Whitney McKnight

WASHINGTON – A sea change is underway in how major depressive and bipolar disorders are diagnosed and treated.

Historically, the absence of an accurate, comprehensive nosology of depression has led to much suffering and confusion. People with bipolar disorder in particular are either not diagnosed early enough or are not diagnosed with the correct “flavor” of depression, according to Roger S. McIntyre, MD, author of updated treatment guidelines for bipolar depression, and the first-ever treatment guidelines for mixed features in major depressive disorder. “Twenty years ago, we would have described bipolar as episodic breakthroughs of mania and depression, with well intervals in between,” Dr. McIntyre said at Summit in Neurology & Psychiatry. “But now, we’ve really changed our fundamental thinking about bipolar disorder.”

Although reasons for the evolution in thinking are many, one of the strongest currents of change flows from the 2013 publication of the DSM-5, according to Dr. McIntyre, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit at University Health Network in Toronto.

“The DSM-5’s authors took a neo-Kraepelinian view that mood disorders are dimensional,” Dr. McIntyre said in an interview. As a result, there’s been a reversal of what he called the “social construct imposed upon the cosmos of mood disorders by the DSM-III that divided that world into either depression or bipolar disorder.”

This return to thinking of mood disorders as existing on a continuum, as psychiatrist Emil Kraepelin, MD, theorized around the turn of the last century, pivots on the decision to do away with mixed states and to instead add the mixed features specifier.

“The move to mixed features is the necessary bridge between bipolar disease and major depressive disorder,” Dr. McIntyre said in the interview.

Therefore, for a period of time between the 1980 publication of the DSM-III and the DSM-5, “real-world” presentations of subsyndromal, opposite-pole symptoms that are common in major depressive disorder (MDD) and in bipolar disorder were not accounted for.

In practical terms, the addition of mixed features means that a patient with mania who presents with subsyndromal depressive symptoms would be seen, for example, to have mania with mixed features. A patient with a depressive episode who presents with subsyndromal hypomanic symptoms would be seen to have depression with mixed features. Therefore, depression with mixed features can be present not only in MDD, but in both bipolar I and II.

New treatment algorithms

This dimensional approach of assessing mixed features along a continuum could lead to better and earlier diagnosis of bipolar depression and more targeted therapies, according to Dr. McIntyre. What he thinks it won’t do is lead to an overzealousness in the overdiagnosis of bipolar depression.

“That is false. We wouldn’t say we’re not going to diagnose bowel cancer because we hear it’s overdiagnosed. But to get the diagnoses right, what we need is fidelity to diagnostic criteria.”

Enter the state of Florida. As part of its best practices for psychotherapeutic use in adults, Florida is the first state to have published evidence-based guidelines for depression with mixed features. Dr. McIntyre is one of the guidelines’ coauthors.

Antidepressants bad, olanzapine worse

Some changes to treatment algorithms might come as a surprise. Despite being among the most commonly prescribed treatments for bipolar disorder, monotherapy with antidepressants is not approved in the guidelines. “Period,” said Dr. McIntyre. “Many patients do well on antidepressants, but the most common outcome is inefficacy.”

It might be better to combine an antidepressant with an atypical antipsychotic, or a mood stabilizer to avoid treatment-emergent mania, or, more commonly, destabilization in patients who are susceptible to subsyndromal mania, he said.

In addition to mitigating symptoms of a depressive episode, atypicals can help suppress hypomanic symptoms. Dr. McIntyre said this is critical to remember, because patients with these combinations of symptoms are “the very persons who shouldn’t get an antidepressant but are also the ones most likely to be prescribed them,” according to old ways of thinking.

As for maintenance in bipolar disorder, Dr. McIntyre believes the axiom, “What gets you well keeps you well,” is a good rule of thumb when going through the algorithm. “It’s not always true, but it’s almost always true.”

Management of MDD with mixed features includes the introduction of atypicals or mood stabilizers such as lithium or lamotrigine in patients with any prior history of hypomania or mania, something Dr. McIntyre said already is beginning to happen in practice.

Olanzapine monotherapy as a first-line treatment of bipolar disorder initially was “demoted” by Dr. McIntyre and his coauthors in Florida’s bipolar treatment guidelines. In the updated version, the atypical remains a second-line therapy behind lurasidone as the recommended first-line therapy because of olanzapine’s tendency to interfere with metabolic processes. Quetiapine also is a first-line therapy, but with the qualification that it, too, could interfere with metabolic processes. Combination therapy with olanzapine plus fluoxetine is second-line.

“Lurasidone does not have the metabolic changes of quetiapine. It doesn’t make sense to treat mania and then erase 25 years of a person’s life because of weight gain,” Dr. McIntyre said.

The average lifespan of people with bipolar disorder is about 20 years shorter than it is for those without serious mental illness.

Inflammation harms cognition

The changes are indicative of how seriously the field has begun to take metabolic disturbance as an adverse event in serious mental illness. Literature on obesity as a “psycho-toxin” is growing, and Dr. McIntyre is among the pioneers.

One study by Dr. McIntyre and his colleagues, currently in press, explores how obesity-related inflammation disturbs the brain’s dopamine system, resulting in interference with executive function. Because it is well established that people with bipolar disorder are more likely to be obese (J Affect Disord. 2008 Sep;110[1-2]:149-55), they also are more susceptible to cognitive impairment than are people of normal weight, according to Dr. McIntyre.

In a 2013 study, Dr. McIntyre and his colleagues showed that a first episode of mania in a person with obesity creates the same level of cognitive impairment as that found in the brains of normal-weight individuals who have experienced five episodes of mania (Psychological Med. 2014 Feb;44[3]:533-41). “There is something about obesity that is brain toxic,” he said.

Proof of concept of this is that cognitive outcomes for people before bariatric surgery are worse than postsurgery outcomes (Am J Surg. 2014 Jun;207[6]:870-6).

Systemic inflammation elevates levels of C-reactive protein, interleukin-1, and other cytokines, and interferes with insulin signaling; all have deleterious effects on cognition, as well as metabolic health. Those disturbances negatively affect emotional regulation, sleep, appetite, and sex drive, as well as executive function, he said.

“Inflammation is a convergent system, implicated across many brain- and body-based disorders. People with bipolar disorder not only have systemic increases in inflammation, but also neuroinflammation,” Dr. McIntyre said.

Accordingly, controlling inflammation becomes essential to chronic management of depression in general and bipolar in particular since, with each successive episode of untreated mania, patients’ ability to think clearly takes a hit. “Cognitive function is the principal determinant of psychosocial function, of workplace visibility, [and] of quality of life in most patient-reported outcomes,” Dr. McIntyre said.

Cognitive impairment also can lead to a worsening of the ability to balance reward and impulse control, leading to higher rates of substance abuse or other psychiatric comorbidities after onset of bipolar disease; a vicious cycle can ensue.

“As cognitive difficulties rise, comorbidities rise. But also, some of the comorbidities we see are reflections of cognitive impairment,” Dr. McIntyre said. To wit, binge eating disorder and bulimia nervosa are common in people with bipolar disorder (J Affect Disord. 2016 Feb;191:216-2).

Citing a recent scientific statement from the American Heart Association recommending that bipolar disorder and MDD should be considered tier II risk factors for cardiovascular disease among youth, the Florida guidelines urge clinicians to regularly screen patients for cardiometabolic disorders – not only for their medical implications but for their potential to flag emergent psychiatric issues.

Pharmacotherapeutics specifically targeting neuroinflammation are not yet ready for clinical practice, but Dr. McIntyre said other, more conventional therapies are available for bipolar disorder that have anti-inflammatory properties, including selective serotonin reuptake inhibitors and lithium. “Lithium is also anti-amyloid and has an anti-suicide effect. It is a drug I would definitely use as first line.”

Some behavioral therapies also are protective against inflammation and are recommended in the guidelines. Those include attention to sleep hygiene, diet, and exercise. “Social rhythm therapy is underutilized. These patients need their day organized. They need aerobics; they need sleep,” Dr. McIntyre said.

