Clinical Psychiatry News

An expert panel has released the first recommendations on the appropriate use of aducanumab (Aduhelm), the controversial anti-amyloid drug that was approved by the U.S. Food and Drug Administration in June for adults with early Alzheimer’s disease.

“There are incredible gaps between the FDA label and what most of us in the field feel needs to happen in terms of detailed guidance on using this drug,” said panel member Alireza Atri, MD, PhD, director of the Banner Sun Health Research Institute (Banner Health) in Sun City, Arizona.

“This is a first-in-class drug where the vast majority of clinicians have no experience with it, and patients and their caregivers are already asking for it, and there are some really important conversations to be had – not only about who may qualify to begin with and also about potential effectiveness and safety,” Dr. Atri added.

The aducanumab recommendations were published online July 27 in the Journal of Prevention of Alzheimer’s Disease to coincide with their presentation at the 2021 Alzheimer’s Association International Conference.

A separate article outlining the key recommendations was published in Alzheimer’s and Dementia: Translational Research and Clinical Interventions.
 

Patient-centered focus

The panel recommends that aducanumab only be used for patients with clinical features similar to those of the patients who took part in the clinical trials that led to the drug’s approval – patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia who have brain amyloid, as confirmed on amyloid positron-emission tomography (PET) or with cerebrospinal fluid (CSF) findings consistent with Alzheimer’s disease.

“You’re giving a drug that’s been approved on accelerated status for lowering amyloid, so amyloid status needs to be verified either by an amyloid PET scan or spinal fluid,” said Dr. Atri.

The panel also recommends that patients under consideration for aducanumab treatment have no psychiatric problems; that they be medically stable with no cardiovascular or cardiopulmonary conditions; that they are not taking anticoagulants; that they have no organ failure; and that they have no active cancer except for low-grade basal and squamous cell carcinomas. Current treatment with cholinesterase inhibitors and memantine is acceptable.

Dr. Atri noted that the prescribing label for the drug provides “broad strokes about titration.” The panel recommends that the drug be titrated to the highest dose to maximize opportunity for efficacy.

Monthly infusions should begin with a dose of 1 mg/kg for the first and second infusions. They should be increased to 3 mg/kg for infusions three and four and to 6 mg/kg for the fifth and sixth infusions. The intended dose of 10 mg/kg should be administered on the seventh infusion. The target dose level of 10 mg/kg should then be continued for the foreseeable future, the panel notes.

Safety monitoring is critically important. The panel recommends structured monitoring for amyloid-related imaging abnormalities of the effusion (ARIA-E) or hemorrhagic (ARIA-H) type. Patients should undergo MRI at least 1 year before aducanumab treatment is initiated or at baseline if there are any suggestions of a focal brain event since the last MRI. MRI should again be conducted before the fifth, seventh, and 12th infusions.

The panel says the “best practice” for providing aducanumab therapy is to adopt a patient-centered focus.
 

‘Not a cure’

“There should be comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits,” said Dr. Atri.

“Patients need to know that this is not a cure. It’s not going to actually make their cognition better, but by removing amyloid, there is a reasonable chance it’s going to slow down clinical decline,” he added.

“You could have two identical twins who would qualify, and when you have this discussion with them, based on the risk and reward calculus, one may reasonably decide, ‘this is not for me,’ and that’s really important,” Dr. Atri added.

He cautioned that these initial recommendations are “a starting point, not a finishing point,” and will be updated as needed.

“This paper takes no stance on advocating for this treatment. But now that it’s available, let’s put up some guardrails and use it appropriately and safety,” Dr. Atri said.

“Clinicians are requesting clarity and more specific information about the appropriate use of this new treatment,” Rebecca Edelmayer, PhD, senior director of scientific engagement, the Alzheimer’s Association, said in an interview.

These first appropriate-use recommendations are “a first step and will certainly evolve over time as the medication is prescribed,” Dr. Edelmayer said.

The research had no specific funding. Dr. Atri has received honoraria for consulting; participating in independent data safety monitoring boards; providing educational lectures, programs, and materials; or serving on advisory boards for AbbVie, Acadia, Allergan, the Alzheimer’s Association, Axovant, AZ Therapies, Biogen, Grifols, Harvard Medical School Graduate Continuing Education, JOMDD, Lundbeck, Merck, Roche/Genentech, Novo Nordisk, Sunovion, and Suven. Dr. Edelmayer has disclosed no relevant financial relationships.

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

An expert panel has released the first recommendations on the appropriate use of aducanumab (Aduhelm), the controversial anti-amyloid drug that was approved by the U.S. Food and Drug Administration in June for adults with early Alzheimer’s disease.

“There are incredible gaps between the FDA label and what most of us in the field feel needs to happen in terms of detailed guidance on using this drug,” said panel member Alireza Atri, MD, PhD, director of the Banner Sun Health Research Institute (Banner Health) in Sun City, Arizona.

“This is a first-in-class drug where the vast majority of clinicians have no experience with it, and patients and their caregivers are already asking for it, and there are some really important conversations to be had – not only about who may qualify to begin with and also about potential effectiveness and safety,” Dr. Atri added.

The aducanumab recommendations were published online July 27 in the Journal of Prevention of Alzheimer’s Disease to coincide with their presentation at the 2021 Alzheimer’s Association International Conference.

A separate article outlining the key recommendations was published in Alzheimer’s and Dementia: Translational Research and Clinical Interventions.
 

