Goldberger observed at the press conference. Should clinicians think of AFib as similar to “a disease like Wolff-Parkinson-White syndrome,” in which the patient usually has a successful ablation, and then “we expect that to last in perpetuity with no further interventions?”

Or, he said, “is atrial fibrillation more a disease like coronary artery disease, where even if they have an intervention, the disease process is still ongoing and requires long-term disease management? I think it’s pretty clear that we’re dealing with the latter case.”

Dr. Goldberger’s report was an interim analysis of an ongoing randomized trial called LEAF (Liraglutide Effect on Atrial Fibrillation), which is comparing patients with AFib assigned to “take” vs. “not take” the GLP-1 receptor agonist liraglutide, an antidiabetic (Victoza) and weight-loss (Saxenda) drug. The trial aims to assess the drug’s apparent ability to shrink atrial epicardial adipose tissue which, Dr. Goldberger said, is thought to contribute to AFib development and influence AFib-ablation outcomes.  

It’s unknown and a limitation of the current analysis, he said, whether the observed link between improved preablation–weight ablation success “is specifically related to weight loss, liraglutide treatment, or both.”

As the invited discussant for Dr. Goldberger’s presentation, David Frankel, MD, observed that studies have been inconsistent on whether substantial weight loss may improve the results of AFib rhythm-control therapy.

Those finding such an association, including LEAF and the influential LEGACY study, differed from others showing a null effect by including “a comprehensive risk factor management” program, observed Dr. Frankel, of the Hospital of the University of Pennsylvania and Penn Heart and Vascular Center, Philadelphia.

Rather than focusing solely on weight loss or sleep apnea as AFib risk factors, he said, the studies linking weight loss to AFib rhythm control also included “hypertension, diabetes, hyperlipidemia, smoking cessation, and alcohol reduction,” Dr. Frankel said. “So it seems clear that to significantly impact AF recurrence, we need to focus on all these contributors to metabolic syndrome.”
 

Comprehensive risk-factor management

LEAF entered patients with AFib, 79% of whom had persistent AF and the rest paroxysmal AF, who followed the RFM program and were randomly assigned also to take liraglutide or placebo. The “nurse-practitioner-led” RFM program, conducted both in-clinic and online, featured “established goals for each patient” using AHA diet and lifestyle recommendations, an exercise prescription, dietary counseling, evaluation and treatment of sleep apnea, and measures to control any diabetes, hyperlipidemia, or hypertension, Dr. Goldberger said. And patients “were counseled on alcohol reduction and smoking cessation as necessary.”

After 3 months, 29 and 30 patients – regardless of randomization assignment – had lost < 3% and at least 3% of baseline body weight, respectively.

Catheter ablation achieved PVI in all patients. A 3-month blanking period followed, after which they went off antiarrhythmic meds.

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

Weight loss before catheter ablation for atrial fibrillation (AFib) in patients who are initially overweight or obese can boost the procedure’s chances for abolishing the arrhythmia, at least in the short term, a new analysis suggests.

The finding comes from a small study that entered such patients with paroxysmal and especially persistent AFib who were candidates for ablation. Those shedding at least 3% of body weight in the months before the procedure while engaged in a structured risk-factor modification (RFM) program were “dramatically” more likely to be AFib-free 6 months later.

The improved ablation efficacy, compared with results in similar patients who didn’t lose as much weight, was most pronounced among those whose AFib had been the persistent form, reported investigators at the annual scientific sessions of the Heart Rhythm Society, held in New Orleans.

Of note, ablations in the study were consistently limited, as much as possible, to standard pulmonary-vein isolation (PVI).

Associations between AFib and obesity and other behavioral and lifestyle-related risk factors are well recognized, but the limited studies of their effect on AFib ablation success have been inconsistent. The current analysis, the group says, points specifically to preablation weight loss as means to improving AFib-ablation outcomes.

“Adjunctive therapy focused on weight loss should be incorporated in the treatment plan for obese patients undergoing ablation for atrial fibrillation,” Jeffrey J. Goldberger, MD, MBA, of the University of Miami, said when presenting the new results at the HRS sessions.

Such a plan is entirely consistent with recent guidelines and especially a 2020 American Heart Association (AHA) consensus statement, but is inconsistently and perhaps even seldom realized in clinical practice.
 

Dramatic increase in success

Even modest weight loss before ablation may help, proposed Dr. Goldberger, who directs his institution’s Center for Atrial Fibrillation. Decreases for the greater-weight-loss group actually averaged less than 6% of baseline body weight.

