TOPLINE:

A genetic predisposition to sleep 5 or fewer hours per night is associated with a significantly higher risk for subsequent depression. However, a genetic propensity to depression is not associated with suboptimal sleep patterns later on, new research shows.

METHODOLOGY:

• The analysis included participants in the English Longitudinal Study of Ageing (ELSA), a prospective cohort study of a representative U.K. sample (mean age, 65 years) that is assessed biennially.
• Researchers collected data on sleep duration and depression through nursing home visits and computer-assisted personal interviews and used combined ELSA waves from 2004 to 2008, when collection of genetic data began.
• Using genome-wide association studies from the U.K. Biobank, the authors constructed polygenic scores (PGSs) to predict an individual’s genetic risk over an average of 8 years for a disease or outcome, overall sleep duration, short sleep (≤ 5 hours nightly), long sleep (≥ 9 hours of sleep nightly), and depression.
• The analysis included two analytic samples; one involved 6,521 persons to determine the role of baseline sleep on depression (assessed using the Center for Epidemiologic Studies Depression Scale) at follow-up, and the other involved 6,070 persons to determine the role of baseline depression on suboptimal sleep at follow-up.

TAKEAWAY:

• After adjustments, including for age and sex, a 1–standard deviation increase in PGS for short sleep was associated with an increase of 14% in odds of developing depression during the follow-up period (odds ratio, 1.14; P = .008).
• There was no significant association of the PGS for sleep duration (P = .053) or long sleep (P = .544) with the onset of depression.
• There were no significant associations between PGS for depression and future overall sleep duration, short sleep, and long sleep by the end of the follow-up, suggesting that different mechanisms underlie the relationship between depression and subsequent onset of suboptimal sleep in older adults.
• Several sensitivity analyses – including additional adjustment for socioeconomic, environmental, and behavioral factors – upheld the findings of the main analysis, highlighting the robustness of the results.

IN PRACTICE:

The study showed that common genetic markers for short sleep play an important role in the incidence of depression in older adults, the authors note, adding that the new findings “support a growing view that short-sleep is more salient to the experience of depression than long sleep” across the lifespan.

SOURCE:

The study was led by Odessa S. Hamilton, department of behavioral science and health, University College London. It was published online  in Translational Psychiatry.

LIMITATIONS:

There are probably intraindividual differences in sleep duration that were not assessed in the study. The depression scale used may be indicative of subclinical depression and not major depressive disorder. The phenotypic sensitivity analyses did not account for comorbidities or medications that can affect sleep duration and depression.

DISCLOSURES:

ELSA is funded by the National Institute on Aging and by a consortium of U.K. government departments coordinated by the National Institute for Health and Care Research. The authors report no relevant conflicts of interests.

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

TOPLINE:

A genetic predisposition to sleep 5 or fewer hours per night is associated with a significantly higher risk for subsequent depression. However, a genetic propensity to depression is not associated with suboptimal sleep patterns later on, new research shows.

METHODOLOGY:

• The analysis included participants in the English Longitudinal Study of Ageing (ELSA), a prospective cohort study of a representative U.K. sample (mean age, 65 years) that is assessed biennially.
• Researchers collected data on sleep duration and depression through nursing home visits and computer-assisted personal interviews and used combined ELSA waves from 2004 to 2008, when collection of genetic data began.
• Using genome-wide association studies from the U.K. Biobank, the authors constructed polygenic scores (PGSs) to predict an individual’s genetic risk over an average of 8 years for a disease or outcome, overall sleep duration, short sleep (≤ 5 hours nightly), long sleep (≥ 9 hours of sleep nightly), and depression.
• The analysis included two analytic samples; one involved 6,521 persons to determine the role of baseline sleep on depression (assessed using the Center for Epidemiologic Studies Depression Scale) at follow-up, and the other involved 6,070 persons to determine the role of baseline depression on suboptimal sleep at follow-up.

TAKEAWAY:

• After adjustments, including for age and sex, a 1–standard deviation increase in PGS for short sleep was associated with an increase of 14% in odds of developing depression during the follow-up period (odds ratio, 1.14; P = .008).
• There was no significant association of the PGS for sleep duration (P = .053) or long sleep (P = .544) with the onset of depression.
• There were no significant associations between PGS for depression and future overall sleep duration, short sleep, and long sleep by the end of the follow-up, suggesting that different mechanisms underlie the relationship between depression and subsequent onset of suboptimal sleep in older adults.
• Several sensitivity analyses – including additional adjustment for socioeconomic, environmental, and behavioral factors – upheld the findings of the main analysis, highlighting the robustness of the results.

IN PRACTICE:

The study showed that common genetic markers for short sleep play an important role in the incidence of depression in older adults, the authors note, adding that the new findings “support a growing view that short-sleep is more salient to the experience of depression than long sleep” across the lifespan.

SOURCE:

The study was led by Odessa S. Hamilton, department of behavioral science and health, University College London. It was published online  in Translational Psychiatry.

LIMITATIONS:

There are probably intraindividual differences in sleep duration that were not assessed in the study. The depression scale used may be indicative of subclinical depression and not major depressive disorder. The phenotypic sensitivity analyses did not account for comorbidities or medications that can affect sleep duration and depression.

DISCLOSURES:

ELSA is funded by the National Institute on Aging and by a consortium of U.K. government departments coordinated by the National Institute for Health and Care Research. The authors report no relevant conflicts of interests.

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

TOPLINE:

A genetic predisposition to sleep 5 or fewer hours per night is associated with a significantly higher risk for subsequent depression. However, a genetic propensity to depression is not associated with suboptimal sleep patterns later on, new research shows.

METHODOLOGY:

• The analysis included participants in the English Longitudinal Study of Ageing (ELSA), a prospective cohort study of a representative U.K. sample (mean age, 65 years) that is assessed biennially.
• Researchers collected data on sleep duration and depression through nursing home visits and computer-assisted personal interviews and used combined ELSA waves from 2004 to 2008, when collection of genetic data began.
• Using genome-wide association studies from the U.K. Biobank, the authors constructed polygenic scores (PGSs) to predict an individual’s genetic risk over an average of 8 years for a disease or outcome, overall sleep duration, short sleep (≤ 5 hours nightly), long sleep (≥ 9 hours of sleep nightly), and depression.
• The analysis included two analytic samples; one involved 6,521 persons to determine the role of baseline sleep on depression (assessed using the Center for Epidemiologic Studies Depression Scale) at follow-up, and the other involved 6,070 persons to determine the role of baseline depression on suboptimal sleep at follow-up.

