Helping patients heal after a bruising election campaign

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Changed

One of us practices in the “new south” community of Charlotte, N.C., “a red state”; the other is in the “blue bubble” of Washington. In our respective polarized zones, the divergent reactions we heard about the presidential candidates were akin to projective responses to Rorschach tests.

As mental health clinicians, we knew that the country was wounded and in need of healing long before the outcome of the unconventional and acrimonious 2016 American presidential race. So, we were concerned about how patients, clinicians, and divergent communities would go about healing after an 18-month pre-election slugfest that revealed bigotry that persists more than 150 years after the Civil War.

Background of ‘two sides’

None of the nasty rhetoric delivered by our now president-elect or the clearly defensive responses we heard from our former secretary of state were going to be easily forgotten after Nov. 8, 2016. As the process unfolded, however, the voice of psychiatry, with some notable exceptions (the blog of Justin Frank, MD, for example), was absent from the public dialogue.

Dr. Darlene Ifill-Taylor

Nevertheless, writing in June of this year, Bill Moyers and Michael Winship summed up the private assessment of many professionals and the fears for many of a Trump presidency:

There is a virus infecting our politics and right now it’s flourishing with a scarlet fever. It feeds on fear, paranoia and bigotry. All that was required for it to spread was a timely opportunity – and an opportunist with no scruples. ... There have been stretches of history when this virus lay dormant. ... Today its carrier is Donald Trump, but others came before him: narcissistic demagogues who lie and distort in pursuit of power and self-promotion. Bullies all, swaggering across the landscape with fistfuls of false promises, smears, innuendo and hatred for others, spite and spittle for anyone of a different race, faith, gender, or nationality.1

Alternatively, some had a smoldering fear of the progressive agenda to bring “others” – more women, African Americans, Latinos, the LGBTQ community, Muslims, and the disabled – securely under the tent of American democracy. Others, especially the underemployed cohort in neglected and struggling communities in Middle America, were simply opposed to a continuation of “politics as usual,” a.k.a. Hillary Clinton, and were desperate for change.

Dr. Constance E. Dunlap

The opposition views were summed up in the innuendo of the slogan: “Make America Great Again.” By the election, the tensions had begun to resemble the aggressive spirit of a sporting event: It’s “us” versus “them.”

Causes of concern

In the months leading up to the election, violent events strained the societal divisions. The police use of force2 resulted in the near-daily deaths of African American men and women and other people of color at the hands of police officers. The events built on a long and growing list of violent acts – the racially motivated shootings of nine men and women in a Charleston, S.C., church, the bombing injuries and deaths at the Boston Marathon, the shooting deaths of 20 children and 6 adults at Sandy Hook Elementary School, the homophobia-motivated shootings in a Florida nightclub – that have heightened levels of fear, anxiety, and concern for personal and family safety. For many, life has felt fragile and out of control, the perfect setup to motivate the electorate to cast their votes for the person they imagined had the most power and most interest in restoring their sense of control over their lives and, ultimately, their sense of safety.

Why the fear? A psychodynamic analysis

As psychiatrists trained in psychodynamic theory, we are quite familiar with the concept of identifying with the aggressor as a means of coping. The classic example is when a child watches his or her parents in an abusive relationship and identifies with the abusive parent in an attempt to avoid identifying with the victimized parent.

This dynamic is one that seems to have played out during this presidential election. By October 2016, Donald J. Trump already reportedly had insulted more than 280 people, places, and things on Twitter.3 Despite the evidence that Mr. Trump verbally bullied not only his opponents, but also the media, Latinos, women, the LGBTQ community, the Republican Party (his claimed party), and Muslims, people came out in numbers high enough to make him America’s president-elect. In the classic process of bullying his perceived enemies, those considered “the other,” he assigned names such as “crooked Hillary,” “little Marco,” and “lyin’ Ted” – just as a bully at school assigns names to the kid he’s decided does not have enough worth to be called by his given name.

He depicted women who accused him of sexual assault as either not being pretty enough to be worthy of assault or self-serving in their public accusations. Mexicans entering this country were referred to as “rapists and thugs.” African Americans were told that their lives are so bad that they “have nothing to lose” if they voted for a candidate who talked about erecting a wall to block out other people of color, and changing immigration laws that would banish an entire religion from entering our country.
 

 

 

The ‘blue bubble’ – Those who voted for Mrs. Clinton

So … this happened. And, in our consulting rooms, we are seeing a stark increase in the numbers of individuals, couples, and families reporting overwhelming anxiety, sadness, and a sense of de-realization (“it’s surreal”). At the core of their anxiety is concern for self, family, and friends as well as concern for the country as a whole.

The post-election notions that families would be immediately broken up, parents deported, the Affordable Care Act immediately dismantled, and countries bombed immediately after Election Day did not become realities. However, there is valid reason to be concerned. The Southern Poverty Law Center has noted a significant increase in post-election hate crimes throughout the nation.4

The new South ‘red states’ – those who voted for Mr. Trump

Trump supporters are feeling victorious because their “underdog” candidate ran an unconventional presidential campaign and won. However, some who voted for Mr. Trump will at some point experience anxiety when the excitement of “winning” wears off. Psychoanalyst Justin Frank speaks to this and more in his Nov. 9, 2016, blog in which he concludes: “While we mourn and blame others and ourselves for our American tragedy, Trump voters must eventually look at themselves in the mirror and exclaim, ‘what have we done?’ ”5

In his Oct. 25, 2016, New York Times article, Michael Barbaro summarized the behaviors that will become increasingly of concern to all as Mr. Trump accepts the oath of office:

The intense ambitions and undisciplined behaviors of Mr. Trump have confounded even those close to him.... In interviews, Mr. Trump makes clear just how difficult it is for him to imagine – let alone accept – defeat....

“I never had a failure,” Mr. Trump said in one of the interviews, despite his repeated corporate bankruptcies and business setbacks, “because I always turned a failure into a success.”
6

This fundamental inability to accept responsibility and the attempt to distort reality is something that must concern each of us, regardless of our ideological differences.

Distress tolerance as a model for healing

Even before the outcome of the election, we were hearing from patients who did not feel safe and who reported being “terrified” about what our country might become. This is where a focus on processing the pain and decreasing anxiety is necessary. This is not an anxiety we can medicate with anxiolytics or rationalize by telling ourselves and our patients that the best man won “fair and square.” We have each – by this time – experienced patients who are quite shaken by this turn of events.

Although it has not received much press, many consider Mr. Trump’s victory to be, in part, a “white backlash.” Many supporters of Mr. Trump have felt too ashamed to publicly admit their support for a candidate who at least by innuendo incited fear, anger, and violence. This failure has created an anxiety reminiscent of the daytime anxiety experienced by people who survived nighttime lynchings in small Southern towns. The day after the lynching, it was not unusual for African American men, women, and children to wonder if their grocer, banker, postal carrier, or sheriff had donned a white hood the night before and lynched someone in their community.

The question of survival, how to survive the unimaginable, is what most distresses people. They’ve wondered out loud whether they, their family, and friends would be attacked and/or killed by those who now feel emboldened and authorized to act on their latent aggressive impulses. And, our patients’ fears are legitimate because, unfortunately, studies show that verbal aggression is correlated with increased risk of physical violence and even murder.7

In the dialectical behavioral therapy (DBT) construct developed by Marsha M. Linehan, PhD, the goals of distress tolerance are crisis survival, reality acceptance, and then freedom.8

As we apply our skills, we are uniquely positioned to help our patients and their families survive this crisis, accept that this is our president-elect, and ultimately be free from the anxiety created by the behavior that we all witnessed. We can aid in the navigation through this storm.

Acceptance

We’re already on to reality acceptance. The reality that so many African Americans and people of color have been living is now known and experienced by many who had felt immune to being marginalized. They now understand the loss of security that accompanies overwhelming fear of being the object of verbal, emotional, and physical aggression and violence.

Some are coping by entertaining fantasies that this election outcome will be undone, that the Electoral College will not approve our president-elect when it meets on Dec. 19 or that Mr. Trump will be impeached early in this upcoming term. The results of the presidential election are unlikely to be undone, so having more than 2 months between Election Day and the inauguration to work on acceptance will be helpful. The goal here is to accept the past, be hopeful about the future, and be vigilant in the present.
 

 

 

Freedom

Now, on to freedom. Our goal is to have all of our patients, families, colleagues, and communities able to live without fear that our leaders are not able to apply humanitarian principles to keep all of us safe. The next few months are crucial. Americans must speak out and debride the wound that bullying intentionally causes. Just as with a school bully, Mr. Trump’s behavior has to be called what it is, not sugarcoated or normalized.

History is full of critical moments in time in which, even in our fear, we said nothing. Even the most empathic of us watched the bully at school and felt relief that his behavior was not directed toward us. But we must not avert our gaze.

Bill Moyers and Michael Winship compared Mr. Trump to Sen. Joseph McCarthy, whose reign of terror was ended when journalist Edward R. Murrow courageously spoke out in defiance of the senator. At the end of one of his segments on “See It Now,” Mr. Murrow concluded as he signed off:

We will not walk in fear, one of another. We will not be driven by fear into an age of unreason, if we dig deep in our history and our doctrine, and remember that we are not descended from fearful men — not from men who feared to write, to speak, to associate and to defend causes that were, for the moment, unpopular.9

And, so, how do we cope?

Fortunately, we understand bullying. The bully doesn’t take over the entire school and won’t have the power to take over one’s entire life if the behavior is brought out in the open and openly discussed. But bullies need to accept responsibility, which is what Sen. Harry Reid of Nevada and other legislators urged President-elect Trump to do in days immediately following the election.10 They have called on him to discourage the fear, anger, and violence leading up to and following the election. This action on Mr. Trump’s part would promote a vitally needed national healing process.

Ultimately, this is “the land of the free, the home of the brave …” and we will do what we have always done as psychiatrists and mental health professionals who help to heal wounds. Not all of us will participate in social justice initiatives. However, each of us can listen with intense compassion and interest to those with whom we identify politically and to those whose views diverge from our own. This is our most potent tool in a conflict where we don’t understand the motives of unpredictable leaders or their followers. It is only with this skilled listening that a space is created in which each “other” hears the “other.” This is where real healing begins.

The views expressed in this article are solely those of the authors, and are not meant to represent the views of the American Psychiatric Association, Novant Health, Clinical Psychiatry News, or any other organization.

References

1. http://billposters/story/trump-virus-dark-age-unreason

2. http://blackdoctor.org/495036/national-medical-association-statement-on-police-use-of-force

3. http://www.nytimes.com/interactive/2016/01/28/upshot/donald-trump-twitter-insults.html?_r=0

4. https://www.splcenter.org/hatewatch/2016/11/11/over-200-incidents-hateful-harassment-and-intimidation-election-day

5. http://www.obamaonthecouch.com

6. http://www.nytimes.com/2016/10/26/us/politics/donald-trump-interviews.html

7. “The Nature of Prejudice,” (New York: Perseus Books Publishing, 1979).

