MDedge Psychiatry

The effect of the highly touted MIND diet with mild calorie restriction offered no greater protection against cognitive decline than a control diet with mild calorie restriction alone in healthy adults at risk for dementia, results of a new randomized trial show.

Given the strong base of evidence from observational studies that demonstrate the benefits of the MIND diet on cognitive decline, Alzheimer’s disease (AD), and neuropathologic changes such as reduced beta amyloid and tau associated with AD, the study’s results were “unexpected,” study investigator Lisa L. Barnes, PhD, with the Rush Alzheimer’s Disease Center, Chicago, said in an interview.

“One possibility is the trial may not have been long enough to see an effect. It’s also possible that participants in the control diet group benefited just as much as those in the MIND diet group because they also improved their diets to focus on weight loss,” Dr. Barnes said.

“Although we did not see a specific effect of the MIND diet, people in both groups improved their cognitive function, suggesting that a healthy diet in general is good for cognitive function,” she added.

The findings were presented at the annual Alzheimer’s Association International Conference and simultaneously published online in the New England Journal of Medicine.
 

Randomized trial

A hybrid of the Dietary Approaches to Stop Hypertension (DASH) and Mediterranean diet, the MIND diet includes foods and nutrients that have been putatively associated with a decreased risk of dementia.

To further investigate, the researchers conducted a randomized trial that included 604 older adults without cognitive impairment who had a family history of dementia, a body mass index greater than 25, and a suboptimal diet determined via a 14-item questionnaire.

For 3 years, 301 were randomly assigned to follow the MIND-diet with mild calorie restriction and 303 to follow a control diet with mild calorie restriction only. All participants received counseling to help them adhere to their assigned diet, plus support to promote weight loss of 3%-5% by year 3.

The primary endpoint was the change from baseline in global cognition and in specific cognitive domains through year 3. Cognition was assessed with an established battery of 12 publicly available cognitive function tests.

The secondary endpoint was the change from baseline in MRI-derived measures of brain characteristics in a nonrandom sample of participants.

“We had good adherence to the assigned diets and both groups lost weight, on average about 5 kilograms in both groups,” Dr. Barnes noted in her presentation.

From baseline through 3 years, small improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group versus 0.170 standardized units in the control-diet group.

However, in intention-to-treat analysis, the mean change in score did not differ significantly between groups, with an estimated mean difference at the end of the trial of 0.035 standardized units (P = .23).

At the trial’s conclusion, there were also no between-group differences in change in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI.

Dr. Barnes noted that the trial was limited to well-educated, older adults, mostly of European descent. Other limitations include the small sample size of those who received MRI and follow-up that was shorter than a typical observational study.

Dr. Barnes noted that this is a single study and that there needs to be more randomized trials of the MIND diet that, as with the observational research, follow participants for a longer period of time.
 

More to brain health than diet

Reached for comment, Majid Fotuhi, MD, PhD, adjunct professor of neuroscience at George Washington University, Washington, noted that participants who enroll in clinical trials that focus on diet become more aware of their eating habits and shift toward a healthier diet.

“This may explain the reason why both groups of participants in this study improved,” said Dr. Fotuhi, medical director of NeuroGrow Brain Fitness Center, McLean, Va.

However, he believes that better brain health requires a multipronged approach.

“In order to see significant results, people need to improve their diet, become physically fit, sleep well, reduce their stress, engage in cognitively challenging activities, and develop a positive mind set,” said Dr. Fotuhi.

“Interventions that target only one of these goals may not produce results that are as remarkable as multimodal programs, which target all of these goals,” Dr. Fotuhi said.

Dr. Fotuhi developed a multidimensional “brain fitness program” that has shown to provide multiple benefits for individuals with memory loss, attention deficit hyperactivity disorder, and post-concussion syndrome.

“Having provided our 12-week program for thousands of patients in the past 10 years, I have noticed a synergistic effect in patients who incorporate all of these changes in their day-to-day life and maintain it over time. They often become sharper and feel better overall,” Dr. Fotuhi told this news organization.

The study was supported by the National Institute on Aging. Disclosures for study authors are listed with the original article. Dr. Fotuhi has disclosed no relevant financial relationships.

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

The effect of the highly touted MIND diet with mild calorie restriction offered no greater protection against cognitive decline than a control diet with mild calorie restriction alone in healthy adults at risk for dementia, results of a new randomized trial show.

Given the strong base of evidence from observational studies that demonstrate the benefits of the MIND diet on cognitive decline, Alzheimer’s disease (AD), and neuropathologic changes such as reduced beta amyloid and tau associated with AD, the study’s results were “unexpected,” study investigator Lisa L. Barnes, PhD, with the Rush Alzheimer’s Disease Center, Chicago, said in an interview.

“One possibility is the trial may not have been long enough to see an effect. It’s also possible that participants in the control diet group benefited just as much as those in the MIND diet group because they also improved their diets to focus on weight loss,” Dr. Barnes said.

“Although we did not see a specific effect of the MIND diet, people in both groups improved their cognitive function, suggesting that a healthy diet in general is good for cognitive function,” she added.

The findings were presented at the annual Alzheimer’s Association International Conference and simultaneously published online in the New England Journal of Medicine.
 

Randomized trial

A hybrid of the Dietary Approaches to Stop Hypertension (DASH) and Mediterranean diet, the MIND diet includes foods and nutrients that have been putatively associated with a decreased risk of dementia.

To further investigate, the researchers conducted a randomized trial that included 604 older adults without cognitive impairment who had a family history of dementia, a body mass index greater than 25, and a suboptimal diet determined via a 14-item questionnaire.

For 3 years, 301 were randomly assigned to follow the MIND-diet with mild calorie restriction and 303 to follow a control diet with mild calorie restriction only. All participants received counseling to help them adhere to their assigned diet, plus support to promote weight loss of 3%-5% by year 3.

The primary endpoint was the change from baseline in global cognition and in specific cognitive domains through year 3. Cognition was assessed with an established battery of 12 publicly available cognitive function tests.

The secondary endpoint was the change from baseline in MRI-derived measures of brain characteristics in a nonrandom sample of participants.

“We had good adherence to the assigned diets and both groups lost weight, on average about 5 kilograms in both groups,” Dr. Barnes noted in her presentation.

From baseline through 3 years, small improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group versus 0.170 standardized units in the control-diet group.

However, in intention-to-treat analysis, the mean change in score did not differ significantly between groups, with an estimated mean difference at the end of the trial of 0.035 standardized units (P = .23).

At the trial’s conclusion, there were also no between-group differences in change in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI.

Dr. Barnes noted that the trial was limited to well-educated, older adults, mostly of European descent. Other limitations include the small sample size of those who received MRI and follow-up that was shorter than a typical observational study.

Dr. Barnes noted that this is a single study and that there needs to be more randomized trials of the MIND diet that, as with the observational research, follow participants for a longer period of time.
 

More to brain health than diet

Reached for comment, Majid Fotuhi, MD, PhD, adjunct professor of neuroscience at George Washington University, Washington, noted that participants who enroll in clinical trials that focus on diet become more aware of their eating habits and shift toward a healthier diet.

“This may explain the reason why both groups of participants in this study improved,” said Dr. Fotuhi, medical director of NeuroGrow Brain Fitness Center, McLean, Va.

However, he believes that better brain health requires a multipronged approach.

“In order to see significant results, people need to improve their diet, become physically fit, sleep well, reduce their stress, engage in cognitively challenging activities, and develop a positive mind set,” said Dr. Fotuhi.

“Interventions that target only one of these goals may not produce results that are as remarkable as multimodal programs, which target all of these goals,” Dr. Fotuhi said.

Dr. Fotuhi developed a multidimensional “brain fitness program” that has shown to provide multiple benefits for individuals with memory loss, attention deficit hyperactivity disorder, and post-concussion syndrome.

“Having provided our 12-week program for thousands of patients in the past 10 years, I have noticed a synergistic effect in patients who incorporate all of these changes in their day-to-day life and maintain it over time. They often become sharper and feel better overall,” Dr. Fotuhi told this news organization.

The study was supported by the National Institute on Aging. Disclosures for study authors are listed with the original article. Dr. Fotuhi has disclosed no relevant financial relationships.

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

The effect of the highly touted MIND diet with mild calorie restriction offered no greater protection against cognitive decline than a control diet with mild calorie restriction alone in healthy adults at risk for dementia, results of a new randomized trial show.

Given the strong base of evidence from observational studies that demonstrate the benefits of the MIND diet on cognitive decline, Alzheimer’s disease (AD), and neuropathologic changes such as reduced beta amyloid and tau associated with AD, the study’s results were “unexpected,” study investigator Lisa L. Barnes, PhD, with the Rush Alzheimer’s Disease Center, Chicago, said in an interview.

“One possibility is the trial may not have been long enough to see an effect. It’s also possible that participants in the control diet group benefited just as much as those in the MIND diet group because they also improved their diets to focus on weight loss,” Dr. Barnes said.

“Although we did not see a specific effect of the MIND diet, people in both groups improved their cognitive function, suggesting that a healthy diet in general is good for cognitive function,” she added.

The findings were presented at the annual Alzheimer’s Association International Conference and simultaneously published online in the New England Journal of Medicine.
 

Randomized trial

A hybrid of the Dietary Approaches to Stop Hypertension (DASH) and Mediterranean diet, the MIND diet includes foods and nutrients that have been putatively associated with a decreased risk of dementia.

To further investigate, the researchers conducted a randomized trial that included 604 older adults without cognitive impairment who had a family history of dementia, a body mass index greater than 25, and a suboptimal diet determined via a 14-item questionnaire.

For 3 years, 301 were randomly assigned to follow the MIND-diet with mild calorie restriction and 303 to follow a control diet with mild calorie restriction only. All participants received counseling to help them adhere to their assigned diet, plus support to promote weight loss of 3%-5% by year 3.

The primary endpoint was the change from baseline in global cognition and in specific cognitive domains through year 3. Cognition was assessed with an established battery of 12 publicly available cognitive function tests.

The secondary endpoint was the change from baseline in MRI-derived measures of brain characteristics in a nonrandom sample of participants.

“We had good adherence to the assigned diets and both groups lost weight, on average about 5 kilograms in both groups,” Dr. Barnes noted in her presentation.

From baseline through 3 years, small improvements in global cognition scores were observed in both groups, with increases of 0.205 standardized units in the MIND-diet group versus 0.170 standardized units in the control-diet group.

However, in intention-to-treat analysis, the mean change in score did not differ significantly between groups, with an estimated mean difference at the end of the trial of 0.035 standardized units (P = .23).

At the trial’s conclusion, there were also no between-group differences in change in white-matter hyperintensities, hippocampal volumes, and total gray- and white-matter volumes on MRI.

Dr. Barnes noted that the trial was limited to well-educated, older adults, mostly of European descent. Other limitations include the small sample size of those who received MRI and follow-up that was shorter than a typical observational study.

Dr. Barnes noted that this is a single study and that there needs to be more randomized trials of the MIND diet that, as with the observational research, follow participants for a longer period of time.
 

More to brain health than diet

Reached for comment, Majid Fotuhi, MD, PhD, adjunct professor of neuroscience at George Washington University, Washington, noted that participants who enroll in clinical trials that focus on diet become more aware of their eating habits and shift toward a healthier diet.

“This may explain the reason why both groups of participants in this study improved,” said Dr. Fotuhi, medical director of NeuroGrow Brain Fitness Center, McLean, Va.

However, he believes that better brain health requires a multipronged approach.

“In order to see significant results, people need to improve their diet, become physically fit, sleep well, reduce their stress, engage in cognitively challenging activities, and develop a positive mind set,” said Dr. Fotuhi.

“Interventions that target only one of these goals may not produce results that are as remarkable as multimodal programs, which target all of these goals,” Dr. Fotuhi said.

Dr. Fotuhi developed a multidimensional “brain fitness program” that has shown to provide multiple benefits for individuals with memory loss, attention deficit hyperactivity disorder, and post-concussion syndrome.

“Having provided our 12-week program for thousands of patients in the past 10 years, I have noticed a synergistic effect in patients who incorporate all of these changes in their day-to-day life and maintain it over time. They often become sharper and feel better overall,” Dr. Fotuhi told this news organization.

The study was supported by the National Institute on Aging. Disclosures for study authors are listed with the original article. Dr. Fotuhi has disclosed no relevant financial relationships.