Patient-centered focus

The panel recommends that aducanumab only be used for patients with clinical features similar to those of the patients who took part in the clinical trials that led to the drug’s approval – patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia who have brain amyloid, as confirmed on amyloid positron-emission tomography (PET) or with cerebrospinal fluid (CSF) findings consistent with Alzheimer’s disease.

“You’re giving a drug that’s been approved on accelerated status for lowering amyloid, so amyloid status needs to be verified either by an amyloid PET scan or spinal fluid,” said Dr. Atri.

The panel also recommends that patients under consideration for aducanumab treatment have no psychiatric problems; that they be medically stable with no cardiovascular or cardiopulmonary conditions; that they are not taking anticoagulants; that they have no organ failure; and that they have no active cancer except for low-grade basal and squamous cell carcinomas. Current treatment with cholinesterase inhibitors and memantine is acceptable.

Dr. Atri noted that the prescribing label for the drug provides “broad strokes about titration.” The panel recommends that the drug be titrated to the highest dose to maximize opportunity for efficacy.

Monthly infusions should begin with a dose of 1 mg/kg for the first and second infusions. They should be increased to 3 mg/kg for infusions three and four and to 6 mg/kg for the fifth and sixth infusions. The intended dose of 10 mg/kg should be administered on the seventh infusion. The target dose level of 10 mg/kg should then be continued for the foreseeable future, the panel notes.

Safety monitoring is critically important. The panel recommends structured monitoring for amyloid-related imaging abnormalities of the effusion (ARIA-E) or hemorrhagic (ARIA-H) type. Patients should undergo MRI at least 1 year before aducanumab treatment is initiated or at baseline if there are any suggestions of a focal brain event since the last MRI. MRI should again be conducted before the fifth, seventh, and 12th infusions.

The panel says the “best practice” for providing aducanumab therapy is to adopt a patient-centered focus.
 

‘Not a cure’

“There should be comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits,” said Dr. Atri.

“Patients need to know that this is not a cure. It’s not going to actually make their cognition better, but by removing amyloid, there is a reasonable chance it’s going to slow down clinical decline,” he added.

“You could have two identical twins who would qualify, and when you have this discussion with them, based on the risk and reward calculus, one may reasonably decide, ‘this is not for me,’ and that’s really important,” Dr. Atri added.

He cautioned that these initial recommendations are “a starting point, not a finishing point,” and will be updated as needed.

“This paper takes no stance on advocating for this treatment. But now that it’s available, let’s put up some guardrails and use it appropriately and safety,” Dr. Atri said.

“Clinicians are requesting clarity and more specific information about the appropriate use of this new treatment,” Rebecca Edelmayer, PhD, senior director of scientific engagement, the Alzheimer’s Association, said in an interview.

These first appropriate-use recommendations are “a first step and will certainly evolve over time as the medication is prescribed,” Dr. Edelmayer said.

The research had no specific funding. Dr. Atri has received honoraria for consulting; participating in independent data safety monitoring boards; providing educational lectures, programs, and materials; or serving on advisory boards for AbbVie, Acadia, Allergan, the Alzheimer’s Association, Axovant, AZ Therapies, Biogen, Grifols, Harvard Medical School Graduate Continuing Education, JOMDD, Lundbeck, Merck, Roche/Genentech, Novo Nordisk, Sunovion, and Suven. Dr. Edelmayer has disclosed no relevant financial relationships.

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

An expert panel has released the first recommendations on the appropriate use of aducanumab (Aduhelm), the controversial anti-amyloid drug that was approved by the U.S. Food and Drug Administration in June for adults with early Alzheimer’s disease.

“There are incredible gaps between the FDA label and what most of us in the field feel needs to happen in terms of detailed guidance on using this drug,” said panel member Alireza Atri, MD, PhD, director of the Banner Sun Health Research Institute (Banner Health) in Sun City, Arizona.

“This is a first-in-class drug where the vast majority of clinicians have no experience with it, and patients and their caregivers are already asking for it, and there are some really important conversations to be had – not only about who may qualify to begin with and also about potential effectiveness and safety,” Dr. Atri added.

The aducanumab recommendations were published online July 27 in the Journal of Prevention of Alzheimer’s Disease to coincide with their presentation at the 2021 Alzheimer’s Association International Conference.

A separate article outlining the key recommendations was published in Alzheimer’s and Dementia: Translational Research and Clinical Interventions.
 

Patient-centered focus

The panel recommends that aducanumab only be used for patients with clinical features similar to those of the patients who took part in the clinical trials that led to the drug’s approval – patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia who have brain amyloid, as confirmed on amyloid positron-emission tomography (PET) or with cerebrospinal fluid (CSF) findings consistent with Alzheimer’s disease.

“You’re giving a drug that’s been approved on accelerated status for lowering amyloid, so amyloid status needs to be verified either by an amyloid PET scan or spinal fluid,” said Dr. Atri.

The panel also recommends that patients under consideration for aducanumab treatment have no psychiatric problems; that they be medically stable with no cardiovascular or cardiopulmonary conditions; that they are not taking anticoagulants; that they have no organ failure; and that they have no active cancer except for low-grade basal and squamous cell carcinomas. Current treatment with cholinesterase inhibitors and memantine is acceptable.

Dr. Atri noted that the prescribing label for the drug provides “broad strokes about titration.” The panel recommends that the drug be titrated to the highest dose to maximize opportunity for efficacy.