8. DBT® Skills Training Handouts and Worksheets, Second Edition (New York: The Guilford Press, 2014).

9. http://billmoyers.com/story/trump-virus-dark-age-unreason

10. http://www.reid.senate.gov/press_releases/2016-11-11-reid-statement-on-the-election-of-donald-trump#.WC0iA6IrKgR

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is the immediate past president of the Washington Psychiatric Society, and associate clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics. Dr. Ifill-Taylor, a child, adolescent, and adult psychiatrist, is in practice as a medical director in Charlotte, N.C. Previously, she was in private practice in the Washington area and worked as a staff psychiatrist for the Department of Veterans Affairs. She is particularly interested in the effect of our social, political, and occupational environment on mental and physical health.

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One of us practices in the “new south” community of Charlotte, N.C., “a red state”; the other is in the “blue bubble” of Washington. In our respective polarized zones, the divergent reactions we heard about the presidential candidates were akin to projective responses to Rorschach tests.

As mental health clinicians, we knew that the country was wounded and in need of healing long before the outcome of the unconventional and acrimonious 2016 American presidential race. So, we were concerned about how patients, clinicians, and divergent communities would go about healing after an 18-month pre-election slugfest that revealed bigotry that persists more than 150 years after the Civil War.

Background of ‘two sides’

None of the nasty rhetoric delivered by our now president-elect or the clearly defensive responses we heard from our former secretary of state were going to be easily forgotten after Nov. 8, 2016. As the process unfolded, however, the voice of psychiatry, with some notable exceptions (the blog of Justin Frank, MD, for example), was absent from the public dialogue.

Dr. Darlene Ifill-Taylor

Nevertheless, writing in June of this year, Bill Moyers and Michael Winship summed up the private assessment of many professionals and the fears for many of a Trump presidency:

There is a virus infecting our politics and right now it’s flourishing with a scarlet fever. It feeds on fear, paranoia and bigotry. All that was required for it to spread was a timely opportunity – and an opportunist with no scruples. ... There have been stretches of history when this virus lay dormant. ... Today its carrier is Donald Trump, but others came before him: narcissistic demagogues who lie and distort in pursuit of power and self-promotion. Bullies all, swaggering across the landscape with fistfuls of false promises, smears, innuendo and hatred for others, spite and spittle for anyone of a different race, faith, gender, or nationality.1

Alternatively, some had a smoldering fear of the progressive agenda to bring “others” – more women, African Americans, Latinos, the LGBTQ community, Muslims, and the disabled – securely under the tent of American democracy. Others, especially the underemployed cohort in neglected and struggling communities in Middle America, were simply opposed to a continuation of “politics as usual,” a.k.a. Hillary Clinton, and were desperate for change.

Dr. Constance E. Dunlap

The opposition views were summed up in the innuendo of the slogan: “Make America Great Again.” By the election, the tensions had begun to resemble the aggressive spirit of a sporting event: It’s “us” versus “them.”

Causes of concern

In the months leading up to the election, violent events strained the societal divisions. The police use of force2 resulted in the near-daily deaths of African American men and women and other people of color at the hands of police officers. The events built on a long and growing list of violent acts – the racially motivated shootings of nine men and women in a Charleston, S.C., church, the bombing injuries and deaths at the Boston Marathon, the shooting deaths of 20 children and 6 adults at Sandy Hook Elementary School, the homophobia-motivated shootings in a Florida nightclub – that have heightened levels of fear, anxiety, and concern for personal and family safety. For many, life has felt fragile and out of control, the perfect setup to motivate the electorate to cast their votes for the person they imagined had the most power and most interest in restoring their sense of control over their lives and, ultimately, their sense of safety.

Why the fear? A psychodynamic analysis

As psychiatrists trained in psychodynamic theory, we are quite familiar with the concept of identifying with the aggressor as a means of coping. The classic example is when a child watches his or her parents in an abusive relationship and identifies with the abusive parent in an attempt to avoid identifying with the victimized parent.

This dynamic is one that seems to have played out during this presidential election. By October 2016, Donald J. Trump already reportedly had insulted more than 280 people, places, and things on Twitter.3 Despite the evidence that Mr. Trump verbally bullied not only his opponents, but also the media, Latinos, women, the LGBTQ community, the Republican Party (his claimed party), and Muslims, people came out in numbers high enough to make him America’s president-elect. In the classic process of bullying his perceived enemies, those considered “the other,” he assigned names such as “crooked Hillary,” “little Marco,” and “lyin’ Ted” – just as a bully at school assigns names to the kid he’s decided does not have enough worth to be called by his given name.

He depicted women who accused him of sexual assault as either not being pretty enough to be worthy of assault or self-serving in their public accusations. Mexicans entering this country were referred to as “rapists and thugs.” African Americans were told that their lives are so bad that they “have nothing to lose” if they voted for a candidate who talked about erecting a wall to block out other people of color, and changing immigration laws that would banish an entire religion from entering our country.
 

 

 

The ‘blue bubble’ – Those who voted for Mrs. Clinton

So … this happened. And, in our consulting rooms, we are seeing a stark increase in the numbers of individuals, couples, and families reporting overwhelming anxiety, sadness, and a sense of de-realization (“it’s surreal”). At the core of their anxiety is concern for self, family, and friends as well as concern for the country as a whole.

The post-election notions that families would be immediately broken up, parents deported, the Affordable Care Act immediately dismantled, and countries bombed immediately after Election Day did not become realities. However, there is valid reason to be concerned. The Southern Poverty Law Center has noted a significant increase in post-election hate crimes throughout the nation.4

The new South ‘red states’ – those who voted for Mr. Trump

Trump supporters are feeling victorious because their “underdog” candidate ran an unconventional presidential campaign and won. However, some who voted for Mr. Trump will at some point experience anxiety when the excitement of “winning” wears off. Psychoanalyst Justin Frank speaks to this and more in his Nov. 9, 2016, blog in which he concludes: “While we mourn and blame others and ourselves for our American tragedy, Trump voters must eventually look at themselves in the mirror and exclaim, ‘what have we done?’ ”5

In his Oct. 25, 2016, New York Times article, Michael Barbaro summarized the behaviors that will become increasingly of concern to all as Mr. Trump accepts the oath of office:

The intense ambitions and undisciplined behaviors of Mr. Trump have confounded even those close to him.... In interviews, Mr. Trump makes clear just how difficult it is for him to imagine – let alone accept – defeat....

“I never had a failure,” Mr. Trump said in one of the interviews, despite his repeated corporate bankruptcies and business setbacks, “because I always turned a failure into a success.”
6

This fundamental inability to accept responsibility and the attempt to distort reality is something that must concern each of us, regardless of our ideological differences.

Distress tolerance as a model for healing

Even before the outcome of the election, we were hearing from patients who did not feel safe and who reported being “terrified” about what our country might become. This is where a focus on processing the pain and decreasing anxiety is necessary. This is not an anxiety we can medicate with anxiolytics or rationalize by telling ourselves and our patients that the best man won “fair and square.” We have each – by this time – experienced patients who are quite shaken by this turn of events.

Although it has not received much press, many consider Mr. Trump’s victory to be, in part, a “white backlash.” Many supporters of Mr. Trump have felt too ashamed to publicly admit their support for a candidate who at least by innuendo incited fear, anger, and violence. This failure has created an anxiety reminiscent of the daytime anxiety experienced by people who survived nighttime lynchings in small Southern towns. The day after the lynching, it was not unusual for African American men, women, and children to wonder if their grocer, banker, postal carrier, or sheriff had donned a white hood the night before and lynched someone in their community.

The question of survival, how to survive the unimaginable, is what most distresses people. They’ve wondered out loud whether they, their family, and friends would be attacked and/or killed by those who now feel emboldened and authorized to act on their latent aggressive impulses. And, our patients’ fears are legitimate because, unfortunately, studies show that verbal aggression is correlated with increased risk of physical violence and even murder.7

In the dialectical behavioral therapy (DBT) construct developed by Marsha M. Linehan, PhD, the goals of distress tolerance are crisis survival, reality acceptance, and then freedom.8

As we apply our skills, we are uniquely positioned to help our patients and their families survive this crisis, accept that this is our president-elect, and ultimately be free from the anxiety created by the behavior that we all witnessed. We can aid in the navigation through this storm.

Acceptance

We’re already on to reality acceptance. The reality that so many African Americans and people of color have been living is now known and experienced by many who had felt immune to being marginalized. They now understand the loss of security that accompanies overwhelming fear of being the object of verbal, emotional, and physical aggression and violence.

Some are coping by entertaining fantasies that this election outcome will be undone, that the Electoral College will not approve our president-elect when it meets on Dec. 19 or that Mr. Trump will be impeached early in this upcoming term. The results of the presidential election are unlikely to be undone, so having more than 2 months between Election Day and the inauguration to work on acceptance will be helpful. The goal here is to accept the past, be hopeful about the future, and be vigilant in the present.
 

 

 

Freedom

Now, on to freedom. Our goal is to have all of our patients, families, colleagues, and communities able to live without fear that our leaders are not able to apply humanitarian principles to keep all of us safe. The next few months are crucial. Americans must speak out and debride the wound that bullying intentionally causes. Just as with a school bully, Mr. Trump’s behavior has to be called what it is, not sugarcoated or normalized.

History is full of critical moments in time in which, even in our fear, we said nothing. Even the most empathic of us watched the bully at school and felt relief that his behavior was not directed toward us. But we must not avert our gaze.

Bill Moyers and Michael Winship compared Mr. Trump to Sen. Joseph McCarthy, whose reign of terror was ended when journalist Edward R. Murrow courageously spoke out in defiance of the senator. At the end of one of his segments on “See It Now,” Mr. Murrow concluded as he signed off:

We will not walk in fear, one of another. We will not be driven by fear into an age of unreason, if we dig deep in our history and our doctrine, and remember that we are not descended from fearful men — not from men who feared to write, to speak, to associate and to defend causes that were, for the moment, unpopular.9

And, so, how do we cope?

Fortunately, we understand bullying. The bully doesn’t take over the entire school and won’t have the power to take over one’s entire life if the behavior is brought out in the open and openly discussed. But bullies need to accept responsibility, which is what Sen. Harry Reid of Nevada and other legislators urged President-elect Trump to do in days immediately following the election.10 They have called on him to discourage the fear, anger, and violence leading up to and following the election. This action on Mr. Trump’s part would promote a vitally needed national healing process.

Ultimately, this is “the land of the free, the home of the brave …” and we will do what we have always done as psychiatrists and mental health professionals who help to heal wounds. Not all of us will participate in social justice initiatives. However, each of us can listen with intense compassion and interest to those with whom we identify politically and to those whose views diverge from our own. This is our most potent tool in a conflict where we don’t understand the motives of unpredictable leaders or their followers. It is only with this skilled listening that a space is created in which each “other” hears the “other.” This is where real healing begins.

The views expressed in this article are solely those of the authors, and are not meant to represent the views of the American Psychiatric Association, Novant Health, Clinical Psychiatry News, or any other organization.

References

1. http://billposters/story/trump-virus-dark-age-unreason

2. http://blackdoctor.org/495036/national-medical-association-statement-on-police-use-of-force

3. http://www.nytimes.com/interactive/2016/01/28/upshot/donald-trump-twitter-insults.html?_r=0

4. https://www.splcenter.org/hatewatch/2016/11/11/over-200-incidents-hateful-harassment-and-intimidation-election-day

5. http://www.obamaonthecouch.com

6. http://www.nytimes.com/2016/10/26/us/politics/donald-trump-interviews.html

7. “The Nature of Prejudice,” (New York: Perseus Books Publishing, 1979).