TAKEAWAY:

• After adjustments, including for age and sex, a 1–standard deviation increase in PGS for short sleep was associated with an increase of 14% in odds of developing depression during the follow-up period (odds ratio, 1.14; P = .008).
• There was no significant association of the PGS for sleep duration (P = .053) or long sleep (P = .544) with the onset of depression.
• There were no significant associations between PGS for depression and future overall sleep duration, short sleep, and long sleep by the end of the follow-up, suggesting that different mechanisms underlie the relationship between depression and subsequent onset of suboptimal sleep in older adults.
• Several sensitivity analyses – including additional adjustment for socioeconomic, environmental, and behavioral factors – upheld the findings of the main analysis, highlighting the robustness of the results.

IN PRACTICE:

The study showed that common genetic markers for short sleep play an important role in the incidence of depression in older adults, the authors note, adding that the new findings “support a growing view that short-sleep is more salient to the experience of depression than long sleep” across the lifespan.

SOURCE:

The study was led by Odessa S. Hamilton, department of behavioral science and health, University College London. It was published online  in Translational Psychiatry.

LIMITATIONS:

There are probably intraindividual differences in sleep duration that were not assessed in the study. The depression scale used may be indicative of subclinical depression and not major depressive disorder. The phenotypic sensitivity analyses did not account for comorbidities or medications that can affect sleep duration and depression.

DISCLOSURES:

ELSA is funded by the National Institute on Aging and by a consortium of U.K. government departments coordinated by the National Institute for Health and Care Research. The authors report no relevant conflicts of interests.

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

Training in medicine has long been thought of as a tough process, but the issue of creating a psychologically safe environment for young doctors is now being highlighted as an important way of providing an improved learning environment, which will ultimately lead to better patient care. And cardiology is one field that needs to work harder on this.  

“We all remember attendings who made our training experience memorable, who made us excited to come to work and learn, and who inspired us to become better,” Vivek Kulkarni, MD, wrote in a recent commentary. “Unfortunately, we also all remember the learning environments where we were terrified, where thriving took a backseat to surviving, and where learning was an afterthought.”

Writing in an article in the Journal of the American College of Cardiology, Dr. Kulkarni asked the question: “Why are some learning environments better than others, and what can we do to improve the learning environment for our trainees?”

Dr. Kulkarni, director of the training program for cardiology fellows at Cooper University Hospital, Camden, New Jersey, said cardiology is a specialty that hasn’t paid much attention to the idea of psychological safety in training. “There may be some people in some institutions that do pay attention to this but as wider field we could do better.”

Dr. Kulkarni explained that psychological safety is the comfort to engage with others genuinely, with honesty and without fear.

It has been defined as a “willingness to take interpersonal risks at work, whether to admit error, ask a question, seek help, or simply say ‘I don’t know,’ ” or as “the perception that a working environment is safe for team members to express a concern, ask a question, or acknowledge a mistake without fear of humiliation, retaliation, blame, or being ignored.”

“In the medical environment we usually work in teams: older doctors, younger doctors, nurses, other staff,” Dr. Kulkarni said in an interview. “A psychologically safe environment would be one where a trainee feels comfortable so that they can ask a question about something that they don’t understand. That comfort comes from the idea that it is okay to get something wrong or to not know something and to ask for help.

“The flip side of that is an environment in which people are so afraid to make a mistake out of fear of retribution or punishment that they don’t take risks, or they don’t openly acknowledge when they might need help with something,” he said. “That would be a psychologically unsafe environment.”

What exactly this looks like varies in different environments and culture of the group, he noted, “but in general, you can tell if you are part of a psychologically safe environment because you are excited to come to work and feel comfortable at work.”

Dr. Kulkarni added that a growing body of literature now shows that psychological safety is critical for optimal learning but that cardiovascular fellowship training poses unique barriers to psychological safety.
 

‘Arrogant, unkind, and unwelcoming’

First, he said that the “high-stakes” nature of cardiology, in which decisions often must be made quickly and can have life-or-death consequences, can create fear about making mistakes and that some trainees may be so afraid that they cannot speak up and ask for help when struggling or cannot incorporate feedback in real time.

Second, in medicine at large, there is a stereotype that cardiologists can be “arrogant, unkind, and unwelcoming,” which may discourage new fellows from honest interaction.

Third, cardiology involves many different technical skills that fellows have little to no previous experience with; this may contribute to a perceived sense of being judged when making mistakes or asking for help.

Finally, demographics may be a factor, with only one in eight cardiologists in the United States being women and only 7.5% of cardiologists being from traditionally underrepresented racial and ethnic minority groups, which Dr. Kulkarni said may lead to a lack of psychological safety because of “bias, microaggressions, or even just a lack of mentors of similar backgrounds.”

But he believes that the cardiology training culture is improving.

“I think it is getting better. Even the fact that I can publish this article is a positive sign. I think there’s an audience for this type of thing now.”

He believes that part of the reason for this is the availability of research and evidence showing there are better ways to teach than the old traditional approaches.

He noted that some teaching physicians receive training on how to teach and some don’t, and this is an area that could be improved.

“I think the knowledge of how to produce psychologically safe environments is already there,” he said. “It just has to be standardized and publicized. That would make the learning environment better.”

“Nothing about this is groundbreaking,” he added. “We all know psychologically unsafe environments exist. The novelty is just that it is now starting to be discussed. It’s one of those things that we can likely improve the ways our trainees learn and the kind of doctors we produce just by thinking a little bit more carefully about the way we interact with each other.”

Dr. Kulkarni said trainees often drop out because they have had a negative experience of feeling psychologically unsafe. “They may drop out of medicine all together or they may choose to pursue a career in a different part of medicine, where they perceive a more psychologically safe environment.”

He also suggested that this issue can affect patient care.

“If the medical team does not provide a psychologically safe environment for trainees, it is very likely that that team is not operating as effectively as it could, and it is very likely that patients being taken care of by that team may have missed opportunities for better care,” he concluded. Examples could include trainees recognizing errors and bringing things that might not be right to the attention of their superiors. “That is something that requires some degree of psychological safety.”
 

Action for improvement

Dr. Kulkarni suggested several strategies to promote psychological safety in cardiology training.

As a first step, institutions should investigate the culture of learning within their fellowship programs and gather feedback from anonymous surveys of fellows. They can then implement policies to address gaps.

He noted that, at Cooper University Hospital, standardized documents have been created that explicitly outline policies for attendings on teaching services, which establish expectations for all team members, encourage fellows to ask for help, set guidelines for feedback conversations with fellows, and delineate situations when calling the attending is expected.

Dr. Kulkarni also suggested that cardiologists involved in teaching fellows can try several strategies to promote psychological safety. These include setting clear expectations on their tasks and graded autonomy, inviting participation in decisions, acknowledging that gaps in knowledge are not a personal failure but rather a normal part of the growth process, encouraging fellows to seek help when they need it, fostering collegial relationships with fellows, acknowledging your own uncertainty in difficult situations, checking in about emotions after challenging situations, and seeking feedback on your own performance.

He added that changes on a larger scale are also needed, such as training for cardiology program directors including more on this issue as well as developing best practices.