Future is now

Although the “whole-person” approach is still nascent – seeing depression as a collection of what Dr. McIntyre said are alterations in the neural circuitry amounting to a series of “disconnection syndromes” – psychiatry already has entered a new era where disease models are more comprehensive, he said.

This new way of thinking can connect the dots between why, for example, so many people with bipolar depression also have drug and alcohol abuse. It also could help explain why in bipolar there is so much obesity, or why there is so much anxiety, he said. “We’ve moved away from the rather silly, overly simplistic notions that you have too much or too little serotonin. Or that there was too much or too little dopamine causing mania. It made for convenient sound bytes, but it was probably just superstition we were gravitating to.”

The guidelines have been peer reviewed and will be published in the Journal of Clinical Psychiatry later this year, Dr. McIntyre said.

The meeting was held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Dr. McIntyre disclosed that he has numerous industry relationships, including with AstraZeneca, Eli Lilly, Janssen Ortho, Lundbeck, Pfizer, and Shire.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – A sea change is underway in how major depressive and bipolar disorders are diagnosed and treated.

Historically, the absence of an accurate, comprehensive nosology of depression has led to much suffering and confusion. People with bipolar disorder in particular are either not diagnosed early enough or are not diagnosed with the correct “flavor” of depression, according to Roger S. McIntyre, MD, author of updated treatment guidelines for bipolar depression, and the first-ever treatment guidelines for mixed features in major depressive disorder. “Twenty years ago, we would have described bipolar as episodic breakthroughs of mania and depression, with well intervals in between,” Dr. McIntyre said at Summit in Neurology & Psychiatry. “But now, we’ve really changed our fundamental thinking about bipolar disorder.”

Although reasons for the evolution in thinking are many, one of the strongest currents of change flows from the 2013 publication of the DSM-5, according to Dr. McIntyre, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit at University Health Network in Toronto.

“The DSM-5’s authors took a neo-Kraepelinian view that mood disorders are dimensional,” Dr. McIntyre said in an interview. As a result, there’s been a reversal of what he called the “social construct imposed upon the cosmos of mood disorders by the DSM-III that divided that world into either depression or bipolar disorder.”

This return to thinking of mood disorders as existing on a continuum, as psychiatrist Emil Kraepelin, MD, theorized around the turn of the last century, pivots on the decision to do away with mixed states and to instead add the mixed features specifier.

“The move to mixed features is the necessary bridge between bipolar disease and major depressive disorder,” Dr. McIntyre said in the interview.

Therefore, for a period of time between the 1980 publication of the DSM-III and the DSM-5, “real-world” presentations of subsyndromal, opposite-pole symptoms that are common in major depressive disorder (MDD) and in bipolar disorder were not accounted for.

In practical terms, the addition of mixed features means that a patient with mania who presents with subsyndromal depressive symptoms would be seen, for example, to have mania with mixed features. A patient with a depressive episode who presents with subsyndromal hypomanic symptoms would be seen to have depression with mixed features. Therefore, depression with mixed features can be present not only in MDD, but in both bipolar I and II.

New treatment algorithms

This dimensional approach of assessing mixed features along a continuum could lead to better and earlier diagnosis of bipolar depression and more targeted therapies, according to Dr. McIntyre. What he thinks it won’t do is lead to an overzealousness in the overdiagnosis of bipolar depression.

“That is false. We wouldn’t say we’re not going to diagnose bowel cancer because we hear it’s overdiagnosed. But to get the diagnoses right, what we need is fidelity to diagnostic criteria.”

Enter the state of Florida. As part of its best practices for psychotherapeutic use in adults, Florida is the first state to have published evidence-based guidelines for depression with mixed features. Dr. McIntyre is one of the guidelines’ coauthors.

Antidepressants bad, olanzapine worse

Some changes to treatment algorithms might come as a surprise. Despite being among the most commonly prescribed treatments for bipolar disorder, monotherapy with antidepressants is not approved in the guidelines. “Period,” said Dr. McIntyre. “Many patients do well on antidepressants, but the most common outcome is inefficacy.”

It might be better to combine an antidepressant with an atypical antipsychotic, or a mood stabilizer to avoid treatment-emergent mania, or, more commonly, destabilization in patients who are susceptible to subsyndromal mania, he said.

In addition to mitigating symptoms of a depressive episode, atypicals can help suppress hypomanic symptoms. Dr. McIntyre said this is critical to remember, because patients with these combinations of symptoms are “the very persons who shouldn’t get an antidepressant but are also the ones most likely to be prescribed them,” according to old ways of thinking.

As for maintenance in bipolar disorder, Dr. McIntyre believes the axiom, “What gets you well keeps you well,” is a good rule of thumb when going through the algorithm. “It’s not always true, but it’s almost always true.”

Management of MDD with mixed features includes the introduction of atypicals or mood stabilizers such as lithium or lamotrigine in patients with any prior history of hypomania or mania, something Dr. McIntyre said already is beginning to happen in practice.

Olanzapine monotherapy as a first-line treatment of bipolar disorder initially was “demoted” by Dr. McIntyre and his coauthors in Florida’s bipolar treatment guidelines. In the updated version, the atypical remains a second-line therapy behind lurasidone as the recommended first-line therapy because of olanzapine’s tendency to interfere with metabolic processes. Quetiapine also is a first-line therapy, but with the qualification that it, too, could interfere with metabolic processes. Combination therapy with olanzapine plus fluoxetine is second-line.

“Lurasidone does not have the metabolic changes of quetiapine. It doesn’t make sense to treat mania and then erase 25 years of a person’s life because of weight gain,” Dr. McIntyre said.

The average lifespan of people with bipolar disorder is about 20 years shorter than it is for those without serious mental illness.

Inflammation harms cognition

The changes are indicative of how seriously the field has begun to take metabolic disturbance as an adverse event in serious mental illness. Literature on obesity as a “psycho-toxin” is growing, and Dr. McIntyre is among the pioneers.

One study by Dr. McIntyre and his colleagues, currently in press, explores how obesity-related inflammation disturbs the brain’s dopamine system, resulting in interference with executive function. Because it is well established that people with bipolar disorder are more likely to be obese (J Affect Disord. 2008 Sep;110[1-2]:149-55), they also are more susceptible to cognitive impairment than are people of normal weight, according to Dr. McIntyre.

In a 2013 study, Dr. McIntyre and his colleagues showed that a first episode of mania in a person with obesity creates the same level of cognitive impairment as that found in the brains of normal-weight individuals who have experienced five episodes of mania (Psychological Med. 2014 Feb;44[3]:533-41). “There is something about obesity that is brain toxic,” he said.

Proof of concept of this is that cognitive outcomes for people before bariatric surgery are worse than postsurgery outcomes (Am J Surg. 2014 Jun;207[6]:870-6).

Systemic inflammation elevates levels of C-reactive protein, interleukin-1, and other cytokines, and interferes with insulin signaling; all have deleterious effects on cognition, as well as metabolic health. Those disturbances negatively affect emotional regulation, sleep, appetite, and sex drive, as well as executive function, he said.

“Inflammation is a convergent system, implicated across many brain- and body-based disorders. People with bipolar disorder not only have systemic increases in inflammation, but also neuroinflammation,” Dr. McIntyre said.

Accordingly, controlling inflammation becomes essential to chronic management of depression in general and bipolar in particular since, with each successive episode of untreated mania, patients’ ability to think clearly takes a hit. “Cognitive function is the principal determinant of psychosocial function, of workplace visibility, [and] of quality of life in most patient-reported outcomes,” Dr. McIntyre said.

Cognitive impairment also can lead to a worsening of the ability to balance reward and impulse control, leading to higher rates of substance abuse or other psychiatric comorbidities after onset of bipolar disease; a vicious cycle can ensue.