8. DBT® Skills Training Handouts and Worksheets, Second Edition (New York: The Guilford Press, 2014).

9. http://billmoyers.com/story/trump-virus-dark-age-unreason

10. http://www.reid.senate.gov/press_releases/2016-11-11-reid-statement-on-the-election-of-donald-trump#.WC0iA6IrKgR

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is the immediate past president of the Washington Psychiatric Society, and associate clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics. Dr. Ifill-Taylor, a child, adolescent, and adult psychiatrist, is in practice as a medical director in Charlotte, N.C. Previously, she was in private practice in the Washington area and worked as a staff psychiatrist for the Department of Veterans Affairs. She is particularly interested in the effect of our social, political, and occupational environment on mental and physical health.

One of us practices in the “new south” community of Charlotte, N.C., “a red state”; the other is in the “blue bubble” of Washington. In our respective polarized zones, the divergent reactions we heard about the presidential candidates were akin to projective responses to Rorschach tests.

As mental health clinicians, we knew that the country was wounded and in need of healing long before the outcome of the unconventional and acrimonious 2016 American presidential race. So, we were concerned about how patients, clinicians, and divergent communities would go about healing after an 18-month pre-election slugfest that revealed bigotry that persists more than 150 years after the Civil War.

Background of ‘two sides’

None of the nasty rhetoric delivered by our now president-elect or the clearly defensive responses we heard from our former secretary of state were going to be easily forgotten after Nov. 8, 2016. As the process unfolded, however, the voice of psychiatry, with some notable exceptions (the blog of Justin Frank, MD, for example), was absent from the public dialogue.

Dr. Darlene Ifill-Taylor

Nevertheless, writing in June of this year, Bill Moyers and Michael Winship summed up the private assessment of many professionals and the fears for many of a Trump presidency:

There is a virus infecting our politics and right now it’s flourishing with a scarlet fever. It feeds on fear, paranoia and bigotry. All that was required for it to spread was a timely opportunity – and an opportunist with no scruples. ... There have been stretches of history when this virus lay dormant. ... Today its carrier is Donald Trump, but others came before him: narcissistic demagogues who lie and distort in pursuit of power and self-promotion. Bullies all, swaggering across the landscape with fistfuls of false promises, smears, innuendo and hatred for others, spite and spittle for anyone of a different race, faith, gender, or nationality.1

Alternatively, some had a smoldering fear of the progressive agenda to bring “others” – more women, African Americans, Latinos, the LGBTQ community, Muslims, and the disabled – securely under the tent of American democracy. Others, especially the underemployed cohort in neglected and struggling communities in Middle America, were simply opposed to a continuation of “politics as usual,” a.k.a. Hillary Clinton, and were desperate for change.

Dr. Constance E. Dunlap

The opposition views were summed up in the innuendo of the slogan: “Make America Great Again.” By the election, the tensions had begun to resemble the aggressive spirit of a sporting event: It’s “us” versus “them.”

Causes of concern

In the months leading up to the election, violent events strained the societal divisions. The police use of force2 resulted in the near-daily deaths of African American men and women and other people of color at the hands of police officers. The events built on a long and growing list of violent acts – the racially motivated shootings of nine men and women in a Charleston, S.C., church, the bombing injuries and deaths at the Boston Marathon, the shooting deaths of 20 children and 6 adults at Sandy Hook Elementary School, the homophobia-motivated shootings in a Florida nightclub – that have heightened levels of fear, anxiety, and concern for personal and family safety. For many, life has felt fragile and out of control, the perfect setup to motivate the electorate to cast their votes for the person they imagined had the most power and most interest in restoring their sense of control over their lives and, ultimately, their sense of safety.

Why the fear? A psychodynamic analysis

As psychiatrists trained in psychodynamic theory, we are quite familiar with the concept of identifying with the aggressor as a means of coping. The classic example is when a child watches his or her parents in an abusive relationship and identifies with the abusive parent in an attempt to avoid identifying with the victimized parent.

This dynamic is one that seems to have played out during this presidential election. By October 2016, Donald J. Trump already reportedly had insulted more than 280 people, places, and things on Twitter.3 Despite the evidence that Mr. Trump verbally bullied not only his opponents, but also the media, Latinos, women, the LGBTQ community, the Republican Party (his claimed party), and Muslims, people came out in numbers high enough to make him America’s president-elect. In the classic process of bullying his perceived enemies, those considered “the other,” he assigned names such as “crooked Hillary,” “little Marco,” and “lyin’ Ted” – just as a bully at school assigns names to the kid he’s decided does not have enough worth to be called by his given name.

He depicted women who accused him of sexual assault as either not being pretty enough to be worthy of assault or self-serving in their public accusations. Mexicans entering this country were referred to as “rapists and thugs.” African Americans were told that their lives are so bad that they “have nothing to lose” if they voted for a candidate who talked about erecting a wall to block out other people of color, and changing immigration laws that would banish an entire religion from entering our country.
 

 

 

The ‘blue bubble’ – Those who voted for Mrs. Clinton

So … this happened. And, in our consulting rooms, we are seeing a stark increase in the numbers of individuals, couples, and families reporting overwhelming anxiety, sadness, and a sense of de-realization (“it’s surreal”). At the core of their anxiety is concern for self, family, and friends as well as concern for the country as a whole.

The post-election notions that families would be immediately broken up, parents deported, the Affordable Care Act immediately dismantled, and countries bombed immediately after Election Day did not become realities. However, there is valid reason to be concerned. The Southern Poverty Law Center has noted a significant increase in post-election hate crimes throughout the nation.4

The new South ‘red states’ – those who voted for Mr. Trump

Trump supporters are feeling victorious because their “underdog” candidate ran an unconventional presidential campaign and won. However, some who voted for Mr. Trump will at some point experience anxiety when the excitement of “winning” wears off. Psychoanalyst Justin Frank speaks to this and more in his Nov. 9, 2016, blog in which he concludes: “While we mourn and blame others and ourselves for our American tragedy, Trump voters must eventually look at themselves in the mirror and exclaim, ‘what have we done?’ ”5

In his Oct. 25, 2016, New York Times article, Michael Barbaro summarized the behaviors that will become increasingly of concern to all as Mr. Trump accepts the oath of office:

The intense ambitions and undisciplined behaviors of Mr. Trump have confounded even those close to him.... In interviews, Mr. Trump makes clear just how difficult it is for him to imagine – let alone accept – defeat....

“I never had a failure,” Mr. Trump said in one of the interviews, despite his repeated corporate bankruptcies and business setbacks, “because I always turned a failure into a success.”
6

This fundamental inability to accept responsibility and the attempt to distort reality is something that must concern each of us, regardless of our ideological differences.

Distress tolerance as a model for healing

Even before the outcome of the election, we were hearing from patients who did not feel safe and who reported being “terrified” about what our country might become. This is where a focus on processing the pain and decreasing anxiety is necessary. This is not an anxiety we can medicate with anxiolytics or rationalize by telling ourselves and our patients that the best man won “fair and square.” We have each – by this time – experienced patients who are quite shaken by this turn of events.

Although it has not received much press, many consider Mr. Trump’s victory to be, in part, a “white backlash.” Many supporters of Mr. Trump have felt too ashamed to publicly admit their support for a candidate who at least by innuendo incited fear, anger, and violence. This failure has created an anxiety reminiscent of the daytime anxiety experienced by people who survived nighttime lynchings in small Southern towns. The day after the lynching, it was not unusual for African American men, women, and children to wonder if their grocer, banker, postal carrier, or sheriff had donned a white hood the night before and lynched someone in their community.

The question of survival, how to survive the unimaginable, is what most distresses people. They’ve wondered out loud whether they, their family, and friends would be attacked and/or killed by those who now feel emboldened and authorized to act on their latent aggressive impulses. And, our patients’ fears are legitimate because, unfortunately, studies show that verbal aggression is correlated with increased risk of physical violence and even murder.7

In the dialectical behavioral therapy (DBT) construct developed by Marsha M. Linehan, PhD, the goals of distress tolerance are crisis survival, reality acceptance, and then freedom.8

As we apply our skills, we are uniquely positioned to help our patients and their families survive this crisis, accept that this is our president-elect, and ultimately be free from the anxiety created by the behavior that we all witnessed. We can aid in the navigation through this storm.

Acceptance

We’re already on to reality acceptance. The reality that so many African Americans and people of color have been living is now known and experienced by many who had felt immune to being marginalized. They now understand the loss of security that accompanies overwhelming fear of being the object of verbal, emotional, and physical aggression and violence.

Some are coping by entertaining fantasies that this election outcome will be undone, that the Electoral College will not approve our president-elect when it meets on Dec. 19 or that Mr. Trump will be impeached early in this upcoming term. The results of the presidential election are unlikely to be undone, so having more than 2 months between Election Day and the inauguration to work on acceptance will be helpful. The goal here is to accept the past, be hopeful about the future, and be vigilant in the present.
 

 

 

Freedom

Now, on to freedom. Our goal is to have all of our patients, families, colleagues, and communities able to live without fear that our leaders are not able to apply humanitarian principles to keep all of us safe. The next few months are crucial. Americans must speak out and debride the wound that bullying intentionally causes. Just as with a school bully, Mr. Trump’s behavior has to be called what it is, not sugarcoated or normalized.

History is full of critical moments in time in which, even in our fear, we said nothing. Even the most empathic of us watched the bully at school and felt relief that his behavior was not directed toward us. But we must not avert our gaze.

Bill Moyers and Michael Winship compared Mr. Trump to Sen. Joseph McCarthy, whose reign of terror was ended when journalist Edward R. Murrow courageously spoke out in defiance of the senator. At the end of one of his segments on “See It Now,” Mr. Murrow concluded as he signed off:

We will not walk in fear, one of another. We will not be driven by fear into an age of unreason, if we dig deep in our history and our doctrine, and remember that we are not descended from fearful men — not from men who feared to write, to speak, to associate and to defend causes that were, for the moment, unpopular.9

And, so, how do we cope?

Fortunately, we understand bullying. The bully doesn’t take over the entire school and won’t have the power to take over one’s entire life if the behavior is brought out in the open and openly discussed. But bullies need to accept responsibility, which is what Sen. Harry Reid of Nevada and other legislators urged President-elect Trump to do in days immediately following the election.10 They have called on him to discourage the fear, anger, and violence leading up to and following the election. This action on Mr. Trump’s part would promote a vitally needed national healing process.

Ultimately, this is “the land of the free, the home of the brave …” and we will do what we have always done as psychiatrists and mental health professionals who help to heal wounds. Not all of us will participate in social justice initiatives. However, each of us can listen with intense compassion and interest to those with whom we identify politically and to those whose views diverge from our own. This is our most potent tool in a conflict where we don’t understand the motives of unpredictable leaders or their followers. It is only with this skilled listening that a space is created in which each “other” hears the “other.” This is where real healing begins.

The views expressed in this article are solely those of the authors, and are not meant to represent the views of the American Psychiatric Association, Novant Health, Clinical Psychiatry News, or any other organization.

References

1. http://billposters/story/trump-virus-dark-age-unreason

2. http://blackdoctor.org/495036/national-medical-association-statement-on-police-use-of-force

3. http://www.nytimes.com/interactive/2016/01/28/upshot/donald-trump-twitter-insults.html?_r=0

4. https://www.splcenter.org/hatewatch/2016/11/11/over-200-incidents-hateful-harassment-and-intimidation-election-day

5. http://www.obamaonthecouch.com

6. http://www.nytimes.com/2016/10/26/us/politics/donald-trump-interviews.html

7. “The Nature of Prejudice,” (New York: Perseus Books Publishing, 1979).

