Whitney McKnight

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

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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.

[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

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

Talk about sex with patients and their families, and have ongoing, age-appropriate discussions over the course of a patient’s development, urges an updated clinical report from the American Academy of Pediatrics.

Citing gaps in school-based sexuality education programs nationally, the report calls on you to do more to ensure patients have adequate information about preventing teen pregnancy, HIV, and other sexually transmitted diseases.

The report will be seen as good news by pediatricians and others, lead author and chairperson of the AAP Committee on Adolescence, Cora Collette Breuner, MD, said in an interview.

“Pediatricians, parents, and school administrators have been asking for this updated information,” Dr. Breuner said. “Pediatricians want more clarification, more resources, and more evidence for what they are already doing.”

The report, Sexuality Education for Children and Adolescents, is published online and is free to the general public. It is the AAP’s first update on sexuality education since 2001, and includes lists of resources specifically for clinicians, parents, and schools.

“We found that only one out of three adolescent patients receive any information on sexuality from their pediatrician, and if they did, the conversation lasted less than 40 seconds,” Dr. Breuner said, citing a review of health maintenance visits. Dr. Breuneris also a professor of adolescent medicine at the Seattle Children’s Hospital.

Even if less than a minute is all that you have to devote to discussing sexual health with a patient, Dr. Breuner said it’s well worth it, in part because it can help prevent teens from turning to often unreliable sources of information on the Internet, and because it can help fill the gap for teens whose families don’t want to address the topic, or whose schools do not offer programs to address it.

“The conversations should cover a range of aspects of sexual health, including healthy sexual development, interpersonal and consensual relationships, affection, intimacy, and body image,” Dr. Breuner said. “The research shows that just talking about abstinence is not enough.”

Such conversations also should address sexual anatomy and reproduction, sexually transmitted infections, sexual orientation, gender identity, abstinence, contraception, and reproductive rights and responsibilities, according to the report.

The report cites a meta-analysis finding that parents who were trained on how to effectively communicate about sex with their adolescents had better conversations on the subject than parents who were not. Such conversations correlated with a delay in teen sexual debut and an increased use of contraception and condoms.

Talking with young persons about their sexuality is also a way to help screen them for depression and suicidality, Dr. Breuner said. “These issues can often be uncovered when talking with kids about sexuality, particularly with those who are questioning their sexual identity.”

The report also suggests pediatricians discuss issues of physical, cognitive, and psychosexual development with parents of young children during well visits over time.

Earlier this year, in conjunction with the North American Society of Pediatric and Adolescent Gynecology, the AAP issued its first clinical guidance on addressing sexual health in adolescents with special needs (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

Neither Dr. Breuner nor the authors of the clinical report had any relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

Talk about sex with patients and their families, and have ongoing, age-appropriate discussions over the course of a patient’s development, urges an updated clinical report from the American Academy of Pediatrics.

Citing gaps in school-based sexuality education programs nationally, the report calls on you to do more to ensure patients have adequate information about preventing teen pregnancy, HIV, and other sexually transmitted diseases.

The report will be seen as good news by pediatricians and others, lead author and chairperson of the AAP Committee on Adolescence, Cora Collette Breuner, MD, said in an interview.

“Pediatricians, parents, and school administrators have been asking for this updated information,” Dr. Breuner said. “Pediatricians want more clarification, more resources, and more evidence for what they are already doing.”

The report, Sexuality Education for Children and Adolescents, is published online and is free to the general public. It is the AAP’s first update on sexuality education since 2001, and includes lists of resources specifically for clinicians, parents, and schools.

“We found that only one out of three adolescent patients receive any information on sexuality from their pediatrician, and if they did, the conversation lasted less than 40 seconds,” Dr. Breuner said, citing a review of health maintenance visits. Dr. Breuneris also a professor of adolescent medicine at the Seattle Children’s Hospital.

Even if less than a minute is all that you have to devote to discussing sexual health with a patient, Dr. Breuner said it’s well worth it, in part because it can help prevent teens from turning to often unreliable sources of information on the Internet, and because it can help fill the gap for teens whose families don’t want to address the topic, or whose schools do not offer programs to address it.