“As cognitive difficulties rise, comorbidities rise. But also, some of the comorbidities we see are reflections of cognitive impairment,” Dr. McIntyre said. To wit, binge eating disorder and bulimia nervosa are common in people with bipolar disorder (J Affect Disord. 2016 Feb;191:216-2).

Citing a recent scientific statement from the American Heart Association recommending that bipolar disorder and MDD should be considered tier II risk factors for cardiovascular disease among youth, the Florida guidelines urge clinicians to regularly screen patients for cardiometabolic disorders – not only for their medical implications but for their potential to flag emergent psychiatric issues.

Pharmacotherapeutics specifically targeting neuroinflammation are not yet ready for clinical practice, but Dr. McIntyre said other, more conventional therapies are available for bipolar disorder that have anti-inflammatory properties, including selective serotonin reuptake inhibitors and lithium. “Lithium is also anti-amyloid and has an anti-suicide effect. It is a drug I would definitely use as first line.”

Some behavioral therapies also are protective against inflammation and are recommended in the guidelines. Those include attention to sleep hygiene, diet, and exercise. “Social rhythm therapy is underutilized. These patients need their day organized. They need aerobics; they need sleep,” Dr. McIntyre said.

Future is now

Although the “whole-person” approach is still nascent – seeing depression as a collection of what Dr. McIntyre said are alterations in the neural circuitry amounting to a series of “disconnection syndromes” – psychiatry already has entered a new era where disease models are more comprehensive, he said.

This new way of thinking can connect the dots between why, for example, so many people with bipolar depression also have drug and alcohol abuse. It also could help explain why in bipolar there is so much obesity, or why there is so much anxiety, he said. “We’ve moved away from the rather silly, overly simplistic notions that you have too much or too little serotonin. Or that there was too much or too little dopamine causing mania. It made for convenient sound bytes, but it was probably just superstition we were gravitating to.”

The guidelines have been peer reviewed and will be published in the Journal of Clinical Psychiatry later this year, Dr. McIntyre said.

The meeting was held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Dr. McIntyre disclosed that he has numerous industry relationships, including with AstraZeneca, Eli Lilly, Janssen Ortho, Lundbeck, Pfizer, and Shire.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – A sea change is underway in how major depressive and bipolar disorders are diagnosed and treated.

Historically, the absence of an accurate, comprehensive nosology of depression has led to much suffering and confusion. People with bipolar disorder in particular are either not diagnosed early enough or are not diagnosed with the correct “flavor” of depression, according to Roger S. McIntyre, MD, author of updated treatment guidelines for bipolar depression, and the first-ever treatment guidelines for mixed features in major depressive disorder. “Twenty years ago, we would have described bipolar as episodic breakthroughs of mania and depression, with well intervals in between,” Dr. McIntyre said at Summit in Neurology & Psychiatry. “But now, we’ve really changed our fundamental thinking about bipolar disorder.”

Although reasons for the evolution in thinking are many, one of the strongest currents of change flows from the 2013 publication of the DSM-5, according to Dr. McIntyre, professor of psychiatry and pharmacology at the University of Toronto, and head of the Mood Disorders Psychopharmacology Unit at University Health Network in Toronto.

“The DSM-5’s authors took a neo-Kraepelinian view that mood disorders are dimensional,” Dr. McIntyre said in an interview. As a result, there’s been a reversal of what he called the “social construct imposed upon the cosmos of mood disorders by the DSM-III that divided that world into either depression or bipolar disorder.”

This return to thinking of mood disorders as existing on a continuum, as psychiatrist Emil Kraepelin, MD, theorized around the turn of the last century, pivots on the decision to do away with mixed states and to instead add the mixed features specifier.

“The move to mixed features is the necessary bridge between bipolar disease and major depressive disorder,” Dr. McIntyre said in the interview.

Therefore, for a period of time between the 1980 publication of the DSM-III and the DSM-5, “real-world” presentations of subsyndromal, opposite-pole symptoms that are common in major depressive disorder (MDD) and in bipolar disorder were not accounted for.

In practical terms, the addition of mixed features means that a patient with mania who presents with subsyndromal depressive symptoms would be seen, for example, to have mania with mixed features. A patient with a depressive episode who presents with subsyndromal hypomanic symptoms would be seen to have depression with mixed features. Therefore, depression with mixed features can be present not only in MDD, but in both bipolar I and II.

New treatment algorithms

This dimensional approach of assessing mixed features along a continuum could lead to better and earlier diagnosis of bipolar depression and more targeted therapies, according to Dr. McIntyre. What he thinks it won’t do is lead to an overzealousness in the overdiagnosis of bipolar depression.

“That is false. We wouldn’t say we’re not going to diagnose bowel cancer because we hear it’s overdiagnosed. But to get the diagnoses right, what we need is fidelity to diagnostic criteria.”

Enter the state of Florida. As part of its best practices for psychotherapeutic use in adults, Florida is the first state to have published evidence-based guidelines for depression with mixed features. Dr. McIntyre is one of the guidelines’ coauthors.

Antidepressants bad, olanzapine worse

Some changes to treatment algorithms might come as a surprise. Despite being among the most commonly prescribed treatments for bipolar disorder, monotherapy with antidepressants is not approved in the guidelines. “Period,” said Dr. McIntyre. “Many patients do well on antidepressants, but the most common outcome is inefficacy.”

It might be better to combine an antidepressant with an atypical antipsychotic, or a mood stabilizer to avoid treatment-emergent mania, or, more commonly, destabilization in patients who are susceptible to subsyndromal mania, he said.

In addition to mitigating symptoms of a depressive episode, atypicals can help suppress hypomanic symptoms. Dr. McIntyre said this is critical to remember, because patients with these combinations of symptoms are “the very persons who shouldn’t get an antidepressant but are also the ones most likely to be prescribed them,” according to old ways of thinking.

As for maintenance in bipolar disorder, Dr. McIntyre believes the axiom, “What gets you well keeps you well,” is a good rule of thumb when going through the algorithm. “It’s not always true, but it’s almost always true.”

Management of MDD with mixed features includes the introduction of atypicals or mood stabilizers such as lithium or lamotrigine in patients with any prior history of hypomania or mania, something Dr. McIntyre said already is beginning to happen in practice.

Olanzapine monotherapy as a first-line treatment of bipolar disorder initially was “demoted” by Dr. McIntyre and his coauthors in Florida’s bipolar treatment guidelines. In the updated version, the atypical remains a second-line therapy behind lurasidone as the recommended first-line therapy because of olanzapine’s tendency to interfere with metabolic processes. Quetiapine also is a first-line therapy, but with the qualification that it, too, could interfere with metabolic processes. Combination therapy with olanzapine plus fluoxetine is second-line.

“Lurasidone does not have the metabolic changes of quetiapine. It doesn’t make sense to treat mania and then erase 25 years of a person’s life because of weight gain,” Dr. McIntyre said.

The average lifespan of people with bipolar disorder is about 20 years shorter than it is for those without serious mental illness.

Inflammation harms cognition

The changes are indicative of how seriously the field has begun to take metabolic disturbance as an adverse event in serious mental illness. Literature on obesity as a “psycho-toxin” is growing, and Dr. McIntyre is among the pioneers.

One study by Dr. McIntyre and his colleagues, currently in press, explores how obesity-related inflammation disturbs the brain’s dopamine system, resulting in interference with executive function. Because it is well established that people with bipolar disorder are more likely to be obese (J Affect Disord. 2008 Sep;110[1-2]:149-55), they also are more susceptible to cognitive impairment than are people of normal weight, according to Dr. McIntyre.

In a 2013 study, Dr. McIntyre and his colleagues showed that a first episode of mania in a person with obesity creates the same level of cognitive impairment as that found in the brains of normal-weight individuals who have experienced five episodes of mania (Psychological Med. 2014 Feb;44[3]:533-41). “There is something about obesity that is brain toxic,” he said.