8. DBT® Skills Training Handouts and Worksheets, Second Edition (New York: The Guilford Press, 2014).

9. http://billmoyers.com/story/trump-virus-dark-age-unreason

10. http://www.reid.senate.gov/press_releases/2016-11-11-reid-statement-on-the-election-of-donald-trump#.WC0iA6IrKgR

Dr. Dunlap, a psychiatrist and psychoanalyst who practices in Washington, is the immediate past president of the Washington Psychiatric Society, and associate clinical professor of psychiatry and behavioral sciences at George Washington University, Washington. She is interested in the role “difference” – race, culture, and ethnicity – plays in interpersonal relationships and group dynamics. Dr. Ifill-Taylor, a child, adolescent, and adult psychiatrist, is in practice as a medical director in Charlotte, N.C. Previously, she was in private practice in the Washington area and worked as a staff psychiatrist for the Department of Veterans Affairs. She is particularly interested in the effect of our social, political, and occupational environment on mental and physical health.

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Hospital factors play key role in readmission risk after surgery

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CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.

Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.

Sara A. Brownlee
“Previous studies across surgical fields have shown significant associations between patient characteristics including age, sex, comorbidity status, race, and insurance level, and outcomes following a range of surgical procedures,” Ms. Brownlee, a medical student at Loyola University Chicago’s Stritch School of Medicine, said at the annual meeting of the Western Surgical Association. “Identifying these associations has helped guide clinical practice and decision-making for both surgeons and patients, and has called attention to areas of health disparities in surgical care. More recently, other aspects of the CDM, including hospital factors like staffing ratios, procedure volume, and the availability of rehabilitation and specialized nursing services, have been investigated to assess the influence these components might have on patient outcomes postoperatively. However, it’s not known how much hospital factors such as these contribute to the variation in surgical outcomes overall. It’s important to know what changes we can make that will have the biggest impact on improving patient outcomes, so that efforts on reducing readmissions are appropriately designed.”

The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.

The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.

Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).

“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”

The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
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CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.

Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.

Sara A. Brownlee
“Previous studies across surgical fields have shown significant associations between patient characteristics including age, sex, comorbidity status, race, and insurance level, and outcomes following a range of surgical procedures,” Ms. Brownlee, a medical student at Loyola University Chicago’s Stritch School of Medicine, said at the annual meeting of the Western Surgical Association. “Identifying these associations has helped guide clinical practice and decision-making for both surgeons and patients, and has called attention to areas of health disparities in surgical care. More recently, other aspects of the CDM, including hospital factors like staffing ratios, procedure volume, and the availability of rehabilitation and specialized nursing services, have been investigated to assess the influence these components might have on patient outcomes postoperatively. However, it’s not known how much hospital factors such as these contribute to the variation in surgical outcomes overall. It’s important to know what changes we can make that will have the biggest impact on improving patient outcomes, so that efforts on reducing readmissions are appropriately designed.”

The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.

The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.

Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).

“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”

The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.

 

CORONADO, CALIF. – Variation in readmission risk across hospitals following certain surgical procedures is more attributable to hospital factors than to patient characteristics, results from a large analysis demonstrated.

Such is the impact of the care delivery macro environment (CDM), which Sarah A. Brownlee and coauthors defined as a series of complex interactions between patient characteristics and imposed hospital attributes than can impact patient outcomes postoperatively.

Sara A. Brownlee
“Previous studies across surgical fields have shown significant associations between patient characteristics including age, sex, comorbidity status, race, and insurance level, and outcomes following a range of surgical procedures,” Ms. Brownlee, a medical student at Loyola University Chicago’s Stritch School of Medicine, said at the annual meeting of the Western Surgical Association. “Identifying these associations has helped guide clinical practice and decision-making for both surgeons and patients, and has called attention to areas of health disparities in surgical care. More recently, other aspects of the CDM, including hospital factors like staffing ratios, procedure volume, and the availability of rehabilitation and specialized nursing services, have been investigated to assess the influence these components might have on patient outcomes postoperatively. However, it’s not known how much hospital factors such as these contribute to the variation in surgical outcomes overall. It’s important to know what changes we can make that will have the biggest impact on improving patient outcomes, so that efforts on reducing readmissions are appropriately designed.”

The purpose of the current study was to determine the relative contribution of various aspects of the CDM to 1-year readmission risk after surgery. Working with colleagues Anai Kothari, MD, and Paul Kuo MD, in the One:MAP Section of Clinical informatics and Analytics in the department of surgery at Loyola University Medical Center, Ms. Brownlee analyzed the Healthcare Cost and Utilization Project State Inpatient Databases from Florida, New York, and Washington between 2009 and 2013, which were linked to the American Hospital Association Annual Survey from that same time period.

The researchers used smoothed hazard estimates to determine all-cause readmission in the year after surgery, and multilevel survival models with shared frailty to determine the relative impact of hospital versus patient characteristics on the heterogeneity of readmission risk between hospitals. They limited the analysis to patients aged 18 years and older who underwent one the following procedures: abdominal aortic aneurysm repair, pancreatectomy, colectomy, coronary artery bypass graft, and total hip arthroplasty.

Ms. Brownlee reported results from 502,157 patients who underwent surgical procedures at 347 hospitals. The 1-year readmission rate was 23.5%, and ranged from 12% to 36% across procedures. After controlling for procedure, the researchers observed a 7.9% variation in readmission risk between hospitals. Staffing accounted for 9.8% of variance, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%), patient ZIP code (3.8%), hospital perioperative resources such as inpatient rehab (2.9%), hospital volume (2.8%), and patient clinical characteristics (2.1%). The following hospital characteristics were significantly associated with a lower risk of 1-year readmission: high physician/bed ratio (hazard ratio 0.85; P = .00017); transplant status (HR 0.87; P = .022); high-income ZIP code (HR 0.89; P less than .001); high nurse bed/bed ratio (HR 0.90; P = .047), and cancer center designation (HR 0.93; P = .021).

“Compared to patient clinical characteristics, hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes,” Ms. Brownlee concluded. “However, it’s important to note that in the present study, over 70% of variation in readmission rates is not explained by the covariates that we analyzed. It’s possible that there are other factors we need to consider. That’s where the direction of this research is going. Much of the variation in readmission risk across hospitals cannot be characterized with currently utilized administrative data.”

The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.
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Key clinical point: Hospital factors such as staffing ratios, perioperative resources, and structural elements account for more variation in postoperative outcomes.

Major finding: Staffing accounted for 9.8% of variance in readmission risk between hospitals, followed by hospital structural characteristics such as teaching status and clinical programs (7.5%).

Data source: Results from 502,157 patients who underwent surgical procedures at 347 hospitals in three states.

Disclosures: The National Institutes of Health provided funding for the study. Ms. Brownlee reported having no financial disclosures.

Recovery path complicated for trauma patients with VTE

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– Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.

Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”

Dr. Belinda McCully
However, she continued, severe hemorrhage can lead to a hypocoagulable state that is further exacerbated by hemodilution, acidosis, and hypothermia, creating traumatic-induced coagulopathy. “Despite this hypocoagulable state, VTEs are still present in this patient population.”

Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.

Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).

Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”

The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
 

 

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– Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.

Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”

Dr. Belinda McCully
However, she continued, severe hemorrhage can lead to a hypocoagulable state that is further exacerbated by hemodilution, acidosis, and hypothermia, creating traumatic-induced coagulopathy. “Despite this hypocoagulable state, VTEs are still present in this patient population.”

Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.

Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).

Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”

The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
 

 

 

– Patients who develop a venous thromboembolism (VTE) following severe hemorrhage are more susceptible to complications, compared with their counterparts who do not; they also exhibit hypercoagulability and enhanced platelet function at admission, and have delayed recovery of coagulation and platelet function following injury.

Those are the key findings from a secondary analysis of data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized 680 severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells (JAMA 2015;313[5]:471-82). “The prevention of VTE following traumatic injury is an ongoing challenge,” Belinda H. McCully, PhD, said at the annual meeting of the Western Surgical Association. “Despite prophylaxis, about 25% of patients present with VTE, which is associated with higher complications and an increased risk for mortality. Common risk factors for mortality include age, body mass index, extremity injury, and immobility, but the precise mechanisms that contribute to VTE development are not well understood. We do know that the three main factors contributing to thrombosis include static flow, endothelial injury, and hypercoagulability. Clinically, coagulation is the most feasible factor to assess, mainly through the use of conventional coagulation tests, thromboelastography, platelet levels, and platelet function assays.”

Dr. Belinda McCully
However, she continued, severe hemorrhage can lead to a hypocoagulable state that is further exacerbated by hemodilution, acidosis, and hypothermia, creating traumatic-induced coagulopathy. “Despite this hypocoagulable state, VTEs are still present in this patient population.”

Dr. McCully of the division of trauma, critical care, and acute care surgery in the department of surgery at Oregon Health & Science University, Portland, and her associates hypothesized that enhanced, earlier recovery of coagulation function is associated with increased VTE risk in severely injured trauma patients. To test this hypothesis, they conducted a secondary analysis of the PROPPR database, excluding patients who received anticoagulants, to rule out any bias against VTE development, as well as patients who died within 24 hours, to reduce the survival bias. This left 558 patients: 475 who did not develop a VTE, and 83 who did (defined as those who developed deep vein thrombosis or pulmonary embolism). Patient characteristics of interest included age, sex, BMI, mechanism of injury, and injury severity, as well as the transfusion group, the type of blood products given, and the percentage of patients given procoagulants. The investigators also assessed length of stay and complication incidence previously defined by the trial. During the trial, blood samples were taken from admission up to 72 hours and were used to asses both whole blood coagulation using thromboelastography and platelet function using the Multiplate assay.

Dr. McCully reported that VTE patients and non-VTE patients demonstrated similar admission platelet function activity and inhibition of all platelet function parameters at 24 hours (P less than .05). The onset of platelet function recovery was delayed in VTE patients, specifically for arachidonic acid, adenosine-5’-diphosphate, and collagen. Changes in thromboelastography, clot time to initiation, formation, rate of formation, and strength and index of platelet function from admission to 2 hours indicated increasing hypocoagulability (P less than .05) but suppressed clot lysis in both groups. Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).

Adverse outcomes were also more prevalent in the VTE group, compared with the non-VTE group, and included systemic inflammatory response syndrome (82% vs. 72%), acute kidney injury (36% vs. 26%), infection (61% vs. 31%), sepsis (60% vs. 28%), and pneumonia (34% vs. 19%; P less than 0.05 for all associations). Conversely, regression analysis showed that VTE was associated only with total hospital days (odds ratio, 1.12), while adverse events were similar between the two groups. “From this we can conclude that VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission, and compensatory mechanisms in response to a delayed recovery of coagulation and platelet function,” Dr. McCully said.

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis of prospectively collected data. “We also plan to assess plasma markers of clot strength and fibrinolysis, which is an ongoing process,” she said. “Despite excluding patients that died within 24 hours, there was still a survival bias in the VTE group.”

The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.
 

 

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Key clinical point: VTE development following trauma may be attributed to hypercoagulable thromboelastography parameters and enhanced platelet function at admission.