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

The risks of common postpartum mental health (PMH) problems may soon be more predictable, thanks to a new comprehensive index for identifying mothers’ 1-year risk at time of delivery.

Developed by Canadian researchers, the easily implementable PMH CAREPLAN index “creates a framework for clinically actionable risk stratification that could assist patients and providers in determining an individual’s level of risk for common postpartum mental health disorders and direct them to appropriate intervention,” wrote a group led by Simone N. Vigod, MD, MSc, head of the department of psychiatry at Women’s College Hospital, Toronto, in the British Journal of Psychiatry.

courtesy Women's College Hospital

After giving birth, women are especially vulnerable to major depression, anxiety, PTSD, and obsessive-compulsive disorder, which have a general postpartum prevalence of 7%-20%.

Common PMH disorders are to be distinguished from the more rare but severe PMH disorders such as postpartum psychosis and bipolar disorder, the researchers stressed.

“We know there are interventions that can prevent these disorders, but these seem to work best in people who are at high risk for developing the illnesses, “ Dr. Vigod said. “So, we wanted to be able to determine the level of risk that a person might actually experience them.”

In an ideal world, she continued, physicians might be able to say to a patient: “You have a 50% chance of developing postpartum depression and anxiety, so it may be worth investing your time and resources in a course of preventive psychotherapy.” Or: “You have a 90% chance of developing these disorders, so it might be worth going back on your medications even though you are breastfeeding.” Or: “You have only a 1% chance of developing them, so probably it’s not worthwhile to go back on your medication prophylactically.”

A need for a new assessment tool, akin to the Framingham Risk Score for 10-year cardiovascular events and the FRAX scoring system for 10-year fracture risk, was evident since previous indices based largely on patient self-reporting have had moderate predictive capacity, and have not been adopted in clinical practice, Dr. Vigod and associates noted.
 

Split-cohort design

Using population-based health administrative data and hospital birth records from Ontario during 2012-2015, Dr. Vigod’s group created and internally validated a predictive model for common PMH disorders in a cohort of 152,362 mothers. They then converted it to a risk index after validation in an additional cohort of 75,772 mothers. The women had delivered live infants during 2012-2014.

A common PMH disorder occurred in 13,608 mothers, while 214,526 were unaffected.

Independently associated PMH variables were many: prenatal care provider, mental health diagnosis history and medications during pregnancy, psychiatric hospital admissions or ED visits, conception type and complications, and apprehension of newborn by child services. Other factors were region of maternal origin, extremes of gestational age at birth, primary maternal language, lactation intention, maternal age, and number of prenatal visits.

Based on a broad span of scores from 0 to 39, 1-year common PMH disorder risk ranged from 1.5% to 40.5%, with an overall 1-year prevalence of 6%, consistent with previous studies. That included 11,262 (5%) mothers with an anxiety or related disorder, 3,392 (1.5%) with a depressive episode, and 1,046 (0.5%) with both. The best trade-off of sensitivity/specificity for risk appeared to be at a screening threshold score of 17 or above.
 

Risk drivers

PMH-affected mothers were slightly younger than unaffected women (mean age, 29.9 years vs. 30.6 years), more likely to be primiparous (45.2% vs. 42%), and less likely to be recent immigrants (16.7% vs. 27.2%).

They were also more likely to have previously experienced postpartum depression (4.4% vs. 1.4%), any depression (15.3% vs. 4.4%), and any anxiety disorder (13.8% vs. 4.3%).

As to lifestyle, smoking was more common in women with PMH (15.0% vs. 10.2%), as were the use of nonprescribed substances (3% vs. 1.4%) and intimate partner violence in pregnancy (2.7% vs. 1.5%).

In addition, the affected group experienced more pregnancy complications than their unaffected peers (16% vs. 13.9%), preterm birth (8.2% vs. 6.8%), and Apgar scores below 7 at 1 or 5 minutes (10.5% vs. 7.6%).

Low income did not appear to have an impact since just over 20% in either group fell into the lowest neighborhood income quintile.

courtesy Northwestern Medicine

Commenting on the index but not involved in developing it, LaTasha D. Nelson, MD, an associate professor or medicine and a maternal-fetal medicine specialist at Northwestern Medicine in Chicago, doubted the Canadian model would work as well in the more fragmented U.S. health care system, compared with Canada’s universal model with its large provincial health databases.

She also found the large number of variables and broad score range potentially problematic, especially if the risk threshold is set at less than half the maximum score at 17, at which some low-risk mothers might get screening and perhaps intervention. “Are we going to use up the resources we have for those who might not need help, or are we going to treat someone who really needs it?” she asked.

Another concern is the postpartum timing of assessment. At Dr. Nelson’s center, mothers are checked for mental health at two points during pregnancy and those with higher scores are triaged for further care.

Dr. Nelson was also puzzled by the score-lowering impact of prenatal care given by a nurse practitioner and “other” provider : –5 and –2, respectively, versus +3 for a midwife and +1 for a family doctor. “This may capture more relaxed, easy-going multiparous mothers who felt comfortable turning to an NP,” she said.

It may indeed reflect that the risk level of a person who sees those providers is overall lower, Dr. Vigod agreed. “This is one reason why we would want to see replication of these results in other jurisdictions and by other ways of diagnosis before putting it out into clinical practice.”

As to the score-lowering effect of not speaking English as the primary tongue, Dr. Nelson wondered, “is that because we’re taking better care of mothers who speak the main language and missing those who speak other languages? Are they not getting the same level of interrogation?”

It may be that individuals in these groups were less likely to access mental health care, Dr. Vigod agreed, or it might reflect the so-called healthy immigrant effect or culturally different levels of postpartum support. “It might mean that there are more people who benefit from community-level protective factors in these groups. We know that social support is an important protective factor.”

Despite her reservations about the index, Dr. Nelson said that increasing attention to the pre- and postnatal mental health of mothers is an important part of maternal care. “This is an issue that needs to be recognized.”

The next step, Dr. Vigod said, is to determine whether the index holds up in other populations. “Then, we would want to test it out to see if recommending interventions based on a certain level of risk improves outcomes. At what percentage risk would starting an antidepressant medication result in a reduced risk for postpartum depression or anxiety – 90%, 80%, 70%, or less?”

The study received funding from the Canadian Institutes of Health Research. Data were analyzed by ICES, an independent nonprofit research organization that holds population-based data. Dr. Vigod reported royalties from UpToDate for materials related to depression and pregnancy. Dr. Nelson disclosed no relevant competing interests.

The risks of common postpartum mental health (PMH) problems may soon be more predictable, thanks to a new comprehensive index for identifying mothers’ 1-year risk at time of delivery.

Developed by Canadian researchers, the easily implementable PMH CAREPLAN index “creates a framework for clinically actionable risk stratification that could assist patients and providers in determining an individual’s level of risk for common postpartum mental health disorders and direct them to appropriate intervention,” wrote a group led by Simone N. Vigod, MD, MSc, head of the department of psychiatry at Women’s College Hospital, Toronto, in the British Journal of Psychiatry.

courtesy Women's College Hospital

After giving birth, women are especially vulnerable to major depression, anxiety, PTSD, and obsessive-compulsive disorder, which have a general postpartum prevalence of 7%-20%.

Common PMH disorders are to be distinguished from the more rare but severe PMH disorders such as postpartum psychosis and bipolar disorder, the researchers stressed.

“We know there are interventions that can prevent these disorders, but these seem to work best in people who are at high risk for developing the illnesses, “ Dr. Vigod said. “So, we wanted to be able to determine the level of risk that a person might actually experience them.”

In an ideal world, she continued, physicians might be able to say to a patient: “You have a 50% chance of developing postpartum depression and anxiety, so it may be worth investing your time and resources in a course of preventive psychotherapy.” Or: “You have a 90% chance of developing these disorders, so it might be worth going back on your medications even though you are breastfeeding.” Or: “You have only a 1% chance of developing them, so probably it’s not worthwhile to go back on your medication prophylactically.”

A need for a new assessment tool, akin to the Framingham Risk Score for 10-year cardiovascular events and the FRAX scoring system for 10-year fracture risk, was evident since previous indices based largely on patient self-reporting have had moderate predictive capacity, and have not been adopted in clinical practice, Dr. Vigod and associates noted.
 

Split-cohort design

Using population-based health administrative data and hospital birth records from Ontario during 2012-2015, Dr. Vigod’s group created and internally validated a predictive model for common PMH disorders in a cohort of 152,362 mothers. They then converted it to a risk index after validation in an additional cohort of 75,772 mothers. The women had delivered live infants during 2012-2014.

A common PMH disorder occurred in 13,608 mothers, while 214,526 were unaffected.

Independently associated PMH variables were many: prenatal care provider, mental health diagnosis history and medications during pregnancy, psychiatric hospital admissions or ED visits, conception type and complications, and apprehension of newborn by child services. Other factors were region of maternal origin, extremes of gestational age at birth, primary maternal language, lactation intention, maternal age, and number of prenatal visits.

Based on a broad span of scores from 0 to 39, 1-year common PMH disorder risk ranged from 1.5% to 40.5%, with an overall 1-year prevalence of 6%, consistent with previous studies. That included 11,262 (5%) mothers with an anxiety or related disorder, 3,392 (1.5%) with a depressive episode, and 1,046 (0.5%) with both. The best trade-off of sensitivity/specificity for risk appeared to be at a screening threshold score of 17 or above.
 

Risk drivers

PMH-affected mothers were slightly younger than unaffected women (mean age, 29.9 years vs. 30.6 years), more likely to be primiparous (45.2% vs. 42%), and less likely to be recent immigrants (16.7% vs. 27.2%).

They were also more likely to have previously experienced postpartum depression (4.4% vs. 1.4%), any depression (15.3% vs. 4.4%), and any anxiety disorder (13.8% vs. 4.3%).

As to lifestyle, smoking was more common in women with PMH (15.0% vs. 10.2%), as were the use of nonprescribed substances (3% vs. 1.4%) and intimate partner violence in pregnancy (2.7% vs. 1.5%).

In addition, the affected group experienced more pregnancy complications than their unaffected peers (16% vs. 13.9%), preterm birth (8.2% vs. 6.8%), and Apgar scores below 7 at 1 or 5 minutes (10.5% vs. 7.6%).

Low income did not appear to have an impact since just over 20% in either group fell into the lowest neighborhood income quintile.

courtesy Northwestern Medicine

Commenting on the index but not involved in developing it, LaTasha D. Nelson, MD, an associate professor or medicine and a maternal-fetal medicine specialist at Northwestern Medicine in Chicago, doubted the Canadian model would work as well in the more fragmented U.S. health care system, compared with Canada’s universal model with its large provincial health databases.

She also found the large number of variables and broad score range potentially problematic, especially if the risk threshold is set at less than half the maximum score at 17, at which some low-risk mothers might get screening and perhaps intervention. “Are we going to use up the resources we have for those who might not need help, or are we going to treat someone who really needs it?” she asked.

Another concern is the postpartum timing of assessment. At Dr. Nelson’s center, mothers are checked for mental health at two points during pregnancy and those with higher scores are triaged for further care.

Dr. Nelson was also puzzled by the score-lowering impact of prenatal care given by a nurse practitioner and “other” provider : –5 and –2, respectively, versus +3 for a midwife and +1 for a family doctor. “This may capture more relaxed, easy-going multiparous mothers who felt comfortable turning to an NP,” she said.

It may indeed reflect that the risk level of a person who sees those providers is overall lower, Dr. Vigod agreed. “This is one reason why we would want to see replication of these results in other jurisdictions and by other ways of diagnosis before putting it out into clinical practice.”

As to the score-lowering effect of not speaking English as the primary tongue, Dr. Nelson wondered, “is that because we’re taking better care of mothers who speak the main language and missing those who speak other languages? Are they not getting the same level of interrogation?”

It may be that individuals in these groups were less likely to access mental health care, Dr. Vigod agreed, or it might reflect the so-called healthy immigrant effect or culturally different levels of postpartum support. “It might mean that there are more people who benefit from community-level protective factors in these groups. We know that social support is an important protective factor.”

Despite her reservations about the index, Dr. Nelson said that increasing attention to the pre- and postnatal mental health of mothers is an important part of maternal care. “This is an issue that needs to be recognized.”

The next step, Dr. Vigod said, is to determine whether the index holds up in other populations. “Then, we would want to test it out to see if recommending interventions based on a certain level of risk improves outcomes. At what percentage risk would starting an antidepressant medication result in a reduced risk for postpartum depression or anxiety – 90%, 80%, 70%, or less?”

