Neurology

Researchers have published one of the first studies to characterize the association between the consumption of legal cannabis and subsequent pharmacologic and neurobehavioral outcomes, with somewhat surprising results.

The study showed that, although cannabis consumption did not affect most short-term neurobehavioral measures, it delayed recall memory and impaired balance.

The investigation also showed that users of much more potent cannabis concentrates actually demonstrated similar or lower levels of subjective drug intoxication and short-term impairment than did their counterparts who used lower-potency forms of the cannabis flower.

“It does not appear that the potency being used matters that much,” senior investigator Kent E. Hutchison, PhD, said in an interview. “People seem to be titrating to a certain level of intoxication or a certain level of feeling high. And for some people that requires a lot of drug, and for other people not as much.”

“As a first study, this was very useful in the sense that nobody really knew the effects of high-potency cannabis products,” added Dr. Hutchison, a professor of psychology and neuroscience at the University of Colorado Boulder.

The study was published online June 10 in JAMA Psychiatry.

Widespread availability, little research

Recreational cannabis is now legal in 11 states and the District of Columbia, while medical cannabis is legal in 33. However, despite growing popularity of cannabis, there is little research on its potential health and biobehavioral risks, largely because of federal restrictions on cannabis research.

Cannabis users typically consume various forms of the cannabis flower, which can boast concentrations of the psychoactive cannabinoid delta-9-tetrahydrocannabinol (THC) of up to 30%. However, use of concentrated forms of cannabis – which are made by extracting plant cannabinoids into a different form – is increasing.

Such formulations can boast THC concentrations as high as 90%. Nevertheless, data regarding the relative risks of these higher-strength products are limited.

Previous research has shown a variety of negative short-term and long-term neurobehavioral effects associated with cannabis use, including harmful cognitive and motor effects. Extended exposure to THC may also negatively affect brain regions that are associated with the control of coordinated movement, and create brain-activation deficits in motor control regions that persist well beyond the effects of short-term intoxication.

Despite such findings, Dr. Hutchison said the existing literature on the subject does not yield a real-world view of current cannabis use because it tends to focus on low-THC products that are increasingly less common in today’s legal market.

Given such shortcomings, the investigators wanted to address persistent questions surrounding the neurobehavioral effects of legal cannabis flower products (16% or 24% THC) and cannabis concentrate products (70% or 90% THC). In doing so, they examined three primary topics:

• The association between short-term use of these products and THC plasma levels; subjective intoxication; and mood, cognitive performance, and balance
• Differences in such associations between users of cannabis flower and concentrate products
• Potential variations in these associations by THC potency

High- versus low-potency varieties

The study included 133 individuals (aged 21-70 years), who were designated as either cannabis flower users or cannabis concentrate users. Participants had all used cannabis at least four times in the previous month with no adverse reaction and were not receiving treatment for a psychotic disorder or bipolar disorder.

Participants were randomly assigned to consume either higher-potency or lower-potency products that had been purchased from a local dispensary. Flower users were randomized to purchase 3 g of either a 16% THC or 24% THC product, while concentrate users were randomized to purchase 1g of either 70% THC or 90% THC.

Participants completed a series of four assessments, one at baseline and three others at a mobile laboratory. The mobile laboratory assessments occurred before, immediately after, and one hour after participants had all consumed their cannabis ad libitum.

Of the original cohort of 133 participants, 55 flower cannabis users (mean age, 28.8 years; 46% women) and 66 concentrate cannabis users (mean age, 28.3 years; 45% women) complied with the study’s instructions and had complete data.

The study’s primary outcome measures included plasma cannabinoids, subjective drug intoxication and mood, and neurobehavioral outcomes such as attention, memory, inhibitory control, and balance.

Mixed results

With respect to cannabis concentrations, results showed that users of concentrate exhibited higher levels of both plasma THC and the active metabolite of THC (11-hydroxy-delta⁹-THC) across all points than did their counterparts who used cannabis flower products.

Specifically, mean plasma THC levels were 1,016 ± 1,380 mcg/ml in concentrate users and 455±503 mcg/mL in flower users after ad libitum cannabis consumption. Nevertheless, self-reported levels of intoxication were no different between users of cannabis flower or concentrate products.

Although results also showed that most neurobehavioral measures were not altered by short-term cannabis consumption, there were some notable exceptions. There was a negative linear effect with delayed verbal recall errors, suggesting poorer performance after cannabis use (F_{1, 203} = 32.31; P < .001).

On the other hand, investigators found a positive linear effect with inhibitory control and working memory, which actually suggests better performance after cannabis use. This finding, the researchers note, may be the result of a practice effect. Cannabis flower users performed better across all inhibitory control assessments.

The researchers also tested participants’ balance with their eyes open and closed. In the eyes-open condition, they found a trend toward impaired balance after cannabis use, though this normalized within an hour. When subjects closed their eyes, however, researchers observed a significant short-term increase in sway after cannabis use, which fell back to pre-use levels one hour after use (F_{1, 203} = 18.88; P < .001).

Of note, outcomes did not differ between groups according to the type of cannabis product consumed or its relative potency.

The study yielded several surprising findings, beginning with self-reported intoxication levels, which were not statistically significant between different cannabis flower and concentrate users, despite significantly different plasma THC levels between the two groups.

Dr. Hutchison explained that this may be the result of greater THC tolerance among concentrate users, THC saturation of cannabinoid receptors, or interindividual differences among users with respect to cannabis metabolism or sensitivity.

“I thought for sure that high-potency users would be much more compromised,” he said. “I guess it just goes to show we have a lot to learn about how these things work.”

Additionally, there were virtually no significant changes in acute performance after cannabis use, with the exception of delayed verbal recall. In fact, the most marked change observed in the study was the effect of cannabis on balance immediately after drug use, though these changes seemed to abate within an hour.

Nevertheless, the study highlights several potential public health implications of cannabis consumption, Dr. Hutchison added. “What happens when people with high blood concentrations decide to quit?” he asked. “Do they have trouble quitting? Do they have withdrawal symptoms?”

The long-term effects of cannabis use is another important question that still needs to be answered, he added.

Finally, Dr. Hutchison noted that, although the study showed little difference between users of cannabis flower and concentrates, study participants were all experienced users.

“There is certainly the potential for harm when a naive person uses cannabis concentrate,” he said. “Suddenly they have way more THC than they thought they were going to get, and that’s where a lot of people get into trouble with cannabis.”

Pitfalls and hurdles

In an accompanying editorial, Margaret Haney, PhD, of Columbia University Irving Medical Center, New York, explained that cannabis’ awkward position as simultaneously legal and illegal, medical and recreational, has hampered researchers’ ability to study its effects as comprehensively as they would otherwise like.