“The conversations should cover a range of aspects of sexual health, including healthy sexual development, interpersonal and consensual relationships, affection, intimacy, and body image,” Dr. Breuner said. “The research shows that just talking about abstinence is not enough.”

Such conversations also should address sexual anatomy and reproduction, sexually transmitted infections, sexual orientation, gender identity, abstinence, contraception, and reproductive rights and responsibilities, according to the report.

The report cites a meta-analysis finding that parents who were trained on how to effectively communicate about sex with their adolescents had better conversations on the subject than parents who were not. Such conversations correlated with a delay in teen sexual debut and an increased use of contraception and condoms.

Talking with young persons about their sexuality is also a way to help screen them for depression and suicidality, Dr. Breuner said. “These issues can often be uncovered when talking with kids about sexuality, particularly with those who are questioning their sexual identity.”

The report also suggests pediatricians discuss issues of physical, cognitive, and psychosexual development with parents of young children during well visits over time.

Earlier this year, in conjunction with the North American Society of Pediatric and Adolescent Gynecology, the AAP issued its first clinical guidance on addressing sexual health in adolescents with special needs (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

Neither Dr. Breuner nor the authors of the clinical report had any relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

Talk about sex with patients and their families, and have ongoing, age-appropriate discussions over the course of a patient’s development, urges an updated clinical report from the American Academy of Pediatrics.

Citing gaps in school-based sexuality education programs nationally, the report calls on you to do more to ensure patients have adequate information about preventing teen pregnancy, HIV, and other sexually transmitted diseases.

The report will be seen as good news by pediatricians and others, lead author and chairperson of the AAP Committee on Adolescence, Cora Collette Breuner, MD, said in an interview.

“Pediatricians, parents, and school administrators have been asking for this updated information,” Dr. Breuner said. “Pediatricians want more clarification, more resources, and more evidence for what they are already doing.”

The report, Sexuality Education for Children and Adolescents, is published online and is free to the general public. It is the AAP’s first update on sexuality education since 2001, and includes lists of resources specifically for clinicians, parents, and schools.

“We found that only one out of three adolescent patients receive any information on sexuality from their pediatrician, and if they did, the conversation lasted less than 40 seconds,” Dr. Breuner said, citing a review of health maintenance visits. Dr. Breuneris also a professor of adolescent medicine at the Seattle Children’s Hospital.

Even if less than a minute is all that you have to devote to discussing sexual health with a patient, Dr. Breuner said it’s well worth it, in part because it can help prevent teens from turning to often unreliable sources of information on the Internet, and because it can help fill the gap for teens whose families don’t want to address the topic, or whose schools do not offer programs to address it.

“The conversations should cover a range of aspects of sexual health, including healthy sexual development, interpersonal and consensual relationships, affection, intimacy, and body image,” Dr. Breuner said. “The research shows that just talking about abstinence is not enough.”

Such conversations also should address sexual anatomy and reproduction, sexually transmitted infections, sexual orientation, gender identity, abstinence, contraception, and reproductive rights and responsibilities, according to the report.

The report cites a meta-analysis finding that parents who were trained on how to effectively communicate about sex with their adolescents had better conversations on the subject than parents who were not. Such conversations correlated with a delay in teen sexual debut and an increased use of contraception and condoms.

Talking with young persons about their sexuality is also a way to help screen them for depression and suicidality, Dr. Breuner said. “These issues can often be uncovered when talking with kids about sexuality, particularly with those who are questioning their sexual identity.”

The report also suggests pediatricians discuss issues of physical, cognitive, and psychosexual development with parents of young children during well visits over time.

Earlier this year, in conjunction with the North American Society of Pediatric and Adolescent Gynecology, the AAP issued its first clinical guidance on addressing sexual health in adolescents with special needs (Pediatrics. 2006. doi: 10.1542/peds.2006-1115).

Neither Dr. Breuner nor the authors of the clinical report had any relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Alzheimer’s disease symptoms can be managed with simple algorithms that include ruling out other physiologic concerns and making some lifestyle modifications, according to an expert.