Monthly infusions should begin with a dose of 1 mg/kg for the first and second infusions. They should be increased to 3 mg/kg for infusions three and four and to 6 mg/kg for the fifth and sixth infusions. The intended dose of 10 mg/kg should be administered on the seventh infusion. The target dose level of 10 mg/kg should then be continued for the foreseeable future, the panel notes.

Safety monitoring is critically important. The panel recommends structured monitoring for amyloid-related imaging abnormalities of the effusion (ARIA-E) or hemorrhagic (ARIA-H) type. Patients should undergo MRI at least 1 year before aducanumab treatment is initiated or at baseline if there are any suggestions of a focal brain event since the last MRI. MRI should again be conducted before the fifth, seventh, and 12th infusions.

The panel says the “best practice” for providing aducanumab therapy is to adopt a patient-centered focus.
 

‘Not a cure’

“There should be comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits,” said Dr. Atri.

“Patients need to know that this is not a cure. It’s not going to actually make their cognition better, but by removing amyloid, there is a reasonable chance it’s going to slow down clinical decline,” he added.

“You could have two identical twins who would qualify, and when you have this discussion with them, based on the risk and reward calculus, one may reasonably decide, ‘this is not for me,’ and that’s really important,” Dr. Atri added.

He cautioned that these initial recommendations are “a starting point, not a finishing point,” and will be updated as needed.

“This paper takes no stance on advocating for this treatment. But now that it’s available, let’s put up some guardrails and use it appropriately and safety,” Dr. Atri said.

“Clinicians are requesting clarity and more specific information about the appropriate use of this new treatment,” Rebecca Edelmayer, PhD, senior director of scientific engagement, the Alzheimer’s Association, said in an interview.

These first appropriate-use recommendations are “a first step and will certainly evolve over time as the medication is prescribed,” Dr. Edelmayer said.

The research had no specific funding. Dr. Atri has received honoraria for consulting; participating in independent data safety monitoring boards; providing educational lectures, programs, and materials; or serving on advisory boards for AbbVie, Acadia, Allergan, the Alzheimer’s Association, Axovant, AZ Therapies, Biogen, Grifols, Harvard Medical School Graduate Continuing Education, JOMDD, Lundbeck, Merck, Roche/Genentech, Novo Nordisk, Sunovion, and Suven. Dr. Edelmayer has disclosed no relevant financial relationships.

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

“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”

Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?

Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.

Our difficulty in discussing race in part comes from the lack of representation by Black and Brown psychiatrists. Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.¹ Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience² and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.³ While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.

It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician⁴ and about three-fourths of students come from families whose income falls among the top two quintiles.⁵ Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.

The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.⁶ This is a serious issue that needs to change on a structural and systemic level.

Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.⁷ Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.⁸ This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.⁹

Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.¹⁰ This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”¹¹

At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.

Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:

• Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
• Human experience, which explores the interaction of patients and providers and how biases play a role.
• Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
• History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.

In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.^12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.

Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.

How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.

Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
 

Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

References

1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.

2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.

3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.

4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.

5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).

6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.

7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.

8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.

9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.

10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.

11. Black pioneers in mental health. Mental Health America. 2021.

12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.

13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.

“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”

Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?

Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.

Our difficulty in discussing race in part comes from the lack of representation by Black and Brown psychiatrists. Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.¹ Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience² and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.³ While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.

It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician⁴ and about three-fourths of students come from families whose income falls among the top two quintiles.⁵ Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.

The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.⁶ This is a serious issue that needs to change on a structural and systemic level.

Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.⁷ Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.⁸ This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.⁹

Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.¹⁰ This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”¹¹

At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.

Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:

• Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
• Human experience, which explores the interaction of patients and providers and how biases play a role.
• Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
• History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.

In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.^12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.

Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.

How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.

Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
 

Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

References

1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.

2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.

3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.

4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.

5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).

6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.

7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.

8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.

9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.

10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.

11. Black pioneers in mental health. Mental Health America. 2021.

12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.

13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.

“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”

Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?

Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.

Our difficulty in discussing race in part comes from the lack of representation by Black and Brown psychiatrists. Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.¹ Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience² and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.³ While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.

It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician⁴ and about three-fourths of students come from families whose income falls among the top two quintiles.⁵ Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.

The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.⁶ This is a serious issue that needs to change on a structural and systemic level.

Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.⁷ Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.⁸ This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.⁹

Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.¹⁰ This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”¹¹

At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.

Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:

• Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
• Human experience, which explores the interaction of patients and providers and how biases play a role.
• Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
• History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.

In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.^12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.

Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.

How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.

Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
 

Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

References

1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.

2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.

3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.

4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.

5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).

6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.

7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.

8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.

9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.

10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.

11. Black pioneers in mental health. Mental Health America. 2021.

12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.

13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.

Marine omega-3 fatty acids may be a promising add-on therapy for improving symptoms of borderline personality disorder (BPD), new research suggests.

A meta-analysis of four randomized controlled trials showed that adjunctive omega-3 fatty polyunsaturated fatty acids (PUFAs) significantly reduced overall BPD symptom severity, particularly affect dysregulation and impulsive behavior.

“Given the mechanisms of action and beneficial side effect profile, this [analysis] suggests that omega-3 fatty acids could be considered as add-on treatment” for patients with BPD, senior author Roel J. T. Mocking MD, PhD, resident in psychiatry and postdoctoral researcher at Academisch Medisch Centrum, Amsterdam, said in an interview.

The findings were published online in the Journal of Clinical Psychiatry.
 

Urgent need

“There are several effective treatments, but not all patients respond sufficiently,” which points to an urgent need for additional treatment options, Dr. Mocking said.