The study received funding from the Canadian Institutes of Health Research. Data were analyzed by ICES, an independent nonprofit research organization that holds population-based data. Dr. Vigod reported royalties from UpToDate for materials related to depression and pregnancy. Dr. Nelson disclosed no relevant competing interests.

The risks of common postpartum mental health (PMH) problems may soon be more predictable, thanks to a new comprehensive index for identifying mothers’ 1-year risk at time of delivery.

Developed by Canadian researchers, the easily implementable PMH CAREPLAN index “creates a framework for clinically actionable risk stratification that could assist patients and providers in determining an individual’s level of risk for common postpartum mental health disorders and direct them to appropriate intervention,” wrote a group led by Simone N. Vigod, MD, MSc, head of the department of psychiatry at Women’s College Hospital, Toronto, in the British Journal of Psychiatry.

courtesy Women's College Hospital

After giving birth, women are especially vulnerable to major depression, anxiety, PTSD, and obsessive-compulsive disorder, which have a general postpartum prevalence of 7%-20%.

Common PMH disorders are to be distinguished from the more rare but severe PMH disorders such as postpartum psychosis and bipolar disorder, the researchers stressed.

“We know there are interventions that can prevent these disorders, but these seem to work best in people who are at high risk for developing the illnesses, “ Dr. Vigod said. “So, we wanted to be able to determine the level of risk that a person might actually experience them.”

In an ideal world, she continued, physicians might be able to say to a patient: “You have a 50% chance of developing postpartum depression and anxiety, so it may be worth investing your time and resources in a course of preventive psychotherapy.” Or: “You have a 90% chance of developing these disorders, so it might be worth going back on your medications even though you are breastfeeding.” Or: “You have only a 1% chance of developing them, so probably it’s not worthwhile to go back on your medication prophylactically.”

A need for a new assessment tool, akin to the Framingham Risk Score for 10-year cardiovascular events and the FRAX scoring system for 10-year fracture risk, was evident since previous indices based largely on patient self-reporting have had moderate predictive capacity, and have not been adopted in clinical practice, Dr. Vigod and associates noted.
 

Split-cohort design

Using population-based health administrative data and hospital birth records from Ontario during 2012-2015, Dr. Vigod’s group created and internally validated a predictive model for common PMH disorders in a cohort of 152,362 mothers. They then converted it to a risk index after validation in an additional cohort of 75,772 mothers. The women had delivered live infants during 2012-2014.

A common PMH disorder occurred in 13,608 mothers, while 214,526 were unaffected.

Independently associated PMH variables were many: prenatal care provider, mental health diagnosis history and medications during pregnancy, psychiatric hospital admissions or ED visits, conception type and complications, and apprehension of newborn by child services. Other factors were region of maternal origin, extremes of gestational age at birth, primary maternal language, lactation intention, maternal age, and number of prenatal visits.

Based on a broad span of scores from 0 to 39, 1-year common PMH disorder risk ranged from 1.5% to 40.5%, with an overall 1-year prevalence of 6%, consistent with previous studies. That included 11,262 (5%) mothers with an anxiety or related disorder, 3,392 (1.5%) with a depressive episode, and 1,046 (0.5%) with both. The best trade-off of sensitivity/specificity for risk appeared to be at a screening threshold score of 17 or above.
 

Risk drivers

PMH-affected mothers were slightly younger than unaffected women (mean age, 29.9 years vs. 30.6 years), more likely to be primiparous (45.2% vs. 42%), and less likely to be recent immigrants (16.7% vs. 27.2%).

They were also more likely to have previously experienced postpartum depression (4.4% vs. 1.4%), any depression (15.3% vs. 4.4%), and any anxiety disorder (13.8% vs. 4.3%).

As to lifestyle, smoking was more common in women with PMH (15.0% vs. 10.2%), as were the use of nonprescribed substances (3% vs. 1.4%) and intimate partner violence in pregnancy (2.7% vs. 1.5%).

In addition, the affected group experienced more pregnancy complications than their unaffected peers (16% vs. 13.9%), preterm birth (8.2% vs. 6.8%), and Apgar scores below 7 at 1 or 5 minutes (10.5% vs. 7.6%).

Low income did not appear to have an impact since just over 20% in either group fell into the lowest neighborhood income quintile.

courtesy Northwestern Medicine

Commenting on the index but not involved in developing it, LaTasha D. Nelson, MD, an associate professor or medicine and a maternal-fetal medicine specialist at Northwestern Medicine in Chicago, doubted the Canadian model would work as well in the more fragmented U.S. health care system, compared with Canada’s universal model with its large provincial health databases.

She also found the large number of variables and broad score range potentially problematic, especially if the risk threshold is set at less than half the maximum score at 17, at which some low-risk mothers might get screening and perhaps intervention. “Are we going to use up the resources we have for those who might not need help, or are we going to treat someone who really needs it?” she asked.

Another concern is the postpartum timing of assessment. At Dr. Nelson’s center, mothers are checked for mental health at two points during pregnancy and those with higher scores are triaged for further care.

Dr. Nelson was also puzzled by the score-lowering impact of prenatal care given by a nurse practitioner and “other” provider : –5 and –2, respectively, versus +3 for a midwife and +1 for a family doctor. “This may capture more relaxed, easy-going multiparous mothers who felt comfortable turning to an NP,” she said.

It may indeed reflect that the risk level of a person who sees those providers is overall lower, Dr. Vigod agreed. “This is one reason why we would want to see replication of these results in other jurisdictions and by other ways of diagnosis before putting it out into clinical practice.”

As to the score-lowering effect of not speaking English as the primary tongue, Dr. Nelson wondered, “is that because we’re taking better care of mothers who speak the main language and missing those who speak other languages? Are they not getting the same level of interrogation?”

It may be that individuals in these groups were less likely to access mental health care, Dr. Vigod agreed, or it might reflect the so-called healthy immigrant effect or culturally different levels of postpartum support. “It might mean that there are more people who benefit from community-level protective factors in these groups. We know that social support is an important protective factor.”

Despite her reservations about the index, Dr. Nelson said that increasing attention to the pre- and postnatal mental health of mothers is an important part of maternal care. “This is an issue that needs to be recognized.”

The next step, Dr. Vigod said, is to determine whether the index holds up in other populations. “Then, we would want to test it out to see if recommending interventions based on a certain level of risk improves outcomes. At what percentage risk would starting an antidepressant medication result in a reduced risk for postpartum depression or anxiety – 90%, 80%, 70%, or less?”

The study received funding from the Canadian Institutes of Health Research. Data were analyzed by ICES, an independent nonprofit research organization that holds population-based data. Dr. Vigod reported royalties from UpToDate for materials related to depression and pregnancy. Dr. Nelson disclosed no relevant competing interests.

The key to reducing problem drinking may just be an app away.

A brief intervention with web- and app-based components helped risky drinkers substantially reduce their alcohol intake to a level that is considered not to be hazardous, researchers in Australia have found.

Participants in the randomized controlled trial tracked information about their alcohol consumption, including the quantity and frequency. The intervention then generated an impulsivity score and implications for their risk for alcohol-related disorders and diseases, hospitalization, and death. The findings were published in Alcohol: Clinical & Experimental Research.

Worldwide each year, alcohol consumption accounts for 5.3% of all deaths. In the United States, an estimated 29.5 million people older than 12 years had alcohol use disorder in 2021.

More than 60% of people with alcohol use problems never seek out in-person treatment. Many are deterred from doing so by fear of judgment, stigma, and embarrassment, especially those at the low end of the alcohol use severity spectrum, according to the Australian researchers. Such fear-based barriers, however, may be overcome through the anonymity of a smartphone app.

The researchers tested whether hazardous drinkers who receive personalized feedback about their alcohol consumption and level of self-control would reduce their problem drinking more than hazardous drinkers who received only personalized information about their alcohol consumption or no feedback at all would.

“I knew from my previous research that just putting in the information is not enough to change someone’s drinking: It seems that putting in the information and then having someone tell you, ‘You drank x number of drinks, and that level of drinking is high according to Australian or WHO [World Health Organization] standards’ seems to be the critical point,” said Antoinette Poulton, PhD, of the University of Melbourne, who developed the app and led the study.

The study was conducted among first-year psychology students at the University of Melbourne between 2020 and 2022.

Each of the 313 participants in the study (average age 21.7 years; 74% women) provided estimates of alcohol intake over 14 days. A subset of 178 individuals utilized Alcohol Capture, the validated smartphone app, which records alcohol intake in real-time and includes an online cognitive task assessing impulsivity.

Participants were categorized as “hazardous” or “nonharmful” drinkers according to guidelines from the World Health Organization and were divided into three groups. Members in the alcohol intake feedback (Alc) group were given personalized feedback about their alcohol consumption, including whether their drinking exceeded Australian and/or WHO guidelines. Others were assigned to the Alc plus cognitive feedback (AlcCog) group and received the same feedback plus details about their level of self-control and information about the links between poor self-control and vulnerability for transition to alcohol use disorder. The control group did not receive personalized feedback. After 8 weeks, alcohol intake was again recorded over 14 days.

Relative to hazardous drinkers in the control group, total alcohol consumption among risky drinkers in the Alc group fell by 32% (or 3.8 standard drinks per week) and by 35% (or 4.2 standard drinks per week) in the AlcCog group, according to the researchers. That difference was not statistically significant.

“Our brief electronic intervention had clear impact on the drinking behavior of hazardous drinkers,” the researchers reported. “In fact, following the intervention, hazardous drinkers did not differ from non-harmful ones on total alcohol intake, quantity of intake per drinking day, or frequency of six or more drinking occasions.”

Drinks per drinking day also decreased by 31% (or 1.6 standard drinks) and 32% (or 2.1 standard drinks) in the Alc and AlcCog groups, respectively, compared with the control group.

Alcohol use did not appear to change among nonharmful drinkers in any of the study groups.

“This is a nice study, because it shows that a simple, small intervention can really have a profound effect on hazardous drinking,” said Akhil Anand, MD, an addiction psychiatrist and Medical Director of the Alcohol and Drug Recovery Center at Cleveland Clinic. “It’s hard to say if this intervention would work on very severe cases, but I like it because it’s anonymous, it’s quick, it’s easily accessible, and it doesn’t take too much health care personnel power to apply it,” Dr. Anand added.

This research was supported by an Early Career Researcher grant from the University of Melbourne. Dr. Poulton and Dr. Anand reported no financial conflicts of interest.

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

The key to reducing problem drinking may just be an app away.

A brief intervention with web- and app-based components helped risky drinkers substantially reduce their alcohol intake to a level that is considered not to be hazardous, researchers in Australia have found.

Participants in the randomized controlled trial tracked information about their alcohol consumption, including the quantity and frequency. The intervention then generated an impulsivity score and implications for their risk for alcohol-related disorders and diseases, hospitalization, and death. The findings were published in Alcohol: Clinical & Experimental Research.

Worldwide each year, alcohol consumption accounts for 5.3% of all deaths. In the United States, an estimated 29.5 million people older than 12 years had alcohol use disorder in 2021.

More than 60% of people with alcohol use problems never seek out in-person treatment. Many are deterred from doing so by fear of judgment, stigma, and embarrassment, especially those at the low end of the alcohol use severity spectrum, according to the Australian researchers. Such fear-based barriers, however, may be overcome through the anonymity of a smartphone app.

The researchers tested whether hazardous drinkers who receive personalized feedback about their alcohol consumption and level of self-control would reduce their problem drinking more than hazardous drinkers who received only personalized information about their alcohol consumption or no feedback at all would.

“I knew from my previous research that just putting in the information is not enough to change someone’s drinking: It seems that putting in the information and then having someone tell you, ‘You drank x number of drinks, and that level of drinking is high according to Australian or WHO [World Health Organization] standards’ seems to be the critical point,” said Antoinette Poulton, PhD, of the University of Melbourne, who developed the app and led the study.

The study was conducted among first-year psychology students at the University of Melbourne between 2020 and 2022.

Each of the 313 participants in the study (average age 21.7 years; 74% women) provided estimates of alcohol intake over 14 days. A subset of 178 individuals utilized Alcohol Capture, the validated smartphone app, which records alcohol intake in real-time and includes an online cognitive task assessing impulsivity.