“These approaches are neither hopelessly complicated nor random,” Richard J. Caselli, MD, said at Summit in Neurology & Psychiatry, held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Key to diagnosis and management is to understand the differences between Alzheimer’s, dementia, and nondisabling cognitive impairment. “Alzheimer’s disease is the most common cause of dementia, but it is not synonymous with dementia,” said Dr. Caselli, a neurologist at the Mayo Clinic in Scottsdale, Ariz. “Dementia is not memory loss alone but the disabling impairment of multiple cognitive functions.”

Mild cognitive impairment typically means that a patient is still able to conduct his or her activities of daily living despite having memory (or other cognitive) problems.

Although it is possible for a traumatic event such as a family upset, hip replacement surgery, or an infection, to provoke signs of cognitive impairment, it is not usually “down to one day where all hell broke loose and ever since then, [the patient] hasn’t been the same,” Dr. Caselli said. “There are a lot of different reasons why a person can have cognitive difficulty, although with degenerative causes of dementia, it is a gradual onset problem.”

Alzheimer’s disease has a lengthy preclinical phase and can take as long as 15 years (or more) to finally present with symptoms of memory loss after onset, he added.

Changes in behavior, sleep

Behavioral changes in the patient, such as increasing paranoia, delusional states, aggression, and agitation, are an especially problematic aspect of the disease, Dr. Caselli said. Medications such as atypical and typical antipsychotics are off label, but can be effective in helping to manage psychosis and agitation, he said. Antipsychotic medications carry black box warnings from the Food and Drug Administration for use in the elderly, highlighting an increased risk of sudden death, especially in patients with underlying cardiac problems. Dr. Caselli said that, anecdotally, he had not yet seen any such severe adverse events when using atypical antipsychotics in this population, but vigilance should nonetheless be maintained. He also mentioned that pimavanserin, a selective serotonin 5-HT2A inverse agonist, recently was approved for psychosis in Parkinson’s disease, but that he so far has not had any personal experience with it.

Changes in sleep patterns also can offer clues to the type of dementia the patient may have. Pay close attention to the presence of any dream enactment behavior that may be a clue for REM sleep behavior disorder, which as been associated with Parkinson’s disease and dementia with Lewy bodies, according to Dr. Caselli.

Addressing other medical concerns such as restless legs syndrome, hypersomnolence, or nocturia can help patients get better sleep, and in turn, improve their overall disposition.

Physiologic concerns

Comorbid medical conditions such as a urinary tract infection, cancer, or end organ failure, as well as postoperative states and polypharmacy, also should be considered as potentially contributing to altered cognition. Although the physical exam for a person with Alzheimer’s disease tends to be normal, there are some types of dementia that might present with visual loss, aphasia, Parkinsonism, or signs of motor neuron disease, Dr. Caselli said.

Particularly in late-stage dementia, if patients have experienced a fracture or recently have had surgery, an abrupt decline in status could indicate they are in severe pain. “They aren’t going to be able to tell you that, though, and you will just have to be sensitive and attuned to that [possibility],” Dr. Caselli said.

Neuropsychological, other tests

A variety of widely available formal and informal tests can help evaluate a person’s orientation, learning and memory, and constructional and spatial abilities, such as accurately drawing the face of a clock. Language skills testing is important, particularly comprehension, which can be more subtle to detect but can prove key to the differential diagnosis and management.

Neuropsychological testing can reveal different patterns of cognitive impairment. For example, tests sensitive to mental or physical speed can help indicate whether a person has vascular dementia or Parkinson’s disease, two forms of impairment that involve slower cognition. Contrast this with people in the beginning stages of Alzheimer’s, who tend to be much less affected on such tests, Dr. Caselli said.

The conventional wisdom is that brain imaging often yields little diagnostic information in Alzheimer’s, but Dr. Caselli showed examples of tumors, strokes, focal atrophy, and amyloid angiopathy, as imaged abnormalities interfering with cognition. “Imaging in dementia is an important thing to do.”

Meanwhile, don’t ignore the basic lab tests such as blood counts, blood sugar, metabolic panels, and so forth. “Most of the time you don’t find these things, but sometimes you do,” Dr. Caselli said, noting that other clinical tests such as those used for a variety of encephalopathies or fungal infections also can be useful. “I am looking for something I can fix, not just reinforce that the 82-year-old man in front of me with a 2-year history of progressive memory loss has Alzheimer’s.”