Dmitriy Danilchenko/Shutterstock

He noted that, although “several prior studies showed promising effects of omega-3 fatty acids” for patients with BPD, those studies were relatively small, which precluded more definitive overall conclusions.

The investigators wanted to combine results of the earlier studies to provide a combined estimate of overall effectiveness of the use of omega-3 fatty acids for patients with BP, with the intention of “guiding clinicians and individuals suffering from borderline personality disorder to decide on whether they should add omega-3 fatty acids to their treatment.”

The analyzed four studies that had a total of 137 patients. Three of the studies included patients diagnosed with BPD; one included individuals with recurrent self-harm, most of whom were also diagnosed with BPD.

Omega-3 fatty acids were used as monotherapy in one study. In the other studies, they were used as add-on therapy to other agents, such as antidepressants, benzodiazepines, and/or valproic acid. None of the studies included patients who were taking antipsychotics.

The type of omega-3 PUFAs were derived from marine rather than plant sources.

Three studies compared omega-3 fatty acids with placebo. One study compared valproic acid monotherapy with valproic acid plus omega-3 fatty acids and did not include a placebo group.
 

Significant symptom reduction

Random-effects meta-analyses showed an “overall significant decreasing effect” of omega-3 fatty acids on overall BPD symptom severity (standardized difference in means, 0.54; 95% CI, 0.91-0.17; P = .004) in the omega-3 group compared with the control group, with a medium effect size.

The investigators added that there was “no relevant heterogeneity” (P = .45).

Although heterogeneity was “more pronounced” in the affective dysregulation symptom domain, it did not reach statistical significance, the researchers noted.

The impulsive behavioral dyscontrol and cognitive perceptual symptom domains had “no relevant heterogeneity.” On the other hand, there was “substantial heterogeneity” in the global functioning symptom group.

Omega-3 fatty acids “have multiple bioactive roles in the brain. For example, they form essential components of the membrane of brain cells and thereby influence the structure and functioning of the brain. They also have an effect on inflammation levels in the brain,” Dr. Mocking said.

“Because we cannot synthesize these omega-3 fatty acids ourselves, we are dependent on our diet. The main dietary source of omega-3 fatty acids is fatty fish. However, since the industrial revolution, we eat less and less fatty fish, risking deficiency of omega-3 fatty acids causing brain dysfunction,” he added.

Dr. Mocking noted that the mechanisms of action of omega-3 fatty acids differ from those of other treatments for BPD, such as psychotherapy, antidepressants, or antipsychotics.

This “suggests that they could be combined to increase overall effectiveness,” he said.
 

Important benefit

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said that the benefit of omega-3 “on impulsivity and mood symptoms is especially important, as these are some of the most debilitating aspects of BPD and lead to service utilization, such as ER, primary care, and specialty care.”

In addition, “impulsivity often presages suicidality,” he noted.

Dr. McIntyre, who is also chair and executive director of the Brain and Cognition Discovery Foundation in Toronto and was not involved with the study, called the effect size “quite reasonable.”

“The mechanistic story is very strong around anti-inflammatory effect, which particularly implied mood and cognition. In other words, inflammation is highly associated with mood and cognitive difficulties,” he said.

However, Dr. McIntyre also pointed to several significant challenges, including “quality assurance on the purchase of the product of fish oil, as it is not sufficiently regulated.” It is also unclear which individuals are more likely to benefit from it.

For example, major depressive disorder data have shown that “fish oils are not as effective as we hoped but are especially effective in people with baseline elevation of inflammatory markers,” Dr. McIntyre said.

“In other words, is there a way to identify a biomarkers/biosignature or phenomenology that’s more likely to identify a subgroup of people with BPD who might benefit benefiting from omega-3?” he asked.

Dr. Mocking and the other investigators reported no relevant financial relationships. Dr. McIntyre has received research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

Marine omega-3 fatty acids may be a promising add-on therapy for improving symptoms of borderline personality disorder (BPD), new research suggests.

A meta-analysis of four randomized controlled trials showed that adjunctive omega-3 fatty polyunsaturated fatty acids (PUFAs) significantly reduced overall BPD symptom severity, particularly affect dysregulation and impulsive behavior.

“Given the mechanisms of action and beneficial side effect profile, this [analysis] suggests that omega-3 fatty acids could be considered as add-on treatment” for patients with BPD, senior author Roel J. T. Mocking MD, PhD, resident in psychiatry and postdoctoral researcher at Academisch Medisch Centrum, Amsterdam, said in an interview.

The findings were published online in the Journal of Clinical Psychiatry.
 

Urgent need

“There are several effective treatments, but not all patients respond sufficiently,” which points to an urgent need for additional treatment options, Dr. Mocking said.

Dmitriy Danilchenko/Shutterstock

He noted that, although “several prior studies showed promising effects of omega-3 fatty acids” for patients with BPD, those studies were relatively small, which precluded more definitive overall conclusions.

The investigators wanted to combine results of the earlier studies to provide a combined estimate of overall effectiveness of the use of omega-3 fatty acids for patients with BP, with the intention of “guiding clinicians and individuals suffering from borderline personality disorder to decide on whether they should add omega-3 fatty acids to their treatment.”

The analyzed four studies that had a total of 137 patients. Three of the studies included patients diagnosed with BPD; one included individuals with recurrent self-harm, most of whom were also diagnosed with BPD.