“With a federally illegal drug legalized in individual states, scientists constrained, and federal agencies somewhat silent, clinicians have none of the data that guide their decisions for other medications (eg, which indication, product, cannabinoid ratio, dose, or route of administration; what risks for individual patients [eg, pregnant, adolescent, psychiatric?]),” Dr. Haney wrote.

These pitfalls are compounded by the significant regulatory hurdles.

“The FDA is appropriately cautious about what it allows scientists to test in patients, and none of the products available in dispensaries or online have undergone the safety and manufacturing procedures needed for FDA approval,” she continued. “How then to conduct the studies so needed?”

Yet as Haney noted, giving cannabinoid researchers a Schedule I exemption may help address many of the barriers facing these scientists. Such a move, she said, would increase the number of randomized controlled trials being performed, “and thereby begin to breach the divide between the use of these products and empirical evidence.”

Dr. Hutchison has disclosed no relevant financial relationships. Dr. Haney disclosed funding from the US National Institute on Drug Abuse and from the Thompson Family Foundation Initiative. The study was funded by the NIH and Colorado Department of Public Health and Environment.

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

Researchers have published one of the first studies to characterize the association between the consumption of legal cannabis and subsequent pharmacologic and neurobehavioral outcomes, with somewhat surprising results.

The study showed that, although cannabis consumption did not affect most short-term neurobehavioral measures, it delayed recall memory and impaired balance.

The investigation also showed that users of much more potent cannabis concentrates actually demonstrated similar or lower levels of subjective drug intoxication and short-term impairment than did their counterparts who used lower-potency forms of the cannabis flower.

“It does not appear that the potency being used matters that much,” senior investigator Kent E. Hutchison, PhD, said in an interview. “People seem to be titrating to a certain level of intoxication or a certain level of feeling high. And for some people that requires a lot of drug, and for other people not as much.”

“As a first study, this was very useful in the sense that nobody really knew the effects of high-potency cannabis products,” added Dr. Hutchison, a professor of psychology and neuroscience at the University of Colorado Boulder.

The study was published online June 10 in JAMA Psychiatry.

Widespread availability, little research

Recreational cannabis is now legal in 11 states and the District of Columbia, while medical cannabis is legal in 33. However, despite growing popularity of cannabis, there is little research on its potential health and biobehavioral risks, largely because of federal restrictions on cannabis research.

Cannabis users typically consume various forms of the cannabis flower, which can boast concentrations of the psychoactive cannabinoid delta-9-tetrahydrocannabinol (THC) of up to 30%. However, use of concentrated forms of cannabis – which are made by extracting plant cannabinoids into a different form – is increasing.

Such formulations can boast THC concentrations as high as 90%. Nevertheless, data regarding the relative risks of these higher-strength products are limited.

Previous research has shown a variety of negative short-term and long-term neurobehavioral effects associated with cannabis use, including harmful cognitive and motor effects. Extended exposure to THC may also negatively affect brain regions that are associated with the control of coordinated movement, and create brain-activation deficits in motor control regions that persist well beyond the effects of short-term intoxication.

Despite such findings, Dr. Hutchison said the existing literature on the subject does not yield a real-world view of current cannabis use because it tends to focus on low-THC products that are increasingly less common in today’s legal market.

Given such shortcomings, the investigators wanted to address persistent questions surrounding the neurobehavioral effects of legal cannabis flower products (16% or 24% THC) and cannabis concentrate products (70% or 90% THC). In doing so, they examined three primary topics:

• The association between short-term use of these products and THC plasma levels; subjective intoxication; and mood, cognitive performance, and balance
• Differences in such associations between users of cannabis flower and concentrate products
• Potential variations in these associations by THC potency

High- versus low-potency varieties

The study included 133 individuals (aged 21-70 years), who were designated as either cannabis flower users or cannabis concentrate users. Participants had all used cannabis at least four times in the previous month with no adverse reaction and were not receiving treatment for a psychotic disorder or bipolar disorder.

Participants were randomly assigned to consume either higher-potency or lower-potency products that had been purchased from a local dispensary. Flower users were randomized to purchase 3 g of either a 16% THC or 24% THC product, while concentrate users were randomized to purchase 1g of either 70% THC or 90% THC.

Participants completed a series of four assessments, one at baseline and three others at a mobile laboratory. The mobile laboratory assessments occurred before, immediately after, and one hour after participants had all consumed their cannabis ad libitum.

Of the original cohort of 133 participants, 55 flower cannabis users (mean age, 28.8 years; 46% women) and 66 concentrate cannabis users (mean age, 28.3 years; 45% women) complied with the study’s instructions and had complete data.

The study’s primary outcome measures included plasma cannabinoids, subjective drug intoxication and mood, and neurobehavioral outcomes such as attention, memory, inhibitory control, and balance.

Mixed results

With respect to cannabis concentrations, results showed that users of concentrate exhibited higher levels of both plasma THC and the active metabolite of THC (11-hydroxy-delta⁹-THC) across all points than did their counterparts who used cannabis flower products.

Specifically, mean plasma THC levels were 1,016 ± 1,380 mcg/ml in concentrate users and 455±503 mcg/mL in flower users after ad libitum cannabis consumption. Nevertheless, self-reported levels of intoxication were no different between users of cannabis flower or concentrate products.

Although results also showed that most neurobehavioral measures were not altered by short-term cannabis consumption, there were some notable exceptions. There was a negative linear effect with delayed verbal recall errors, suggesting poorer performance after cannabis use (F_{1, 203} = 32.31; P < .001).

On the other hand, investigators found a positive linear effect with inhibitory control and working memory, which actually suggests better performance after cannabis use. This finding, the researchers note, may be the result of a practice effect. Cannabis flower users performed better across all inhibitory control assessments.

The researchers also tested participants’ balance with their eyes open and closed. In the eyes-open condition, they found a trend toward impaired balance after cannabis use, though this normalized within an hour. When subjects closed their eyes, however, researchers observed a significant short-term increase in sway after cannabis use, which fell back to pre-use levels one hour after use (F_{1, 203} = 18.88; P < .001).

Of note, outcomes did not differ between groups according to the type of cannabis product consumed or its relative potency.

The study yielded several surprising findings, beginning with self-reported intoxication levels, which were not statistically significant between different cannabis flower and concentrate users, despite significantly different plasma THC levels between the two groups.

Dr. Hutchison explained that this may be the result of greater THC tolerance among concentrate users, THC saturation of cannabinoid receptors, or interindividual differences among users with respect to cannabis metabolism or sensitivity.

“I thought for sure that high-potency users would be much more compromised,” he said. “I guess it just goes to show we have a lot to learn about how these things work.”