Proof of concept of this is that cognitive outcomes for people before bariatric surgery are worse than postsurgery outcomes (Am J Surg. 2014 Jun;207[6]:870-6).

Systemic inflammation elevates levels of C-reactive protein, interleukin-1, and other cytokines, and interferes with insulin signaling; all have deleterious effects on cognition, as well as metabolic health. Those disturbances negatively affect emotional regulation, sleep, appetite, and sex drive, as well as executive function, he said.

“Inflammation is a convergent system, implicated across many brain- and body-based disorders. People with bipolar disorder not only have systemic increases in inflammation, but also neuroinflammation,” Dr. McIntyre said.

Accordingly, controlling inflammation becomes essential to chronic management of depression in general and bipolar in particular since, with each successive episode of untreated mania, patients’ ability to think clearly takes a hit. “Cognitive function is the principal determinant of psychosocial function, of workplace visibility, [and] of quality of life in most patient-reported outcomes,” Dr. McIntyre said.

Cognitive impairment also can lead to a worsening of the ability to balance reward and impulse control, leading to higher rates of substance abuse or other psychiatric comorbidities after onset of bipolar disease; a vicious cycle can ensue.

“As cognitive difficulties rise, comorbidities rise. But also, some of the comorbidities we see are reflections of cognitive impairment,” Dr. McIntyre said. To wit, binge eating disorder and bulimia nervosa are common in people with bipolar disorder (J Affect Disord. 2016 Feb;191:216-2).

Citing a recent scientific statement from the American Heart Association recommending that bipolar disorder and MDD should be considered tier II risk factors for cardiovascular disease among youth, the Florida guidelines urge clinicians to regularly screen patients for cardiometabolic disorders – not only for their medical implications but for their potential to flag emergent psychiatric issues.

Pharmacotherapeutics specifically targeting neuroinflammation are not yet ready for clinical practice, but Dr. McIntyre said other, more conventional therapies are available for bipolar disorder that have anti-inflammatory properties, including selective serotonin reuptake inhibitors and lithium. “Lithium is also anti-amyloid and has an anti-suicide effect. It is a drug I would definitely use as first line.”

Some behavioral therapies also are protective against inflammation and are recommended in the guidelines. Those include attention to sleep hygiene, diet, and exercise. “Social rhythm therapy is underutilized. These patients need their day organized. They need aerobics; they need sleep,” Dr. McIntyre said.

Future is now

Although the “whole-person” approach is still nascent – seeing depression as a collection of what Dr. McIntyre said are alterations in the neural circuitry amounting to a series of “disconnection syndromes” – psychiatry already has entered a new era where disease models are more comprehensive, he said.

This new way of thinking can connect the dots between why, for example, so many people with bipolar depression also have drug and alcohol abuse. It also could help explain why in bipolar there is so much obesity, or why there is so much anxiety, he said. “We’ve moved away from the rather silly, overly simplistic notions that you have too much or too little serotonin. Or that there was too much or too little dopamine causing mania. It made for convenient sound bytes, but it was probably just superstition we were gravitating to.”

The guidelines have been peer reviewed and will be published in the Journal of Clinical Psychiatry later this year, Dr. McIntyre said.

The meeting was held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Dr. McIntyre disclosed that he has numerous industry relationships, including with AstraZeneca, Eli Lilly, Janssen Ortho, Lundbeck, Pfizer, and Shire.

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – What would the world look like for people with first-episode psychosis if they could be identified before they ended up in care? And what if once identified, they could begin receiving treatment immediately?

Those questions are not just hypothetical to Danielle Schlosser, PhD

Using online screening based on proven tools, followed by enrollment in a secured, closed community created through the use of a smartphone app, Dr. Schlosser and her colleagues are delivering remote care to people with first-episode psychosis, rather than making them come to the clinic.

“It’s controversial, but you’re not doing anything meaningful if you don’t stir things up,” Dr. Schlosser said in an interview. “Why do we have to have a one-size-fits-all model?”

Statistics from NIMH show that duration of psychosis before treatment is 1-3 years. People in the early stages of psychosis, typically in their late teens or early 20s, often do not find their way to care until after admittance through an emergency department or a brush with the law, Dr. Schlosser said. Once diagnosed, clinically meaningful improvements in outcomes in this cohort often are impeded by cognitive and motivational impairment, including fear of stigma, or logistical challenges such as finding reliable transportation to a treatment site. According to the World Health Organization, half of all people with schizophrenia globally are not receiving treatment.

“We can do better,” Dr. Schlosser said.

In the PRIME design trials, Dr. Schlosser and her colleagues are evaluating how “user-centered design” might improve treatment delivery. In stage 1 of the study, two design phases, each with a separate group of 10 participants with recent-onset schizophrenia, helped a global design firm called IDEO arrive at a product that Dr. Schlosser and her colleagues described in a study published online as “casual, friendly, and nonstigmatizing, which is in line with the recovery model of psychosis” (JMIR Res Protoc. 2016;5[2]:e77).

The app included short motivational texts from trained therapists, a feature for individualized goal setting in prognostically important psychosocial domains, opportunities for social networking via direct peer-to-peer messaging, and a community “moments feed” aimed at capturing and reinforcing rewarding experiences and achieving goals.

After 12 weeks of using the app, Dr. Schlosser and her coinvestigators found that trial participants, all of whom had been asked to use it at least once a week, had used it an average of once every other day and had actively engaged with its various features with every log-in. Retention and satisfaction was 100% in each group, and levels of engagement from stage 1 to stage 2 increased by what Dr. Schlosser and her coauthors reported as “two- or threefold” in almost each aspect of the platform.

Dr. Schlosser said such impressive results have continued now that the study has entered stage 2, which is being conducted across the United States, Canada, and Mexico. Fifty people have enrolled, Dr. Schlosser said.

“So far, we have a 93% retention in our clinical trial, which is very high for this population,” she said. “We’re also seeing that two-thirds of the population are self-referred. You just don’t see that in early psychosis research.”

She credits those results in part to the study’s online recruitment design, but Dr. Schlosser said the patient-reported outcomes are the most gratifying.

“We got a letter from a mom who said she wished we could have seen her daughter’s face when she saw that everyone in her [online] group looks ‘normal.’ Her daughter was looking for hope, and she found it mirrored back at her,” Dr. Schlosser said. “They are not their illness.”

A prime reason people with recent-onset schizophrenia don’t access formal treatment is the fear they will be stigmatized, Dr. Schlosser said. Furthermore, she said, since most of those affected are young, creative, and “antiestablishment” in their attitudes, they already deal with stigma. The most effective treatment experience needed to be based on those kinds of values, she said.

“They want more control in their lives, and they want to connect with others like them. The idea of seeking care in a traditional setting is a deterrent for these people,” Dr. Schlosser said in the interview. “So, rather than build a new building, we built them a digital platform.”

A few audience members expressed concern that such a treatment model may expose these patients to unnecessary harm. Dr. Schlosser replied in the interview that even in clinical settings, patients prescribed medications still may be noncompliant. “We are not the enforcers of medications. It’s still the patient’s choice. Maybe I am being too provocative, but if people don’t want to take medications, then we try to work with them where they are,” she said.

In addition to the support from the online community, trial participants spend an average of 20 minutes with the coaching staff, making the model a “very low resource” one, according to Dr. Schlosser.

PRIME is expected to complete in the spring 2018, at which time the data collected potentially will be used to refine user-designed apps for use in other mental disorders, Dr. Schlosser said.

“I want to promote a digital system of care so that we can move immediately from when we identify a person is at risk to immediately giving them support. I think we can improve things so that we don’t just have equivalent levels of care but optimal ones,” Dr. Schlosser told the audience. “What we have had as our system of care to date isn’t working.”

Dr. Schlosser did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – What would the world look like for people with first-episode psychosis if they could be identified before they ended up in care? And what if once identified, they could begin receiving treatment immediately?