There is a wide range of other differential diagnoses to consider testing for in the appropriate setting related to vascular, inflammatory, infectious, nutritional, neoplastic, metabolic, and other pathophysiologic processes. Just remember, it isn’t always Alzheimer’s, and because we can’t ‘fix’ Alzheimer’s, it’s important to make sure we have ruled out all other reasonable possibilities,” Dr. Caselli said. Keep in mind there is a lot of mixed pathology in dementia, he added.

Genetic testing can be important in patients with early-onset Alzheimer’s and a family history because there are several known disease-causing autosomal dominant mutations that, if identified in the patient, may have implications for first-degree relatives, including children. Young adult children have important life decisions to make that could be influenced by their own genetic status. Genetic testing is less likely to be helpful in patients with late-onset dementia with or without a family history, because the results will not alter management. Biomarkers can indicate the actual presence of pathology, but at this point, do not offer a reliable time frame for the evolution of symptoms, he said.

Dr. Caselli receives research funding from Merck as well as the National Institute on Aging.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Alzheimer’s disease symptoms can be managed with simple algorithms that include ruling out other physiologic concerns and making some lifestyle modifications, according to an expert.

“These approaches are neither hopelessly complicated nor random,” Richard J. Caselli, MD, said at Summit in Neurology & Psychiatry, held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Key to diagnosis and management is to understand the differences between Alzheimer’s, dementia, and nondisabling cognitive impairment. “Alzheimer’s disease is the most common cause of dementia, but it is not synonymous with dementia,” said Dr. Caselli, a neurologist at the Mayo Clinic in Scottsdale, Ariz. “Dementia is not memory loss alone but the disabling impairment of multiple cognitive functions.”

Mild cognitive impairment typically means that a patient is still able to conduct his or her activities of daily living despite having memory (or other cognitive) problems.

Although it is possible for a traumatic event such as a family upset, hip replacement surgery, or an infection, to provoke signs of cognitive impairment, it is not usually “down to one day where all hell broke loose and ever since then, [the patient] hasn’t been the same,” Dr. Caselli said. “There are a lot of different reasons why a person can have cognitive difficulty, although with degenerative causes of dementia, it is a gradual onset problem.”

Alzheimer’s disease has a lengthy preclinical phase and can take as long as 15 years (or more) to finally present with symptoms of memory loss after onset, he added.

Changes in behavior, sleep

Behavioral changes in the patient, such as increasing paranoia, delusional states, aggression, and agitation, are an especially problematic aspect of the disease, Dr. Caselli said. Medications such as atypical and typical antipsychotics are off label, but can be effective in helping to manage psychosis and agitation, he said. Antipsychotic medications carry black box warnings from the Food and Drug Administration for use in the elderly, highlighting an increased risk of sudden death, especially in patients with underlying cardiac problems. Dr. Caselli said that, anecdotally, he had not yet seen any such severe adverse events when using atypical antipsychotics in this population, but vigilance should nonetheless be maintained. He also mentioned that pimavanserin, a selective serotonin 5-HT2A inverse agonist, recently was approved for psychosis in Parkinson’s disease, but that he so far has not had any personal experience with it.

Changes in sleep patterns also can offer clues to the type of dementia the patient may have. Pay close attention to the presence of any dream enactment behavior that may be a clue for REM sleep behavior disorder, which as been associated with Parkinson’s disease and dementia with Lewy bodies, according to Dr. Caselli.

Addressing other medical concerns such as restless legs syndrome, hypersomnolence, or nocturia can help patients get better sleep, and in turn, improve their overall disposition.

Physiologic concerns

Comorbid medical conditions such as a urinary tract infection, cancer, or end organ failure, as well as postoperative states and polypharmacy, also should be considered as potentially contributing to altered cognition. Although the physical exam for a person with Alzheimer’s disease tends to be normal, there are some types of dementia that might present with visual loss, aphasia, Parkinsonism, or signs of motor neuron disease, Dr. Caselli said.