Additionally, there were virtually no significant changes in acute performance after cannabis use, with the exception of delayed verbal recall. In fact, the most marked change observed in the study was the effect of cannabis on balance immediately after drug use, though these changes seemed to abate within an hour.

Nevertheless, the study highlights several potential public health implications of cannabis consumption, Dr. Hutchison added. “What happens when people with high blood concentrations decide to quit?” he asked. “Do they have trouble quitting? Do they have withdrawal symptoms?”

The long-term effects of cannabis use is another important question that still needs to be answered, he added.

Finally, Dr. Hutchison noted that, although the study showed little difference between users of cannabis flower and concentrates, study participants were all experienced users.

“There is certainly the potential for harm when a naive person uses cannabis concentrate,” he said. “Suddenly they have way more THC than they thought they were going to get, and that’s where a lot of people get into trouble with cannabis.”

Pitfalls and hurdles

In an accompanying editorial, Margaret Haney, PhD, of Columbia University Irving Medical Center, New York, explained that cannabis’ awkward position as simultaneously legal and illegal, medical and recreational, has hampered researchers’ ability to study its effects as comprehensively as they would otherwise like.

“With a federally illegal drug legalized in individual states, scientists constrained, and federal agencies somewhat silent, clinicians have none of the data that guide their decisions for other medications (eg, which indication, product, cannabinoid ratio, dose, or route of administration; what risks for individual patients [eg, pregnant, adolescent, psychiatric?]),” Dr. Haney wrote.

These pitfalls are compounded by the significant regulatory hurdles.

“The FDA is appropriately cautious about what it allows scientists to test in patients, and none of the products available in dispensaries or online have undergone the safety and manufacturing procedures needed for FDA approval,” she continued. “How then to conduct the studies so needed?”

Yet as Haney noted, giving cannabinoid researchers a Schedule I exemption may help address many of the barriers facing these scientists. Such a move, she said, would increase the number of randomized controlled trials being performed, “and thereby begin to breach the divide between the use of these products and empirical evidence.”

Dr. Hutchison has disclosed no relevant financial relationships. Dr. Haney disclosed funding from the US National Institute on Drug Abuse and from the Thompson Family Foundation Initiative. The study was funded by the NIH and Colorado Department of Public Health and Environment.

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

Researchers have published one of the first studies to characterize the association between the consumption of legal cannabis and subsequent pharmacologic and neurobehavioral outcomes, with somewhat surprising results.

The study showed that, although cannabis consumption did not affect most short-term neurobehavioral measures, it delayed recall memory and impaired balance.

The investigation also showed that users of much more potent cannabis concentrates actually demonstrated similar or lower levels of subjective drug intoxication and short-term impairment than did their counterparts who used lower-potency forms of the cannabis flower.

“It does not appear that the potency being used matters that much,” senior investigator Kent E. Hutchison, PhD, said in an interview. “People seem to be titrating to a certain level of intoxication or a certain level of feeling high. And for some people that requires a lot of drug, and for other people not as much.”

“As a first study, this was very useful in the sense that nobody really knew the effects of high-potency cannabis products,” added Dr. Hutchison, a professor of psychology and neuroscience at the University of Colorado Boulder.

The study was published online June 10 in JAMA Psychiatry.

Widespread availability, little research

Recreational cannabis is now legal in 11 states and the District of Columbia, while medical cannabis is legal in 33. However, despite growing popularity of cannabis, there is little research on its potential health and biobehavioral risks, largely because of federal restrictions on cannabis research.

Cannabis users typically consume various forms of the cannabis flower, which can boast concentrations of the psychoactive cannabinoid delta-9-tetrahydrocannabinol (THC) of up to 30%. However, use of concentrated forms of cannabis – which are made by extracting plant cannabinoids into a different form – is increasing.

Such formulations can boast THC concentrations as high as 90%. Nevertheless, data regarding the relative risks of these higher-strength products are limited.

Previous research has shown a variety of negative short-term and long-term neurobehavioral effects associated with cannabis use, including harmful cognitive and motor effects. Extended exposure to THC may also negatively affect brain regions that are associated with the control of coordinated movement, and create brain-activation deficits in motor control regions that persist well beyond the effects of short-term intoxication.

Despite such findings, Dr. Hutchison said the existing literature on the subject does not yield a real-world view of current cannabis use because it tends to focus on low-THC products that are increasingly less common in today’s legal market.

Given such shortcomings, the investigators wanted to address persistent questions surrounding the neurobehavioral effects of legal cannabis flower products (16% or 24% THC) and cannabis concentrate products (70% or 90% THC). In doing so, they examined three primary topics:

• The association between short-term use of these products and THC plasma levels; subjective intoxication; and mood, cognitive performance, and balance
• Differences in such associations between users of cannabis flower and concentrate products
• Potential variations in these associations by THC potency

High- versus low-potency varieties

The study included 133 individuals (aged 21-70 years), who were designated as either cannabis flower users or cannabis concentrate users. Participants had all used cannabis at least four times in the previous month with no adverse reaction and were not receiving treatment for a psychotic disorder or bipolar disorder.

Participants were randomly assigned to consume either higher-potency or lower-potency products that had been purchased from a local dispensary. Flower users were randomized to purchase 3 g of either a 16% THC or 24% THC product, while concentrate users were randomized to purchase 1g of either 70% THC or 90% THC.

Participants completed a series of four assessments, one at baseline and three others at a mobile laboratory. The mobile laboratory assessments occurred before, immediately after, and one hour after participants had all consumed their cannabis ad libitum.

Of the original cohort of 133 participants, 55 flower cannabis users (mean age, 28.8 years; 46% women) and 66 concentrate cannabis users (mean age, 28.3 years; 45% women) complied with the study’s instructions and had complete data.

The study’s primary outcome measures included plasma cannabinoids, subjective drug intoxication and mood, and neurobehavioral outcomes such as attention, memory, inhibitory control, and balance.

Mixed results

With respect to cannabis concentrations, results showed that users of concentrate exhibited higher levels of both plasma THC and the active metabolite of THC (11-hydroxy-delta⁹-THC) across all points than did their counterparts who used cannabis flower products.

Specifically, mean plasma THC levels were 1,016 ± 1,380 mcg/ml in concentrate users and 455±503 mcg/mL in flower users after ad libitum cannabis consumption. Nevertheless, self-reported levels of intoxication were no different between users of cannabis flower or concentrate products.

Although results also showed that most neurobehavioral measures were not altered by short-term cannabis consumption, there were some notable exceptions. There was a negative linear effect with delayed verbal recall errors, suggesting poorer performance after cannabis use (F_{1, 203} = 32.31; P < .001).