Those questions are not just hypothetical to Danielle Schlosser, PhD

Using online screening based on proven tools, followed by enrollment in a secured, closed community created through the use of a smartphone app, Dr. Schlosser and her colleagues are delivering remote care to people with first-episode psychosis, rather than making them come to the clinic.

“It’s controversial, but you’re not doing anything meaningful if you don’t stir things up,” Dr. Schlosser said in an interview. “Why do we have to have a one-size-fits-all model?”

Statistics from NIMH show that duration of psychosis before treatment is 1-3 years. People in the early stages of psychosis, typically in their late teens or early 20s, often do not find their way to care until after admittance through an emergency department or a brush with the law, Dr. Schlosser said. Once diagnosed, clinically meaningful improvements in outcomes in this cohort often are impeded by cognitive and motivational impairment, including fear of stigma, or logistical challenges such as finding reliable transportation to a treatment site. According to the World Health Organization, half of all people with schizophrenia globally are not receiving treatment.

“We can do better,” Dr. Schlosser said.

In the PRIME design trials, Dr. Schlosser and her colleagues are evaluating how “user-centered design” might improve treatment delivery. In stage 1 of the study, two design phases, each with a separate group of 10 participants with recent-onset schizophrenia, helped a global design firm called IDEO arrive at a product that Dr. Schlosser and her colleagues described in a study published online as “casual, friendly, and nonstigmatizing, which is in line with the recovery model of psychosis” (JMIR Res Protoc. 2016;5[2]:e77).

The app included short motivational texts from trained therapists, a feature for individualized goal setting in prognostically important psychosocial domains, opportunities for social networking via direct peer-to-peer messaging, and a community “moments feed” aimed at capturing and reinforcing rewarding experiences and achieving goals.

After 12 weeks of using the app, Dr. Schlosser and her coinvestigators found that trial participants, all of whom had been asked to use it at least once a week, had used it an average of once every other day and had actively engaged with its various features with every log-in. Retention and satisfaction was 100% in each group, and levels of engagement from stage 1 to stage 2 increased by what Dr. Schlosser and her coauthors reported as “two- or threefold” in almost each aspect of the platform.

Dr. Schlosser said such impressive results have continued now that the study has entered stage 2, which is being conducted across the United States, Canada, and Mexico. Fifty people have enrolled, Dr. Schlosser said.

“So far, we have a 93% retention in our clinical trial, which is very high for this population,” she said. “We’re also seeing that two-thirds of the population are self-referred. You just don’t see that in early psychosis research.”

She credits those results in part to the study’s online recruitment design, but Dr. Schlosser said the patient-reported outcomes are the most gratifying.

“We got a letter from a mom who said she wished we could have seen her daughter’s face when she saw that everyone in her [online] group looks ‘normal.’ Her daughter was looking for hope, and she found it mirrored back at her,” Dr. Schlosser said. “They are not their illness.”

A prime reason people with recent-onset schizophrenia don’t access formal treatment is the fear they will be stigmatized, Dr. Schlosser said. Furthermore, she said, since most of those affected are young, creative, and “antiestablishment” in their attitudes, they already deal with stigma. The most effective treatment experience needed to be based on those kinds of values, she said.

“They want more control in their lives, and they want to connect with others like them. The idea of seeking care in a traditional setting is a deterrent for these people,” Dr. Schlosser said in the interview. “So, rather than build a new building, we built them a digital platform.”

A few audience members expressed concern that such a treatment model may expose these patients to unnecessary harm. Dr. Schlosser replied in the interview that even in clinical settings, patients prescribed medications still may be noncompliant. “We are not the enforcers of medications. It’s still the patient’s choice. Maybe I am being too provocative, but if people don’t want to take medications, then we try to work with them where they are,” she said.

In addition to the support from the online community, trial participants spend an average of 20 minutes with the coaching staff, making the model a “very low resource” one, according to Dr. Schlosser.

PRIME is expected to complete in the spring 2018, at which time the data collected potentially will be used to refine user-designed apps for use in other mental disorders, Dr. Schlosser said.

“I want to promote a digital system of care so that we can move immediately from when we identify a person is at risk to immediately giving them support. I think we can improve things so that we don’t just have equivalent levels of care but optimal ones,” Dr. Schlosser told the audience. “What we have had as our system of care to date isn’t working.”

Dr. Schlosser did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – What would the world look like for people with first-episode psychosis if they could be identified before they ended up in care? And what if once identified, they could begin receiving treatment immediately?

Those questions are not just hypothetical to Danielle Schlosser, PhD

Using online screening based on proven tools, followed by enrollment in a secured, closed community created through the use of a smartphone app, Dr. Schlosser and her colleagues are delivering remote care to people with first-episode psychosis, rather than making them come to the clinic.

“It’s controversial, but you’re not doing anything meaningful if you don’t stir things up,” Dr. Schlosser said in an interview. “Why do we have to have a one-size-fits-all model?”

Statistics from NIMH show that duration of psychosis before treatment is 1-3 years. People in the early stages of psychosis, typically in their late teens or early 20s, often do not find their way to care until after admittance through an emergency department or a brush with the law, Dr. Schlosser said. Once diagnosed, clinically meaningful improvements in outcomes in this cohort often are impeded by cognitive and motivational impairment, including fear of stigma, or logistical challenges such as finding reliable transportation to a treatment site. According to the World Health Organization, half of all people with schizophrenia globally are not receiving treatment.

“We can do better,” Dr. Schlosser said.

In the PRIME design trials, Dr. Schlosser and her colleagues are evaluating how “user-centered design” might improve treatment delivery. In stage 1 of the study, two design phases, each with a separate group of 10 participants with recent-onset schizophrenia, helped a global design firm called IDEO arrive at a product that Dr. Schlosser and her colleagues described in a study published online as “casual, friendly, and nonstigmatizing, which is in line with the recovery model of psychosis” (JMIR Res Protoc. 2016;5[2]:e77).

The app included short motivational texts from trained therapists, a feature for individualized goal setting in prognostically important psychosocial domains, opportunities for social networking via direct peer-to-peer messaging, and a community “moments feed” aimed at capturing and reinforcing rewarding experiences and achieving goals.

After 12 weeks of using the app, Dr. Schlosser and her coinvestigators found that trial participants, all of whom had been asked to use it at least once a week, had used it an average of once every other day and had actively engaged with its various features with every log-in. Retention and satisfaction was 100% in each group, and levels of engagement from stage 1 to stage 2 increased by what Dr. Schlosser and her coauthors reported as “two- or threefold” in almost each aspect of the platform.

Dr. Schlosser said such impressive results have continued now that the study has entered stage 2, which is being conducted across the United States, Canada, and Mexico. Fifty people have enrolled, Dr. Schlosser said.

“So far, we have a 93% retention in our clinical trial, which is very high for this population,” she said. “We’re also seeing that two-thirds of the population are self-referred. You just don’t see that in early psychosis research.”

She credits those results in part to the study’s online recruitment design, but Dr. Schlosser said the patient-reported outcomes are the most gratifying.

“We got a letter from a mom who said she wished we could have seen her daughter’s face when she saw that everyone in her [online] group looks ‘normal.’ Her daughter was looking for hope, and she found it mirrored back at her,” Dr. Schlosser said. “They are not their illness.”

A prime reason people with recent-onset schizophrenia don’t access formal treatment is the fear they will be stigmatized, Dr. Schlosser said. Furthermore, she said, since most of those affected are young, creative, and “antiestablishment” in their attitudes, they already deal with stigma. The most effective treatment experience needed to be based on those kinds of values, she said.

“They want more control in their lives, and they want to connect with others like them. The idea of seeking care in a traditional setting is a deterrent for these people,” Dr. Schlosser said in the interview. “So, rather than build a new building, we built them a digital platform.”

A few audience members expressed concern that such a treatment model may expose these patients to unnecessary harm. Dr. Schlosser replied in the interview that even in clinical settings, patients prescribed medications still may be noncompliant. “We are not the enforcers of medications. It’s still the patient’s choice. Maybe I am being too provocative, but if people don’t want to take medications, then we try to work with them where they are,” she said.