“If we as a community could come together and agree on the things needed to create a psychologically safe environment for training, that would be a big improvement.”
 

Addressing the challenges of different generations

In a response to Dr. Kulkarni’s article, Margo Vassar, MD, The Queen’s Medical Center, Honolulu, and Sandra Lewis, MD, Legacy Health System, Portland, Ore., make the case that to succeed in providing psychological safety, the cardiovascular community also needs to address intergenerational cultural challenges.

“Twenty years ago, to have raised the idea of psychological safety in any phase of training would likely have been met with intergenerational pushback and complete disregard,” they say, adding that: “Asking senior Baby Boomer cardiologists to develop skills to implement psychological safety, with just a list of action items, to suddenly create safe environments, belies the challenges inherent in intergenerational understanding and collaboration.”

In an interview, Dr. Lewis elaborated: “Many cardiology training program directors are Baby Boomers, but there is a whole new group of younger people moving in, and the way they deal with things and communicate is quite different.”

Dr. Lewis gave an example of when she was in training the attending was the “be all and end all,” and it was not expected that fellows would ask questions. “I think there is more communication now and a willingness to take risks and ask questions.”

But she said because everyone is so busy now, building relationships within a team can be difficult.

“We don’t have the doctors’ lounge anymore. We don’t sit and have lunch together. Computers are taking over now, no one actually talks to each other anymore,” she said. “We need to try to get to know each other and become colleagues. It’s easy when you don’t know somebody to be abrupt or brusque; it’s harder when you’re friends.”

She noted that the Mayo Clinic is one institution that is doing a lot of work on this, arranging for groups of doctors to go out for dinner together to get to know each other.

“This bringing people together socially happens in a lot of workplaces, and it can happen in medicine.”

Dr. Lewis, who has some leadership positions at the American College of Cardiology, said the organization is focusing on “intergenerational opportunities and challenges” to help improve psychological safety for trainees.

Noting that a recent survey of medical residents found that “contemporary residents were more likely than their predecessors to agree with negative perceptions of cardiology,” Lewis said the ACC is also reaching out to medical residents who may think that cardiology is an unwelcoming environment to enter and to minority groups of medical residents such as women and ethnic minorities to try and attract them to become cardiology fellows.

“If fellows find in hard to speak up because they are in this hierarchical learning situation, that can be even more difficult if you feel you’re in a minority group. ... We need to create a culture of colleagues rather than perpetuating a culture of us and them, to provide a safe and thriving cardiovascular community,” she added.

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

Training in medicine has long been thought of as a tough process, but the issue of creating a psychologically safe environment for young doctors is now being highlighted as an important way of providing an improved learning environment, which will ultimately lead to better patient care. And cardiology is one field that needs to work harder on this.  

“We all remember attendings who made our training experience memorable, who made us excited to come to work and learn, and who inspired us to become better,” Vivek Kulkarni, MD, wrote in a recent commentary. “Unfortunately, we also all remember the learning environments where we were terrified, where thriving took a backseat to surviving, and where learning was an afterthought.”

Writing in an article in the Journal of the American College of Cardiology, Dr. Kulkarni asked the question: “Why are some learning environments better than others, and what can we do to improve the learning environment for our trainees?”

Dr. Kulkarni, director of the training program for cardiology fellows at Cooper University Hospital, Camden, New Jersey, said cardiology is a specialty that hasn’t paid much attention to the idea of psychological safety in training. “There may be some people in some institutions that do pay attention to this but as wider field we could do better.”

Dr. Kulkarni explained that psychological safety is the comfort to engage with others genuinely, with honesty and without fear.

It has been defined as a “willingness to take interpersonal risks at work, whether to admit error, ask a question, seek help, or simply say ‘I don’t know,’ ” or as “the perception that a working environment is safe for team members to express a concern, ask a question, or acknowledge a mistake without fear of humiliation, retaliation, blame, or being ignored.”

“In the medical environment we usually work in teams: older doctors, younger doctors, nurses, other staff,” Dr. Kulkarni said in an interview. “A psychologically safe environment would be one where a trainee feels comfortable so that they can ask a question about something that they don’t understand. That comfort comes from the idea that it is okay to get something wrong or to not know something and to ask for help.

“The flip side of that is an environment in which people are so afraid to make a mistake out of fear of retribution or punishment that they don’t take risks, or they don’t openly acknowledge when they might need help with something,” he said. “That would be a psychologically unsafe environment.”

What exactly this looks like varies in different environments and culture of the group, he noted, “but in general, you can tell if you are part of a psychologically safe environment because you are excited to come to work and feel comfortable at work.”

Dr. Kulkarni added that a growing body of literature now shows that psychological safety is critical for optimal learning but that cardiovascular fellowship training poses unique barriers to psychological safety.
 

‘Arrogant, unkind, and unwelcoming’

First, he said that the “high-stakes” nature of cardiology, in which decisions often must be made quickly and can have life-or-death consequences, can create fear about making mistakes and that some trainees may be so afraid that they cannot speak up and ask for help when struggling or cannot incorporate feedback in real time.

Second, in medicine at large, there is a stereotype that cardiologists can be “arrogant, unkind, and unwelcoming,” which may discourage new fellows from honest interaction.

Third, cardiology involves many different technical skills that fellows have little to no previous experience with; this may contribute to a perceived sense of being judged when making mistakes or asking for help.

Finally, demographics may be a factor, with only one in eight cardiologists in the United States being women and only 7.5% of cardiologists being from traditionally underrepresented racial and ethnic minority groups, which Dr. Kulkarni said may lead to a lack of psychological safety because of “bias, microaggressions, or even just a lack of mentors of similar backgrounds.”

But he believes that the cardiology training culture is improving.

“I think it is getting better. Even the fact that I can publish this article is a positive sign. I think there’s an audience for this type of thing now.”

He believes that part of the reason for this is the availability of research and evidence showing there are better ways to teach than the old traditional approaches.

He noted that some teaching physicians receive training on how to teach and some don’t, and this is an area that could be improved.

“I think the knowledge of how to produce psychologically safe environments is already there,” he said. “It just has to be standardized and publicized. That would make the learning environment better.”

“Nothing about this is groundbreaking,” he added. “We all know psychologically unsafe environments exist. The novelty is just that it is now starting to be discussed. It’s one of those things that we can likely improve the ways our trainees learn and the kind of doctors we produce just by thinking a little bit more carefully about the way we interact with each other.”

Dr. Kulkarni said trainees often drop out because they have had a negative experience of feeling psychologically unsafe. “They may drop out of medicine all together or they may choose to pursue a career in a different part of medicine, where they perceive a more psychologically safe environment.”

He also suggested that this issue can affect patient care.