On the other hand, investigators found a positive linear effect with inhibitory control and working memory, which actually suggests better performance after cannabis use. This finding, the researchers note, may be the result of a practice effect. Cannabis flower users performed better across all inhibitory control assessments.

The researchers also tested participants’ balance with their eyes open and closed. In the eyes-open condition, they found a trend toward impaired balance after cannabis use, though this normalized within an hour. When subjects closed their eyes, however, researchers observed a significant short-term increase in sway after cannabis use, which fell back to pre-use levels one hour after use (F_{1, 203} = 18.88; P < .001).

Of note, outcomes did not differ between groups according to the type of cannabis product consumed or its relative potency.

The study yielded several surprising findings, beginning with self-reported intoxication levels, which were not statistically significant between different cannabis flower and concentrate users, despite significantly different plasma THC levels between the two groups.

Dr. Hutchison explained that this may be the result of greater THC tolerance among concentrate users, THC saturation of cannabinoid receptors, or interindividual differences among users with respect to cannabis metabolism or sensitivity.

“I thought for sure that high-potency users would be much more compromised,” he said. “I guess it just goes to show we have a lot to learn about how these things work.”

Additionally, there were virtually no significant changes in acute performance after cannabis use, with the exception of delayed verbal recall. In fact, the most marked change observed in the study was the effect of cannabis on balance immediately after drug use, though these changes seemed to abate within an hour.

Nevertheless, the study highlights several potential public health implications of cannabis consumption, Dr. Hutchison added. “What happens when people with high blood concentrations decide to quit?” he asked. “Do they have trouble quitting? Do they have withdrawal symptoms?”

The long-term effects of cannabis use is another important question that still needs to be answered, he added.

Finally, Dr. Hutchison noted that, although the study showed little difference between users of cannabis flower and concentrates, study participants were all experienced users.

“There is certainly the potential for harm when a naive person uses cannabis concentrate,” he said. “Suddenly they have way more THC than they thought they were going to get, and that’s where a lot of people get into trouble with cannabis.”

Pitfalls and hurdles

In an accompanying editorial, Margaret Haney, PhD, of Columbia University Irving Medical Center, New York, explained that cannabis’ awkward position as simultaneously legal and illegal, medical and recreational, has hampered researchers’ ability to study its effects as comprehensively as they would otherwise like.

“With a federally illegal drug legalized in individual states, scientists constrained, and federal agencies somewhat silent, clinicians have none of the data that guide their decisions for other medications (eg, which indication, product, cannabinoid ratio, dose, or route of administration; what risks for individual patients [eg, pregnant, adolescent, psychiatric?]),” Dr. Haney wrote.

These pitfalls are compounded by the significant regulatory hurdles.

“The FDA is appropriately cautious about what it allows scientists to test in patients, and none of the products available in dispensaries or online have undergone the safety and manufacturing procedures needed for FDA approval,” she continued. “How then to conduct the studies so needed?”

Yet as Haney noted, giving cannabinoid researchers a Schedule I exemption may help address many of the barriers facing these scientists. Such a move, she said, would increase the number of randomized controlled trials being performed, “and thereby begin to breach the divide between the use of these products and empirical evidence.”

Dr. Hutchison has disclosed no relevant financial relationships. Dr. Haney disclosed funding from the US National Institute on Drug Abuse and from the Thompson Family Foundation Initiative. The study was funded by the NIH and Colorado Department of Public Health and Environment.

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

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Food and Drug Administration has approved expanded use of Dysport to treat upper- and lower-limb spasticity – including that caused by cerebral palsy – for patients as young as 2 years and older, according to manufacturer Ipsen Biopharmaceuticals.

When Dysport (abobotulinumtoxinA) initially was approved for treating pediatric lower limb spasticity by the FDA in 2016, Ipsen was granted Orphan Drug exclusivity for children whose lower-limb spasticity was caused by cerebral palsy. In 2019, Dysport was approved by the FDA for treating of upper-limb spasticity in children 2 years older. But if that spasticity was caused by cerebral palsy, Dysport could be used to treat it only through Orphan Drug exclusivity granted to another manufacturer, according to an Ipsen press release.

“The proactive step to resolve the uncertainty created by the previous CP [cerebral palsy] carve out enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper- and lower-limb spasticity,” Sarah Helen Evans, MD, division chief of rehabilitation medicine in the department of pediatrics at the Children’s Hospital of Philadelphia, said in the press release.

The most common adverse effects among children with lower-limb spasticity treated with Dysport were nasopharyngitis, cough, and pyrexia. Among children with upper-limb spasticity, the most common effects associated with Dysport treatment were upper respiratory tract infection and pharyngitis.

The press release also included a warning of the distant spread of the botulinum toxin from the area of injection hours to weeks afterward, causing symptoms including blurred vision, generalized muscle weakness, and swallowing and breathing difficulties that can be life threatening; there have been reports of death.

Suspected adverse effects can be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

[email protected]

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

[email protected]

The efficacy of the influenza vaccine when given to patients with multiple sclerosis (MS) is similar to that in healthy controls, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.

The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.

The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.

Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.

The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.

The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.

According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.

Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.

[email protected]

With a rapidly growing older adult population, increased attention has been given to cognitive changes that occur with age, with a focus on optimizing the cognitive health of aging individuals.¹ Given the absence of pharmaceutical treatments to prevent cognitive decline, there is an increased need for health care systems to offer alternative or behavioral interventions that can mitigate the effects of cognitive decline in aging.

Notably, many individuals are able to maintain or even improve cognitive functioning throughout their lifespan, with some research implicating health behaviors as an important factor for promoting brain health with age. Specifically, sleep, exercise, eating habits, social engagement, and cognitive stimulation have been linked to improved cognitive functioning.^2-8 In addition to the potential benefits for brain health, there is evidence that greater investment in attaining health goals is associated with subjective reports of higher well-being, fewer mental health symptoms, lower physical health stresses, decreased caregiver burden, and increased functional independence linked with longer independent living.⁹ The latter has a substantial financial impact, such that the positive consequence of increased independence is likely staving off the need for admission to assisted living and adult family homes, which can be costly.