In addition to the support from the online community, trial participants spend an average of 20 minutes with the coaching staff, making the model a “very low resource” one, according to Dr. Schlosser.

PRIME is expected to complete in the spring 2018, at which time the data collected potentially will be used to refine user-designed apps for use in other mental disorders, Dr. Schlosser said.

“I want to promote a digital system of care so that we can move immediately from when we identify a person is at risk to immediately giving them support. I think we can improve things so that we don’t just have equivalent levels of care but optimal ones,” Dr. Schlosser told the audience. “What we have had as our system of care to date isn’t working.”

Dr. Schlosser did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

Fibrosis progression in hepatitis C virus–infected individuals is not linear, is associated with Clues to fibrosis progression in chronic hepatitis C infectionClues to fibrosis progression in chronic hepatitis C infection–related flares, and varies according to stage, with those who are least fibrotic tending to have the highest progression, according to a study.

Identifying which patients with hepatitis C virus (HCV) infection will likely progress to cirrhosis has historically been a challenge, creating some difficulty adhering to guidelines recommending that patients at greater risk of fibrosis be among those prioritized for treatment. Having an ability to more accurately diagnose those most at risk could help to better guide treatment prioritization and clinical management.

To that end, Marija Zeremski, PhD, and her colleagues at Weill Cornell Medical School, New York, analyzed 936 biopsies taken from 378 patients seen at a single site between 1997 and 2013. At the time of the first biopsy, nearly two-thirds of the patients were white men in their late 40s to mid-50s, with chronic HCV infection. Nearly 88% of all patients were HCV genotype 1 infected (J Infect Dis. 2016. doi: 10.1093/infdis/jiw332).

In the study, investigators found that between the first and a follow-up biopsy, 57.4% of patients progressed by at least one fibrosis stage, 16.1% of patients had more severe fibrosis progressions of at least two stages, and 10.6% developed either stage 3-4 or 4, with nearly 6% of patients progressing to cirrhosis. Fibrosis progression between the first and last biopsies was associated with less fibrosis on the first biopsy (P less than .001).

Increased necroinflammation and the presence of at least one alanine aminotransferase (ALT) flare greater than 200 U/L during follow-up was also significantly associated with fibrosis progression (odds ratio [OR], 2.64, P less than .007). HCV genotype 3–infected patients were significantly more likely to progress to cirrhosis (P less than .001).

Intrahepatic inflammation at the time of the initial biopsy was at grade 1 or lower in 36.4% of patients, while 56.9% of patients had grade 2 (moderate) inflammation. Severe inflammation (grade 3 or higher) was found in 6.7% of patients reviewed. There was no fibrosis in 11.9% of patients, stage 1 level of fibrosis in 32.3%, stage 2 in 39.4%, and stage 3 in 16.4% of patients.

Moderate to severe fibrosis, defined as equal to or greater than stage 2, was significantly associated with elevated inflammation (greater or equal to grade 2) on the initial biopsy (OR, 9.00; P less than .001). Steatosis testing was performed on 222 patients; 59% tested positive for it. This was significantly associated with stage 2 or higher fibrosis (OR, 2.39; P = .002), and grade 2 or higher levels of inflammation (OR, 4.07; P less than .001) on the initial biopsy.

The highest fibrosis progression rate occurred between stages 0 and 1; the lowest, between stages 2 and 3.

Consecutive biopsies were separated by at least 1 year; patients were either HCV treatment naive or were treatment nonresponders. There were a total of 558 consecutive biopsy pairs available to analyze stage progression. The time between the first and last biopsies was 6.5 years (plus or minus 3 years), while the mean duration between adjacent biopsies was 4.4 years (plus or minus 1.9 years). Data regarding HCV treatment between liver biopsies were available for all but 45 patients. Forty-three percent of the remaining patients did not achieve a sustained virologic response after treatment.

Patients who’d had a cirrhosis diagnosis according to the first biopsy, those for whom treatment induced viral eradication, or those who’d had liver transplantation between biopsies were all excluded from the review.

The investigators wrote that their finding about the association between genotype 3 and cirrhosis should be “interpreted cautiously” because of the low number of these patients in their study.

This article was updated August 17, 2016.

[email protected]

On Twitter @whitneymcknight

Fibrosis progression in hepatitis C virus–infected individuals is not linear, is associated with Clues to fibrosis progression in chronic hepatitis C infectionClues to fibrosis progression in chronic hepatitis C infection–related flares, and varies according to stage, with those who are least fibrotic tending to have the highest progression, according to a study.

Identifying which patients with hepatitis C virus (HCV) infection will likely progress to cirrhosis has historically been a challenge, creating some difficulty adhering to guidelines recommending that patients at greater risk of fibrosis be among those prioritized for treatment. Having an ability to more accurately diagnose those most at risk could help to better guide treatment prioritization and clinical management.

To that end, Marija Zeremski, PhD, and her colleagues at Weill Cornell Medical School, New York, analyzed 936 biopsies taken from 378 patients seen at a single site between 1997 and 2013. At the time of the first biopsy, nearly two-thirds of the patients were white men in their late 40s to mid-50s, with chronic HCV infection. Nearly 88% of all patients were HCV genotype 1 infected (J Infect Dis. 2016. doi: 10.1093/infdis/jiw332).

In the study, investigators found that between the first and a follow-up biopsy, 57.4% of patients progressed by at least one fibrosis stage, 16.1% of patients had more severe fibrosis progressions of at least two stages, and 10.6% developed either stage 3-4 or 4, with nearly 6% of patients progressing to cirrhosis. Fibrosis progression between the first and last biopsies was associated with less fibrosis on the first biopsy (P less than .001).

Increased necroinflammation and the presence of at least one alanine aminotransferase (ALT) flare greater than 200 U/L during follow-up was also significantly associated with fibrosis progression (odds ratio [OR], 2.64, P less than .007). HCV genotype 3–infected patients were significantly more likely to progress to cirrhosis (P less than .001).

Intrahepatic inflammation at the time of the initial biopsy was at grade 1 or lower in 36.4% of patients, while 56.9% of patients had grade 2 (moderate) inflammation. Severe inflammation (grade 3 or higher) was found in 6.7% of patients reviewed. There was no fibrosis in 11.9% of patients, stage 1 level of fibrosis in 32.3%, stage 2 in 39.4%, and stage 3 in 16.4% of patients.

Moderate to severe fibrosis, defined as equal to or greater than stage 2, was significantly associated with elevated inflammation (greater or equal to grade 2) on the initial biopsy (OR, 9.00; P less than .001). Steatosis testing was performed on 222 patients; 59% tested positive for it. This was significantly associated with stage 2 or higher fibrosis (OR, 2.39; P = .002), and grade 2 or higher levels of inflammation (OR, 4.07; P less than .001) on the initial biopsy.

The highest fibrosis progression rate occurred between stages 0 and 1; the lowest, between stages 2 and 3.

Consecutive biopsies were separated by at least 1 year; patients were either HCV treatment naive or were treatment nonresponders. There were a total of 558 consecutive biopsy pairs available to analyze stage progression. The time between the first and last biopsies was 6.5 years (plus or minus 3 years), while the mean duration between adjacent biopsies was 4.4 years (plus or minus 1.9 years). Data regarding HCV treatment between liver biopsies were available for all but 45 patients. Forty-three percent of the remaining patients did not achieve a sustained virologic response after treatment.

Patients who’d had a cirrhosis diagnosis according to the first biopsy, those for whom treatment induced viral eradication, or those who’d had liver transplantation between biopsies were all excluded from the review.

The investigators wrote that their finding about the association between genotype 3 and cirrhosis should be “interpreted cautiously” because of the low number of these patients in their study.

This article was updated August 17, 2016.