Major finding: Compared with patients in the non-VTE group, the VTE group had lower mortality (4% vs. 13%) but increased total hospital days (a mean of 30 vs. 16; P less than .05).

Data source: A secondary analysis of 558 patients from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, which randomized severely injured trauma patients from 12 level I trauma centers to receive 1:1:1 or 1:1:2 ratios of plasma to platelets to red blood cells.

Disclosures: The PROPPR study was supported by the National Heart, Lung, and Blood Institute and by the Department of Defense. Dr. McCully reported having no relevant financial disclosures.

VIDEO: Statins cut mortality in ankylosing spondylitis, psoriatic arthritis

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WASHINGTON – Statins lowered all-cause mortality by 32% in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in a retrospective cohort study.

The magnitude of benefit from statins in these two disease states is greater than that found in the general population (estimated 9%-14% reduction in all-cause mortality) and than that reported in patients with rheumatoid arthritis (RA, 21% reduction), said Amar Oza, MD, a second-year rheumatology fellow at Massachusetts General Hospital and Harvard Medical School, both in Boston.

“This is a unique study. The benefit of statins has not been looked at in AS and PsA, specifically,” Dr. Oza explained. “More data are needed” to establish this benefit with certainty, he added.

The data were presented at the annual meeting of the American College of Rheumatology, and Dr. Oza discussed the findings in a video interview.

The study compared 2,904 patients with AS or PsA who initiated statins between 2000 and 2014 with 2,904 propensity-matched AS or PsA patients who did not initiate statins during that period. Patients were drawn from a United Kingdom general population database.

The investigators used a propensity score that accounted for 50 confounding variables to match the two cohorts. These variables included, but were not limited to, disease duration, socioeconomic status, body mass index, lifestyle factors, and medication use.

“This study is the first step in elucidating the benefit of statins in AS and PsA. It is a good step forward. If additional data substantiate that AS and PsA patients have a low threshold for statins, I can envision statins for both primary and secondary prevention in this patient population,” Dr. Oza stated.

The authors had no relevant financial disclosures.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

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WASHINGTON – Statins lowered all-cause mortality by 32% in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in a retrospective cohort study.

The magnitude of benefit from statins in these two disease states is greater than that found in the general population (estimated 9%-14% reduction in all-cause mortality) and than that reported in patients with rheumatoid arthritis (RA, 21% reduction), said Amar Oza, MD, a second-year rheumatology fellow at Massachusetts General Hospital and Harvard Medical School, both in Boston.

“This is a unique study. The benefit of statins has not been looked at in AS and PsA, specifically,” Dr. Oza explained. “More data are needed” to establish this benefit with certainty, he added.

The data were presented at the annual meeting of the American College of Rheumatology, and Dr. Oza discussed the findings in a video interview.

The study compared 2,904 patients with AS or PsA who initiated statins between 2000 and 2014 with 2,904 propensity-matched AS or PsA patients who did not initiate statins during that period. Patients were drawn from a United Kingdom general population database.

The investigators used a propensity score that accounted for 50 confounding variables to match the two cohorts. These variables included, but were not limited to, disease duration, socioeconomic status, body mass index, lifestyle factors, and medication use.

“This study is the first step in elucidating the benefit of statins in AS and PsA. It is a good step forward. If additional data substantiate that AS and PsA patients have a low threshold for statins, I can envision statins for both primary and secondary prevention in this patient population,” Dr. Oza stated.

The authors had no relevant financial disclosures.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

 

WASHINGTON – Statins lowered all-cause mortality by 32% in patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in a retrospective cohort study.

The magnitude of benefit from statins in these two disease states is greater than that found in the general population (estimated 9%-14% reduction in all-cause mortality) and than that reported in patients with rheumatoid arthritis (RA, 21% reduction), said Amar Oza, MD, a second-year rheumatology fellow at Massachusetts General Hospital and Harvard Medical School, both in Boston.

“This is a unique study. The benefit of statins has not been looked at in AS and PsA, specifically,” Dr. Oza explained. “More data are needed” to establish this benefit with certainty, he added.

The data were presented at the annual meeting of the American College of Rheumatology, and Dr. Oza discussed the findings in a video interview.

The study compared 2,904 patients with AS or PsA who initiated statins between 2000 and 2014 with 2,904 propensity-matched AS or PsA patients who did not initiate statins during that period. Patients were drawn from a United Kingdom general population database.

The investigators used a propensity score that accounted for 50 confounding variables to match the two cohorts. These variables included, but were not limited to, disease duration, socioeconomic status, body mass index, lifestyle factors, and medication use.

“This study is the first step in elucidating the benefit of statins in AS and PsA. It is a good step forward. If additional data substantiate that AS and PsA patients have a low threshold for statins, I can envision statins for both primary and secondary prevention in this patient population,” Dr. Oza stated.

The authors had no relevant financial disclosures.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

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How Does Physical Activity Differ in Mild Alzheimer’s Disease?

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People with Alzheimer’s disease have different daily patterns of activity, compared with healthy controls, according to research published online ahead of print October 4 in the Journal of Alzheimer’s Disease. Understanding this different daily pattern in physical activity could be key to designing interventions and improving sleep for people with early Alzheimer’s disease, perhaps by targeting more physical activity in morning, said the researchers.

Too little is known about patterns of activity for people experiencing the early stages of Alzheimer’s disease, according to Amber Watts, PhD, Assistant Professor of Clinical Psychology at the University of Kansas in Lawrence. For instance, researchers have lacked useful data about how the progression of the disease itself plays a role in diminishing day-to-day physical activity.

Amber Watts, PhD
“Physical activity is important for brain function,” she said. “We know that people who are physically active are less likely to develop Alzheimer’s disease. But we also know that for people already living with Alzheimer’s disease, physical activity can help them function better, decline more slowly, and help them with symptoms like agitation, wandering, and sleeplessness.”

Vijay R. Varma, PhD, a postdoctoral fellow at the National Institute on Aging, and Dr. Watts analyzed the daily physical activity of 92 volunteers with and without mild Alzheimer’s disease at the University of Kansas’s Alzheimer’s Disease Center in Kansas City. Participants wore Actigraph GT3X+ accelerometers for a week.Mild Alzheimer’s disease was associated with less moderate-intensity physical activity, lower peak activity, and lower physical activity complexity, particularly during the morning. Mild Alzheimer’s disease was not associated with greater sedentary activity or less lower-intensity physical activity across the day after adjusting for noncognitive covariates.

The kinds of physical activity helpful to people with Alzheimer’s disease might be simple activities such as finding time to walk around the neighborhood, said Dr. Watts. “Walking is actually the best thing,” she said. “It is low risk, it is safe, anyone can do it, it doesn’t require specific equipment, it can be done anywhere. There are other light-intensity activities like stretching, tai chi, household chores, gardening, walking around the mall—those are also beneficial. People with Alzheimer’s disease do not have to go to the gym, they just need to do something that keeps them moving and keeps them from sitting continuously.”

Suggested Reading

Varma VR, Watts A. Daily physical activity patterns during the early stage of Alzheimer’s disease. J Alzheimers Dis. 2016 Oct 4 [Epub ahead of print].

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People with Alzheimer’s disease have different daily patterns of activity, compared with healthy controls, according to research published online ahead of print October 4 in the Journal of Alzheimer’s Disease. Understanding this different daily pattern in physical activity could be key to designing interventions and improving sleep for people with early Alzheimer’s disease, perhaps by targeting more physical activity in morning, said the researchers.

Too little is known about patterns of activity for people experiencing the early stages of Alzheimer’s disease, according to Amber Watts, PhD, Assistant Professor of Clinical Psychology at the University of Kansas in Lawrence. For instance, researchers have lacked useful data about how the progression of the disease itself plays a role in diminishing day-to-day physical activity.

Amber Watts, PhD
“Physical activity is important for brain function,” she said. “We know that people who are physically active are less likely to develop Alzheimer’s disease. But we also know that for people already living with Alzheimer’s disease, physical activity can help them function better, decline more slowly, and help them with symptoms like agitation, wandering, and sleeplessness.”

Vijay R. Varma, PhD, a postdoctoral fellow at the National Institute on Aging, and Dr. Watts analyzed the daily physical activity of 92 volunteers with and without mild Alzheimer’s disease at the University of Kansas’s Alzheimer’s Disease Center in Kansas City. Participants wore Actigraph GT3X+ accelerometers for a week.Mild Alzheimer’s disease was associated with less moderate-intensity physical activity, lower peak activity, and lower physical activity complexity, particularly during the morning. Mild Alzheimer’s disease was not associated with greater sedentary activity or less lower-intensity physical activity across the day after adjusting for noncognitive covariates.

The kinds of physical activity helpful to people with Alzheimer’s disease might be simple activities such as finding time to walk around the neighborhood, said Dr. Watts. “Walking is actually the best thing,” she said. “It is low risk, it is safe, anyone can do it, it doesn’t require specific equipment, it can be done anywhere. There are other light-intensity activities like stretching, tai chi, household chores, gardening, walking around the mall—those are also beneficial. People with Alzheimer’s disease do not have to go to the gym, they just need to do something that keeps them moving and keeps them from sitting continuously.”

Suggested Reading

Varma VR, Watts A. Daily physical activity patterns during the early stage of Alzheimer’s disease. J Alzheimers Dis. 2016 Oct 4 [Epub ahead of print].

People with Alzheimer’s disease have different daily patterns of activity, compared with healthy controls, according to research published online ahead of print October 4 in the Journal of Alzheimer’s Disease. Understanding this different daily pattern in physical activity could be key to designing interventions and improving sleep for people with early Alzheimer’s disease, perhaps by targeting more physical activity in morning, said the researchers.

Too little is known about patterns of activity for people experiencing the early stages of Alzheimer’s disease, according to Amber Watts, PhD, Assistant Professor of Clinical Psychology at the University of Kansas in Lawrence. For instance, researchers have lacked useful data about how the progression of the disease itself plays a role in diminishing day-to-day physical activity.

Amber Watts, PhD
“Physical activity is important for brain function,” she said. “We know that people who are physically active are less likely to develop Alzheimer’s disease. But we also know that for people already living with Alzheimer’s disease, physical activity can help them function better, decline more slowly, and help them with symptoms like agitation, wandering, and sleeplessness.”

Vijay R. Varma, PhD, a postdoctoral fellow at the National Institute on Aging, and Dr. Watts analyzed the daily physical activity of 92 volunteers with and without mild Alzheimer’s disease at the University of Kansas’s Alzheimer’s Disease Center in Kansas City. Participants wore Actigraph GT3X+ accelerometers for a week.Mild Alzheimer’s disease was associated with less moderate-intensity physical activity, lower peak activity, and lower physical activity complexity, particularly during the morning. Mild Alzheimer’s disease was not associated with greater sedentary activity or less lower-intensity physical activity across the day after adjusting for noncognitive covariates.

The kinds of physical activity helpful to people with Alzheimer’s disease might be simple activities such as finding time to walk around the neighborhood, said Dr. Watts. “Walking is actually the best thing,” she said. “It is low risk, it is safe, anyone can do it, it doesn’t require specific equipment, it can be done anywhere. There are other light-intensity activities like stretching, tai chi, household chores, gardening, walking around the mall—those are also beneficial. People with Alzheimer’s disease do not have to go to the gym, they just need to do something that keeps them moving and keeps them from sitting continuously.”