Participants were categorized as “hazardous” or “nonharmful” drinkers according to guidelines from the World Health Organization and were divided into three groups. Members in the alcohol intake feedback (Alc) group were given personalized feedback about their alcohol consumption, including whether their drinking exceeded Australian and/or WHO guidelines. Others were assigned to the Alc plus cognitive feedback (AlcCog) group and received the same feedback plus details about their level of self-control and information about the links between poor self-control and vulnerability for transition to alcohol use disorder. The control group did not receive personalized feedback. After 8 weeks, alcohol intake was again recorded over 14 days.

Relative to hazardous drinkers in the control group, total alcohol consumption among risky drinkers in the Alc group fell by 32% (or 3.8 standard drinks per week) and by 35% (or 4.2 standard drinks per week) in the AlcCog group, according to the researchers. That difference was not statistically significant.

“Our brief electronic intervention had clear impact on the drinking behavior of hazardous drinkers,” the researchers reported. “In fact, following the intervention, hazardous drinkers did not differ from non-harmful ones on total alcohol intake, quantity of intake per drinking day, or frequency of six or more drinking occasions.”

Drinks per drinking day also decreased by 31% (or 1.6 standard drinks) and 32% (or 2.1 standard drinks) in the Alc and AlcCog groups, respectively, compared with the control group.

Alcohol use did not appear to change among nonharmful drinkers in any of the study groups.

“This is a nice study, because it shows that a simple, small intervention can really have a profound effect on hazardous drinking,” said Akhil Anand, MD, an addiction psychiatrist and Medical Director of the Alcohol and Drug Recovery Center at Cleveland Clinic. “It’s hard to say if this intervention would work on very severe cases, but I like it because it’s anonymous, it’s quick, it’s easily accessible, and it doesn’t take too much health care personnel power to apply it,” Dr. Anand added.

This research was supported by an Early Career Researcher grant from the University of Melbourne. Dr. Poulton and Dr. Anand reported no financial conflicts of interest.

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

The key to reducing problem drinking may just be an app away.

A brief intervention with web- and app-based components helped risky drinkers substantially reduce their alcohol intake to a level that is considered not to be hazardous, researchers in Australia have found.

Participants in the randomized controlled trial tracked information about their alcohol consumption, including the quantity and frequency. The intervention then generated an impulsivity score and implications for their risk for alcohol-related disorders and diseases, hospitalization, and death. The findings were published in Alcohol: Clinical & Experimental Research.

Worldwide each year, alcohol consumption accounts for 5.3% of all deaths. In the United States, an estimated 29.5 million people older than 12 years had alcohol use disorder in 2021.

More than 60% of people with alcohol use problems never seek out in-person treatment. Many are deterred from doing so by fear of judgment, stigma, and embarrassment, especially those at the low end of the alcohol use severity spectrum, according to the Australian researchers. Such fear-based barriers, however, may be overcome through the anonymity of a smartphone app.

The researchers tested whether hazardous drinkers who receive personalized feedback about their alcohol consumption and level of self-control would reduce their problem drinking more than hazardous drinkers who received only personalized information about their alcohol consumption or no feedback at all would.

“I knew from my previous research that just putting in the information is not enough to change someone’s drinking: It seems that putting in the information and then having someone tell you, ‘You drank x number of drinks, and that level of drinking is high according to Australian or WHO [World Health Organization] standards’ seems to be the critical point,” said Antoinette Poulton, PhD, of the University of Melbourne, who developed the app and led the study.

The study was conducted among first-year psychology students at the University of Melbourne between 2020 and 2022.

Each of the 313 participants in the study (average age 21.7 years; 74% women) provided estimates of alcohol intake over 14 days. A subset of 178 individuals utilized Alcohol Capture, the validated smartphone app, which records alcohol intake in real-time and includes an online cognitive task assessing impulsivity.

Participants were categorized as “hazardous” or “nonharmful” drinkers according to guidelines from the World Health Organization and were divided into three groups. Members in the alcohol intake feedback (Alc) group were given personalized feedback about their alcohol consumption, including whether their drinking exceeded Australian and/or WHO guidelines. Others were assigned to the Alc plus cognitive feedback (AlcCog) group and received the same feedback plus details about their level of self-control and information about the links between poor self-control and vulnerability for transition to alcohol use disorder. The control group did not receive personalized feedback. After 8 weeks, alcohol intake was again recorded over 14 days.

Relative to hazardous drinkers in the control group, total alcohol consumption among risky drinkers in the Alc group fell by 32% (or 3.8 standard drinks per week) and by 35% (or 4.2 standard drinks per week) in the AlcCog group, according to the researchers. That difference was not statistically significant.

“Our brief electronic intervention had clear impact on the drinking behavior of hazardous drinkers,” the researchers reported. “In fact, following the intervention, hazardous drinkers did not differ from non-harmful ones on total alcohol intake, quantity of intake per drinking day, or frequency of six or more drinking occasions.”

Drinks per drinking day also decreased by 31% (or 1.6 standard drinks) and 32% (or 2.1 standard drinks) in the Alc and AlcCog groups, respectively, compared with the control group.

Alcohol use did not appear to change among nonharmful drinkers in any of the study groups.

“This is a nice study, because it shows that a simple, small intervention can really have a profound effect on hazardous drinking,” said Akhil Anand, MD, an addiction psychiatrist and Medical Director of the Alcohol and Drug Recovery Center at Cleveland Clinic. “It’s hard to say if this intervention would work on very severe cases, but I like it because it’s anonymous, it’s quick, it’s easily accessible, and it doesn’t take too much health care personnel power to apply it,” Dr. Anand added.

This research was supported by an Early Career Researcher grant from the University of Melbourne. Dr. Poulton and Dr. Anand reported no financial conflicts of interest.

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

Physicians’ demonstrations of empathy toward their patients can decrease the sensation of pain. These are the results of a study, recently published in the Proceedings of the National Academy of Sciences, that was conducted by a team led by neuroscientist Dan-Mikael Ellingsen, PhD, from Oslo University Hospital.

The researchers used functional MRI to scan the brains of 20 patients with chronic pain to investigate how a physician’s demeanor may affect patients’ sensitivity to pain, including effects in the central nervous system. During the scans, which were conducted in two sessions, the patients’ legs were exposed to stimuli that ranged from painless to moderately painful. The patients recorded perceived pain intensity using a scale. The physicians also underwent fMRI.

Half of the patients were subjected to the pain stimuli while alone; the other half were subjected to pain while in the presence of a physician. The latter group of patients was divided into two subgroups. Half of the patients had spoken to the accompanying physician before the examination. They discussed the history of the patient’s condition to date, among other things. The other half underwent the brain scans without any prior interaction with a physician.
 

Worse when alone

Dr. Ellingsen and his colleagues found that patients who were alone during the examination reported greater pain than those who were in the presence of a physician, even though they were subjected to stimuli of the same intensity. In instances in which the physician and patient had already spoken before the brain scan, patients additionally felt that the physician was empathetic and understood their pain. Furthermore, the physicians were better able to estimate the pain that their patients experienced.

The patients who had a physician by their side consistently experienced pain that was milder than the pain experienced by those who were alone. For pairs that had spoken beforehand, the patients considered their physician to be better able to understand their pain, and the physicians estimated the perceived pain intensity of their patients more accurately.
 

Evidence of trust

There was greater activity in the dorsolateral and ventrolateral prefrontal cortex, as well as in the primary and secondary somatosensory areas, in patients in the subgroup that had spoken to a physician. For the physicians, compared with the comparison group, there was an increase in correspondence between activity in the dorsolateral prefrontal cortex and activity in the secondary somatosensory areas of patients, which is a brain region that is known to react to pain. The brain activity correlation increased in line with the self-reported mutual trust between the physician and patient.

“These results prove that empathy and support can decrease pain intensity,” the investigators write. The data shed light on the brain processes behind the social modulation of pain during the interaction between the physician and the patient. Concordances in the brain are increased by greater therapeutic alliance.
 

Beyond medication

Winfried Meissner, MD, head of the pain clinic at the department of anesthesiology and intensive care medicine at Jena University Hospital, Germany, and former president of the German Pain Society, said in an interview: “I view this as a vital study that impressively demonstrates that effective, intensive pain therapy is not just a case of administering the correct analgesic.”

“Instead, a focus should be placed on what common sense tells us, which is just how crucial an empathetic attitude from physicians and good communication with patients are when it comes to the success of any therapy,” Dr. Meissner added. Unfortunately, such an attitude and such communication often are not provided in clinical practice because of limitations on time.

“Now, with objectively collected data from patients and physicians, [Dr.] Ellingsen’s team has been able to demonstrate that human interaction has a decisive impact on the treatment of patients experiencing pain,” said Dr. Meissner. “The study should encourage practitioners to treat communication just as seriously as the pharmacology of analgesics.”
 

Perception and attitude

“The study shows remarkably well that empathetic conversation between the physician and patient represents a valuable therapeutic method and should be recognized as such,” emphasized Dr. Meissner. Of course, conversation cannot replace pharmacologic treatment, but it can supplement and reinforce it. Furthermore, a physician’s empathy presumably has an effect that is at least as great as a suitable analgesic.

“Pain is more than just sensory perception,” explained Dr. Meissner. “We all know that it has a strong affective component, and perception is greatly determined by context.” This can be seen, for example, in athletes, who often attribute less importance to their pain and can successfully perform competitively despite a painful injury.
 

Positive expectations

Dr. Meissner advised all physicians to treat patients with pain empathetically. He encourages them to ask patients about their pain, accompanying symptoms, possible fears, and other mental stress and to take these factors seriously.

Moreover, the findings accentuate the effect of prescribed analgesics. “Numerous studies have meanwhile shown that the more positive a patient’s expectations, the better the effect of a medication,” said Dr. Meissner. “We physicians must exploit this effect, too.”

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

Physicians’ demonstrations of empathy toward their patients can decrease the sensation of pain. These are the results of a study, recently published in the Proceedings of the National Academy of Sciences, that was conducted by a team led by neuroscientist Dan-Mikael Ellingsen, PhD, from Oslo University Hospital.

The researchers used functional MRI to scan the brains of 20 patients with chronic pain to investigate how a physician’s demeanor may affect patients’ sensitivity to pain, including effects in the central nervous system. During the scans, which were conducted in two sessions, the patients’ legs were exposed to stimuli that ranged from painless to moderately painful. The patients recorded perceived pain intensity using a scale. The physicians also underwent fMRI.

Half of the patients were subjected to the pain stimuli while alone; the other half were subjected to pain while in the presence of a physician. The latter group of patients was divided into two subgroups. Half of the patients had spoken to the accompanying physician before the examination. They discussed the history of the patient’s condition to date, among other things. The other half underwent the brain scans without any prior interaction with a physician.
 

Worse when alone

Dr. Ellingsen and his colleagues found that patients who were alone during the examination reported greater pain than those who were in the presence of a physician, even though they were subjected to stimuli of the same intensity. In instances in which the physician and patient had already spoken before the brain scan, patients additionally felt that the physician was empathetic and understood their pain. Furthermore, the physicians were better able to estimate the pain that their patients experienced.

The patients who had a physician by their side consistently experienced pain that was milder than the pain experienced by those who were alone. For pairs that had spoken beforehand, the patients considered their physician to be better able to understand their pain, and the physicians estimated the perceived pain intensity of their patients more accurately.
 

Evidence of trust

There was greater activity in the dorsolateral and ventrolateral prefrontal cortex, as well as in the primary and secondary somatosensory areas, in patients in the subgroup that had spoken to a physician. For the physicians, compared with the comparison group, there was an increase in correspondence between activity in the dorsolateral prefrontal cortex and activity in the secondary somatosensory areas of patients, which is a brain region that is known to react to pain. The brain activity correlation increased in line with the self-reported mutual trust between the physician and patient.

“These results prove that empathy and support can decrease pain intensity,” the investigators write. The data shed light on the brain processes behind the social modulation of pain during the interaction between the physician and the patient. Concordances in the brain are increased by greater therapeutic alliance.
 

Beyond medication

Winfried Meissner, MD, head of the pain clinic at the department of anesthesiology and intensive care medicine at Jena University Hospital, Germany, and former president of the German Pain Society, said in an interview: “I view this as a vital study that impressively demonstrates that effective, intensive pain therapy is not just a case of administering the correct analgesic.”

“Instead, a focus should be placed on what common sense tells us, which is just how crucial an empathetic attitude from physicians and good communication with patients are when it comes to the success of any therapy,” Dr. Meissner added. Unfortunately, such an attitude and such communication often are not provided in clinical practice because of limitations on time.