Yet it was apparently enough to improve ablation outcomes significantly: Eighty-eight percent were free of AFib 6 months after the procedure, compared with 61% for patients who lost less than 3% of their preablation weight.

For improving ablation success, he said, “We’re talking about a moderate amount of weight loss. These patients are not going from being obese to being thin. They’re still quite overweight.”

In an analysis limited to the four-fifths of patients with persistent AFib, “we saw the same pattern,” Dr. Goldberger said at a media presentation prior to his formal report at the HRS sessions.

Moreover, that subgroup’s benefit persisted out to 12 months, at which time 42% and 81% of patients with less and greater weight loss, respectively, were free of AFib. That represents, he said, “a really tremendous – dramatic, actually – increase in success of pulmonary vein isolation in those who lost weight.”

“We’ve known for a long time that weight loss is important for preventing atrial fibrillation or increasing the success rates of the different treatments we use,” Cynthia M. Tracy, MD, said in an interview. “Probably in some studies, weight loss has been as effective as antiarrhythmics.”

A loss of 3% body weight “is not a lot,” she said. In the current analysis, “It’s notable that it made that much difference with even a fairly modest amount of weight loss.”

Now when asked, “ ‘How much do I have to lose before you’ll consider doing my ablation?’ we have a bit more concrete data to give patients and doctors as to what amount might be beneficial,” said Dr. Tracy of George Washington University Hospital, Washington, who is not associated with the study.
 

Evolving view of AFib

The findings are emblematic of the profession’s evolving view of AFib and its management, Dr. Goldberger observed at the press conference. Should clinicians think of AFib as similar to “a disease like Wolff-Parkinson-White syndrome,” in which the patient usually has a successful ablation, and then “we expect that to last in perpetuity with no further interventions?”

Or, he said, “is atrial fibrillation more a disease like coronary artery disease, where even if they have an intervention, the disease process is still ongoing and requires long-term disease management? I think it’s pretty clear that we’re dealing with the latter case.”

Dr. Goldberger’s report was an interim analysis of an ongoing randomized trial called LEAF (Liraglutide Effect on Atrial Fibrillation), which is comparing patients with AFib assigned to “take” vs. “not take” the GLP-1 receptor agonist liraglutide, an antidiabetic (Victoza) and weight-loss (Saxenda) drug. The trial aims to assess the drug’s apparent ability to shrink atrial epicardial adipose tissue which, Dr. Goldberger said, is thought to contribute to AFib development and influence AFib-ablation outcomes.  

It’s unknown and a limitation of the current analysis, he said, whether the observed link between improved preablation–weight ablation success “is specifically related to weight loss, liraglutide treatment, or both.”

As the invited discussant for Dr. Goldberger’s presentation, David Frankel, MD, observed that studies have been inconsistent on whether substantial weight loss may improve the results of AFib rhythm-control therapy.

Those finding such an association, including LEAF and the influential LEGACY study, differed from others showing a null effect by including “a comprehensive risk factor management” program, observed Dr. Frankel, of the Hospital of the University of Pennsylvania and Penn Heart and Vascular Center, Philadelphia.

Rather than focusing solely on weight loss or sleep apnea as AFib risk factors, he said, the studies linking weight loss to AFib rhythm control also included “hypertension, diabetes, hyperlipidemia, smoking cessation, and alcohol reduction,” Dr. Frankel said. “So it seems clear that to significantly impact AF recurrence, we need to focus on all these contributors to metabolic syndrome.”
 

Comprehensive risk-factor management

LEAF entered patients with AFib, 79% of whom had persistent AF and the rest paroxysmal AF, who followed the RFM program and were randomly assigned also to take liraglutide or placebo. The “nurse-practitioner-led” RFM program, conducted both in-clinic and online, featured “established goals for each patient” using AHA diet and lifestyle recommendations, an exercise prescription, dietary counseling, evaluation and treatment of sleep apnea, and measures to control any diabetes, hyperlipidemia, or hypertension, Dr. Goldberger said. And patients “were counseled on alcohol reduction and smoking cessation as necessary.”

After 3 months, 29 and 30 patients – regardless of randomization assignment – had lost < 3% and at least 3% of baseline body weight, respectively.

Catheter ablation achieved PVI in all patients. A 3-month blanking period followed, after which they went off antiarrhythmic meds.

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