Omega-3 fatty acids were used as monotherapy in one study. In the other studies, they were used as add-on therapy to other agents, such as antidepressants, benzodiazepines, and/or valproic acid. None of the studies included patients who were taking antipsychotics.

The type of omega-3 PUFAs were derived from marine rather than plant sources.

Three studies compared omega-3 fatty acids with placebo. One study compared valproic acid monotherapy with valproic acid plus omega-3 fatty acids and did not include a placebo group.
 

Significant symptom reduction

Random-effects meta-analyses showed an “overall significant decreasing effect” of omega-3 fatty acids on overall BPD symptom severity (standardized difference in means, 0.54; 95% CI, 0.91-0.17; P = .004) in the omega-3 group compared with the control group, with a medium effect size.

The investigators added that there was “no relevant heterogeneity” (P = .45).

Although heterogeneity was “more pronounced” in the affective dysregulation symptom domain, it did not reach statistical significance, the researchers noted.

The impulsive behavioral dyscontrol and cognitive perceptual symptom domains had “no relevant heterogeneity.” On the other hand, there was “substantial heterogeneity” in the global functioning symptom group.

Omega-3 fatty acids “have multiple bioactive roles in the brain. For example, they form essential components of the membrane of brain cells and thereby influence the structure and functioning of the brain. They also have an effect on inflammation levels in the brain,” Dr. Mocking said.

“Because we cannot synthesize these omega-3 fatty acids ourselves, we are dependent on our diet. The main dietary source of omega-3 fatty acids is fatty fish. However, since the industrial revolution, we eat less and less fatty fish, risking deficiency of omega-3 fatty acids causing brain dysfunction,” he added.

Dr. Mocking noted that the mechanisms of action of omega-3 fatty acids differ from those of other treatments for BPD, such as psychotherapy, antidepressants, or antipsychotics.

This “suggests that they could be combined to increase overall effectiveness,” he said.
 

Important benefit

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said that the benefit of omega-3 “on impulsivity and mood symptoms is especially important, as these are some of the most debilitating aspects of BPD and lead to service utilization, such as ER, primary care, and specialty care.”

In addition, “impulsivity often presages suicidality,” he noted.

Dr. McIntyre, who is also chair and executive director of the Brain and Cognition Discovery Foundation in Toronto and was not involved with the study, called the effect size “quite reasonable.”

“The mechanistic story is very strong around anti-inflammatory effect, which particularly implied mood and cognition. In other words, inflammation is highly associated with mood and cognitive difficulties,” he said.

However, Dr. McIntyre also pointed to several significant challenges, including “quality assurance on the purchase of the product of fish oil, as it is not sufficiently regulated.” It is also unclear which individuals are more likely to benefit from it.

For example, major depressive disorder data have shown that “fish oils are not as effective as we hoped but are especially effective in people with baseline elevation of inflammatory markers,” Dr. McIntyre said.

“In other words, is there a way to identify a biomarkers/biosignature or phenomenology that’s more likely to identify a subgroup of people with BPD who might benefit benefiting from omega-3?” he asked.

Dr. Mocking and the other investigators reported no relevant financial relationships. Dr. McIntyre has received research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

Marine omega-3 fatty acids may be a promising add-on therapy for improving symptoms of borderline personality disorder (BPD), new research suggests.

A meta-analysis of four randomized controlled trials showed that adjunctive omega-3 fatty polyunsaturated fatty acids (PUFAs) significantly reduced overall BPD symptom severity, particularly affect dysregulation and impulsive behavior.

“Given the mechanisms of action and beneficial side effect profile, this [analysis] suggests that omega-3 fatty acids could be considered as add-on treatment” for patients with BPD, senior author Roel J. T. Mocking MD, PhD, resident in psychiatry and postdoctoral researcher at Academisch Medisch Centrum, Amsterdam, said in an interview.

The findings were published online in the Journal of Clinical Psychiatry.
 

Urgent need

“There are several effective treatments, but not all patients respond sufficiently,” which points to an urgent need for additional treatment options, Dr. Mocking said.

Dmitriy Danilchenko/Shutterstock

He noted that, although “several prior studies showed promising effects of omega-3 fatty acids” for patients with BPD, those studies were relatively small, which precluded more definitive overall conclusions.

The investigators wanted to combine results of the earlier studies to provide a combined estimate of overall effectiveness of the use of omega-3 fatty acids for patients with BP, with the intention of “guiding clinicians and individuals suffering from borderline personality disorder to decide on whether they should add omega-3 fatty acids to their treatment.”

The analyzed four studies that had a total of 137 patients. Three of the studies included patients diagnosed with BPD; one included individuals with recurrent self-harm, most of whom were also diagnosed with BPD.

Omega-3 fatty acids were used as monotherapy in one study. In the other studies, they were used as add-on therapy to other agents, such as antidepressants, benzodiazepines, and/or valproic acid. None of the studies included patients who were taking antipsychotics.

The type of omega-3 PUFAs were derived from marine rather than plant sources.

Three studies compared omega-3 fatty acids with placebo. One study compared valproic acid monotherapy with valproic acid plus omega-3 fatty acids and did not include a placebo group.
 

Significant symptom reduction

Random-effects meta-analyses showed an “overall significant decreasing effect” of omega-3 fatty acids on overall BPD symptom severity (standardized difference in means, 0.54; 95% CI, 0.91-0.17; P = .004) in the omega-3 group compared with the control group, with a medium effect size.

The investigators added that there was “no relevant heterogeneity” (P = .45).