“If the medical team does not provide a psychologically safe environment for trainees, it is very likely that that team is not operating as effectively as it could, and it is very likely that patients being taken care of by that team may have missed opportunities for better care,” he concluded. Examples could include trainees recognizing errors and bringing things that might not be right to the attention of their superiors. “That is something that requires some degree of psychological safety.”
 

Action for improvement

Dr. Kulkarni suggested several strategies to promote psychological safety in cardiology training.

As a first step, institutions should investigate the culture of learning within their fellowship programs and gather feedback from anonymous surveys of fellows. They can then implement policies to address gaps.

He noted that, at Cooper University Hospital, standardized documents have been created that explicitly outline policies for attendings on teaching services, which establish expectations for all team members, encourage fellows to ask for help, set guidelines for feedback conversations with fellows, and delineate situations when calling the attending is expected.

Dr. Kulkarni also suggested that cardiologists involved in teaching fellows can try several strategies to promote psychological safety. These include setting clear expectations on their tasks and graded autonomy, inviting participation in decisions, acknowledging that gaps in knowledge are not a personal failure but rather a normal part of the growth process, encouraging fellows to seek help when they need it, fostering collegial relationships with fellows, acknowledging your own uncertainty in difficult situations, checking in about emotions after challenging situations, and seeking feedback on your own performance.

He added that changes on a larger scale are also needed, such as training for cardiology program directors including more on this issue as well as developing best practices.

“If we as a community could come together and agree on the things needed to create a psychologically safe environment for training, that would be a big improvement.”
 

Addressing the challenges of different generations

In a response to Dr. Kulkarni’s article, Margo Vassar, MD, The Queen’s Medical Center, Honolulu, and Sandra Lewis, MD, Legacy Health System, Portland, Ore., make the case that to succeed in providing psychological safety, the cardiovascular community also needs to address intergenerational cultural challenges.

“Twenty years ago, to have raised the idea of psychological safety in any phase of training would likely have been met with intergenerational pushback and complete disregard,” they say, adding that: “Asking senior Baby Boomer cardiologists to develop skills to implement psychological safety, with just a list of action items, to suddenly create safe environments, belies the challenges inherent in intergenerational understanding and collaboration.”

In an interview, Dr. Lewis elaborated: “Many cardiology training program directors are Baby Boomers, but there is a whole new group of younger people moving in, and the way they deal with things and communicate is quite different.”

Dr. Lewis gave an example of when she was in training the attending was the “be all and end all,” and it was not expected that fellows would ask questions. “I think there is more communication now and a willingness to take risks and ask questions.”

But she said because everyone is so busy now, building relationships within a team can be difficult.

“We don’t have the doctors’ lounge anymore. We don’t sit and have lunch together. Computers are taking over now, no one actually talks to each other anymore,” she said. “We need to try to get to know each other and become colleagues. It’s easy when you don’t know somebody to be abrupt or brusque; it’s harder when you’re friends.”

She noted that the Mayo Clinic is one institution that is doing a lot of work on this, arranging for groups of doctors to go out for dinner together to get to know each other.

“This bringing people together socially happens in a lot of workplaces, and it can happen in medicine.”

Dr. Lewis, who has some leadership positions at the American College of Cardiology, said the organization is focusing on “intergenerational opportunities and challenges” to help improve psychological safety for trainees.

Noting that a recent survey of medical residents found that “contemporary residents were more likely than their predecessors to agree with negative perceptions of cardiology,” Lewis said the ACC is also reaching out to medical residents who may think that cardiology is an unwelcoming environment to enter and to minority groups of medical residents such as women and ethnic minorities to try and attract them to become cardiology fellows.

“If fellows find in hard to speak up because they are in this hierarchical learning situation, that can be even more difficult if you feel you’re in a minority group. ... We need to create a culture of colleagues rather than perpetuating a culture of us and them, to provide a safe and thriving cardiovascular community,” she added.

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

Training in medicine has long been thought of as a tough process, but the issue of creating a psychologically safe environment for young doctors is now being highlighted as an important way of providing an improved learning environment, which will ultimately lead to better patient care. And cardiology is one field that needs to work harder on this.  

“We all remember attendings who made our training experience memorable, who made us excited to come to work and learn, and who inspired us to become better,” Vivek Kulkarni, MD, wrote in a recent commentary. “Unfortunately, we also all remember the learning environments where we were terrified, where thriving took a backseat to surviving, and where learning was an afterthought.”

Writing in an article in the Journal of the American College of Cardiology, Dr. Kulkarni asked the question: “Why are some learning environments better than others, and what can we do to improve the learning environment for our trainees?”

Dr. Kulkarni, director of the training program for cardiology fellows at Cooper University Hospital, Camden, New Jersey, said cardiology is a specialty that hasn’t paid much attention to the idea of psychological safety in training. “There may be some people in some institutions that do pay attention to this but as wider field we could do better.”

Dr. Kulkarni explained that psychological safety is the comfort to engage with others genuinely, with honesty and without fear.

It has been defined as a “willingness to take interpersonal risks at work, whether to admit error, ask a question, seek help, or simply say ‘I don’t know,’ ” or as “the perception that a working environment is safe for team members to express a concern, ask a question, or acknowledge a mistake without fear of humiliation, retaliation, blame, or being ignored.”

“In the medical environment we usually work in teams: older doctors, younger doctors, nurses, other staff,” Dr. Kulkarni said in an interview. “A psychologically safe environment would be one where a trainee feels comfortable so that they can ask a question about something that they don’t understand. That comfort comes from the idea that it is okay to get something wrong or to not know something and to ask for help.

“The flip side of that is an environment in which people are so afraid to make a mistake out of fear of retribution or punishment that they don’t take risks, or they don’t openly acknowledge when they might need help with something,” he said. “That would be a psychologically unsafe environment.”

What exactly this looks like varies in different environments and culture of the group, he noted, “but in general, you can tell if you are part of a psychologically safe environment because you are excited to come to work and feel comfortable at work.”

Dr. Kulkarni added that a growing body of literature now shows that psychological safety is critical for optimal learning but that cardiovascular fellowship training poses unique barriers to psychological safety.
 

‘Arrogant, unkind, and unwelcoming’

First, he said that the “high-stakes” nature of cardiology, in which decisions often must be made quickly and can have life-or-death consequences, can create fear about making mistakes and that some trainees may be so afraid that they cannot speak up and ask for help when struggling or cannot incorporate feedback in real time.

Second, in medicine at large, there is a stereotype that cardiologists can be “arrogant, unkind, and unwelcoming,” which may discourage new fellows from honest interaction.

Third, cardiology involves many different technical skills that fellows have little to no previous experience with; this may contribute to a perceived sense of being judged when making mistakes or asking for help.

Finally, demographics may be a factor, with only one in eight cardiologists in the United States being women and only 7.5% of cardiologists being from traditionally underrepresented racial and ethnic minority groups, which Dr. Kulkarni said may lead to a lack of psychological safety because of “bias, microaggressions, or even just a lack of mentors of similar backgrounds.”