[email protected]

On Twitter @whitneymcknight

Fibrosis progression in hepatitis C virus–infected individuals is not linear, is associated with Clues to fibrosis progression in chronic hepatitis C infectionClues to fibrosis progression in chronic hepatitis C infection–related flares, and varies according to stage, with those who are least fibrotic tending to have the highest progression, according to a study.

Identifying which patients with hepatitis C virus (HCV) infection will likely progress to cirrhosis has historically been a challenge, creating some difficulty adhering to guidelines recommending that patients at greater risk of fibrosis be among those prioritized for treatment. Having an ability to more accurately diagnose those most at risk could help to better guide treatment prioritization and clinical management.

To that end, Marija Zeremski, PhD, and her colleagues at Weill Cornell Medical School, New York, analyzed 936 biopsies taken from 378 patients seen at a single site between 1997 and 2013. At the time of the first biopsy, nearly two-thirds of the patients were white men in their late 40s to mid-50s, with chronic HCV infection. Nearly 88% of all patients were HCV genotype 1 infected (J Infect Dis. 2016. doi: 10.1093/infdis/jiw332).

In the study, investigators found that between the first and a follow-up biopsy, 57.4% of patients progressed by at least one fibrosis stage, 16.1% of patients had more severe fibrosis progressions of at least two stages, and 10.6% developed either stage 3-4 or 4, with nearly 6% of patients progressing to cirrhosis. Fibrosis progression between the first and last biopsies was associated with less fibrosis on the first biopsy (P less than .001).

Increased necroinflammation and the presence of at least one alanine aminotransferase (ALT) flare greater than 200 U/L during follow-up was also significantly associated with fibrosis progression (odds ratio [OR], 2.64, P less than .007). HCV genotype 3–infected patients were significantly more likely to progress to cirrhosis (P less than .001).

Intrahepatic inflammation at the time of the initial biopsy was at grade 1 or lower in 36.4% of patients, while 56.9% of patients had grade 2 (moderate) inflammation. Severe inflammation (grade 3 or higher) was found in 6.7% of patients reviewed. There was no fibrosis in 11.9% of patients, stage 1 level of fibrosis in 32.3%, stage 2 in 39.4%, and stage 3 in 16.4% of patients.

Moderate to severe fibrosis, defined as equal to or greater than stage 2, was significantly associated with elevated inflammation (greater or equal to grade 2) on the initial biopsy (OR, 9.00; P less than .001). Steatosis testing was performed on 222 patients; 59% tested positive for it. This was significantly associated with stage 2 or higher fibrosis (OR, 2.39; P = .002), and grade 2 or higher levels of inflammation (OR, 4.07; P less than .001) on the initial biopsy.

The highest fibrosis progression rate occurred between stages 0 and 1; the lowest, between stages 2 and 3.

Consecutive biopsies were separated by at least 1 year; patients were either HCV treatment naive or were treatment nonresponders. There were a total of 558 consecutive biopsy pairs available to analyze stage progression. The time between the first and last biopsies was 6.5 years (plus or minus 3 years), while the mean duration between adjacent biopsies was 4.4 years (plus or minus 1.9 years). Data regarding HCV treatment between liver biopsies were available for all but 45 patients. Forty-three percent of the remaining patients did not achieve a sustained virologic response after treatment.

Patients who’d had a cirrhosis diagnosis according to the first biopsy, those for whom treatment induced viral eradication, or those who’d had liver transplantation between biopsies were all excluded from the review.

The investigators wrote that their finding about the association between genotype 3 and cirrhosis should be “interpreted cautiously” because of the low number of these patients in their study.

This article was updated August 17, 2016.

[email protected]

On Twitter @whitneymcknight

Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.

“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.

Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.

Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.

When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.

But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.

Components of collaborative care

In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.

“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.

“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.

The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.

Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.

An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.

Legislative support

The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.

Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.

Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.

In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.

Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.

Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.

Partnerships inevitable

In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.

“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”

Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.

Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.

“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”

[email protected]

On Twitter @whitneymcknight

Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.

“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.

Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.

Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.

When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.

But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.

Components of collaborative care

In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.

“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.

“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.

The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.

Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.

An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.

Legislative support

The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.

Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.

Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.

In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.

Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.

Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.

Partnerships inevitable

In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.

“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”

Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.

Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.

“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”

[email protected]

On Twitter @whitneymcknight

Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.

“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.

Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.

Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.

When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.

But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.

Components of collaborative care

In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.

“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.

“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.

The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.

Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.

An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.

Legislative support

The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.

Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.

Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.

In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.

Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.

Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.

Partnerships inevitable

In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.

“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”

Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.

Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.

“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial 

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial 

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial 

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD. – A smartphone application helped decrease depressive symptoms and improve confidence in self care for low-income pregnant women in their third trimester, a pilot study has shown.

“There is a difficulty in bringing mental health into the OB setting, particularly for underserved communities, in part because of too much to accomplish during a visit or because some women don’t think it’s the appropriate place to talk about their mental health concerns,” Liisa Hantsoo, PhD, a researcher at the Penn Center for Women’s Behavioral Wellness in Philadelphia, said during the annual National Institute of Mental Health Conference on Mental Health Services Research.

However, in a single academic site pilot study of 64 pregnant women, most of whom were covered under Medicaid, Dr. Hantsoo and her colleagues found that when the women were given access to their obstetrician’s office via a smartphone app integrated into the practice, they were significantly more likely to open up about their mental health concerns, spend more time in conversation with their clinician when symptoms increased, and experience fewer symptoms of depression and anxiety.

“Participants used the app frequently, they reported feeling more positive about their emotions, and they reported feeling more confident about taking care of their own health during their third trimester,” Dr. Hantsoo said.

All women in the study were assessed for depression using the Patient Health Questionnaire depression module (PHQ-9). Women with scores of 5 or higher who were no more than 32 weeks pregnant were included in the study. The women – more than half of whom had a prior history of mental illness – were also assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). And they were asked to rate their satisfaction levels with their OB care at baseline, including whether they believed their care team connected with them as individuals. The study participants were all in their mid-20s and had previously given birth.

Twenty-two women were randomly assigned to use a control app, which only allowed self-initiated communication with the practice through an established patient portal not designed specifically for mental health. Another 23 women were assigned to the same control app plus an app designed by Ginger.io for mental health self-care and symptom tracking. The study app included daily cognitive-behavioral therapy messages, other behavioral health educational messages, and prompts to record self-assessments of mood that were monitored daily by a care coordinator. The remaining 19 women were assigned to both apps and received additional prompts throughout the day to record their thoughts and mood, which were also monitored. If a patient’s depressive symptoms increased, the care coordinator alerted a physician in the practice, who then contacted the patient.

By week 8, the study app users had significantly decreased PHQ-9 scores (P = .001) and significantly decreased GAD-7 scores (P = .003). The combined study cohorts (women using the study app and those with the study app plus prompts to record mood) also self-reported significantly improved mood ratings at week 8 (P = .03). The combined study groups also reported more confidence in their ability to care for themselves, particularly in their third trimester, compared with women using only the control app (P = .002).

The difference is likely because of the ways that the study app was integrated into care, Dr. Hantsoo said. “Apps allow self-monitoring and identify your patterns over time, but they are also limited in that they aren’t often integrated into treatment or care, leaving a person hanging in distress if they enter their data, but then not having it seem to go anywhere. This app allowed patients to interact with their providers.”

Use of any app did not significantly affect how participants rated their overall care, although at least half of all study app users reported feeling more confident in their ability to assess and manage their moods and their overall health, particularly in their third trimester.

As for the physicians who participated in the study, they reported needing more time each week to respond to app-triggered patient needs. “It was a bit of a disruption, but they did report they thought it was worthwhile to do,” Dr. Hantsoo said in an interview.

Support for this study was provided by Ginger.io and by the Penn Medicine Center for Health Care Innovation. Dr. Hantsoo reported having no relevant financial

[email protected]

On Twitter @whitneymcknight

Why is your geriatric patient whose life seemed fulfilling before retirement now talking about not feeling “right”? “Am I depressed, or is this normal,” your patient wants to know. What should be your reply, and what interventions can you take to help this patient in the context of a 15-minute appointment?