Despite the role of health behaviors in brain aging and overall health and functioning, research indicates that only a small number of older adults (12.8%) follow recommended guidelines for healthy lifestyle factors.¹⁰ Education has been identified as one factor associated with the likelihood of engaging in positive health behaviors, prompting the delivery of health-education interventions. Most psychoeducational interventions have traditionally focused on one aspect of behavior change at a time (eg, sleep); however, Gross and colleaguesconducted a meta-analysis of cognitive interventions and in addition to the overall positive benefits (effect size 0.38), they also found suggestive evidence that interventions that combined multiple training strategies were associated with larger training gains (P = .04) after adjusting for multiple comparisons.¹¹ For example, Miller and colleagues found a significant improvement on both subjective and objective measures of memory following a multicomponent approach that combined training in memory skills, stress reduction, nutrition, and physical activity.¹²

In addition to the potential positive impacts of health behaviors on brain health, findings suggest that targeted emphasis on health behavior change may have the potential to stave off mild cognitiveimpairment (MCI) or dementia even if for a short time. Given the increasing prevalence rates of MCI with age (6.7% in adults aged 60-64 years, reaching 25.2% in adults aged 80-84 years¹³) and dementia (prevalence of MCI converting to dementia is 18-40%¹⁴), as well as the corresponding emotional, financial, and family-oriented consequences (eg, impact on the well-being of family caregivers), the need for behavioral interventions that seek to optimize brain health is becoming increasingly apparent.

More than 9 million veterans are now aged ≥ 65 years.¹⁵ In addition to representing nearly half of all veterans and a sizable portion of aging adults in the US, older veterans are at increased risk of frailty, mortality, and high rates of chronic medical/mental health conditions that can lead to accelerated cognitive aging.^6-17 Together, these conditions highlight the importance of developing comprehensive psychoeducational and behavioral interventions in this population. To address this need, we developed a novel psychoeducation and behavior change group called the Healthy Aging Project-Brain (HAP-B, pronounced “happy”). The HAP-B intervention was designed to promote healthy brain aging by using empirically supported health behavior change strategies, including education, personalized goal setting, and community support. The primary aim of this project was to develop and implement an intervention that was feasible and acceptable (eg, could be implemented in our setting, was appropriate for a veteran population) and to determine any positive outcomes/preliminary effects on overall health and well-being.

Methods

We recruited veterans aged ≥ 50 years through primary care clinics and self-referrals via flyers in the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS), Seattle Division hospital. We targeted the “worried well” and welcomed veterans with MCI and mental health diagnoses. Notably, if there were significant mental health and/or substance use concerns, we encouraged veterans to seek focused care and stabilization prior to or concurrent with group participation. Exclusion criteria included presence of suicidality/homicidality, untreated or unstable substance use disorder, or a diagnosis of dementia. Exclusion criteria were assessed by the referring health care providers (HCPs), when appropriate, and through a health record review. Group facilitators used their clinical judgment to monitor participants if they began experiencing more severe cognitive impairment or acute mental health concerns. Although we did not encounter any of these instances, facilitators were prepared to discuss any concerns with the veteran and their referring HCP. Participants sampled were from 1 of 5 groups offered between January 2018 and March 2019. A waiver from the institutional review board was obtained after meeting criteria for quality improvement/quality assurance (QI/QA) for this study.

Procedures

At the initial stages of development, our team conducted a needs assessment to identify health-related areas where HCPs felt veterans would benefit from additional education and support. The needs assessment was conducted across primary care, geriatric extended care, and the Geriatric Research, Education, and Clinical Center (GRECC) at VAPSHCS. Combining the needs assessment results with the available research base, we identified sleep, physical activity, social engagement, and cognitive stimulation as areas for focus. Notably, although nutrition has been identified as an important factor in cognitive aging, a diet and nutrition class was already available to older veterans at the Seattle VA; hence, we chose to limit overlap by not covering this topic in our group.

The group was offered on a quarterly basis as six 90-minute psychoeducational classes to allow time for didactics, discussion, and practice without overloading participants with information. Each group consisted of 4 to 9 veterans led by 2 cofacilitators. Group structure allowed for feedback and ideas from group members as well as accountability for engaging in behavior change. Cognitive functioning was not formally evaluated. Attendees were asked but not required to complete questionnaires before the classes began and again at completion. In addition at the completion of each group, feedback was collected from veterans and used to modify group content (Figure).

Two pilot groups were implemented in early and mid-2018 with iterative changes after each group. Then we revised the assessment battery and implemented the current version (v1.0), which was first offered in the fall of 2018 and was used with the final 3 groups. Noteworthy changes included weekly check-ins to assess use of health behavior logs and progress toward individual goals, additional pre-and postgroup measures, and in vivo skills practice relevant to the topic being discussed that day.

Each session began with a check-in, which included a review of daily logs and SMART (specific, measurable, attainable, relevant/realistic, and timebound) goals from the previous week.¹⁸ This allowed for praise/reinforcement of health behaviors as well as discussion of potential barriers. Second, an overview of research focusing on the relationship between aging, brain health, and the topic of the day was presented. As an example, in the discussion of social engagement, research was presented about the link between social isolation and cognitive decline; the indirect benefits of social support (eg, social support is linked to improved physical and mental health, which, in turn, is associated with less cognitive decline); and the direct benefits of social support (eg, high levels of emotional support are associated with better cognitive function) (Table 1).⁶

Next, facilitators reviewed skills and strategies to improve functioning in the topic of discussion. During the social engagement group, for example, facilitators discussed tips to improve social skills (eg, asking open-ended questions) and how to build social support into a daily routine (eg, scheduling weekly phone calls with family and friends). Following this discussion of skills, an activity was practiced, reinforcing learned material. During the social engagement group, veterans were invited to use small talk strategies with fellow group members. Finally, group sessions ended with each participant identifying a SMART goal for the coming week and troubleshooting potential barriers to success. SMART goals were kept broad, so veterans could choose a goal related to the topic discussed at the group that day (eg, scheduling a phone call with a friend twice in the coming week during the social engagement-focused group) or choose any other goal to focus on (eg, a sleep-related goal). Similarly, goals could change week to week, or could remain the same throughout the 6-week classes.

Measures

The questionnaires used for QI/QA analyses included the Satisfaction with Life Scale (SWLS); Geriatric Depression Scale-Short Form (GDS-S); Social Support Survey Instrument (SSSI); Pittsburg Sleep Quality Index (PSQI); Medical Outcomes Survey-Short Form (MOS-36 SF); and a self-efficacy scale (adapted from Huckans and colleagues for traumatic brain injury).^19-24 Written feedback was collected at the end of the last group to assess perception of progress, self-perceived behavior change, what was helpful or unhelpful, and how likely the participants were to recommend the group to other veterans (0 to 3, very unlikely to very likely).