Suggested Reading

Varma VR, Watts A. Daily physical activity patterns during the early stage of Alzheimer’s disease. J Alzheimers Dis. 2016 Oct 4 [Epub ahead of print].

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REBOA may be a safe alternative to RTACC in the acute care setting

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– Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.

Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.

XiXinXing/ThinkStock
REBOA is an emerging and less invasive method of aortic occlusion during traumatic arrest. “Recent evidence published in the Journal of Trauma suggests that REBOA has similar outcomes to resuscitative thoracotomy with aortic cross-clamping or RTACC,” said Dr. Teeter, who is currently an emergency medicine resident at the University of North Carolina, Chapel Hill, but conducted this research during a fellowship at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center in Baltimore.

Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.

Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.

Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”

All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.

While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.

Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.

Overall, patient survival was dismal. Only one patient who received REBOA survived.

Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.

In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.

“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”

At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.

Dr. David Hampton
In a subsequent presentation, David Hampton, MD, a surgical critical care fellow at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center, confirmed that many recent studies have demonstrated that REBOA is a comparable alternative to emergency thoracotomies. In fact, REBOA is commonly used throughout Japan, the United Kingdom, and in northern Europe; however, in the United States, REBOA is currently only used at a few Level 1 trauma centers and in the military, according to Dr. Hampton.

A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.

In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.

To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.

During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.

Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.

In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.

Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.

The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
 

 

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– Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.

Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.

XiXinXing/ThinkStock
REBOA is an emerging and less invasive method of aortic occlusion during traumatic arrest. “Recent evidence published in the Journal of Trauma suggests that REBOA has similar outcomes to resuscitative thoracotomy with aortic cross-clamping or RTACC,” said Dr. Teeter, who is currently an emergency medicine resident at the University of North Carolina, Chapel Hill, but conducted this research during a fellowship at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center in Baltimore.

Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.

Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.

Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”

All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.

While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.

Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.

Overall, patient survival was dismal. Only one patient who received REBOA survived.

Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.

In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.

“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”

At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.

Dr. David Hampton
In a subsequent presentation, David Hampton, MD, a surgical critical care fellow at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center, confirmed that many recent studies have demonstrated that REBOA is a comparable alternative to emergency thoracotomies. In fact, REBOA is commonly used throughout Japan, the United Kingdom, and in northern Europe; however, in the United States, REBOA is currently only used at a few Level 1 trauma centers and in the military, according to Dr. Hampton.

A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.

In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.

To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.

During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.

Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.

In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.

Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.

The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
 

 

 

– Resuscitative endovascular balloon occlusion of the aorta (REBOA) could be an acceptable alternative to thoracotomy in traumatic arrest patients who are hemorrhaging below the diaphragm, according to the results of a small pilot study which were presented by William Teeter, MD, at the annual clinical congress of the American College of Surgeons.

Furthermore, virtual simulation training sufficiently prepares surgeons to safely use the REBOA technique in the acute care setting, a separate study found. Importantly, this training has the potential to allow REBOA to become a widespread tool for surgeons regardless of their endovascular surgical experience.

XiXinXing/ThinkStock
REBOA is an emerging and less invasive method of aortic occlusion during traumatic arrest. “Recent evidence published in the Journal of Trauma suggests that REBOA has similar outcomes to resuscitative thoracotomy with aortic cross-clamping or RTACC,” said Dr. Teeter, who is currently an emergency medicine resident at the University of North Carolina, Chapel Hill, but conducted this research during a fellowship at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center in Baltimore.

Dr. Teeter presented the preliminary results of a pilot study involving 19 patients who received RTACC between 2008 and 2013 and 17 patients who received REBOA between 2013 and 2015. All study participants were trauma patients who arrived at the R Adams Cowley Shock Trauma Center in arrest or arrested shortly after arrival.

Age, gender, Glasgow Coma Scale, and injury severity score were the same or similar between the two groups, Dr. Teeter reported. Mean systolic blood pressure at admission was 14 mmHg for the REBOA group and 28 mmHg for the RTACC group; however, the majority of patients (82% of REBOA patients and 73% of RTACC patients) arrived with a blood pressure of 0, reported Dr. Teeter.

Importantly, patients in the RTACC group who had penetrating chest injury were excluded for this analysis, Dr. Teeter noted, adding that there was a slightly higher incidence of blunt trauma within the REBOA group likely due to “a change in practice at the trauma center during this time.”

All resuscitations were captured with real-time videography. Continuous vitals were also collected and analyzed.

While more RTACC patients survived to the operating room (53% vs. 68%), among the REBOA group there were more patients who experienced return of spontaneous circulation (53% vs. 37%). However, neither of these results was statistically significant.

Following occlusion of the aorta, the blood pressure measures, taken from continuous vital signs and averaged over a 15-minute period, were 80 mmHg for the REBOA group and 46 mmHg for the RTACC group. Again, this result was statistically insignificant but trended toward favoring REBOA.

Overall, patient survival was dismal. Only one patient who received REBOA survived.

Following Dr. Teeter’s presentation, the study’s assigned discussant, Nicole A. Stassen, MD, of the University of Rochester Medical Center, N.Y., noted that while post-occlusion blood pressure was higher for the REBOA group it seemed not to matter as the majority of patients did not survive. Dr. Stassen also asked if these preliminary results were sufficient to inform or change clinical practice.

In response, Dr. Teeter explained that the pilot study was conducted at a time when the literature was unclear about how patients would respond to open versus endovascular occlusion, and this data helped guide further research and resuscitation efforts.

“At our center there has been a marked change in practice regarding which patients receive resuscitative thoracotomy and which get REBOA,” he added and concluded that “these and previous data suggest that the time performing thoracotomy for resuscitation purposes may be better spent performing CPR with REBOA.”

At the very least, this pilot study demonstrated that “REBOA may be an acceptable alternative to RTACC.” Further analysis of larger study populations will be published soon and will show that REBOA may be preferred over RTACC, according to Dr. Teeter.

Dr. David Hampton
In a subsequent presentation, David Hampton, MD, a surgical critical care fellow at the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center, confirmed that many recent studies have demonstrated that REBOA is a comparable alternative to emergency thoracotomies. In fact, REBOA is commonly used throughout Japan, the United Kingdom, and in northern Europe; however, in the United States, REBOA is currently only used at a few Level 1 trauma centers and in the military, according to Dr. Hampton.

A major hindrance to wider-spread REBOA use in the United States is the lack of endovascular training for surgeons during residency which has resulted in a limited number of surgeons who can perform the REBOA technique and a limited number of surgeons who can teach the procedure to others, said Dr. Hampton.

In lieu of experience, formalized 1- or 2-day endovascular simulation courses, such as BEST, were created to prepare surgeons to use techniques such as REBOA. Prior validation studies, including those conducted by researchers at the University of Maryland, demonstrated that surgeons who participated in these courses improved surgical technique and increased their surgical knowledge base, Dr. Hampton reported.

To further elucidate the benefits of these training courses on the successful use of REBOA in the acute care setting, Dr. Hampton and his associates selected nine acute care surgeons with varying endovascular surgical experience to complete the 1-day BEST course and then compared surgeons’ performances of the REBOA technique after successful course completion.

During the study, a total of 28 REBOA procedures were performed, 17 by the surgeons with no endovascular experience, and the remaining 11 by surgeons with endovascular surgical experience.

Overall, there was no difference in wire placements, sheath insertion, position or localization of balloons, or balloon inflation. In addition, there was no difference in mortality among patients, and there were no known REBOA complications during this study.

In conclusion, endovascular experience during residency is not a prerequisite for safe REBOA placement, Dr. Hampton commented.

Taken together, these two research studies are really helping to break ground on REBOA use in the acute care setting, commented an audience member.

The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.
 

 

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Key clinical point: REBOA and RTACC had similar outcomes in a small pilot study.

Major finding: More RTACC patients survived to the operating room (53% vs. 68%), but more REBOA patients experienced return of spontaneous circulation (53% vs. 37%).

Data source: Pilot study involving 36 trauma patients who received either RTACC or REBOA.

Disclosures: The Department of Defense funded Dr. Teeter’s study. Dr. Teeter and Dr. Hampton both reported having no disclosures.

Report Provides Update on Alzheimer’s Disease Drug Pipeline

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WASHINGTON, DC—Fifty-seven new drugs for Alzheimer’s disease currently are in phase II studies, according to an analysis conducted by Researchers Against Alzheimer’s (RA2). Nearly twice as many mechanisms of action are being tested in phase II than in phase III clinical trials, the group said. This diverse pipeline could provide physicians, persons with Alzheimer’s disease, and their loved ones with new ways to combat the disease in the future.

Advancements in Alzheimer’s Disease Drug Development

As the development of these compounds progresses, and the science of Alzheimer’s disease drug development advances, policy makers, clinical researchers, drug developers, and other Alzheimer’s disease drug partners need to create new clinical trial infrastructure and designs that allow for rapid recruitment and testing, consistent high-quality data, and prompt data disclosure, said RA2.

“These potentially game-changing drugs on the horizon may make Alzheimer’s [disease] a manageable disease,” said George Vradenburg, Cofounder and Chair of USAgainstAlzheimer’s, a group that advocates for a cure for Alzheimer’s disease. “To assure our best shot at success, we must ensure that the necessary investments are being made to build a 21st-century infrastructure to test their effectiveness and an innovation-friendly path to market [for] those in need,” he said.

George Vradenburg

The first RA2 pipeline analysis released in March found 17 Alzheimer’s disease drugs in phase III clinical trials planned to launch in the next five years. However, since the initial phase III pipeline report was issued, several Alzheimer’s disease drug candidates have moved from phase II to phase III clinical trials. According to the most recent analysis, 23 Alzheimer’s disease drugs are in phase III clinical trials. In all, 19 drugs could reach the market in the next five years, according to RA2.

Researchers and pharmaceutical companies are increasingly focusing on disease-modifying prevention drugs, such as those that can be administered to people at risk for Alzheimer’s disease before symptoms appear. These drugs could prevent or delay the development of dementia symptoms.

A similar approach is used to prevent people who are HIV-positive from developing AIDS symptoms. These drugs represent a different approach from symptomatic drugs, which are intended to treat Alzheimer’s disease symptoms such as agitation, cognitive loss, hallucinations, or depression.

Several changes are required to maintain a diverse pipeline of preventive and symptomatic drugs, according to the analysis, which was reviewed by academic research experts and select RA2 members. These changes include a standing, high-performance clinical trial infrastructure that allows for rapid testing and fast failure or success.

In addition, the field needs robust biomarkers that help to indicate disease severity or progression and help to assess the effectiveness of drugs in populations without any symptoms, potentially preventing the development of symptoms altogether, according to the analysis. A greater understanding of biomarker research will assist researchers and clinicians to prescribe medicines to the appropriate populations.

New end points for trials are another necessary change, said the group. Many of the current scales used in Alzheimer’s disease trials will not be effective in people in early stages of the disease, since symptoms like cognitive decline may occur late in the disease.

Clinicians and researchers also should develop mechanisms for actively sharing information about which treatments work best with certain patient populations, according to the analysis.

Finally, the field requires innovative clinical trial designs to increase flexibility for drug developers. Such designs include adaptive trials that are modified based on patient outcomes, as well as trials of combinations of novel treatments. The latter trials could include drugs with demonstrated target engagement, but without efficacy as monotherapy.