“Now, with objectively collected data from patients and physicians, [Dr.] Ellingsen’s team has been able to demonstrate that human interaction has a decisive impact on the treatment of patients experiencing pain,” said Dr. Meissner. “The study should encourage practitioners to treat communication just as seriously as the pharmacology of analgesics.”
 

Perception and attitude

“The study shows remarkably well that empathetic conversation between the physician and patient represents a valuable therapeutic method and should be recognized as such,” emphasized Dr. Meissner. Of course, conversation cannot replace pharmacologic treatment, but it can supplement and reinforce it. Furthermore, a physician’s empathy presumably has an effect that is at least as great as a suitable analgesic.

“Pain is more than just sensory perception,” explained Dr. Meissner. “We all know that it has a strong affective component, and perception is greatly determined by context.” This can be seen, for example, in athletes, who often attribute less importance to their pain and can successfully perform competitively despite a painful injury.
 

Positive expectations

Dr. Meissner advised all physicians to treat patients with pain empathetically. He encourages them to ask patients about their pain, accompanying symptoms, possible fears, and other mental stress and to take these factors seriously.

Moreover, the findings accentuate the effect of prescribed analgesics. “Numerous studies have meanwhile shown that the more positive a patient’s expectations, the better the effect of a medication,” said Dr. Meissner. “We physicians must exploit this effect, too.”

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

Physicians’ demonstrations of empathy toward their patients can decrease the sensation of pain. These are the results of a study, recently published in the Proceedings of the National Academy of Sciences, that was conducted by a team led by neuroscientist Dan-Mikael Ellingsen, PhD, from Oslo University Hospital.

The researchers used functional MRI to scan the brains of 20 patients with chronic pain to investigate how a physician’s demeanor may affect patients’ sensitivity to pain, including effects in the central nervous system. During the scans, which were conducted in two sessions, the patients’ legs were exposed to stimuli that ranged from painless to moderately painful. The patients recorded perceived pain intensity using a scale. The physicians also underwent fMRI.

Half of the patients were subjected to the pain stimuli while alone; the other half were subjected to pain while in the presence of a physician. The latter group of patients was divided into two subgroups. Half of the patients had spoken to the accompanying physician before the examination. They discussed the history of the patient’s condition to date, among other things. The other half underwent the brain scans without any prior interaction with a physician.
 

Worse when alone

Dr. Ellingsen and his colleagues found that patients who were alone during the examination reported greater pain than those who were in the presence of a physician, even though they were subjected to stimuli of the same intensity. In instances in which the physician and patient had already spoken before the brain scan, patients additionally felt that the physician was empathetic and understood their pain. Furthermore, the physicians were better able to estimate the pain that their patients experienced.

The patients who had a physician by their side consistently experienced pain that was milder than the pain experienced by those who were alone. For pairs that had spoken beforehand, the patients considered their physician to be better able to understand their pain, and the physicians estimated the perceived pain intensity of their patients more accurately.
 

Evidence of trust

There was greater activity in the dorsolateral and ventrolateral prefrontal cortex, as well as in the primary and secondary somatosensory areas, in patients in the subgroup that had spoken to a physician. For the physicians, compared with the comparison group, there was an increase in correspondence between activity in the dorsolateral prefrontal cortex and activity in the secondary somatosensory areas of patients, which is a brain region that is known to react to pain. The brain activity correlation increased in line with the self-reported mutual trust between the physician and patient.

“These results prove that empathy and support can decrease pain intensity,” the investigators write. The data shed light on the brain processes behind the social modulation of pain during the interaction between the physician and the patient. Concordances in the brain are increased by greater therapeutic alliance.
 

Beyond medication

Winfried Meissner, MD, head of the pain clinic at the department of anesthesiology and intensive care medicine at Jena University Hospital, Germany, and former president of the German Pain Society, said in an interview: “I view this as a vital study that impressively demonstrates that effective, intensive pain therapy is not just a case of administering the correct analgesic.”

“Instead, a focus should be placed on what common sense tells us, which is just how crucial an empathetic attitude from physicians and good communication with patients are when it comes to the success of any therapy,” Dr. Meissner added. Unfortunately, such an attitude and such communication often are not provided in clinical practice because of limitations on time.

“Now, with objectively collected data from patients and physicians, [Dr.] Ellingsen’s team has been able to demonstrate that human interaction has a decisive impact on the treatment of patients experiencing pain,” said Dr. Meissner. “The study should encourage practitioners to treat communication just as seriously as the pharmacology of analgesics.”
 

Perception and attitude

“The study shows remarkably well that empathetic conversation between the physician and patient represents a valuable therapeutic method and should be recognized as such,” emphasized Dr. Meissner. Of course, conversation cannot replace pharmacologic treatment, but it can supplement and reinforce it. Furthermore, a physician’s empathy presumably has an effect that is at least as great as a suitable analgesic.

“Pain is more than just sensory perception,” explained Dr. Meissner. “We all know that it has a strong affective component, and perception is greatly determined by context.” This can be seen, for example, in athletes, who often attribute less importance to their pain and can successfully perform competitively despite a painful injury.
 

Positive expectations

Dr. Meissner advised all physicians to treat patients with pain empathetically. He encourages them to ask patients about their pain, accompanying symptoms, possible fears, and other mental stress and to take these factors seriously.

Moreover, the findings accentuate the effect of prescribed analgesics. “Numerous studies have meanwhile shown that the more positive a patient’s expectations, the better the effect of a medication,” said Dr. Meissner. “We physicians must exploit this effect, too.”

This article was translated from the Medscape German Edition and a version appeared on Medscape.com.

Chronic constipation may be associated with worsening cognitive function, new data from three prospective cohort studies with more than 100,000 adults show.

Compared with individuals who have a bowel movement once daily, adults with constipation who have a bowel movement every 3 days or more had significantly worse cognition that was commensurate with an additional 3 years of chronological cognitive aging, the investigators found.

“We should watch for symptoms of abnormal intestinal function, especially constipation, in older individuals, as these symptoms may hint at a higher risk of cognitive decline in the future,” study investigator Chaoran Ma, MD, PhD, former research fellow at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and current assistant professor at the University of Massachusetts Amherst, said in an interview.

The findings were presented at the Alzheimer’s Association International Conference.
 

Prevent constipation, improve brain health?

It’s estimated that 16% of the world’s population suffers from constipation. The problem is more common in older adults, owing to age-related factors such as a lack of dietary fiber and exercise and the use of constipating drugs to treat other medical conditions.

Chronic constipation – defined as having bowel movements every 3 days or more – has been associated with long-term health problems, such as inflammation, hormonal imbalances, anxiety, and depression.

However, few studies have investigated variations in intestinal motility and cognitive function.

“Our study provides first-of-its-kind evidence that examined a wide spectrum of bowel movement frequency, especially an analysis of the more frequent end, in relation to cognitive function,” Dr. Ma said.

The analysis involved data from 112,753 women and men from the Nurses’ Health Study (aged 30-55 years), the Nurses’ Health Study II (aged 25-42), and the Health Professionals Follow-up Study (aged 40-75).

Data on participants’ bowel movement frequency was collected between 2012 and 2013, and self-assessments of cognitive function were obtained from 2014 to 2017. A subgroup of 12,696 participants completed a standard neuropsychological test battery for objective cognitive assessment between 2014 and 2018.

The results show that bowel movement frequency was associated with overall objective cognitive function and learning and working memory in an inverse J-shape dose-response manner (both P for nonlinearity < .05).

Compared with adults who had one bowel movement daily, those who only had a bowel movement every 3 or more days had significantly worse cognition, equivalent to 3 years of additional aging (95% confidence interval, 1.2-4.7).

The researchers also observed similar J-shape dose-response relationships of bowel movement frequency with the odds of subjective cognitive decline and the likelihood of having more subjective cognitive complaints over time.

Compared with once-daily bowel movements, having bowel movements every 3 or more days was associated with a greater likelihood of subjective cognitive decline (odds ratio, 1.73; 95% CI, 1.60-1.86).

These relationships were generally consistent across the three cohorts and subgroups.

“These results stress the importance of clinicians discussing gut health, especially constipation, with their older patients,” senior investigator Dong Wang, MD, ScD, with Harvard Medical School and Brigham and Women’s Hospital, said in a conference statement.

“Interventions for preventing constipation and improving gut health include adopting healthy diets enriched with high-fiber and high-polyphenol foods such as fruits, vegetables, and whole grains; taking fiber supplementation; drinking plenty of water every day; and having regular physical activity,” Dr. Wang added.

The researchers also explored the role of the gut microbiome in the association between bowel movement frequency and cognitive function in a subgroup of 515 women and men.

They found that bowel movement frequency and subjective cognition were significantly associated with the overall variation of the gut microbiome (both P < .005) and specific microbial species.

“This research adds further evidence for a link between the microbiome and gastrointestinal function with cognitive function,” Dr. Ma said in an interview.
 

Interconnected systems

Commenting on the study in a conference statement, Heather M. Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that “our body systems are all interconnected. When one system is malfunctioning, it impacts other systems. When that dysfunction isn’t addressed, it can create a waterfall of consequences for the rest of the body.”

Dr. Snyder cautioned, however, that “there are a lot of unanswered questions about the connection between the health of our digestive system and our long-term cognitive function. Answering these questions may uncover novel therapeutic and risk-reduction approaches for Alzheimer’s and other dementias.”

In an interview, Percy Griffin, PhD, director of scientific engagement at the Alzheimer’s Association, noted that the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk, is evaluating the impact of behavioral interventions on the gut-brain axis.

“We want to better understand how engaging in healthier habits can impact microorganisms in the gut and how changes in gut bacteria relate to brain health,” Dr. Griffin said.

The study was funded by the National Institutes of Health. Dr. Ma, Dr. Wang, Dr. Snyder, and Dr. Griffin have no relevant disclosures.

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

Chronic constipation may be associated with worsening cognitive function, new data from three prospective cohort studies with more than 100,000 adults show.

Compared with individuals who have a bowel movement once daily, adults with constipation who have a bowel movement every 3 days or more had significantly worse cognition that was commensurate with an additional 3 years of chronological cognitive aging, the investigators found.

“We should watch for symptoms of abnormal intestinal function, especially constipation, in older individuals, as these symptoms may hint at a higher risk of cognitive decline in the future,” study investigator Chaoran Ma, MD, PhD, former research fellow at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and current assistant professor at the University of Massachusetts Amherst, said in an interview.

The findings were presented at the Alzheimer’s Association International Conference.
 

Prevent constipation, improve brain health?

It’s estimated that 16% of the world’s population suffers from constipation. The problem is more common in older adults, owing to age-related factors such as a lack of dietary fiber and exercise and the use of constipating drugs to treat other medical conditions.

Chronic constipation – defined as having bowel movements every 3 days or more – has been associated with long-term health problems, such as inflammation, hormonal imbalances, anxiety, and depression.

However, few studies have investigated variations in intestinal motility and cognitive function.

“Our study provides first-of-its-kind evidence that examined a wide spectrum of bowel movement frequency, especially an analysis of the more frequent end, in relation to cognitive function,” Dr. Ma said.

The analysis involved data from 112,753 women and men from the Nurses’ Health Study (aged 30-55 years), the Nurses’ Health Study II (aged 25-42), and the Health Professionals Follow-up Study (aged 40-75).

Data on participants’ bowel movement frequency was collected between 2012 and 2013, and self-assessments of cognitive function were obtained from 2014 to 2017. A subgroup of 12,696 participants completed a standard neuropsychological test battery for objective cognitive assessment between 2014 and 2018.

The results show that bowel movement frequency was associated with overall objective cognitive function and learning and working memory in an inverse J-shape dose-response manner (both P for nonlinearity < .05).

Compared with adults who had one bowel movement daily, those who only had a bowel movement every 3 or more days had significantly worse cognition, equivalent to 3 years of additional aging (95% confidence interval, 1.2-4.7).

The researchers also observed similar J-shape dose-response relationships of bowel movement frequency with the odds of subjective cognitive decline and the likelihood of having more subjective cognitive complaints over time.

Compared with once-daily bowel movements, having bowel movements every 3 or more days was associated with a greater likelihood of subjective cognitive decline (odds ratio, 1.73; 95% CI, 1.60-1.86).

These relationships were generally consistent across the three cohorts and subgroups.

“These results stress the importance of clinicians discussing gut health, especially constipation, with their older patients,” senior investigator Dong Wang, MD, ScD, with Harvard Medical School and Brigham and Women’s Hospital, said in a conference statement.