To promote consistency with other health and behavior change interventions at the VA, HAP-B used resources from the Whole Health model SMART goals. Research supports the use of self-monitoring techniques like SMART goals for behavior change.²⁵

To facilitate skills practice and self-monitoring between classes, veterans were asked to complete 2 homework assignments. First, at the end of each group, each veteran identified a specific SMART goal to focus on and track in the coming week. Goals were unique to each veteran and allowed to change from week to week. Group discussion around SMART goals involved plans for how to address potential barriers; progress toward goals was discussed at the beginning of the following group. Second, veterans were asked to complete a worksheet used to track progress toward the weekly SMART goal and the specific health behaviors related to the 4 domains targeted by HAP-B. For example, when tracking sleep behaviors, veterans noted bedtime, waketime, number of times they woke up during the night, and length of daytime naps if applicable. Tracking logs were provided at the end of each class for personal purposes only. We asked veterans to rate themselves each week on whether they used the tracking sheet to monitor health behaviors; and how successful they were at accomplishing their previously identified SMART goal. We recorded responses on a 0 to 2 scale (0, not good; 1, fair; 2, good). This rating system was developed and implemented in later groups to promote self-monitoring, accountability, and discussion of potential barriers. However, due to the small sample that completed these ratings and the absence of objective corroborating data, these ratings were not included in the current analyses.

Every participant received a manual in binder format, which provided the didactic information for each group session, skills and strategies discussed in each session, and relevant resources in both the VA and community. For example, social engagement resources included information about volunteer opportunities, VA groups that focus on developing interpersonal skills, and recommendations from past group members on social events (eg, dance lessons at a senior center). We also developed a facilitator version of the manual in which we added comments and guidance on topics for discussion. Materials were developed with the goal of optimizing the ease of dissemination to other sites.

Results

Across the 5 groups, 31 veterans enrolled as participants and completed the initial intake measures, with an average of 6 participants per group (range 4-9). The majority (80%) attended at least 5 of the 6 classes. The mean age was 70.7 years, and 90% of participants were men. Seventy percent of participants self-identified as white, 32% African American, and 3% Native American, which is consistent with VAPSHCS demographics. Of the 31 participants, 16 had a mental health diagnosis, and 6 had a cognitive diagnosis.

At the start of the class, the mean (SD) reports of participants were mild depressive symptoms 5.96 (3.8) on the GDS scale, moderate levels of self-efficacy 3.69 (0.5) on the self-efficacy scale, and moderate levels of satisfaction with life 18.08 (6.8) on the SWLS scale (Table 2). Data from 25 of 31 veterans who completed both pregroup and postgroup surveys were analyzed and paired samples t tests without corrections indicated a reduction in depressive symptoms (P = .01), improved self-efficacy (P = .08), and improved satisfaction with life (P = .03). There were no significant differences in self-reported sleep quality or perceived social support from pregroup to postgroup evaluations. Because the sample size was smaller for the MOS-36, which was not used until group 3, and the subscales are composed of few items each, we conducted exploratory analyses of the 8 MOS-36 subscales and found that well-being, physical functioning, role limitations due to physical and emotional functioning, and energy/fatigue significantly improved over time (Ps < .04).

Discussion

The ability and need to promote brain health with age is an emerging priority as our aging population grows. A growing body of evidence supports the role of health behaviors in healthy brain aging. Education and skills training in a group setting provides a supportive, cost-effective approach for increasing overall health in aging adults. Yet older adults are statistically less likely to engage in these behaviors on a regular basis. The current investigation provides preliminary support for a model of care that uses a comprehensive, experiential psychoeducational approach to facilitate behavior change in older adults. Our aim was to develop and implement an intervention that was feasible and acceptable to our older veterans and to determine any positive outcomes/preliminary effects on overall health and well-being.

Participants indicated that they enjoyed the group, learned new skills (per participant feedback and facilitator observation), and experienced improvements in mood, self-efficacy, and life satisfaction. Given the participants’ positive response to the group and its content, as well as continued referrals by HCPs to this group and low difficulty with ongoing recruitment, this program was deemed both feasible and acceptable in our veteran health care setting. Questions remain about the extent to which participants modified their health behaviors given that we did not collect objective measurements of behaviors (eg, time spent exercising), the duration of behavior change (ie, how long during and after the group were behaviors maintained), and the role of premorbid or concurrent characteristics that may moderate the effect of the intervention on health-related outcomes (eg, sleep quality, perceived social support, overall functioning, concurrent interventions, medications).

Strengths and Limitations

This study had a limited sample size and no control group. However, evidence of significant improvements in depressive symptoms, self-efficacy, and life satisfaction in the development groups without a control group is encouraging. This is particularly noteworthy given that older veterans as a group have higher rates of frailty and mortality than do other similarly aged counterparts.¹⁷An additional weakness is the absence of a brief cognitive assessment or other formal assessment as part of the inclusion/exclusion criteria. However, this program development project provides data from a realistic condition (recruited broadly and with few exclusions, offered in similar format as other VA classes), thus adding strength to the interpretation and possibly the generalizability of these findings.

Conclusions

Future directions include disseminating HAP-B materials and procedures across a variety of sites, both VA and non-VA. In line with this goal, we hope to increase sample size and sample diversity while optimizing protocol integrity during the exportation phase. With a greater sample size and power, we aim to examine the role of self-efficacy and other premorbid factors (eg, cognitive functioning at baseline) as mediators for observed changes in pre-/postmeasures and outcomes. We also hope to incorporate objective measures of behavior change, such as fitness trackers, heart rate/pulse monitors, and actigraphy for monitoring sleep. Finally, we are interested in conducting follow-up with past and future participants to detect changes that may occur with learning new skills following the completion of the group (eg, changes in sleep behavior that take time to take effect) and the extent to which participants continue to use the health behavior skills and strategies to maintain or enhance progress in behavioral goals. Finally, although this intervention was initially designed for use with older veterans receiving health care through the VA, we believe the concepts and work products described here can be used with older adults across a wide range of health care settings. Providers interested in trialing HAP-B at their local site are encouraged to contact the authors.

With a rapidly growing older adult population, increased attention has been given to cognitive changes that occur with age, with a focus on optimizing the cognitive health of aging individuals.¹ Given the absence of pharmaceutical treatments to prevent cognitive decline, there is an increased need for health care systems to offer alternative or behavioral interventions that can mitigate the effects of cognitive decline in aging.

Notably, many individuals are able to maintain or even improve cognitive functioning throughout their lifespan, with some research implicating health behaviors as an important factor for promoting brain health with age. Specifically, sleep, exercise, eating habits, social engagement, and cognitive stimulation have been linked to improved cognitive functioning.^2-8 In addition to the potential benefits for brain health, there is evidence that greater investment in attaining health goals is associated with subjective reports of higher well-being, fewer mental health symptoms, lower physical health stresses, decreased caregiver burden, and increased functional independence linked with longer independent living.⁹ The latter has a substantial financial impact, such that the positive consequence of increased independence is likely staving off the need for admission to assisted living and adult family homes, which can be costly.