Particularly in late-stage dementia, if patients have experienced a fracture or recently have had surgery, an abrupt decline in status could indicate they are in severe pain. “They aren’t going to be able to tell you that, though, and you will just have to be sensitive and attuned to that [possibility],” Dr. Caselli said.

Neuropsychological, other tests

A variety of widely available formal and informal tests can help evaluate a person’s orientation, learning and memory, and constructional and spatial abilities, such as accurately drawing the face of a clock. Language skills testing is important, particularly comprehension, which can be more subtle to detect but can prove key to the differential diagnosis and management.

Neuropsychological testing can reveal different patterns of cognitive impairment. For example, tests sensitive to mental or physical speed can help indicate whether a person has vascular dementia or Parkinson’s disease, two forms of impairment that involve slower cognition. Contrast this with people in the beginning stages of Alzheimer’s, who tend to be much less affected on such tests, Dr. Caselli said.

The conventional wisdom is that brain imaging often yields little diagnostic information in Alzheimer’s, but Dr. Caselli showed examples of tumors, strokes, focal atrophy, and amyloid angiopathy, as imaged abnormalities interfering with cognition. “Imaging in dementia is an important thing to do.”

Meanwhile, don’t ignore the basic lab tests such as blood counts, blood sugar, metabolic panels, and so forth. “Most of the time you don’t find these things, but sometimes you do,” Dr. Caselli said, noting that other clinical tests such as those used for a variety of encephalopathies or fungal infections also can be useful. “I am looking for something I can fix, not just reinforce that the 82-year-old man in front of me with a 2-year history of progressive memory loss has Alzheimer’s.”

There is a wide range of other differential diagnoses to consider testing for in the appropriate setting related to vascular, inflammatory, infectious, nutritional, neoplastic, metabolic, and other pathophysiologic processes. Just remember, it isn’t always Alzheimer’s, and because we can’t ‘fix’ Alzheimer’s, it’s important to make sure we have ruled out all other reasonable possibilities,” Dr. Caselli said. Keep in mind there is a lot of mixed pathology in dementia, he added.

Genetic testing can be important in patients with early-onset Alzheimer’s and a family history because there are several known disease-causing autosomal dominant mutations that, if identified in the patient, may have implications for first-degree relatives, including children. Young adult children have important life decisions to make that could be influenced by their own genetic status. Genetic testing is less likely to be helpful in patients with late-onset dementia with or without a family history, because the results will not alter management. Biomarkers can indicate the actual presence of pathology, but at this point, do not offer a reliable time frame for the evolution of symptoms, he said.

Dr. Caselli receives research funding from Merck as well as the National Institute on Aging.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Alzheimer’s disease symptoms can be managed with simple algorithms that include ruling out other physiologic concerns and making some lifestyle modifications, according to an expert.

“These approaches are neither hopelessly complicated nor random,” Richard J. Caselli, MD, said at Summit in Neurology & Psychiatry, held by Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

Key to diagnosis and management is to understand the differences between Alzheimer’s, dementia, and nondisabling cognitive impairment. “Alzheimer’s disease is the most common cause of dementia, but it is not synonymous with dementia,” said Dr. Caselli, a neurologist at the Mayo Clinic in Scottsdale, Ariz. “Dementia is not memory loss alone but the disabling impairment of multiple cognitive functions.”

Mild cognitive impairment typically means that a patient is still able to conduct his or her activities of daily living despite having memory (or other cognitive) problems.

Although it is possible for a traumatic event such as a family upset, hip replacement surgery, or an infection, to provoke signs of cognitive impairment, it is not usually “down to one day where all hell broke loose and ever since then, [the patient] hasn’t been the same,” Dr. Caselli said. “There are a lot of different reasons why a person can have cognitive difficulty, although with degenerative causes of dementia, it is a gradual onset problem.”

Alzheimer’s disease has a lengthy preclinical phase and can take as long as 15 years (or more) to finally present with symptoms of memory loss after onset, he added.