“Interventions for preventing constipation and improving gut health include adopting healthy diets enriched with high-fiber and high-polyphenol foods such as fruits, vegetables, and whole grains; taking fiber supplementation; drinking plenty of water every day; and having regular physical activity,” Dr. Wang added.

The researchers also explored the role of the gut microbiome in the association between bowel movement frequency and cognitive function in a subgroup of 515 women and men.

They found that bowel movement frequency and subjective cognition were significantly associated with the overall variation of the gut microbiome (both P < .005) and specific microbial species.

“This research adds further evidence for a link between the microbiome and gastrointestinal function with cognitive function,” Dr. Ma said in an interview.
 

Interconnected systems

Commenting on the study in a conference statement, Heather M. Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that “our body systems are all interconnected. When one system is malfunctioning, it impacts other systems. When that dysfunction isn’t addressed, it can create a waterfall of consequences for the rest of the body.”

Dr. Snyder cautioned, however, that “there are a lot of unanswered questions about the connection between the health of our digestive system and our long-term cognitive function. Answering these questions may uncover novel therapeutic and risk-reduction approaches for Alzheimer’s and other dementias.”

In an interview, Percy Griffin, PhD, director of scientific engagement at the Alzheimer’s Association, noted that the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk, is evaluating the impact of behavioral interventions on the gut-brain axis.

“We want to better understand how engaging in healthier habits can impact microorganisms in the gut and how changes in gut bacteria relate to brain health,” Dr. Griffin said.

The study was funded by the National Institutes of Health. Dr. Ma, Dr. Wang, Dr. Snyder, and Dr. Griffin have no relevant disclosures.

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

Chronic constipation may be associated with worsening cognitive function, new data from three prospective cohort studies with more than 100,000 adults show.

Compared with individuals who have a bowel movement once daily, adults with constipation who have a bowel movement every 3 days or more had significantly worse cognition that was commensurate with an additional 3 years of chronological cognitive aging, the investigators found.

“We should watch for symptoms of abnormal intestinal function, especially constipation, in older individuals, as these symptoms may hint at a higher risk of cognitive decline in the future,” study investigator Chaoran Ma, MD, PhD, former research fellow at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and current assistant professor at the University of Massachusetts Amherst, said in an interview.

The findings were presented at the Alzheimer’s Association International Conference.
 

Prevent constipation, improve brain health?

It’s estimated that 16% of the world’s population suffers from constipation. The problem is more common in older adults, owing to age-related factors such as a lack of dietary fiber and exercise and the use of constipating drugs to treat other medical conditions.

Chronic constipation – defined as having bowel movements every 3 days or more – has been associated with long-term health problems, such as inflammation, hormonal imbalances, anxiety, and depression.

However, few studies have investigated variations in intestinal motility and cognitive function.

“Our study provides first-of-its-kind evidence that examined a wide spectrum of bowel movement frequency, especially an analysis of the more frequent end, in relation to cognitive function,” Dr. Ma said.

The analysis involved data from 112,753 women and men from the Nurses’ Health Study (aged 30-55 years), the Nurses’ Health Study II (aged 25-42), and the Health Professionals Follow-up Study (aged 40-75).

Data on participants’ bowel movement frequency was collected between 2012 and 2013, and self-assessments of cognitive function were obtained from 2014 to 2017. A subgroup of 12,696 participants completed a standard neuropsychological test battery for objective cognitive assessment between 2014 and 2018.

The results show that bowel movement frequency was associated with overall objective cognitive function and learning and working memory in an inverse J-shape dose-response manner (both P for nonlinearity < .05).

Compared with adults who had one bowel movement daily, those who only had a bowel movement every 3 or more days had significantly worse cognition, equivalent to 3 years of additional aging (95% confidence interval, 1.2-4.7).

The researchers also observed similar J-shape dose-response relationships of bowel movement frequency with the odds of subjective cognitive decline and the likelihood of having more subjective cognitive complaints over time.

Compared with once-daily bowel movements, having bowel movements every 3 or more days was associated with a greater likelihood of subjective cognitive decline (odds ratio, 1.73; 95% CI, 1.60-1.86).

These relationships were generally consistent across the three cohorts and subgroups.

“These results stress the importance of clinicians discussing gut health, especially constipation, with their older patients,” senior investigator Dong Wang, MD, ScD, with Harvard Medical School and Brigham and Women’s Hospital, said in a conference statement.

“Interventions for preventing constipation and improving gut health include adopting healthy diets enriched with high-fiber and high-polyphenol foods such as fruits, vegetables, and whole grains; taking fiber supplementation; drinking plenty of water every day; and having regular physical activity,” Dr. Wang added.

The researchers also explored the role of the gut microbiome in the association between bowel movement frequency and cognitive function in a subgroup of 515 women and men.

They found that bowel movement frequency and subjective cognition were significantly associated with the overall variation of the gut microbiome (both P < .005) and specific microbial species.

“This research adds further evidence for a link between the microbiome and gastrointestinal function with cognitive function,” Dr. Ma said in an interview.
 

Interconnected systems

Commenting on the study in a conference statement, Heather M. Snyder, PhD, vice president of medical and scientific relations at the Alzheimer’s Association, noted that “our body systems are all interconnected. When one system is malfunctioning, it impacts other systems. When that dysfunction isn’t addressed, it can create a waterfall of consequences for the rest of the body.”

Dr. Snyder cautioned, however, that “there are a lot of unanswered questions about the connection between the health of our digestive system and our long-term cognitive function. Answering these questions may uncover novel therapeutic and risk-reduction approaches for Alzheimer’s and other dementias.”

In an interview, Percy Griffin, PhD, director of scientific engagement at the Alzheimer’s Association, noted that the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk, is evaluating the impact of behavioral interventions on the gut-brain axis.

“We want to better understand how engaging in healthier habits can impact microorganisms in the gut and how changes in gut bacteria relate to brain health,” Dr. Griffin said.

The study was funded by the National Institutes of Health. Dr. Ma, Dr. Wang, Dr. Snyder, and Dr. Griffin have no relevant disclosures.

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

Declines in verbal working memory were significantly associated with an increased risk of relapse in remitted psychosis patients, based on data from 110 individuals.

Previous research has suggested that cognitive impairments may predict recurrent psychotic episodes, but data on the association between specific cognitive deficits and relapse of psychosis over time are limited, wrote Tiffany J. Tao, MPhil, a PhD candidate at the University of Hong Kong, and colleagues.

In a naturalistic 1-year follow-up study published in Psychiatry Research , the researchers recruited psychosis patients with full remission for a least 6 months from two outpatient psychiatric clinics. The study population included adults aged 18-55 years, with an average age of 29.2 years; 62% were women. Relapse, defined as a recurrence of psychotic symptoms measured by the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale, was assessed monthly via phone interviews with the use of a smartphone app. Cognitive decline was based on working memory deterioration, assessed monthly via the Visual Patterns Test (VPT) and the Letter-Number Sequencing (LNS) test, respectively, for visual and verbal working memory.

Ms. Tao

Overall, 18 patients (16%) experienced a relapse at 1 year. One-third of these (six patients) required hospitalization, with a median hospital stay of 23 days.

In a multivariate analysis, independent and significant predictors of relapse were verbal working memory deterioration 2 months prior to relapse (P = .029), worse medication adherence (P = .018), and less resilience (P = .014) with odds ratios of 9.445, 0.051, and 0.769, respectively.

“Specifically, declines in verbal working memory were observed beginning at 2 months prior to the relapse episode in both the univariate and multivariate models after controlling for other significant predictors,” the researchers wrote in their discussion.

The mechanism of action for the association remains unclear, but cognitive impairment might reflect dopamine dysregulation or other processes in the prefrontal cortex that could contribute to psychotic relapse, they said.

Other factors include the associations between cognitive impairment and medication nonadherence, and the impact of cognitive impairment on a patient’s ability to manage the stresses of daily living that could trigger a psychotic relapse, they added.

Notably, the current study identified verbal working memory, but not visual working memory, as a predictor of relapse, which is important given the different neurobiological bases for visual and verbal tasks, the researchers wrote.

The study findings were limited by several factors including the inability to identify weaker predictors of relapse given the low relapse rate, and potential lack of generalizability to other less homogeneous populations, and the exclusion of patients with illicit drug use, the researchers noted.

However, the results were strengthened by the prospective measurements that prevented recall bias, and the inclusion of other objective predictors of relapse. The findings highlight the potential for early intervention to prevent relapse based on cognitive assessment, which can be measured objectively in the clinical setting or remotely from home using digital technology, they concluded.

The study received no outside funding. Ms. Tao had no financial conflicts to disclose.

Declines in verbal working memory were significantly associated with an increased risk of relapse in remitted psychosis patients, based on data from 110 individuals.

Previous research has suggested that cognitive impairments may predict recurrent psychotic episodes, but data on the association between specific cognitive deficits and relapse of psychosis over time are limited, wrote Tiffany J. Tao, MPhil, a PhD candidate at the University of Hong Kong, and colleagues.

In a naturalistic 1-year follow-up study published in Psychiatry Research , the researchers recruited psychosis patients with full remission for a least 6 months from two outpatient psychiatric clinics. The study population included adults aged 18-55 years, with an average age of 29.2 years; 62% were women. Relapse, defined as a recurrence of psychotic symptoms measured by the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale, was assessed monthly via phone interviews with the use of a smartphone app. Cognitive decline was based on working memory deterioration, assessed monthly via the Visual Patterns Test (VPT) and the Letter-Number Sequencing (LNS) test, respectively, for visual and verbal working memory.

Ms. Tao

Overall, 18 patients (16%) experienced a relapse at 1 year. One-third of these (six patients) required hospitalization, with a median hospital stay of 23 days.

In a multivariate analysis, independent and significant predictors of relapse were verbal working memory deterioration 2 months prior to relapse (P = .029), worse medication adherence (P = .018), and less resilience (P = .014) with odds ratios of 9.445, 0.051, and 0.769, respectively.

“Specifically, declines in verbal working memory were observed beginning at 2 months prior to the relapse episode in both the univariate and multivariate models after controlling for other significant predictors,” the researchers wrote in their discussion.

The mechanism of action for the association remains unclear, but cognitive impairment might reflect dopamine dysregulation or other processes in the prefrontal cortex that could contribute to psychotic relapse, they said.

Other factors include the associations between cognitive impairment and medication nonadherence, and the impact of cognitive impairment on a patient’s ability to manage the stresses of daily living that could trigger a psychotic relapse, they added.

Notably, the current study identified verbal working memory, but not visual working memory, as a predictor of relapse, which is important given the different neurobiological bases for visual and verbal tasks, the researchers wrote.

The study findings were limited by several factors including the inability to identify weaker predictors of relapse given the low relapse rate, and potential lack of generalizability to other less homogeneous populations, and the exclusion of patients with illicit drug use, the researchers noted.

However, the results were strengthened by the prospective measurements that prevented recall bias, and the inclusion of other objective predictors of relapse. The findings highlight the potential for early intervention to prevent relapse based on cognitive assessment, which can be measured objectively in the clinical setting or remotely from home using digital technology, they concluded.

The study received no outside funding. Ms. Tao had no financial conflicts to disclose.

Declines in verbal working memory were significantly associated with an increased risk of relapse in remitted psychosis patients, based on data from 110 individuals.

Previous research has suggested that cognitive impairments may predict recurrent psychotic episodes, but data on the association between specific cognitive deficits and relapse of psychosis over time are limited, wrote Tiffany J. Tao, MPhil, a PhD candidate at the University of Hong Kong, and colleagues.

In a naturalistic 1-year follow-up study published in Psychiatry Research , the researchers recruited psychosis patients with full remission for a least 6 months from two outpatient psychiatric clinics. The study population included adults aged 18-55 years, with an average age of 29.2 years; 62% were women. Relapse, defined as a recurrence of psychotic symptoms measured by the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale, was assessed monthly via phone interviews with the use of a smartphone app. Cognitive decline was based on working memory deterioration, assessed monthly via the Visual Patterns Test (VPT) and the Letter-Number Sequencing (LNS) test, respectively, for visual and verbal working memory.

Ms. Tao

Overall, 18 patients (16%) experienced a relapse at 1 year. One-third of these (six patients) required hospitalization, with a median hospital stay of 23 days.