Despite the role of health behaviors in brain aging and overall health and functioning, research indicates that only a small number of older adults (12.8%) follow recommended guidelines for healthy lifestyle factors.¹⁰ Education has been identified as one factor associated with the likelihood of engaging in positive health behaviors, prompting the delivery of health-education interventions. Most psychoeducational interventions have traditionally focused on one aspect of behavior change at a time (eg, sleep); however, Gross and colleaguesconducted a meta-analysis of cognitive interventions and in addition to the overall positive benefits (effect size 0.38), they also found suggestive evidence that interventions that combined multiple training strategies were associated with larger training gains (P = .04) after adjusting for multiple comparisons.¹¹ For example, Miller and colleagues found a significant improvement on both subjective and objective measures of memory following a multicomponent approach that combined training in memory skills, stress reduction, nutrition, and physical activity.¹²

In addition to the potential positive impacts of health behaviors on brain health, findings suggest that targeted emphasis on health behavior change may have the potential to stave off mild cognitiveimpairment (MCI) or dementia even if for a short time. Given the increasing prevalence rates of MCI with age (6.7% in adults aged 60-64 years, reaching 25.2% in adults aged 80-84 years¹³) and dementia (prevalence of MCI converting to dementia is 18-40%¹⁴), as well as the corresponding emotional, financial, and family-oriented consequences (eg, impact on the well-being of family caregivers), the need for behavioral interventions that seek to optimize brain health is becoming increasingly apparent.

More than 9 million veterans are now aged ≥ 65 years.¹⁵ In addition to representing nearly half of all veterans and a sizable portion of aging adults in the US, older veterans are at increased risk of frailty, mortality, and high rates of chronic medical/mental health conditions that can lead to accelerated cognitive aging.^6-17 Together, these conditions highlight the importance of developing comprehensive psychoeducational and behavioral interventions in this population. To address this need, we developed a novel psychoeducation and behavior change group called the Healthy Aging Project-Brain (HAP-B, pronounced “happy”). The HAP-B intervention was designed to promote healthy brain aging by using empirically supported health behavior change strategies, including education, personalized goal setting, and community support. The primary aim of this project was to develop and implement an intervention that was feasible and acceptable (eg, could be implemented in our setting, was appropriate for a veteran population) and to determine any positive outcomes/preliminary effects on overall health and well-being.

Methods

We recruited veterans aged ≥ 50 years through primary care clinics and self-referrals via flyers in the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS), Seattle Division hospital. We targeted the “worried well” and welcomed veterans with MCI and mental health diagnoses. Notably, if there were significant mental health and/or substance use concerns, we encouraged veterans to seek focused care and stabilization prior to or concurrent with group participation. Exclusion criteria included presence of suicidality/homicidality, untreated or unstable substance use disorder, or a diagnosis of dementia. Exclusion criteria were assessed by the referring health care providers (HCPs), when appropriate, and through a health record review. Group facilitators used their clinical judgment to monitor participants if they began experiencing more severe cognitive impairment or acute mental health concerns. Although we did not encounter any of these instances, facilitators were prepared to discuss any concerns with the veteran and their referring HCP. Participants sampled were from 1 of 5 groups offered between January 2018 and March 2019. A waiver from the institutional review board was obtained after meeting criteria for quality improvement/quality assurance (QI/QA) for this study.

Procedures

At the initial stages of development, our team conducted a needs assessment to identify health-related areas where HCPs felt veterans would benefit from additional education and support. The needs assessment was conducted across primary care, geriatric extended care, and the Geriatric Research, Education, and Clinical Center (GRECC) at VAPSHCS. Combining the needs assessment results with the available research base, we identified sleep, physical activity, social engagement, and cognitive stimulation as areas for focus. Notably, although nutrition has been identified as an important factor in cognitive aging, a diet and nutrition class was already available to older veterans at the Seattle VA; hence, we chose to limit overlap by not covering this topic in our group.

The group was offered on a quarterly basis as six 90-minute psychoeducational classes to allow time for didactics, discussion, and practice without overloading participants with information. Each group consisted of 4 to 9 veterans led by 2 cofacilitators. Group structure allowed for feedback and ideas from group members as well as accountability for engaging in behavior change. Cognitive functioning was not formally evaluated. Attendees were asked but not required to complete questionnaires before the classes began and again at completion. In addition at the completion of each group, feedback was collected from veterans and used to modify group content (Figure).

Two pilot groups were implemented in early and mid-2018 with iterative changes after each group. Then we revised the assessment battery and implemented the current version (v1.0), which was first offered in the fall of 2018 and was used with the final 3 groups. Noteworthy changes included weekly check-ins to assess use of health behavior logs and progress toward individual goals, additional pre-and postgroup measures, and in vivo skills practice relevant to the topic being discussed that day.

Each session began with a check-in, which included a review of daily logs and SMART (specific, measurable, attainable, relevant/realistic, and timebound) goals from the previous week.¹⁸ This allowed for praise/reinforcement of health behaviors as well as discussion of potential barriers. Second, an overview of research focusing on the relationship between aging, brain health, and the topic of the day was presented. As an example, in the discussion of social engagement, research was presented about the link between social isolation and cognitive decline; the indirect benefits of social support (eg, social support is linked to improved physical and mental health, which, in turn, is associated with less cognitive decline); and the direct benefits of social support (eg, high levels of emotional support are associated with better cognitive function) (Table 1).⁶

Next, facilitators reviewed skills and strategies to improve functioning in the topic of discussion. During the social engagement group, for example, facilitators discussed tips to improve social skills (eg, asking open-ended questions) and how to build social support into a daily routine (eg, scheduling weekly phone calls with family and friends). Following this discussion of skills, an activity was practiced, reinforcing learned material. During the social engagement group, veterans were invited to use small talk strategies with fellow group members. Finally, group sessions ended with each participant identifying a SMART goal for the coming week and troubleshooting potential barriers to success. SMART goals were kept broad, so veterans could choose a goal related to the topic discussed at the group that day (eg, scheduling a phone call with a friend twice in the coming week during the social engagement-focused group) or choose any other goal to focus on (eg, a sleep-related goal). Similarly, goals could change week to week, or could remain the same throughout the 6-week classes.

Measures

The questionnaires used for QI/QA analyses included the Satisfaction with Life Scale (SWLS); Geriatric Depression Scale-Short Form (GDS-S); Social Support Survey Instrument (SSSI); Pittsburg Sleep Quality Index (PSQI); Medical Outcomes Survey-Short Form (MOS-36 SF); and a self-efficacy scale (adapted from Huckans and colleagues for traumatic brain injury).^19-24 Written feedback was collected at the end of the last group to assess perception of progress, self-perceived behavior change, what was helpful or unhelpful, and how likely the participants were to recommend the group to other veterans (0 to 3, very unlikely to very likely).