But he believes that the cardiology training culture is improving.

“I think it is getting better. Even the fact that I can publish this article is a positive sign. I think there’s an audience for this type of thing now.”

He believes that part of the reason for this is the availability of research and evidence showing there are better ways to teach than the old traditional approaches.

He noted that some teaching physicians receive training on how to teach and some don’t, and this is an area that could be improved.

“I think the knowledge of how to produce psychologically safe environments is already there,” he said. “It just has to be standardized and publicized. That would make the learning environment better.”

“Nothing about this is groundbreaking,” he added. “We all know psychologically unsafe environments exist. The novelty is just that it is now starting to be discussed. It’s one of those things that we can likely improve the ways our trainees learn and the kind of doctors we produce just by thinking a little bit more carefully about the way we interact with each other.”

Dr. Kulkarni said trainees often drop out because they have had a negative experience of feeling psychologically unsafe. “They may drop out of medicine all together or they may choose to pursue a career in a different part of medicine, where they perceive a more psychologically safe environment.”

He also suggested that this issue can affect patient care.

“If the medical team does not provide a psychologically safe environment for trainees, it is very likely that that team is not operating as effectively as it could, and it is very likely that patients being taken care of by that team may have missed opportunities for better care,” he concluded. Examples could include trainees recognizing errors and bringing things that might not be right to the attention of their superiors. “That is something that requires some degree of psychological safety.”
 

Action for improvement

Dr. Kulkarni suggested several strategies to promote psychological safety in cardiology training.

As a first step, institutions should investigate the culture of learning within their fellowship programs and gather feedback from anonymous surveys of fellows. They can then implement policies to address gaps.

He noted that, at Cooper University Hospital, standardized documents have been created that explicitly outline policies for attendings on teaching services, which establish expectations for all team members, encourage fellows to ask for help, set guidelines for feedback conversations with fellows, and delineate situations when calling the attending is expected.

Dr. Kulkarni also suggested that cardiologists involved in teaching fellows can try several strategies to promote psychological safety. These include setting clear expectations on their tasks and graded autonomy, inviting participation in decisions, acknowledging that gaps in knowledge are not a personal failure but rather a normal part of the growth process, encouraging fellows to seek help when they need it, fostering collegial relationships with fellows, acknowledging your own uncertainty in difficult situations, checking in about emotions after challenging situations, and seeking feedback on your own performance.

He added that changes on a larger scale are also needed, such as training for cardiology program directors including more on this issue as well as developing best practices.

“If we as a community could come together and agree on the things needed to create a psychologically safe environment for training, that would be a big improvement.”
 

Addressing the challenges of different generations

In a response to Dr. Kulkarni’s article, Margo Vassar, MD, The Queen’s Medical Center, Honolulu, and Sandra Lewis, MD, Legacy Health System, Portland, Ore., make the case that to succeed in providing psychological safety, the cardiovascular community also needs to address intergenerational cultural challenges.

“Twenty years ago, to have raised the idea of psychological safety in any phase of training would likely have been met with intergenerational pushback and complete disregard,” they say, adding that: “Asking senior Baby Boomer cardiologists to develop skills to implement psychological safety, with just a list of action items, to suddenly create safe environments, belies the challenges inherent in intergenerational understanding and collaboration.”

In an interview, Dr. Lewis elaborated: “Many cardiology training program directors are Baby Boomers, but there is a whole new group of younger people moving in, and the way they deal with things and communicate is quite different.”

Dr. Lewis gave an example of when she was in training the attending was the “be all and end all,” and it was not expected that fellows would ask questions. “I think there is more communication now and a willingness to take risks and ask questions.”

But she said because everyone is so busy now, building relationships within a team can be difficult.

“We don’t have the doctors’ lounge anymore. We don’t sit and have lunch together. Computers are taking over now, no one actually talks to each other anymore,” she said. “We need to try to get to know each other and become colleagues. It’s easy when you don’t know somebody to be abrupt or brusque; it’s harder when you’re friends.”

She noted that the Mayo Clinic is one institution that is doing a lot of work on this, arranging for groups of doctors to go out for dinner together to get to know each other.

“This bringing people together socially happens in a lot of workplaces, and it can happen in medicine.”

Dr. Lewis, who has some leadership positions at the American College of Cardiology, said the organization is focusing on “intergenerational opportunities and challenges” to help improve psychological safety for trainees.

Noting that a recent survey of medical residents found that “contemporary residents were more likely than their predecessors to agree with negative perceptions of cardiology,” Lewis said the ACC is also reaching out to medical residents who may think that cardiology is an unwelcoming environment to enter and to minority groups of medical residents such as women and ethnic minorities to try and attract them to become cardiology fellows.

“If fellows find in hard to speak up because they are in this hierarchical learning situation, that can be even more difficult if you feel you’re in a minority group. ... We need to create a culture of colleagues rather than perpetuating a culture of us and them, to provide a safe and thriving cardiovascular community,” she added.

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

TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

TOPLINE:

Black psychiatric inpatients are 85% more likely to be restrained with a physical or mechanical hold or with medication than White patients, and often for longer periods, new research suggests.

METHODOLOGY:

• The study, part of a larger retrospective chart review of inpatient psychiatric electronic medical records (EMRs), included 29,739 adolescents (aged 12-17 years) and adults admitted because of severe and disruptive psychiatric illness or concerns about self-harm.
• A restraint event was defined as a physician-ordered physical or mechanical hold in which patients are unable to move their limbs, body, or head or are given medication to restrict their movement.
• Researchers used scores on the Dynamic Appraisal of Situational Aggression (DASA) at admission to assess risk for aggression among high-risk psychiatric inpatients (scores ranged from a low of 0 to a high of 7).
• From restraint event data extracted from the EMR, researchers investigated whether restraint frequency or duration was affected by “adultification,” a form of racial bias in which adolescents are perceived as being older than their actual age and are treated accordingly.

TAKEAWAY:

• Of the entire cohort, 1867 (6.3%) experienced a restraint event, and 27,872 (93.7%) did not.
• Compared with White patients, restraint was 85% more likely among Black patients (adjusted odds ratio, 1.85; P < .001) and 36% more likely among multiracial patients (aOR, 1.36; P = .006), which researchers suggest may reflect systemic racism within psychiatry and medicine, as well as an implicit or learned perception that people of color are more aggressive and dangerous.
• Lower DASA score at admission (P = .001), shorter length of stay (P < .001), adult age (P = .001), female sex (P = .042), and Black race, compared with White race (P = .001), were significantly associated with longer restraint duration, which may serve as a proxy for psychiatric symptom severity.
• Neither age group alone (adolescent or adult) nor the interaction of race and age group was significantly associated with experiencing a restraint event, suggesting no evidence of “adultification.”