Although heterogeneity was “more pronounced” in the affective dysregulation symptom domain, it did not reach statistical significance, the researchers noted.

The impulsive behavioral dyscontrol and cognitive perceptual symptom domains had “no relevant heterogeneity.” On the other hand, there was “substantial heterogeneity” in the global functioning symptom group.

Omega-3 fatty acids “have multiple bioactive roles in the brain. For example, they form essential components of the membrane of brain cells and thereby influence the structure and functioning of the brain. They also have an effect on inflammation levels in the brain,” Dr. Mocking said.

“Because we cannot synthesize these omega-3 fatty acids ourselves, we are dependent on our diet. The main dietary source of omega-3 fatty acids is fatty fish. However, since the industrial revolution, we eat less and less fatty fish, risking deficiency of omega-3 fatty acids causing brain dysfunction,” he added.

Dr. Mocking noted that the mechanisms of action of omega-3 fatty acids differ from those of other treatments for BPD, such as psychotherapy, antidepressants, or antipsychotics.

This “suggests that they could be combined to increase overall effectiveness,” he said.
 

Important benefit

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said that the benefit of omega-3 “on impulsivity and mood symptoms is especially important, as these are some of the most debilitating aspects of BPD and lead to service utilization, such as ER, primary care, and specialty care.”

In addition, “impulsivity often presages suicidality,” he noted.

Dr. McIntyre, who is also chair and executive director of the Brain and Cognition Discovery Foundation in Toronto and was not involved with the study, called the effect size “quite reasonable.”

“The mechanistic story is very strong around anti-inflammatory effect, which particularly implied mood and cognition. In other words, inflammation is highly associated with mood and cognitive difficulties,” he said.

However, Dr. McIntyre also pointed to several significant challenges, including “quality assurance on the purchase of the product of fish oil, as it is not sufficiently regulated.” It is also unclear which individuals are more likely to benefit from it.

For example, major depressive disorder data have shown that “fish oils are not as effective as we hoped but are especially effective in people with baseline elevation of inflammatory markers,” Dr. McIntyre said.

“In other words, is there a way to identify a biomarkers/biosignature or phenomenology that’s more likely to identify a subgroup of people with BPD who might benefit benefiting from omega-3?” he asked.

Dr. Mocking and the other investigators reported no relevant financial relationships. Dr. McIntyre has received research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, Eisai, Minerva, Intra-Cellular, and AbbVie. Dr. McIntyre is also CEO of AltMed.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.

VladKol/Getty Images

The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.

This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.

The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.

Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
 

Speakers ‘have to be careful’

Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?

John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.

Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.

Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.

Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
 

Big asks, big secrecy

Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.

Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.

The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.

The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.

The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.

An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.

The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.

The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
 

‘It’s all on you’

Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.

“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.

“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.

Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.

A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.

The agreements also reflect America’s litigation-prone culture.

Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”

Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.

The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.

The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.

DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.

“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
 

Other potential pitfalls

Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.

DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.

ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.

Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.

Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
 

How presenters must prepare

Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.

“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.

It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.

Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.

Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.

“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
 

Accept or negotiate?

Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.

“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.

Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.

Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.

If in doubt, talk with a lawyer.

“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.

Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.

As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

The tragic loss of three medical residents in our beloved South Bronx hospital shook us to the core. They were our colleagues and friends – promising young physicians whose lives and contributions to our hospital family will never be forgotten. We miss them and we grieve them.

We have been keenly aware of the growing trend of physician suicides across the country. That’s one of the reasons why, years ago, we established the nationally recognized Helping Healers Heal program across our health system and more recently expanded other mental health counseling and support to our frontline clinicians.

Our focus is wellness and prevention, as well as helping address the sadness, anxiety, and depression that so many of us experience after a traumatic event. During the surge of the COVID pandemic, these programs proved to be essential, as we expanded these services to all staff, not just those on the frontlines of patient care.

We share Dr. Pamela Wible’s concerns about the physician suicide crisis in this country. However, she misrepresented our residency program and made numerous statements that are false and simply hurtful.

Out of respect for our colleagues and their families, we cannot share everything that we know about this tragic and irreparable loss. But we must set the record straight about a number of incorrect references made by Dr. Wible:

1. We lost two residents to suicide. Though no less horrific, the third death was investigated and declared an accident by the police department.

2. Resident work hours and workload are closely monitored to follow guidance set by the New York State Department of Health and by ACGME. In fact, at the peak of the COVID pandemic, when we were caring for nearly 130 intubated patients at a time, we adopted a strict residency program schedule with built-in breaks and reduced shifts and hours. Even at that tasking time, no one worked more than 80 hours. Although the maximum number of patients assigned to an intern allowed by ACGME is 10, we rarely have more than five or six patients assigned to each of our interns.

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

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

A dyadic telehealth intervention to help people with dementia and their caregivers can achieve outcomes similar to those of traditional, in-person approaches. The program combines information, education, and skills training to help participants overcome specific challenges.

“It focuses on individualized problem solving and is tailored to the needs of the person. The focus is not just on educating caregivers, but working on strategies to maintain independence in the person with dementia and support them to remain active and engaged,” said Kate Laver, PhD, who presented the study at the annual meeting of the Alzheimer’s Association International Conference. Dr. Laver is an associate professor in the College of Medicine and Public Health at Flinders University in Adelaide, South Australia.