In a multivariate analysis, independent and significant predictors of relapse were verbal working memory deterioration 2 months prior to relapse (P = .029), worse medication adherence (P = .018), and less resilience (P = .014) with odds ratios of 9.445, 0.051, and 0.769, respectively.

“Specifically, declines in verbal working memory were observed beginning at 2 months prior to the relapse episode in both the univariate and multivariate models after controlling for other significant predictors,” the researchers wrote in their discussion.

The mechanism of action for the association remains unclear, but cognitive impairment might reflect dopamine dysregulation or other processes in the prefrontal cortex that could contribute to psychotic relapse, they said.

Other factors include the associations between cognitive impairment and medication nonadherence, and the impact of cognitive impairment on a patient’s ability to manage the stresses of daily living that could trigger a psychotic relapse, they added.

Notably, the current study identified verbal working memory, but not visual working memory, as a predictor of relapse, which is important given the different neurobiological bases for visual and verbal tasks, the researchers wrote.

The study findings were limited by several factors including the inability to identify weaker predictors of relapse given the low relapse rate, and potential lack of generalizability to other less homogeneous populations, and the exclusion of patients with illicit drug use, the researchers noted.

However, the results were strengthened by the prospective measurements that prevented recall bias, and the inclusion of other objective predictors of relapse. The findings highlight the potential for early intervention to prevent relapse based on cognitive assessment, which can be measured objectively in the clinical setting or remotely from home using digital technology, they concluded.

The study received no outside funding. Ms. Tao had no financial conflicts to disclose.

A 12-week multidimensional “brain fitness program” provides multiple benefits for individuals with attention-deficit/hyperactive disorder, postconcussion syndrome (PCS), and memory loss, new research shows.

The program, which consists of targeted cognitive training and EEG-based neurofeedback, coupled with meditation and diet/lifestyle coaching, led to improvements in memory, attention, mood, alertness, and sleep.

The program promotes “neuroplasticity and was equally effective for patients with all three conditions,” program creator Majid Fotuhi, MD, PhD, said in an interview.

Patients with mild to moderate cognitive symptoms often see “remarkable” results within 3 months of consistently following the program, said Dr. Fotuhi, adjunct professor of neuroscience at George Washington University, Washington, and medical director of NeuroGrow Brain Fitness Center, McLean, Va.

“It actually makes intuitive sense that a healthier and stronger brain would function better and that patients of all ages with various cognitive or emotional symptoms would all benefit from improving the biology of their brain,” Dr. Fotuhi added.

The study was published online in the Journal of Alzheimer’s Disease Reports.
 

Personalized program

The findings are based on 223 children and adults who completed the 12-week NeuroGrow Brain Fitness Program (NeuroGrow BFP), including 71 with ADHD, 88 with PCS, and 64 with memory loss, defined as diagnosed mild cognitive impairment or subjective cognitive decline.

As part of the program, participants undergo a complete neurocognitive evaluation, including tests for verbal memory, complex attention, processing speed, executive functioning, and the Neurocognitive Index.

They also complete questionnaires regarding sleep, mood, diet, exercise, and anxiety/depression, and they undergo quantitative EEG at the beginning and end of the program.

A comparison of before and after neurocognitive test scores showed that all three patient subgroups experienced statistically significant improvements on most measures, the study team reports.

After completing the program, 60%-90% of patients scored higher on cognitive tests and reported having fewer cognitive, sleep, and emotional symptoms.

In all subgroups, the most significant improvement was observed in executive functioning.

“These preliminary findings appear to show that multimodal interventions which are known to increase neuroplasticity in the brain, when personalized, can have benefits for patients with cognitive symptoms from a variety of neurological conditions,” the investigators wrote.

The study’s strengths include a large, community-based sample of patients of different ages who had disruptive symptoms and abnormalities as determined using objective cognitive tests whose progress was monitored by objective and subjective measures.

The chief limitation is the lack of a control or placebo group.

“Though it is difficult to find a comparable group of patients with the exact same profile of cognitive deficits and brain-related symptoms, studying a larger group of patients – and comparing them with a wait-list group – may make it possible to do a more definitive assessment of the NeuroGrow BFP,” the researchers noted.

Dr. Fotuhi said the “secret to the success” of the program is that it involves a full assessment of all cognitive and neurobehavioral symptoms for each patient. This allows for individualized and targeted interventions for specific concerns and symptoms.

He said there is a need to recognize that patients who present to a neurology practice with a single complaint, such as a problem with memory or attention, often have other problems, such as anxiety/depression, stress, insomnia, sedentary lifestyle, obesity, diabetes, sleep apnea, or alcohol overuse.

“Each of these factors can affect their cognitive abilities and need a multimodal set of interventions in order to see full resolution of their cognitive symptoms,” Dr. Fotuhi said.

He has created a series of educational videos to demonstrate the program’s benefits.

The self-pay cost for the NeuroGrow BFP assessment and treatment sessions is approximately $7,000.

Dr. Fotuhi said all of the interventions included in the program are readily available at low cost.

He suggested that health care professionals who lack time or staff for conducting a comprehensive neurocognitive assessment for their patients can provide them with a copy of the Brain Health Index.

“Patients can then be instructed to work on the individual components of their brain health on their own – and measure their brain health index on a weekly basis,” Dr. Fotuhi said. “Private practices or academic centers can use the detailed information I have provided in my paper to develop their own brain fitness program.”
 

Not ready for prime time

Commenting on the study, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association, noted that “nonpharmacologic interventions can help alleviate some of the symptoms associated with dementia.

“The current study investigates nonpharmacologic interventions in a small number of patients with ADHD, postconcussion syndrome, or memory loss. The researchers found improvements on most measures following the brain rehabilitation program.

“While this is interesting, more work is needed in larger, more diverse cohorts before these programs can be applied broadly. Nonpharmacologic interventions are a helpful tool that need to be studied further in future studies,” Dr. Griffin added.

Funding for the study was provided by the NeuroGrow Brain Fitness Center. Dr. Fotuhi, the owner of NeuroGrow, was involved in data analysis, writing, editing, approval, and decision to publish. Dr. Griffin reported no disclosures.

A version of this article appeared on Medscape.com.

A 12-week multidimensional “brain fitness program” provides multiple benefits for individuals with attention-deficit/hyperactive disorder, postconcussion syndrome (PCS), and memory loss, new research shows.

The program, which consists of targeted cognitive training and EEG-based neurofeedback, coupled with meditation and diet/lifestyle coaching, led to improvements in memory, attention, mood, alertness, and sleep.

The program promotes “neuroplasticity and was equally effective for patients with all three conditions,” program creator Majid Fotuhi, MD, PhD, said in an interview.

Patients with mild to moderate cognitive symptoms often see “remarkable” results within 3 months of consistently following the program, said Dr. Fotuhi, adjunct professor of neuroscience at George Washington University, Washington, and medical director of NeuroGrow Brain Fitness Center, McLean, Va.

“It actually makes intuitive sense that a healthier and stronger brain would function better and that patients of all ages with various cognitive or emotional symptoms would all benefit from improving the biology of their brain,” Dr. Fotuhi added.

The study was published online in the Journal of Alzheimer’s Disease Reports.
 

Personalized program

The findings are based on 223 children and adults who completed the 12-week NeuroGrow Brain Fitness Program (NeuroGrow BFP), including 71 with ADHD, 88 with PCS, and 64 with memory loss, defined as diagnosed mild cognitive impairment or subjective cognitive decline.

As part of the program, participants undergo a complete neurocognitive evaluation, including tests for verbal memory, complex attention, processing speed, executive functioning, and the Neurocognitive Index.

They also complete questionnaires regarding sleep, mood, diet, exercise, and anxiety/depression, and they undergo quantitative EEG at the beginning and end of the program.

A comparison of before and after neurocognitive test scores showed that all three patient subgroups experienced statistically significant improvements on most measures, the study team reports.

After completing the program, 60%-90% of patients scored higher on cognitive tests and reported having fewer cognitive, sleep, and emotional symptoms.

In all subgroups, the most significant improvement was observed in executive functioning.

“These preliminary findings appear to show that multimodal interventions which are known to increase neuroplasticity in the brain, when personalized, can have benefits for patients with cognitive symptoms from a variety of neurological conditions,” the investigators wrote.

The study’s strengths include a large, community-based sample of patients of different ages who had disruptive symptoms and abnormalities as determined using objective cognitive tests whose progress was monitored by objective and subjective measures.

The chief limitation is the lack of a control or placebo group.

“Though it is difficult to find a comparable group of patients with the exact same profile of cognitive deficits and brain-related symptoms, studying a larger group of patients – and comparing them with a wait-list group – may make it possible to do a more definitive assessment of the NeuroGrow BFP,” the researchers noted.

Dr. Fotuhi said the “secret to the success” of the program is that it involves a full assessment of all cognitive and neurobehavioral symptoms for each patient. This allows for individualized and targeted interventions for specific concerns and symptoms.

He said there is a need to recognize that patients who present to a neurology practice with a single complaint, such as a problem with memory or attention, often have other problems, such as anxiety/depression, stress, insomnia, sedentary lifestyle, obesity, diabetes, sleep apnea, or alcohol overuse.

“Each of these factors can affect their cognitive abilities and need a multimodal set of interventions in order to see full resolution of their cognitive symptoms,” Dr. Fotuhi said.

He has created a series of educational videos to demonstrate the program’s benefits.

The self-pay cost for the NeuroGrow BFP assessment and treatment sessions is approximately $7,000.

Dr. Fotuhi said all of the interventions included in the program are readily available at low cost.

He suggested that health care professionals who lack time or staff for conducting a comprehensive neurocognitive assessment for their patients can provide them with a copy of the Brain Health Index.

“Patients can then be instructed to work on the individual components of their brain health on their own – and measure their brain health index on a weekly basis,” Dr. Fotuhi said. “Private practices or academic centers can use the detailed information I have provided in my paper to develop their own brain fitness program.”
 

Not ready for prime time

Commenting on the study, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association, noted that “nonpharmacologic interventions can help alleviate some of the symptoms associated with dementia.

“The current study investigates nonpharmacologic interventions in a small number of patients with ADHD, postconcussion syndrome, or memory loss. The researchers found improvements on most measures following the brain rehabilitation program.

“While this is interesting, more work is needed in larger, more diverse cohorts before these programs can be applied broadly. Nonpharmacologic interventions are a helpful tool that need to be studied further in future studies,” Dr. Griffin added.

Funding for the study was provided by the NeuroGrow Brain Fitness Center. Dr. Fotuhi, the owner of NeuroGrow, was involved in data analysis, writing, editing, approval, and decision to publish. Dr. Griffin reported no disclosures.

A version of this article appeared on Medscape.com.

A 12-week multidimensional “brain fitness program” provides multiple benefits for individuals with attention-deficit/hyperactive disorder, postconcussion syndrome (PCS), and memory loss, new research shows.

The program, which consists of targeted cognitive training and EEG-based neurofeedback, coupled with meditation and diet/lifestyle coaching, led to improvements in memory, attention, mood, alertness, and sleep.

The program promotes “neuroplasticity and was equally effective for patients with all three conditions,” program creator Majid Fotuhi, MD, PhD, said in an interview.

Patients with mild to moderate cognitive symptoms often see “remarkable” results within 3 months of consistently following the program, said Dr. Fotuhi, adjunct professor of neuroscience at George Washington University, Washington, and medical director of NeuroGrow Brain Fitness Center, McLean, Va.

“It actually makes intuitive sense that a healthier and stronger brain would function better and that patients of all ages with various cognitive or emotional symptoms would all benefit from improving the biology of their brain,” Dr. Fotuhi added.

The study was published online in the Journal of Alzheimer’s Disease Reports.
 

Personalized program

The findings are based on 223 children and adults who completed the 12-week NeuroGrow Brain Fitness Program (NeuroGrow BFP), including 71 with ADHD, 88 with PCS, and 64 with memory loss, defined as diagnosed mild cognitive impairment or subjective cognitive decline.

As part of the program, participants undergo a complete neurocognitive evaluation, including tests for verbal memory, complex attention, processing speed, executive functioning, and the Neurocognitive Index.

They also complete questionnaires regarding sleep, mood, diet, exercise, and anxiety/depression, and they undergo quantitative EEG at the beginning and end of the program.

A comparison of before and after neurocognitive test scores showed that all three patient subgroups experienced statistically significant improvements on most measures, the study team reports.

After completing the program, 60%-90% of patients scored higher on cognitive tests and reported having fewer cognitive, sleep, and emotional symptoms.