IN PRACTICE:

It’s important to raise awareness about racial differences in restraint events in inpatient psychiatric settings, the authors write, adding that addressing overcrowding and investing in bias assessment and restraint education may reduce bias in the care of agitated patients and the use of restraints.

SOURCE:

The study was carried out by Sonali Singal, BS, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., and colleagues. It was published online  in Psychiatric Services.

LIMITATIONS:

The variables analyzed in the study were limited by the retrospective chart review and by the available EMR data, which may have contained entry errors. Although the investigators used DASA scores to control for differences in aggression, they could not control for symptom severity. The study could not examine the impact of race on seclusion (involuntary confinement), a variable often examined in tandem with restraint, because there were too few such events. The analysis also did not control for substance use disorder, which can influence a patient’s behavior and be related to restraint use.

DISCLOSURES:

Ms. Singal reported no relevant financial relationships. The original article has disclosures of other authors.

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

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

Hearing loss and tinnitus are the top and third most common service-connected disabilities among veterans. According to a Veterans Benefits Administration report, as of fiscal year 2020, more than 1.3 million veterans were receiving disability compensation for hearing loss and more than 2.3 million for tinnitus. Not surprisingly, the US Department of Veterans Affairs (VA) is the largest employer of audiologists and speech-language pathologists in the US.

On the bright side, military hearing losses are at stable levels—but “it’s not improving,” said US Army Lt Col Michael Murphy, chief of the studies and analysis section and Army audiology liaison at the Defense Health Agency Hearing Center of Excellence (HCE), in an interview for Department of Defense news.

Hearing protection is critical to reduce injury. Exposure to firearms, explosives, and other “continuous hazardous noise” puts service members and US Department of Defense (DoD) civilians at risk of permanent hearing loss, said Theresa Schulz, PhD, chief of the HCE prevention and surveillance section. “Good hearing is a key to mission success.”

Hearing protectors, which Shulz calls “the last line of defense from noise-induced hearing loss,” work best when they fit right: protecting against noise and, when necessary, not muffling voices, alarms, and other important sounds. That is why the DoD has updated its requirements for fit testing. All DoD personnel who are exposed to continuous and intermittent noise ≥ 85 decibels (in an 8-hour average) or impulse noise sound pressure ≥ 140 decibels (for ≥ 1 day per year) must be enrolled in a hearing conservation program. Additional criteria are expected for release by December 2023. According to HCE, each service may have more stringent requirements for hearing protector fit testing that better meets the needs of their hearing conservation program.

The question of proper fit was at the root of a recent lawsuit charging 3M with knowingly selling defective earplugs to the US military. The 3M dual-ended Combat Arms Earplug (CAEv2) was designed to eliminate the need for soldiers to carry 2 different sets of earplugs. Worn one way, it was intended to block sound like traditional earplugs; worn in reverse, it would block only certain types of loud battlefield noise while allowing the wearer to hear softer, closer sounds.

However, no 2 ears are the same—even on the same person. According to the HCE, during hearing protection testing, there is a < 2 mm difference in insertion depth between left and right ears for 85% of subjects. A 2016 whistleblower lawsuit accused 3M of not disclosing that the CAEv2 was too short for proper insertion into users’ ears and that it could loosen imperceptibly and fail to form the protective seal.

In 2018, 3M agreed to pay $9.1 million to the Department of Justice to resolve the allegations without admitting liability. That case led to the largest mass tort multidistrict litigation in US history. Last February, Veterans of Foreign Wars (VFW) filed an amicus curiae brief to the Seventh Circuit Court of Appeals in support of claimants seeking relief from 3M for defective ear protection. Approximately 240,000 veterans filed lawsuits against 3M. In September the parties reached a $6 billion settlement—nearly half of 3M’s worth. According to John Muckelbauer, a veteran and general counsel for the VFW in a military.com opinion piece, the settlement achieves balance: not pushing the already financially strapped 3M into bankruptcy, but sending “a strong signal that the safety of our service members can never be compromised.”

Crucially, Muckelbauer notes, the VA says participating in the lawsuit will not result in the loss of health or disability benefits, nor will it adversely affect disability ratings. VA facilities are also barred from recovering any portion of a plaintiff’s award as part of a medical lien.

3M has not admitted responsibility in this settlement either, frustrating the veteran claimants. An admission of guilt was never on the table, says Ronald Miller, Jr., writing for the Lawsuit Information Center, which posts updates on class action lawsuits. “Admitting responsibility would open the door for everyone to opt out and move forward on that admission… Admitting guilt would also be harmful to 3M’s reputation. They have long vigorously denied responsibility, so the optics would be terrible.”

A new twist cropped up almost immediately when claimants began getting cold calls from scammers impersonating employees of Archer Systems LLC, the company designated to administer the settlement. The scammers attempted to extract sensitive personal information, including Social Security numbers. Judge M. Casey Rodgers alerted the Federal Bureau of Investigation and warned claimants to safeguard their data vigilantly and report any fraudulent attempts.

The settlement money will be paid out from 2023 to 2029, with $1 billion in the form of 3M stock, 3M said in a statement. (In August 2023, upon news of the settlement, the price of 3M shares had risen nearly 5%.) Miller says the whole $6 billion will be distributed using a point system that awards amounts according to disability, with, for instance, tinnitus without contemporaneous corroboration getting the least and moderate or greater hearing loss getting the most. “This settlement is a tremendous outcome for veterans of Iraq and Afghanistan who put their lives on the line for our freedom,” said Duane Sarmiento, VFW national commander in a statement. “For those who came home with hearing damage due to 3M’s faulty earplugs, this is not only compensation, it’s a statement that their sacrifices won’t be ignored.”

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

The US Department of Veterans Affairs (VA) has been establishing partnerships right, left, and center to improve and expand care for veterans. Instead of going it alone, VA is partnering with academic affiliates, Native American tribes, and the military to take advantage of state and federal funds.

In California, the VA Palo Alto Health Care System and Stanford Medicine announced a deal to plan, build, and operate a National Cancer Institute–designated joint cancer care and research center on the VA Palo Alto campus. The partnership is another offshoot of the PACT Act, in part because of the number of veterans who need cancer treatment related to, for instance, airborne toxins. The influx of veterans via the PACT Act could represent “the largest expansion of veterans’ benefits in history,” VA Under Secretary for Health Shereef Elnahal, MD, MBA, said at a press event about the collaboration. “This will allow us to partner with every powerhouse academic center in the country if we do this right. For research, training, and care delivery, it’s all one bucket of cancer care that veterans deserve.”

A separate partnership between the Cherokee Nation and Eastern Oklahoma VA Healthcare System will establish a VA clinic inside the Cherokee Nation’s Vinita Health Center, an hour northeast of Tulsa. The clinic, expected to open early next year, will serve any veteran. “Cherokees and other Native Americans serve in the US military at a higher rate than any other group, and veterans hold a special place in our hearts,” Cherokee Nation Principal Chief Chuck Hoskin Jr. said in a statement. “I am honored to do my part in covering veterans’ long-term health needs.”