Changes in behavior, sleep

Behavioral changes in the patient, such as increasing paranoia, delusional states, aggression, and agitation, are an especially problematic aspect of the disease, Dr. Caselli said. Medications such as atypical and typical antipsychotics are off label, but can be effective in helping to manage psychosis and agitation, he said. Antipsychotic medications carry black box warnings from the Food and Drug Administration for use in the elderly, highlighting an increased risk of sudden death, especially in patients with underlying cardiac problems. Dr. Caselli said that, anecdotally, he had not yet seen any such severe adverse events when using atypical antipsychotics in this population, but vigilance should nonetheless be maintained. He also mentioned that pimavanserin, a selective serotonin 5-HT2A inverse agonist, recently was approved for psychosis in Parkinson’s disease, but that he so far has not had any personal experience with it.

Changes in sleep patterns also can offer clues to the type of dementia the patient may have. Pay close attention to the presence of any dream enactment behavior that may be a clue for REM sleep behavior disorder, which as been associated with Parkinson’s disease and dementia with Lewy bodies, according to Dr. Caselli.

Addressing other medical concerns such as restless legs syndrome, hypersomnolence, or nocturia can help patients get better sleep, and in turn, improve their overall disposition.

Physiologic concerns

Comorbid medical conditions such as a urinary tract infection, cancer, or end organ failure, as well as postoperative states and polypharmacy, also should be considered as potentially contributing to altered cognition. Although the physical exam for a person with Alzheimer’s disease tends to be normal, there are some types of dementia that might present with visual loss, aphasia, Parkinsonism, or signs of motor neuron disease, Dr. Caselli said.

Particularly in late-stage dementia, if patients have experienced a fracture or recently have had surgery, an abrupt decline in status could indicate they are in severe pain. “They aren’t going to be able to tell you that, though, and you will just have to be sensitive and attuned to that [possibility],” Dr. Caselli said.

Neuropsychological, other tests

A variety of widely available formal and informal tests can help evaluate a person’s orientation, learning and memory, and constructional and spatial abilities, such as accurately drawing the face of a clock. Language skills testing is important, particularly comprehension, which can be more subtle to detect but can prove key to the differential diagnosis and management.

Neuropsychological testing can reveal different patterns of cognitive impairment. For example, tests sensitive to mental or physical speed can help indicate whether a person has vascular dementia or Parkinson’s disease, two forms of impairment that involve slower cognition. Contrast this with people in the beginning stages of Alzheimer’s, who tend to be much less affected on such tests, Dr. Caselli said.

The conventional wisdom is that brain imaging often yields little diagnostic information in Alzheimer’s, but Dr. Caselli showed examples of tumors, strokes, focal atrophy, and amyloid angiopathy, as imaged abnormalities interfering with cognition. “Imaging in dementia is an important thing to do.”

Meanwhile, don’t ignore the basic lab tests such as blood counts, blood sugar, metabolic panels, and so forth. “Most of the time you don’t find these things, but sometimes you do,” Dr. Caselli said, noting that other clinical tests such as those used for a variety of encephalopathies or fungal infections also can be useful. “I am looking for something I can fix, not just reinforce that the 82-year-old man in front of me with a 2-year history of progressive memory loss has Alzheimer’s.”

There is a wide range of other differential diagnoses to consider testing for in the appropriate setting related to vascular, inflammatory, infectious, nutritional, neoplastic, metabolic, and other pathophysiologic processes. Just remember, it isn’t always Alzheimer’s, and because we can’t ‘fix’ Alzheimer’s, it’s important to make sure we have ruled out all other reasonable possibilities,” Dr. Caselli said. Keep in mind there is a lot of mixed pathology in dementia, he added.

Genetic testing can be important in patients with early-onset Alzheimer’s and a family history because there are several known disease-causing autosomal dominant mutations that, if identified in the patient, may have implications for first-degree relatives, including children. Young adult children have important life decisions to make that could be influenced by their own genetic status. Genetic testing is less likely to be helpful in patients with late-onset dementia with or without a family history, because the results will not alter management. Biomarkers can indicate the actual presence of pathology, but at this point, do not offer a reliable time frame for the evolution of symptoms, he said.

Dr. Caselli receives research funding from Merck as well as the National Institute on Aging.

[email protected]

On Twitter @whitneymcknight