In all subgroups, the most significant improvement was observed in executive functioning.

“These preliminary findings appear to show that multimodal interventions which are known to increase neuroplasticity in the brain, when personalized, can have benefits for patients with cognitive symptoms from a variety of neurological conditions,” the investigators wrote.

The study’s strengths include a large, community-based sample of patients of different ages who had disruptive symptoms and abnormalities as determined using objective cognitive tests whose progress was monitored by objective and subjective measures.

The chief limitation is the lack of a control or placebo group.

“Though it is difficult to find a comparable group of patients with the exact same profile of cognitive deficits and brain-related symptoms, studying a larger group of patients – and comparing them with a wait-list group – may make it possible to do a more definitive assessment of the NeuroGrow BFP,” the researchers noted.

Dr. Fotuhi said the “secret to the success” of the program is that it involves a full assessment of all cognitive and neurobehavioral symptoms for each patient. This allows for individualized and targeted interventions for specific concerns and symptoms.

He said there is a need to recognize that patients who present to a neurology practice with a single complaint, such as a problem with memory or attention, often have other problems, such as anxiety/depression, stress, insomnia, sedentary lifestyle, obesity, diabetes, sleep apnea, or alcohol overuse.

“Each of these factors can affect their cognitive abilities and need a multimodal set of interventions in order to see full resolution of their cognitive symptoms,” Dr. Fotuhi said.

He has created a series of educational videos to demonstrate the program’s benefits.

The self-pay cost for the NeuroGrow BFP assessment and treatment sessions is approximately $7,000.

Dr. Fotuhi said all of the interventions included in the program are readily available at low cost.

He suggested that health care professionals who lack time or staff for conducting a comprehensive neurocognitive assessment for their patients can provide them with a copy of the Brain Health Index.

“Patients can then be instructed to work on the individual components of their brain health on their own – and measure their brain health index on a weekly basis,” Dr. Fotuhi said. “Private practices or academic centers can use the detailed information I have provided in my paper to develop their own brain fitness program.”
 

Not ready for prime time

Commenting on the study, Percy Griffin, PhD, director of scientific engagement for the Alzheimer’s Association, noted that “nonpharmacologic interventions can help alleviate some of the symptoms associated with dementia.

“The current study investigates nonpharmacologic interventions in a small number of patients with ADHD, postconcussion syndrome, or memory loss. The researchers found improvements on most measures following the brain rehabilitation program.

“While this is interesting, more work is needed in larger, more diverse cohorts before these programs can be applied broadly. Nonpharmacologic interventions are a helpful tool that need to be studied further in future studies,” Dr. Griffin added.

Funding for the study was provided by the NeuroGrow Brain Fitness Center. Dr. Fotuhi, the owner of NeuroGrow, was involved in data analysis, writing, editing, approval, and decision to publish. Dr. Griffin reported no disclosures.

A version of this article appeared on Medscape.com.

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.

David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However, he claims in a lawsuit filed July 5 in Allen County Superior Court that an Indiana law that took effect 4 days earlier nullifies the clause because he quit his job with cause. 

Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.

“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”

Lutheran Health’s media relations department did not respond to requests for comment.
 

Noncompete clauses ‘extremely common’

Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.

However, the tide has been turning against them.

About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.

For more about state-by-state restrictions on noncompete clauses, check this chart.

In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.

Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions. 

In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023. 

Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.

Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”

The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
 

Impact on patients

The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.  

State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.

However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.

The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”

For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
 

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

The monoclonal antibody donanemab (Eli Lilly) significantly slows cognitive and functional decline for patients with early, symptomatic Alzheimer’s disease, compared with placebo, results of a phase 3 study showed.

“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.

At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.

The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
 

Primary, secondary endpoints met

The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.

Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.

Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).

The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.

In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.

In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.

The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.

The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
 

Greater benefit with lower tau

However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.

Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.

In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.

Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.

The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.

The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
 

Safety issues

However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.

Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.

An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.

Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
 

Strongest data yet

Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.

“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”

He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”

Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”

The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.

“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.

Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”

He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”

While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.

A version of this article appeared on Medscape.com.

The monoclonal antibody donanemab (Eli Lilly) significantly slows cognitive and functional decline for patients with early, symptomatic Alzheimer’s disease, compared with placebo, results of a phase 3 study showed.

“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.

At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.

The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
 

Primary, secondary endpoints met

The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.

Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.

Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).

The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.

In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.

In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.

The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.

The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
 

Greater benefit with lower tau

However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.

Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.

In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.

Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.

The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.

The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
 

Safety issues

However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.

Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.

An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.

Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
 

Strongest data yet

Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.

“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”

He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”

Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”

The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.

“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.

Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”

He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”

While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.

A version of this article appeared on Medscape.com.

The monoclonal antibody donanemab (Eli Lilly) significantly slows cognitive and functional decline for patients with early, symptomatic Alzheimer’s disease, compared with placebo, results of a phase 3 study showed.

“This trial demonstrates that an antiamyloid drug significantly slows the disease and provides meaningful benefit to patients, and we’re hoping that with approval, we will be able to make that drug available,” said Mark Mintun, MD, VP, pain and neurodegeneration research, Eli Lilly.

At a press briefing highlighting the new results, Maria Carrillo, PhD, chief science officer, Alzheimer’s Association, noted the “palpable excitement” surrounding this new study, which follows on the heels of other promising antiamyloid research. “This is the decade of Alzheimer’s disease, and it will get better from here,” she said.

The findings were presented at the Alzheimer’s Association International Conference and were published online in JAMA.
 

Primary, secondary endpoints met

The TRAILBLAZER-ALZ 2 study included 1,736 patients with mild cognitive impairment (MCI) or mild dementia for whom PET showed evidence of amyloid and tau pathology. The mean age of the participants was 73 years, and most of the participants were White.

Participants were randomly assigned to receive either placebo or donanemab, an investigational IgG1 monoclonal antibody directed against an insoluble, modified, N-terminal, truncated form of beta-amyloid. Donanemab was administered at a dose of 700 mg for the first three doses and 1,400 mg thereafter. The drug was administered intravenously every 4 weeks for up to 72 weeks.

Researchers stratified patients on the basis of the amount of tau, a biomarker for Alzheimer’s disease progression, into a low/medium tau group and a combined tau group (low/medium and high tau).

The primary endpoint was change from baseline to 76 weeks on the integrated Alzheimer’s Disease Rating Scale (iADRS), which measures cognition and activities of daily living.

In those with low/medium tau levels, the least squares mean (LSM) change in iADRS score was −6.02 (95% confidence interval, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25; 95% CI, 1.88 – 4.62; P < .001), representing a 35.1% slowing of disease progression.

In the combined (tau) population, LSM change in iADRS was −10.19 (95% CI, −11.22 to −9.16) in the donanemab group and −13.11 (95% CI, −14.10 to −12.13) in the placebo group (difference, 2.92; 95% CI, 1.51 – 4.33; P < .001), representing a 22.3% slowing of disease progression.

The study also met all secondary endpoints regarding measurements of cognitive and functional decline, including the Clinical Dementia Rating–Sum of Boxes (CDR-SB), which showed 36% slowing of decline (P < .0001) over 18 months.

The authors noted that the changes on these scales were clinically meaningful (considered to be > 20% slowing of clinical progression) for both the low/medium tau and combined populations.
 

Greater benefit with lower tau

However, patients with low/medium tau generally demonstrated effect size estimates that were larger than those of the overall population, which suggests there’s greater benefit when amyloid-lowering therapies are initiated at an earlier disease stage, the investigators noted.

Additional support for clinical relevance was a 38.6% risk reduction of disease progression, as measured on the CDR–Global Score.

In addition, participants who received the active drug benefited in terms of activities of daily living, as demonstrated by 40% less decline (P < .0001) on the Alzheimer’s Disease Cooperative Study–Instrumental Activities of Daily Living Inventory.

Donanemab significantly reduced brain amyloid plaque: 80% (low/medium tau population) and 76% (combined population) of participants achieved amyloid clearance at 76 weeks. The intervention was also associated with a greater decrease in whole-brain volume.

The treatment effect continued to widen after patients were switched to placebo, as evidenced on PET scan at 6 or 12 months, said Dr. Mintun.

The effects of the drug were similar among men and women but were especially pronounced among younger participants, with a 48% slowing on iADRS and a 45% slowing on CDR-SB in those younger than 75 years.
 

Safety issues

However, the drug is not without some safety concerns. Amyloid-related imaging abnormalities (ARIAs) occurred in 36.8% of the treatment group versus 14.9% of the placebo group, and in 40.6% of patients who were homozygous for apo E4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group versus 12.5% in the placebo group.

Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug related among participants who developed serious ARIAs or brain bleeding and swelling.

An important study limitation was that it enrolled primarily White patients (91.5%), which may limit generalizability to other populations, and the age limit was 85 years, which some believe is an inadequate representation of older adults. In addition, the 18-month treatment window limits the long-term understanding of donanemab’s benefits and side effects.

Eli Lilly has filed a submission to the Food and Drug Administration. If approved, donanemab will be the third antiamyloid monoclonal antibody to receive this status, following aducanumab (Aduhelm) and lecanemab (Leqembi).
 

Strongest data yet

Commenting on the study findings, Percy Griffin, PhD, director of scientific engagement, Alzheimer’s Association, said these new results are “very, very exciting” and represent “the strongest data to-date” for antiamyloid monoclonal antibodies in Alzheimer’s disease.

“A good percentage of individuals on the drug actually saw a complete clearance of amyloid, and some had to be taken off the drug, because if you’re on an antiamyloid drug and there’s no amyloid, what are you going for?”

He noted that the study had some unique aspects, including using tau-PET “to see whether or not the drug is more effective in subpopulations.”

Access to this and other antiamyloid therapies should be a priority, said Dr. Griffin. “We have to make sure people who have the potential to benefit from these treatments do.”

The Alzheimer’s Association is calling for Medicare beneficiaries who are living with the disease to receive the same coverage afforded to those with other diseases.

“The Centers for Medicare & Medicaid Services policy to block Medicare access to FDA-approved Alzheimer’s disease treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” Joanne Pike, DrPH, president and CEO of the Alzheimer’s Association, said in a press release.

Also important is tracking the longitudinal performance of these drugs outside of clinical trials, said Dr. Griffin. “Not everyone is going to be in that Goldilocks zone of being able to see a doctor whenever they want and have access to these PET and MRI tools and other things used in clinical trials.”

He noted that the Alzheimer’s Association is leading a network for diagnostics and therapeutics (ALZ-NET) that will track the performance of novel FDA-approved Alzheimer’s disease therapies “in the real world.”

While these are exciting findings for antiamyloid therapy, “we can’t take our foot off the gas, we need more therapies that target different aspects of the disease biology,” said Dr. Griffin.

A version of this article appeared on Medscape.com.

DUBLIN – Patients with psoriatic disease (PsD) face an elevated risk for depression and suicidality that stems from both pathologic inflammatory factors associated with the disease as well as societal stigma, warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.

The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.

“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
 

Mediators of depression

“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”

There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.

“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.

Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.

IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.

“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
 

Talking about depression

“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”

Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”

She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”

Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.

“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.

“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.

Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.

“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”

Perspective from Dr. Merola

In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.

“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.

“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”

These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.

In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’ 

“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”

In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.

Dr. Wallace and Dr. Merola report no relevant financial relationships.

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

DUBLIN – Patients with psoriatic disease (PsD) face an elevated risk for depression and suicidality that stems from both pathologic inflammatory factors associated with the disease as well as societal stigma, warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.

The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.

“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
 

Mediators of depression

“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”

There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.

“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.

Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.

IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.

“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
 

Talking about depression

“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”

Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”

She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”

Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.

“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.

“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.

Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.

“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”

Perspective from Dr. Merola

In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.

“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.

“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”

These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.

In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’ 

“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”

In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.

Dr. Wallace and Dr. Merola report no relevant financial relationships.

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

DUBLIN – Patients with psoriatic disease (PsD) face an elevated risk for depression and suicidality that stems from both pathologic inflammatory factors associated with the disease as well as societal stigma, warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.

The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.

“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
 

Mediators of depression

“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”

There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.

“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.

Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.

IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.

“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
 

Talking about depression

“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”

Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”

She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”

Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.

“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.

“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.

Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.

“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”

Perspective from Dr. Merola

In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.

“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.

“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”

These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.

In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’ 

“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”

In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.

Dr. Wallace and Dr. Merola report no relevant financial relationships.

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