Phase II/III and Phase III Drug Trials

Trials of several phase II/III drugs and one phase III drug will be completed in 2017. The phase II/III treatments include AC-1204, an oral drug intended for patients with mild to moderate Alzheimer’s disease that improves mitochondrial metabolism through chronic ketosis. A combination of albumin and immunoglobulin is being studied for patients with mild to moderate Alzheimer’s disease. It is an IV immunosuppressant with possible antiamyloid antibodies and albumin-binding capacity. Finally, a phase III trial of suvorexant, an oral orexin receptor antagonist under investigation for patients with Alzheimer’s disease and insomnia, will conclude in 2017.

“I am encouraged to see such a range of approaches to treating Alzheimer’s [disease] in phase II development,” said David Morgan, PhD, CEO of the Byrd Alzheimer Institute at the University of South Florida in Tampa. “There is much work that still needs to be done, but the drugs in phase II clinical trials offer a great deal of hope for the future,” he added.

Erica Tricarico

Suggested Reading

Jacobson LH, Callander GE, Hoyer D. Suvorexant for the treatment of insomnia. Expert Rev Clin Pharmacol. 2014; 7(6):711-730.

Cummings J, Aisen PS, DuBois B, et al. Drug development in Alzheimer’s disease: the path to 2025. Alzheimers Res Ther. 2016;8:39.

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WASHINGTON, DC—Fifty-seven new drugs for Alzheimer’s disease currently are in phase II studies, according to an analysis conducted by Researchers Against Alzheimer’s (RA2). Nearly twice as many mechanisms of action are being tested in phase II than in phase III clinical trials, the group said. This diverse pipeline could provide physicians, persons with Alzheimer’s disease, and their loved ones with new ways to combat the disease in the future.

Advancements in Alzheimer’s Disease Drug Development

As the development of these compounds progresses, and the science of Alzheimer’s disease drug development advances, policy makers, clinical researchers, drug developers, and other Alzheimer’s disease drug partners need to create new clinical trial infrastructure and designs that allow for rapid recruitment and testing, consistent high-quality data, and prompt data disclosure, said RA2.

“These potentially game-changing drugs on the horizon may make Alzheimer’s [disease] a manageable disease,” said George Vradenburg, Cofounder and Chair of USAgainstAlzheimer’s, a group that advocates for a cure for Alzheimer’s disease. “To assure our best shot at success, we must ensure that the necessary investments are being made to build a 21st-century infrastructure to test their effectiveness and an innovation-friendly path to market [for] those in need,” he said.

George Vradenburg

The first RA2 pipeline analysis released in March found 17 Alzheimer’s disease drugs in phase III clinical trials planned to launch in the next five years. However, since the initial phase III pipeline report was issued, several Alzheimer’s disease drug candidates have moved from phase II to phase III clinical trials. According to the most recent analysis, 23 Alzheimer’s disease drugs are in phase III clinical trials. In all, 19 drugs could reach the market in the next five years, according to RA2.

Researchers and pharmaceutical companies are increasingly focusing on disease-modifying prevention drugs, such as those that can be administered to people at risk for Alzheimer’s disease before symptoms appear. These drugs could prevent or delay the development of dementia symptoms.

A similar approach is used to prevent people who are HIV-positive from developing AIDS symptoms. These drugs represent a different approach from symptomatic drugs, which are intended to treat Alzheimer’s disease symptoms such as agitation, cognitive loss, hallucinations, or depression.

Several changes are required to maintain a diverse pipeline of preventive and symptomatic drugs, according to the analysis, which was reviewed by academic research experts and select RA2 members. These changes include a standing, high-performance clinical trial infrastructure that allows for rapid testing and fast failure or success.

In addition, the field needs robust biomarkers that help to indicate disease severity or progression and help to assess the effectiveness of drugs in populations without any symptoms, potentially preventing the development of symptoms altogether, according to the analysis. A greater understanding of biomarker research will assist researchers and clinicians to prescribe medicines to the appropriate populations.

New end points for trials are another necessary change, said the group. Many of the current scales used in Alzheimer’s disease trials will not be effective in people in early stages of the disease, since symptoms like cognitive decline may occur late in the disease.

Clinicians and researchers also should develop mechanisms for actively sharing information about which treatments work best with certain patient populations, according to the analysis.

Finally, the field requires innovative clinical trial designs to increase flexibility for drug developers. Such designs include adaptive trials that are modified based on patient outcomes, as well as trials of combinations of novel treatments. The latter trials could include drugs with demonstrated target engagement, but without efficacy as monotherapy.

Phase II/III and Phase III Drug Trials

Trials of several phase II/III drugs and one phase III drug will be completed in 2017. The phase II/III treatments include AC-1204, an oral drug intended for patients with mild to moderate Alzheimer’s disease that improves mitochondrial metabolism through chronic ketosis. A combination of albumin and immunoglobulin is being studied for patients with mild to moderate Alzheimer’s disease. It is an IV immunosuppressant with possible antiamyloid antibodies and albumin-binding capacity. Finally, a phase III trial of suvorexant, an oral orexin receptor antagonist under investigation for patients with Alzheimer’s disease and insomnia, will conclude in 2017.

“I am encouraged to see such a range of approaches to treating Alzheimer’s [disease] in phase II development,” said David Morgan, PhD, CEO of the Byrd Alzheimer Institute at the University of South Florida in Tampa. “There is much work that still needs to be done, but the drugs in phase II clinical trials offer a great deal of hope for the future,” he added.

Erica Tricarico

Suggested Reading

Jacobson LH, Callander GE, Hoyer D. Suvorexant for the treatment of insomnia. Expert Rev Clin Pharmacol. 2014; 7(6):711-730.

Cummings J, Aisen PS, DuBois B, et al. Drug development in Alzheimer’s disease: the path to 2025. Alzheimers Res Ther. 2016;8:39.

WASHINGTON, DC—Fifty-seven new drugs for Alzheimer’s disease currently are in phase II studies, according to an analysis conducted by Researchers Against Alzheimer’s (RA2). Nearly twice as many mechanisms of action are being tested in phase II than in phase III clinical trials, the group said. This diverse pipeline could provide physicians, persons with Alzheimer’s disease, and their loved ones with new ways to combat the disease in the future.

Advancements in Alzheimer’s Disease Drug Development

As the development of these compounds progresses, and the science of Alzheimer’s disease drug development advances, policy makers, clinical researchers, drug developers, and other Alzheimer’s disease drug partners need to create new clinical trial infrastructure and designs that allow for rapid recruitment and testing, consistent high-quality data, and prompt data disclosure, said RA2.

“These potentially game-changing drugs on the horizon may make Alzheimer’s [disease] a manageable disease,” said George Vradenburg, Cofounder and Chair of USAgainstAlzheimer’s, a group that advocates for a cure for Alzheimer’s disease. “To assure our best shot at success, we must ensure that the necessary investments are being made to build a 21st-century infrastructure to test their effectiveness and an innovation-friendly path to market [for] those in need,” he said.

George Vradenburg

The first RA2 pipeline analysis released in March found 17 Alzheimer’s disease drugs in phase III clinical trials planned to launch in the next five years. However, since the initial phase III pipeline report was issued, several Alzheimer’s disease drug candidates have moved from phase II to phase III clinical trials. According to the most recent analysis, 23 Alzheimer’s disease drugs are in phase III clinical trials. In all, 19 drugs could reach the market in the next five years, according to RA2.

Researchers and pharmaceutical companies are increasingly focusing on disease-modifying prevention drugs, such as those that can be administered to people at risk for Alzheimer’s disease before symptoms appear. These drugs could prevent or delay the development of dementia symptoms.

A similar approach is used to prevent people who are HIV-positive from developing AIDS symptoms. These drugs represent a different approach from symptomatic drugs, which are intended to treat Alzheimer’s disease symptoms such as agitation, cognitive loss, hallucinations, or depression.

Several changes are required to maintain a diverse pipeline of preventive and symptomatic drugs, according to the analysis, which was reviewed by academic research experts and select RA2 members. These changes include a standing, high-performance clinical trial infrastructure that allows for rapid testing and fast failure or success.

In addition, the field needs robust biomarkers that help to indicate disease severity or progression and help to assess the effectiveness of drugs in populations without any symptoms, potentially preventing the development of symptoms altogether, according to the analysis. A greater understanding of biomarker research will assist researchers and clinicians to prescribe medicines to the appropriate populations.

New end points for trials are another necessary change, said the group. Many of the current scales used in Alzheimer’s disease trials will not be effective in people in early stages of the disease, since symptoms like cognitive decline may occur late in the disease.

Clinicians and researchers also should develop mechanisms for actively sharing information about which treatments work best with certain patient populations, according to the analysis.

Finally, the field requires innovative clinical trial designs to increase flexibility for drug developers. Such designs include adaptive trials that are modified based on patient outcomes, as well as trials of combinations of novel treatments. The latter trials could include drugs with demonstrated target engagement, but without efficacy as monotherapy.

Phase II/III and Phase III Drug Trials

Trials of several phase II/III drugs and one phase III drug will be completed in 2017. The phase II/III treatments include AC-1204, an oral drug intended for patients with mild to moderate Alzheimer’s disease that improves mitochondrial metabolism through chronic ketosis. A combination of albumin and immunoglobulin is being studied for patients with mild to moderate Alzheimer’s disease. It is an IV immunosuppressant with possible antiamyloid antibodies and albumin-binding capacity. Finally, a phase III trial of suvorexant, an oral orexin receptor antagonist under investigation for patients with Alzheimer’s disease and insomnia, will conclude in 2017.

“I am encouraged to see such a range of approaches to treating Alzheimer’s [disease] in phase II development,” said David Morgan, PhD, CEO of the Byrd Alzheimer Institute at the University of South Florida in Tampa. “There is much work that still needs to be done, but the drugs in phase II clinical trials offer a great deal of hope for the future,” he added.

Erica Tricarico

Suggested Reading

Jacobson LH, Callander GE, Hoyer D. Suvorexant for the treatment of insomnia. Expert Rev Clin Pharmacol. 2014; 7(6):711-730.

Cummings J, Aisen PS, DuBois B, et al. Drug development in Alzheimer’s disease: the path to 2025. Alzheimers Res Ther. 2016;8:39.

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Open, laparoscopic, robotic approaches all sound for distal pancreatectomy

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– The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.

“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.

Dr. Dimitrios Xourafas


Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.

He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).

There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.

There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.

Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).

Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.

Dr. Xourafas had no financial disclosures.
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– The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.

“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.

Dr. Dimitrios Xourafas


Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.

He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).

There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.

There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.

Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).

Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.

Dr. Xourafas had no financial disclosures.

 

– The three approaches to distal pancreatectomy – open, laparoscopic, and robotic – are equally safe and oncologically sound methods in properly selected patients, findings from a NSQIP database study show.

“The three approaches have specific indications for use and advantages in well-selected patients; therefore, demonstrating the superiority of one technique over another remains challenging,” said Dimitrios Xourafas, MD, in his presentation at the annual clinical congress of the American College of Surgeons.

Dr. Dimitrios Xourafas


Laparoscopic surgeries are more likely to result in open conversions than are robotic surgeries – but robotic surgeries take more time to complete. Open surgeries may be best for advanced disease. But all in all, there are no overriding advantages or disadvantages to any of them, reported Dr. Xourafas, a research fellow in surgery at Brigham and Women’s Hospital, Boston.