In this video, part of the Mental Health Consult series of roundtable discussions, our panel members discuss their recommendations for work-up and next steps for managing a 65-year-old recently retired man with a history of prostate cancer but no psychiatric disorders. He has some mild depressive symptoms, and he brings up suicide during the office visit.

Join our panel of experts from George Washington University, Washington, including Katalin Roth, MD, director of geriatrics and palliative medicine; April Barbour, MD, director of the division of general internal medicine; and Lorenzo Norris, MD, medical director of psychiatric and behavioral services, as they discuss how to differentiate between the distress often inherent in life passages and mental illness, and how practice models drive treatment decisions and reimbursement.

[email protected]

On Twitter @whitneymcknight

Why is your geriatric patient whose life seemed fulfilling before retirement now talking about not feeling “right”? “Am I depressed, or is this normal,” your patient wants to know. What should be your reply, and what interventions can you take to help this patient in the context of a 15-minute appointment?

In this video, part of the Mental Health Consult series of roundtable discussions, our panel members discuss their recommendations for work-up and next steps for managing a 65-year-old recently retired man with a history of prostate cancer but no psychiatric disorders. He has some mild depressive symptoms, and he brings up suicide during the office visit.

Join our panel of experts from George Washington University, Washington, including Katalin Roth, MD, director of geriatrics and palliative medicine; April Barbour, MD, director of the division of general internal medicine; and Lorenzo Norris, MD, medical director of psychiatric and behavioral services, as they discuss how to differentiate between the distress often inherent in life passages and mental illness, and how practice models drive treatment decisions and reimbursement.

[email protected]

On Twitter @whitneymcknight

Why is your geriatric patient whose life seemed fulfilling before retirement now talking about not feeling “right”? “Am I depressed, or is this normal,” your patient wants to know. What should be your reply, and what interventions can you take to help this patient in the context of a 15-minute appointment?

In this video, part of the Mental Health Consult series of roundtable discussions, our panel members discuss their recommendations for work-up and next steps for managing a 65-year-old recently retired man with a history of prostate cancer but no psychiatric disorders. He has some mild depressive symptoms, and he brings up suicide during the office visit.

Join our panel of experts from George Washington University, Washington, including Katalin Roth, MD, director of geriatrics and palliative medicine; April Barbour, MD, director of the division of general internal medicine; and Lorenzo Norris, MD, medical director of psychiatric and behavioral services, as they discuss how to differentiate between the distress often inherent in life passages and mental illness, and how practice models drive treatment decisions and reimbursement.

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Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration has approved the once-daily injectable lixisenatide, a glucagonlike peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise for improved glycemic control in adults with type 2 diabetes.

The safety and effectiveness of lixisenatide (Adlyxin, Sanofi) were evaluated either as a standalone therapy or in combination with other FDA-approved treatments in a series of clinical trials that enrolled 5,400 adults with poorly controlled type 2 diabetes. The combinations tested in the GetGoal Duo2 studies included lixisenatide with metformin, sulfonylureas, pioglitazone, or basal insulin. Lixisenatide successfully met the primary endpoint of improved hemoglobin A_1c levels.

Sanofi, the drug’s manufacturer, withdrew its original 2013 application for lixisenatide’s approval pending evaluation of its cardiovascular safety profile using data from the randomized, controlled Evaluation of Lixisenatide in Acute Coronary Syndrome ELIXA trial. In that study of more than 6,000 adults with type 2 diabetes at risk for atherosclerotic cardiovascular disease, lixisenatide did not increase the risk of cardiovascular adverse events, which occurred in 13.2% of placebo patients and 13.4% of treatment group patients (N Engl J Med. 2015;373:2247-57).

The drug’s most common side effects are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Severe hypersensitivity reactions, including anaphylaxis, also were reported in the clinical trials.

Lixisenatide should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis.

The drug will be marketed in disposable, 20-mcg single-dose pens to be injected postprandially, once daily, following initial treatment with a once-daily dose of 10 mcg for 14 days.

Lixisenatide is approved in more than 60 countries and marketed as Lyxumia in over 40, according to information on the manufacturer’s website.

Postmarketing studies for lixisenatide will be required to evaluate dosing, efficacy, and safety in pediatric patients, and to evaluate the drug’s immunogenicity, according to an FDA statement.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration has approved the once-daily injectable lixisenatide, a glucagonlike peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise for improved glycemic control in adults with type 2 diabetes.

The safety and effectiveness of lixisenatide (Adlyxin, Sanofi) were evaluated either as a standalone therapy or in combination with other FDA-approved treatments in a series of clinical trials that enrolled 5,400 adults with poorly controlled type 2 diabetes. The combinations tested in the GetGoal Duo2 studies included lixisenatide with metformin, sulfonylureas, pioglitazone, or basal insulin. Lixisenatide successfully met the primary endpoint of improved hemoglobin A_1c levels.

Sanofi, the drug’s manufacturer, withdrew its original 2013 application for lixisenatide’s approval pending evaluation of its cardiovascular safety profile using data from the randomized, controlled Evaluation of Lixisenatide in Acute Coronary Syndrome ELIXA trial. In that study of more than 6,000 adults with type 2 diabetes at risk for atherosclerotic cardiovascular disease, lixisenatide did not increase the risk of cardiovascular adverse events, which occurred in 13.2% of placebo patients and 13.4% of treatment group patients (N Engl J Med. 2015;373:2247-57).

The drug’s most common side effects are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Severe hypersensitivity reactions, including anaphylaxis, also were reported in the clinical trials.

Lixisenatide should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis.

The drug will be marketed in disposable, 20-mcg single-dose pens to be injected postprandially, once daily, following initial treatment with a once-daily dose of 10 mcg for 14 days.

Lixisenatide is approved in more than 60 countries and marketed as Lyxumia in over 40, according to information on the manufacturer’s website.

Postmarketing studies for lixisenatide will be required to evaluate dosing, efficacy, and safety in pediatric patients, and to evaluate the drug’s immunogenicity, according to an FDA statement.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration has approved the once-daily injectable lixisenatide, a glucagonlike peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise for improved glycemic control in adults with type 2 diabetes.

The safety and effectiveness of lixisenatide (Adlyxin, Sanofi) were evaluated either as a standalone therapy or in combination with other FDA-approved treatments in a series of clinical trials that enrolled 5,400 adults with poorly controlled type 2 diabetes. The combinations tested in the GetGoal Duo2 studies included lixisenatide with metformin, sulfonylureas, pioglitazone, or basal insulin. Lixisenatide successfully met the primary endpoint of improved hemoglobin A_1c levels.

Sanofi, the drug’s manufacturer, withdrew its original 2013 application for lixisenatide’s approval pending evaluation of its cardiovascular safety profile using data from the randomized, controlled Evaluation of Lixisenatide in Acute Coronary Syndrome ELIXA trial. In that study of more than 6,000 adults with type 2 diabetes at risk for atherosclerotic cardiovascular disease, lixisenatide did not increase the risk of cardiovascular adverse events, which occurred in 13.2% of placebo patients and 13.4% of treatment group patients (N Engl J Med. 2015;373:2247-57).

The drug’s most common side effects are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Severe hypersensitivity reactions, including anaphylaxis, also were reported in the clinical trials.

Lixisenatide should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis.

The drug will be marketed in disposable, 20-mcg single-dose pens to be injected postprandially, once daily, following initial treatment with a once-daily dose of 10 mcg for 14 days.

Lixisenatide is approved in more than 60 countries and marketed as Lyxumia in over 40, according to information on the manufacturer’s website.

Postmarketing studies for lixisenatide will be required to evaluate dosing, efficacy, and safety in pediatric patients, and to evaluate the drug’s immunogenicity, according to an FDA statement.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, MD, deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

[email protected]

On Twitter @whitneymcknight