The program is called Care of Persons with Dementia in Their Environments (COPE), and has previously been demonstrated to improve outcomes when conducted through in-person home visits. Over a maximum of ten sessions in 4 months, COPE employs occupational therapists and individuals with nursing skills to identify environmental stressors that can be modified to reduce sensory, physical, and cognitive demands. It also looks for comorbidities in the person with dementia that could be contributing to poor functioning. The goal of COPE is to encourage the person with dementia to reengage in daily activities, and to reduce caregiver burden as a result.

In a 2020 study, Dr. Laver and colleagues showed that COPE is noninferior when delivered by telehealth compared with in-person delivery. They randomized 63 caregiver-patient dyads to telehealth or home visit delivery of the COPE program. Sixty percent of the persons with dementia were male, and the mean caregiver time was 32 months.

Similar improvements in outcomes were seen in both groups, with no statistically significant differences for the primary outcome of change in Caregiver Mastery Index score at 4 months (mean difference, 0.09; 95% confidence interval, –1.26 to 1.45). Similar changes were also seen in the Perceived Change Scale, which is a 13-item caregiver questionnaire that covers day-to-day care challenges, including feeling overwhelmed or upset, sleeping patterns, and availability of personal time.

Not surprisingly, telehealth implementation led to reduced mean travel time (77.2 minutes vs. 255.9 minutes; P < .0001). The face-to-face time was shorter in the telehealth group (308 vs. 337 minutes), though the difference was not statistically significant. Dr. Laver noted that the consent rate was high at 75%, but there were some missed sessions.
 

Lessons learned

During the presentation, Dr. Laver emphasized some lessons learned from conversion to a telehealth model. These included providing a tablet and stand on loan, a user guide with pictures, and an initial on-site training session. The first two sessions were conducted on site to do an in-person demonstration and to assess the participants and the home environment.

She noted that it was important to have an IT support person on call to help participants use the provided tablet if needed, though this was rarely used.

“Although few people (at the time) had their own devices, they were able to quickly master videoconferencing. We felt that it was important to ensure that the first couple of consultations were in person – this enabled the therapist to develop rapport, practice use of videoconferencing, and get a good idea of the person’s environment and relationship with the person with dementia,” said Dr. Laver.

She noted that telehealth can be more efficient, and even preferred, during times like the COVID-19 pandemic, as well as in rural settings. But home visits will always be needed. “They are important for developing rapport and enabling a comprehensive assessment of the person with dementia, relationships, and environment. They are also preferred by some caregivers,” said Dr. Laver.

The demonstration of equivalence to in-person delivery was welcome, said Ingo Kilimann, MD, who comoderated the session where Dr. Laver presented. “We have to bring help to the families where they are, and not just tell them where they can get the help, because some people are just not able to actually come to some specialists’ centers. So it’s very important information that it does work,” said Dr. Kilimann, who is a dementia neurologist and head of the memory clinic at the The German Center for Neurodegenerative Diseases in Bonn.

He added that mixing of on-site and remote sessions is a good model. “I think that is the way to be most effective – to have someone in person at the person with dementia’s house, and then have online support for the rest of the time, and then it can be as successful as a total in-person intervention,” said Dr. Kilimann.

Dr. Laver had no relevant financial disclosures.

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.

With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.

Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.

The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.

“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.

“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.

Mayo and Cleveland Clinic remain tops

Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.

UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.

In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.

Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
 

2021-2022 Best Hospitals honor roll

1. Mayo Clinic, Rochester, Minn.

2. Cleveland Clinic, Cleveland

3. UCLA Medical Center, Los Angeles

4. Johns Hopkins Hospital, Baltimore

5. Massachusetts General Hospital, Boston

6. Cedars-Sinai Medical Center, San Francisco

7. New York–Presbyterian Hospital–Columbia and Cornell, New York

8. NYU Langone Hospitals, New York

9. UCSF Medical Center, San Francisco

10. Northwestern Memorial Hospital, Chicago

11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.

12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.

13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia

14. Brigham and Women’s Hospital, Boston

15. Mayo Clinic–Phoenix, Phoenix

16. Houston Methodist Hospital, Houston

17. (tie) Barnes-Jewish Hospital, St. Louis

17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago

19. Rush University Medical Center, Chicago

20. Vanderbilt University Medical Center, Nashville, Tenn.

For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.

At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty

For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
 

Top five for cancer

1. University of Texas MD Anderson Cancer Center, Houston

2. Memorial Sloan Kettering Cancer Center, New York

3. Mayo Clinic, Rochester, Minn.

4. Dana-Farber/Brigham & Women’s Cancer Center, Boston

5. Cleveland Clinic, Cleveland

Top five for cardiology and heart surgery

1. Cleveland Clinic, Cleveland

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. New York–Presbyterian Hospital–Columbia and Cornell, New York

5. NYU Langone Hospitals, New York

Top five for orthopedics

1. Hospital for Special Surgery, New York

2. Mayo Clinic, Rochester, Minn.

3. Cedars-Sinai Medical Center, Los Angeles

4. NYU Langone Orthopedic Hospital, New York

5. UCLA Medical Center, Los Angeles

The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.

The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.

The full report is available online.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.

That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.

The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.

The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.

A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.

More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.

The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
 

Ethical commitment

The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”

In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.

The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.

While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”

There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.

But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.

“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.

“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.

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

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

In type 2 diabetes (T2D), a greater degree of hyperlipidemia and hypertension, although not hyperglycemia, was associated with measurable cognitive impairment even among patients with only a 4-year mean disease duration, according to a substudy of the GRADE trial.