He and his colleagues used the American College of Surgeons National Surgical Quality Improvement (NSQIP) database for detailed information on 1,815 distal pancreatectomies performed in 2014. These they separated into three groups: open (921), laparoscopic (694) and robotic (200).

There were no differences in baseline characteristics. Mean age of the patients was 62 years. More than 70% of each group had serious comorbidities. Significantly more in the open surgery group had lost 10% or more of their body weight since diagnosis; this was probably related to a higher rate of preoperative chemotherapy in this group, Dr. Xourafas said. Patients having open surgery also were more likely to have undergone radiation therapy.

There were significant, but mixed, differences in operative outcomes. Surgery was longest in the robotic group (243 minutes vs. 205 minutes in the laparoscopic group and 222 minutes in the open group.) Laparoscopic procedures were more likely to convert to open than were robotic (16% vs. 8%). Blood loss was significantly greater in the open group, with 21% needing transfusion vs. 5% laparoscopic and 6% robotic. Close to 100% of patients in the robotic and open groups needed no vascular resection and no reconstruction. In the open group, fewer patients (88%) had no vascular resection, and 84% required no reconstruction, suggesting that these cases were more advanced disease. This finding was also borne out by the larger percentage of tumors that staged at T3 or higher (34% in the open group vs. about 20% in the other groups). However, about half of each group had a malignant tumor subtype and lesion sizes were similar.

Surgical site infections were more common in the open group (10% vs. 7% of the other groups). The length of stay was longest in the open group (7 days vs. 5 in the other groups). The robotic group had the highest rate of pancreatic fistula (21%) although this was not significantly different from the open and laparoscopic rates (16% and 17%, respectively).

Overall morbidity was 45% in the open group, 36% in the laparoscopic group, and 37% in the robotic group. Mortality was 1.5% in the open group, 1% in the laparoscopic group, and 0.5% in the robotic group – not significantly different.

Dr. Xourafas had no financial disclosures.
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Key clinical point: Each approach has its unique advantages and disadvantages in distal pancreatectomy.

Major finding: Surgery was longest in the robotic group (243 minutes), but more patients in the open group needed transfusions (21% vs. 5% of the other groups).

Data source: The database review comprised 1,815 patients.

Disclosures: Dr. Xourafas had no financial disclosures.

Adding metronomic chemo provides no benefit to MAP for osteosarcoma

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Adding low-dose metronomic chemotherapy (oral cyclophosphamide and methotrexate) to standard methotrexate, adriamycin, and platinum (MAP) maintenance treatment did not extend event-free survival in adolescents and young adults with high-grade, resectable osteosarcoma of the extremities, according to investigators.

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Adding low-dose metronomic chemotherapy (oral cyclophosphamide and methotrexate) to standard methotrexate, adriamycin, and platinum (MAP) maintenance treatment did not extend event-free survival in adolescents and young adults with high-grade, resectable osteosarcoma of the extremities, according to investigators.

 

Adding low-dose metronomic chemotherapy (oral cyclophosphamide and methotrexate) to standard methotrexate, adriamycin, and platinum (MAP) maintenance treatment did not extend event-free survival in adolescents and young adults with high-grade, resectable osteosarcoma of the extremities, according to investigators.

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Key clinical point: Adding low-dose metronomic chemotherapy to MAP as maintenance treatment did not extend event-free survival in adolescents and young adults with high-grade, resectable osteosarcoma of the extremities.

Major finding: At 5 years, cumulative event-free survival was 61% with MAP plus metronomic chemotherapy and 64% with MAP alone, a nonsignificant difference.

Data source: A prospective randomized clinical trial involving 296 patients in South America followed for 5 years.

Disclosures: The authors did not provide information on the funding of this study and did not report any conflict-of-interest disclosures.

Which Factors Predict Relapse Freedom After Cessation of MS Treatment?

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Patients with multiple sclerosis (MS) treated with interferon beta or glatiramer acetate who are age 45 or older and have no evidence of clinical disease activity for more than four years have a high likelihood of remaining relapse-free after treatment cessation, according to research published online ahead of print October 20 in Multiple Sclerosis.

The study conducted by Gabriel Bsteh, MD, a neurologist at the Medical University of Innsbruck in Austria, and his colleagues provides evidence in the absence of randomized trials that may help guide discussions with patients—particularly those who have not had a relapse recently—when they ask whether they could discontinue disease-modifying treatment (DMT).

Gabriel Bsteh, MD

The current study involved 221 patients with relapsing-remitting MS who discontinued DMT after more than a year and had documented follow-up at two years. After a median follow-up period of 3.8 years, 98 patients (44.3%) had a relapse. Confirmed disability progression occurred in 46 patients (20.8%), and 15 patients (6.8%) converted to secondary progressive MS.

The independent predictors of absence of relapse after discontinuing treatment included age 45 or older at discontinuation (hazard ratio [HR], 0.47), absence of relapses for four or more years on DMT before discontinuation (HR, 0.29), and absence of contrast-enhancing lesions (HR, 0.46). A combination of age 45 or older and absence of relapses after four or more years on DMT was associated with a very low risk of having a relapse after discontinuation, regardless of MRI results (HR, 0.06).

Higher Expanded Disability Status Scale (EDSS) scores at discontinuation, age older than 45 at discontinuation, and longer disease duration were the only significant independent predictors of disability progression after discontinuation, irrespective of the presence of relapses on DMT or gadolinium-enhancing lesions.

“This [result] underlines the concept of a window of opportunity in the treatment of MS, in the sense that once a certain extent of disability is reached, the impact of relapses, and therefore the effect of anti-inflammatory treatment, is drastically reduced,” said the investigators.

The study is limited by its observational, retrospective nature, but the results emphasized the importance of regular, thorough clinical evaluation of patients with relapsing-remitting MS, said the researchers. “While MRI may have a role in aiding decision making regarding DMT discontinuation, our data clearly show that demographic factors and clinical monitoring go a long way in risk stratification,” they said.

The authors received no financial support for the study, but several of the authors reported participating in meetings or receiving honoraria from various pharmaceutical companies.

Nicola Garrett

Suggested Reading

Bsteh G, Feige J, Ehling R, et al. Discontinuation of disease-modifying therapies in multiple sclerosis - Clinical outcome and prognostic factors. Mult Scler. 2016 Oct 20 [Epub ahead of print].

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Patients with multiple sclerosis (MS) treated with interferon beta or glatiramer acetate who are age 45 or older and have no evidence of clinical disease activity for more than four years have a high likelihood of remaining relapse-free after treatment cessation, according to research published online ahead of print October 20 in Multiple Sclerosis.

The study conducted by Gabriel Bsteh, MD, a neurologist at the Medical University of Innsbruck in Austria, and his colleagues provides evidence in the absence of randomized trials that may help guide discussions with patients—particularly those who have not had a relapse recently—when they ask whether they could discontinue disease-modifying treatment (DMT).

Gabriel Bsteh, MD

The current study involved 221 patients with relapsing-remitting MS who discontinued DMT after more than a year and had documented follow-up at two years. After a median follow-up period of 3.8 years, 98 patients (44.3%) had a relapse. Confirmed disability progression occurred in 46 patients (20.8%), and 15 patients (6.8%) converted to secondary progressive MS.

The independent predictors of absence of relapse after discontinuing treatment included age 45 or older at discontinuation (hazard ratio [HR], 0.47), absence of relapses for four or more years on DMT before discontinuation (HR, 0.29), and absence of contrast-enhancing lesions (HR, 0.46). A combination of age 45 or older and absence of relapses after four or more years on DMT was associated with a very low risk of having a relapse after discontinuation, regardless of MRI results (HR, 0.06).

Higher Expanded Disability Status Scale (EDSS) scores at discontinuation, age older than 45 at discontinuation, and longer disease duration were the only significant independent predictors of disability progression after discontinuation, irrespective of the presence of relapses on DMT or gadolinium-enhancing lesions.

“This [result] underlines the concept of a window of opportunity in the treatment of MS, in the sense that once a certain extent of disability is reached, the impact of relapses, and therefore the effect of anti-inflammatory treatment, is drastically reduced,” said the investigators.

The study is limited by its observational, retrospective nature, but the results emphasized the importance of regular, thorough clinical evaluation of patients with relapsing-remitting MS, said the researchers. “While MRI may have a role in aiding decision making regarding DMT discontinuation, our data clearly show that demographic factors and clinical monitoring go a long way in risk stratification,” they said.

The authors received no financial support for the study, but several of the authors reported participating in meetings or receiving honoraria from various pharmaceutical companies.

Nicola Garrett

Suggested Reading

Bsteh G, Feige J, Ehling R, et al. Discontinuation of disease-modifying therapies in multiple sclerosis - Clinical outcome and prognostic factors. Mult Scler. 2016 Oct 20 [Epub ahead of print].

Patients with multiple sclerosis (MS) treated with interferon beta or glatiramer acetate who are age 45 or older and have no evidence of clinical disease activity for more than four years have a high likelihood of remaining relapse-free after treatment cessation, according to research published online ahead of print October 20 in Multiple Sclerosis.

The study conducted by Gabriel Bsteh, MD, a neurologist at the Medical University of Innsbruck in Austria, and his colleagues provides evidence in the absence of randomized trials that may help guide discussions with patients—particularly those who have not had a relapse recently—when they ask whether they could discontinue disease-modifying treatment (DMT).

Gabriel Bsteh, MD

The current study involved 221 patients with relapsing-remitting MS who discontinued DMT after more than a year and had documented follow-up at two years. After a median follow-up period of 3.8 years, 98 patients (44.3%) had a relapse. Confirmed disability progression occurred in 46 patients (20.8%), and 15 patients (6.8%) converted to secondary progressive MS.

The independent predictors of absence of relapse after discontinuing treatment included age 45 or older at discontinuation (hazard ratio [HR], 0.47), absence of relapses for four or more years on DMT before discontinuation (HR, 0.29), and absence of contrast-enhancing lesions (HR, 0.46). A combination of age 45 or older and absence of relapses after four or more years on DMT was associated with a very low risk of having a relapse after discontinuation, regardless of MRI results (HR, 0.06).

Higher Expanded Disability Status Scale (EDSS) scores at discontinuation, age older than 45 at discontinuation, and longer disease duration were the only significant independent predictors of disability progression after discontinuation, irrespective of the presence of relapses on DMT or gadolinium-enhancing lesions.

“This [result] underlines the concept of a window of opportunity in the treatment of MS, in the sense that once a certain extent of disability is reached, the impact of relapses, and therefore the effect of anti-inflammatory treatment, is drastically reduced,” said the investigators.

The study is limited by its observational, retrospective nature, but the results emphasized the importance of regular, thorough clinical evaluation of patients with relapsing-remitting MS, said the researchers. “While MRI may have a role in aiding decision making regarding DMT discontinuation, our data clearly show that demographic factors and clinical monitoring go a long way in risk stratification,” they said.

The authors received no financial support for the study, but several of the authors reported participating in meetings or receiving honoraria from various pharmaceutical companies.

Nicola Garrett

Suggested Reading

Bsteh G, Feige J, Ehling R, et al. Discontinuation of disease-modifying therapies in multiple sclerosis - Clinical outcome and prognostic factors. Mult Scler. 2016 Oct 20 [Epub ahead of print].

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