The VA serves about 53,000 veterans living in eastern Oklahoma. Officials predict that partnership could serve as a roadmap for how rural America can work with tribes to increase care for veterans. “As we look ahead, this partnership with the VA can be a model for other tribes and communities across the nation,” Hoskin said.

Another collaborative plan, this one by the VA and US Department of Defense (DoD), will give about 37,000 Gulf Coast–area veterans access to care at a new Naval Hospital Pensacola clinic. Local veterans who previously received care from community clinicians or traveled to the Biloxi VA Medical Center in Mississippi will now be able to receive same-day, outpatient surgical care. “This partnership will help VA provide more care, more quickly, to more Gulf Coast veterans—as close to their homes as possible,” said Elnahal.

An agreement with the University of Pennsylvania Health System (UPHS) will improve infrastructure at the Coatesville VA Medical Center by repurposing a recently closed hospital nearby for outpatient, acute mental health, and long-term care services. “The PACT Act allows for great synergy between Penn Medicine and the VA, and we hope to leverage this new model to set the standard for how our nation approaches military medicine,” UPHS CEO Kevin B. Mahoney said.

An Eastern Oklahoma VA Health Care System hospital scheduled to open in 2025 in Tulsa was partially funded through the Communities Helping Invest through Property and Improvements Needed (CHIP-IN) program, the state of Oklahoma, the city of Tulsa, and the nonprofit team of Oklahoma State University Medical and the Anne and Henry Zarrow Foundation. When completed, the 58-bed hospital will serve approximately 38,000 veterans.

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

“On which side of the bed did you get up this morning?” Obviously, your inquisitor assumes that to avoid clumsily crawling over your sleeping partner you always get up on the side with the table stacked with unread books.

You know as well as I do that you have just received a totally undisguised comment on your recent behavior that has been several shades less than cheery. You may have already sensed your own grumpiness. Do you have an explanation? Did the commute leave you with a case of unresolved road rage? Did you wake up feeling unrested? How often does that happen? Do you think you are getting enough sleep?

A few weeks ago I wrote a Letters From Maine column in which I shared a study suggesting that the regularity of an individual’s sleep pattern may, in many cases, be more important than his or her total number of hours slept. In that same column I wrote that sleep scientists don’t as yet have a good definition of sleep irregularity, nor can they give us any more than a broad range for the total number of hours a person needs to maintain wellness.

How do you determine whether you are getting enough sleep? Do you keep a chart of how many times you were asked which side of the bed you got up on in a week? Or is it how you feel in the morning? Is it when you instantly doze off any time you sit down in a quiet place?

Although many adults are clueless (or in denial) that they are sleep deprived, generally if you ask them and take a brief history they will tell you. On the other hand, determining when a child, particularly one who is preverbal, is sleep deprived is a bit more difficult. Asking the patient isn’t going to give you the answer. You must rely on parental observations. And, to some extent, this can be difficult because parents are, by definition, learning on the job. They may not realize the symptoms and behaviors they are seeing in their child are the result of sleep deficiency.

Over the last half century of observing children, I have developed a very low threshold for diagnosing sleep deprivation. Basically, any child who is cranky and not obviously sick is overtired until proven otherwise. For example, colic does not appear on my frequently used, or in fact ever used, list of diagnoses. Colicky is an adjective that I may use to describe some episodic pain or behavior, but colic as a working diagnosis? Never.

When presented with a child who has already been diagnosed with “colic” by its aunt or the lady next door, this is when the astute pediatrician must be at his or her best. If a thorough history, including sleep pattern, yields no obvious evidence of illness, the next step should be some sleep coaching. However, this is where the “until proven otherwise” thing becomes important, because not providing close follow-up and continuing to keep an open mind for the less likely coexisting conditions can be dangerous and certainly not in the patient’s best interest.

For the older child crankiness, temper tantrums, mood disorders and signs and symptoms often (some might say too often) associated with attention-deficit disorder should trigger an immediate investigation of sleep habits and appropriate advice. Less well-known conditions associated with sleep deprivation are migraine and nocturnal leg pains, often mislabeled as growing pains.

The physicians planning on using sleep as a therapeutic modality is going to quickly run into several challenges. First is convincing the parents, the patient, and the family that the condition is to a greater or lesser degree the result of sleep deprivation. Because sleep is still underappreciated as a component of wellness, this is often not an easy sell.

Second, everyone must accept that altering sleep patterns regardless of age is often not easy and will not be achieved in 1 night or 2. Keeping up the drumbeat of encouragement with close follow-up is critical. Parents must be continually reminded that sleep is being used as a medicine and the dose is not measured in hours. The improvement in symptoms will tell us when enough is enough.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

Regularly using marijuana can significantly increase a person’s risk of heart attack, heart failure, and stroke, according to a pair of new studies that will be presented at a major upcoming medical conference.

People who use marijuana daily have a 34% increased risk of heart failure, compared with people who don’t use the drug, according to one of the new studies.

The new findings leverage health data from 157,000 people in the National Institutes of Health “All of Us” research program. Researchers analyzed whether marijuana users were more likely to experience heart failure than nonusers over the course of nearly 4 years. The results indicated that coronary artery disease was behind marijuana users’ increased risk. (Coronary artery disease is the buildup of plaque on the walls of the arteries that supply blood to the heart.)

The research was conducted by a team at Medstar Health, a large Maryland health care system that operates 10 hospitals plus hundreds of clinics. The findings will be presented at the American Heart Association’s Scientific Sessions 2023 in Philadelphia.

“Our results should encourage more researchers to study the use of marijuana to better understand its health implications, especially on cardiovascular risk,” said researcher Yakubu Bene-Alhasan, MD, MPH, a doctor at Medstar Health in Baltimore. “We want to provide the population with high-quality information on marijuana use and to help inform policy decisions at the state level, to educate patients, and to guide health care professionals.”

About one in five people in the United States use marijuana, according to the Centers for Disease Control and Prevention. The majority of U.S. states allow marijuana to be used legally for medical purposes, and more than 20 states have legalized recreational marijuana, a tracker from the National Conference of State Legislatures shows. 

A second study that will be presented at the conference shows that older people with any combination of type 2 diabetes, high blood pressure, and high cholesterol who use marijuana have an increased risk for a major heart or brain event, compared with people who never used the drug. 

The researchers analyzed data for more than 28,000 people age 65 and older who had health conditions that put them at risk for heart problems and whose medical records showed they were marijuana users but not tobacco users. The results showed at least a 20% increased risk of heart attack, stroke, cardiac arrest, or arrhythmia (irregular heartbeat). 

The findings are significant because medical professionals have long said that research on the long-term health effects of using marijuana are limited. 