The association of these cardiovascular (CV) risk factors with impairments in cognition has been reported before, but the findings are notable because the mean duration of T2D was short in a relatively healthy study population, reported a multicenter team of investigators.

The relative impairments in cognitive function “may not be clinically significant given the very small size of the differences,” conceded the authors of this study, led by José A. Luchsinger, MD, but they are consistent with previous reports of the same association in older patients with a longer duration of diabetes. In other words, the data suggest the risk of cognitive loss from CV risk factors in T2D patients begins early.

“A potential explanation for the small differences, compared with those previously reported, is that the GRADE cohort is relatively young with a healthier cardiovascular profile and shorter diabetes duration compared with other studies,” reported the investigators, whose results were published online July 20, 2021, in Diabetes Care.
 

99% complete cognitive assessments

In the GRADE (Glycemia Reduction Approaches in Diabetes: Comparative Effectiveness) trial, 5,018 (99.4%) of the 5,047 enrolled patients completed a battery of cognitive assessments at baseline. Patients were excluded from this study if they had any major CV event in the previous year, if they had T2D for more than 10 years, if they had significant renal impairment, and if they had any history of stage 3 or greater heart failure. Their mean age was 56.7 years.

By cross-sectional analysis, cognitive evaluations, including the Digit Symbol Substitution Test (DSST) and the Spanish English Verbal Learning Test, were evaluated in relation to baseline LDL cholesterol levels, systolic and diastolic blood pressure, hemoglobin A1c, and statin use.

Unlike previous studies in T2D patients, no relationship was observed between cognitive function and A1c level at baseline. However, LDL cholesterol greater than 100 mg/dL was associated with cognitive impairment as measured with the DSST after adjustment for age, sex, education, and general health. The mean difference relative to LDL cholesterol below 70 mg/dL was only 1.8 points, but this was highly significant (P < .001).

Similarly, significant but modest cognitive impairment on DSST score after adjustment for variables were seen for those with a systolic BP between 120 mg and <140 mg relative to either <120 mm Hg or at least 140 mm Hg (P = .014). The same was seen for diastolic BPs of 80 to <90 when compared with either <80 mm Hg or to 90 mm Hg or higher (P = .01).

For those taking statins versus no statins at baseline, there was a 1.4-point mean advantage in DSST score after adjusting for variables (P < .001).

Modest cognitive impairments recorded

Again, the absolute mean differences in the DSST cognitive scores, despite their statistical significance, were modest, according to the authors. In general, the mean difference was rarely greater than 2.0 points and often 1.0 point or less. The authors acknowledged that these changes are of an uncertain clinical significance, but they considered the findings consistent with the association of CV risk factors with cognitive deficits in older T2DM patients or T2DM patients with longer duration of disease.

One difference between this GRADE substudy and previous studies was the lack of an association between cognitive impairment and hyperglycemia. In the ACCORD trial for example, increased levels of blood glycemia were associated with lower performance on numerous tests of cognitive function.

In the Diabetes Control and Complications Trial (DCCT), poorer glycemic control was related to poorer performance on tests of executive function.

Both of those studies also linked hypertension and hyperlipidemia with cognitive deficits, but given that patients in ACCORD had T2DM of substantially longer duration and those in DCCT were older, “it seems reasonable to speculate that, in patients with diabetes duration of less than 10 years, the association between hyperglycemia and cognitive performance may not yet be evident,” the GRADE authors reported.
 

GRADE trial compares drugs in four classes

The GRADE trial was conducted to compare four classes of T2D therapies for long-term glycemic control as expressed by A1c control over time. The results of the trial, presented recently at the 2021 annual scientific sessions of the American Diabetes Association, found that insulin glargine and the glucagonlike peptide–1 receptor agonist liraglutide performed best on the primary endpoint of maintaining A1c below 7.0%. Both performed significantly better than the sulfonylurea glimepiride and the dipeptidyl peptidase–4 inhibitor sitagliptin.

This substudy of baseline cognitive function in the relatively large GRADE trial provided a unique opportunity to evaluate the impact of CV risk factors in patients with T2D of relatively short duration.

While the data support the adverse impact of inadequately controlled modifiable risk factors on cognitive function in T2D patients, David R. Matthews, DPhil, BM, BCh, emeritus professor of diabetes medicine at the University of Oxford (England), noted that the association was weak and advised a cautious interpretation.

“The effect size is very small indeed. The data are found as a subset of multiple testing,” he said in an interview. He suggested the associations might be the result of “data farming,” and he emphasized that the relationships between these risk factors and cognitive deficits are associations that do not imply causation.

Nevertheless, and despite their unclear clinical implications, Dr. Matthews said that these data might still have a message.

“It is another reminder that for many reasons we all need to be alert to the need for lowering hyperlipidemia and hypertension to normal levels – the benefits may not just be limited to cardiovascular outcome,” Dr. Matthews stated.

The lead author of the study, Dr. Luchsinger, also cautioned against overinterpreting the data.

While the data show that “lipid and blood pressure control within recommended guidelines are associated with marginally better cognitive function in patients with type 2 diabetes of less than 5 years duration on average,” he added that “the study is limited by its cross-sectional nature.”

He indicated that further analysis will be helpful in assessing the implications.

“Longitudinal analyses of the same group of individuals will be conducted next year,” noted Dr. Luchsinger, associate professor of medicine and epidemiology, Columbia University Medical Center, New York.

Dr. Luchsinger reported financial relationships with vTv therapeutics. Dr. Matthews reported no potential conflicts of interest.

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

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