“The latest research about cannabis use indicates that smoking and inhaling cannabis increases concentrations of blood carboxyhemoglobin (carbon monoxide, a poisonous gas), tar (partly burned combustible matter) similar to the effects of inhaling a tobacco cigarette, both of which have been linked to heart muscle disease, chest pain, heart rhythm disturbances, heart attacks and other serious conditions,” said Robert L. Page II, PharmD, MSPH, chair of the volunteer writing group for the 2020 American Heart Association Scientific Statement: Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, in a statement. “Together with the results of these two research studies, the cardiovascular risks of cannabis use are becoming clearer and should be carefully considered and monitored by health care professionals and the public.”

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

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

BERLIN – European guidelines now in press for the diagnosis and treatment of body dysmorphic disorder (BDD), a condition defined largely by abnormal perceptions about – and behavior surrounding personal appearance, were outlined in a late-breaker presentation at the annual Congress of the European Academy of Dermatology and Venereology.

The development of guidelines for BDD, a disorder familiar to many clinical dermatologists, is intended as a practical tool, according to Maria-Angeliki Gkini, MD, who has appointments at both Bart’s Health NHS Trust in London and the 401 General Army Hospital in Athens.

Consensus reached by 17 experts

Specifically, 17 experts, all of whom were members of the European Society for Dermatology and Psychiatry proceeded to systematically address a series of clinical questions and recommendations. Consensus was defined as at least 75% of the participants strongly agreeing or agreeing. Several rounds of discussion were often required.

Among the conclusions, the guidelines support uniform screening for BDD in all patients prior to cosmetic procedures. In identifying depression, anxiety, and distorted perceptions, simple tools, such as the Patient Health Questionnaire might be adequate for an initial evaluation, but Dr. Gkini also recommended routinely inquiring about suicidal ideation, which has been reported in up to 80% of individuals with BDD.

Other instruments for screening that can be considered include DSM-5 criteria for BDD and the Body Dysmorphic Disorder Questionnaire–Dermatology Version, which might be particularly useful and appropriate for dermatologists.

One of the reasons to screen for BDD is that these patients often convince themselves that some specific procedure is needed to resolve the source of their obsession. The goal of screening is to verify that it is the dermatologic concern, not an underlying psychiatric disorder that is driving their search for relief. The risk of dermatologic interventions is not only that expectations are not met, but the patient’s perception of a failed intervention “sometimes makes these worse,” Dr. Gkini explained.
 

Collaboration with psychiatrists recommended

The guidelines include suggestions for treatment of BDD. Of these, SSRIs are recommended at high relative doses, according to Dr. Gkini. Consistent with the consensus recommendation of collaborating with mental health specialists, she said that the recommendations acknowledge evidence of greater benefits when SSRIs are combined with psychotherapy.

Katharine A. Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, has been conducting BDD research for several years and has written numerous books and articles about this topic, including a review in the journal Focus. She cautioned that, because of a normal concern for appearance, BDD is easily missed by dermatologists.

“For BDD to be diagnosed, the preoccupation with a nonexistent or slight defect in appearance must cause clinically significant distress or impairment in functioning,” she said in an interview. “This is necessary to differentiate BDD from more normal and common appearance concerns that do not qualify for the diagnosis”

She specified that patients should be considered for cognitive-behavioral therapy rather than psychotherapy, a generic term that covers many forms of treatment. She said that most other types of psychotherapy “are probably not effective” for BDD.

Dr. Phillips highly endorsed the development of BDD guidelines for dermatologists because of the frequency with which physicians in this specialty encounter BDD – and believes that more attention to this diagnosis is needed.

“I recommend that dermatologists who have a patient with BDD collaborate with a psychiatrist in delivering care with an SSRI,” she said. “High doses of these medications are often needed to effectively treat BDD.”

Dr. Gkini reported financial relationships with AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LEO, Novartis, Sanofi, and Regenlab. Dr. Phillips reported no relevant financial relationships.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

Breast cancer is the most common tumor type and second only to lung cancer as a cause of cancer death in women. Nearly 300,000 women (and 2800 men) will receive a new diagnosis of breast cancer in the United States in 2023. Despite improvements in treatment options, breast cancer still will lead to 43,700 deaths among women this year. 

Breast tumors generally are either ductal or lobular in origin. Ductal carcinomas arise in the lining of the milk ducts and are the most commonly found tumor type in breast cancer. Almost 3 in 4 diagnosed breast cancers histologically are invasive ductal carcinomas, which have spread from the source into surrounding structures. It has no specific histologic indicators and is differentiated from ductal carcinoma in situ by its having spread outside the duct. The presence of lymph node involvement in this patient also confirms invasive ductal carcinoma without metastatic spread. Invasive lobular carcinomas occur much less frequently and have a different histologic appearance of smaller cells that appear to be arranged in linear groups.

Mammography involves low-dose radiation and is used in diagnosis and is the most widely used screening technique for breast cancer. As a screening tool, mammography may detect lesions 1-2 years before they become palpable on breast self-examination. While the incidence of breast cancer in women has slowly increased over the past 20 years, mortality has decreased largely as a result of improved awareness and uptake of screening mammography. Current American Cancer Society guidelines recommend continued mammography screenings at least every other year after age 55 and continued for as long as a woman has a life expectancy > 10 years. Screening or diagnosis using MRI is usually reserved for individuals at high risk for breast cancer or a history of breast cancer before age 50. 

For all newly diagnosed primary invasive breast cancers, biomarker testing for estrogen and progesterone receptor expression and HER2 expression are part of the standard workup recommended by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) to help guide treatment decisions. Biomarker testing showed that her tumor was ER+ and HER2-negative, the most common finding in breast cancer. The patient's history did not suggest a risk for BRCA or other familial cancer mutations, but molecular testing was done and was negative for BRCA1 and BRCA2. In postmenopausal women, ASCO and NCCN also recommend use of risk assessment tools, such as Oncotype DX, to determine whether chemotherapy will add benefit to systemic endocrine therapy. Postmenopausal patients with ER+/HER2-negative breast cancer, one to three positive nodes, and a score < 26 on the 21-gene Oncotype DX can safely forego cytotoxic chemotherapy and derive maximum survival benefit from hormonal therapy alone.

This patient was diagnosed with a primary tumor of approximately 25 mm, metastasis to two ipsilateral nodes, and no distant metastasis, or stage IIIA. Her risk recurrence score was 20, indicating that she could safely forego the rigors of cytotoxic chemotherapy. She underwent localized breast-conserving surgery and began adjuvant tamoxifen therapy (x 2 years) to be followed with an aromatase inhibitor (x 3 years). 

Karl J. D'Silva, MD, Clinical Assistant Professor, Department of Medicine, Tufts University School of Medicine, Boston; Medical Director, Department of Oncology and Hematology, Lahey Hospital and Medical Center, Peabody, Massachusetts.

Karl J. D'Silva, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.