To promote consistency with other health and behavior change interventions at the VA, HAP-B used resources from the Whole Health model SMART goals. Research supports the use of self-monitoring techniques like SMART goals for behavior change.²⁵

To facilitate skills practice and self-monitoring between classes, veterans were asked to complete 2 homework assignments. First, at the end of each group, each veteran identified a specific SMART goal to focus on and track in the coming week. Goals were unique to each veteran and allowed to change from week to week. Group discussion around SMART goals involved plans for how to address potential barriers; progress toward goals was discussed at the beginning of the following group. Second, veterans were asked to complete a worksheet used to track progress toward the weekly SMART goal and the specific health behaviors related to the 4 domains targeted by HAP-B. For example, when tracking sleep behaviors, veterans noted bedtime, waketime, number of times they woke up during the night, and length of daytime naps if applicable. Tracking logs were provided at the end of each class for personal purposes only. We asked veterans to rate themselves each week on whether they used the tracking sheet to monitor health behaviors; and how successful they were at accomplishing their previously identified SMART goal. We recorded responses on a 0 to 2 scale (0, not good; 1, fair; 2, good). This rating system was developed and implemented in later groups to promote self-monitoring, accountability, and discussion of potential barriers. However, due to the small sample that completed these ratings and the absence of objective corroborating data, these ratings were not included in the current analyses.

Every participant received a manual in binder format, which provided the didactic information for each group session, skills and strategies discussed in each session, and relevant resources in both the VA and community. For example, social engagement resources included information about volunteer opportunities, VA groups that focus on developing interpersonal skills, and recommendations from past group members on social events (eg, dance lessons at a senior center). We also developed a facilitator version of the manual in which we added comments and guidance on topics for discussion. Materials were developed with the goal of optimizing the ease of dissemination to other sites.

Results

Across the 5 groups, 31 veterans enrolled as participants and completed the initial intake measures, with an average of 6 participants per group (range 4-9). The majority (80%) attended at least 5 of the 6 classes. The mean age was 70.7 years, and 90% of participants were men. Seventy percent of participants self-identified as white, 32% African American, and 3% Native American, which is consistent with VAPSHCS demographics. Of the 31 participants, 16 had a mental health diagnosis, and 6 had a cognitive diagnosis.

At the start of the class, the mean (SD) reports of participants were mild depressive symptoms 5.96 (3.8) on the GDS scale, moderate levels of self-efficacy 3.69 (0.5) on the self-efficacy scale, and moderate levels of satisfaction with life 18.08 (6.8) on the SWLS scale (Table 2). Data from 25 of 31 veterans who completed both pregroup and postgroup surveys were analyzed and paired samples t tests without corrections indicated a reduction in depressive symptoms (P = .01), improved self-efficacy (P = .08), and improved satisfaction with life (P = .03). There were no significant differences in self-reported sleep quality or perceived social support from pregroup to postgroup evaluations. Because the sample size was smaller for the MOS-36, which was not used until group 3, and the subscales are composed of few items each, we conducted exploratory analyses of the 8 MOS-36 subscales and found that well-being, physical functioning, role limitations due to physical and emotional functioning, and energy/fatigue significantly improved over time (Ps < .04).

Discussion

The ability and need to promote brain health with age is an emerging priority as our aging population grows. A growing body of evidence supports the role of health behaviors in healthy brain aging. Education and skills training in a group setting provides a supportive, cost-effective approach for increasing overall health in aging adults. Yet older adults are statistically less likely to engage in these behaviors on a regular basis. The current investigation provides preliminary support for a model of care that uses a comprehensive, experiential psychoeducational approach to facilitate behavior change in older adults. Our aim was to develop and implement an intervention that was feasible and acceptable to our older veterans and to determine any positive outcomes/preliminary effects on overall health and well-being.

Participants indicated that they enjoyed the group, learned new skills (per participant feedback and facilitator observation), and experienced improvements in mood, self-efficacy, and life satisfaction. Given the participants’ positive response to the group and its content, as well as continued referrals by HCPs to this group and low difficulty with ongoing recruitment, this program was deemed both feasible and acceptable in our veteran health care setting. Questions remain about the extent to which participants modified their health behaviors given that we did not collect objective measurements of behaviors (eg, time spent exercising), the duration of behavior change (ie, how long during and after the group were behaviors maintained), and the role of premorbid or concurrent characteristics that may moderate the effect of the intervention on health-related outcomes (eg, sleep quality, perceived social support, overall functioning, concurrent interventions, medications).

Strengths and Limitations

This study had a limited sample size and no control group. However, evidence of significant improvements in depressive symptoms, self-efficacy, and life satisfaction in the development groups without a control group is encouraging. This is particularly noteworthy given that older veterans as a group have higher rates of frailty and mortality than do other similarly aged counterparts.¹⁷An additional weakness is the absence of a brief cognitive assessment or other formal assessment as part of the inclusion/exclusion criteria. However, this program development project provides data from a realistic condition (recruited broadly and with few exclusions, offered in similar format as other VA classes), thus adding strength to the interpretation and possibly the generalizability of these findings.

Conclusions

Future directions include disseminating HAP-B materials and procedures across a variety of sites, both VA and non-VA. In line with this goal, we hope to increase sample size and sample diversity while optimizing protocol integrity during the exportation phase. With a greater sample size and power, we aim to examine the role of self-efficacy and other premorbid factors (eg, cognitive functioning at baseline) as mediators for observed changes in pre-/postmeasures and outcomes. We also hope to incorporate objective measures of behavior change, such as fitness trackers, heart rate/pulse monitors, and actigraphy for monitoring sleep. Finally, we are interested in conducting follow-up with past and future participants to detect changes that may occur with learning new skills following the completion of the group (eg, changes in sleep behavior that take time to take effect) and the extent to which participants continue to use the health behavior skills and strategies to maintain or enhance progress in behavioral goals. Finally, although this intervention was initially designed for use with older veterans receiving health care through the VA, we believe the concepts and work products described here can be used with older adults across a wide range of health care settings. Providers interested in trialing HAP-B at their local site are encouraged to contact the authors.

With a rapidly growing older adult population, increased attention has been given to cognitive changes that occur with age, with a focus on optimizing the cognitive health of aging individuals.¹ Given the absence of pharmaceutical treatments to prevent cognitive decline, there is an increased need for health care systems to offer alternative or behavioral interventions that can mitigate the effects of cognitive decline in aging.

Notably, many individuals are able to maintain or even improve cognitive functioning throughout their lifespan, with some research implicating health behaviors as an important factor for promoting brain health with age. Specifically, sleep, exercise, eating habits, social engagement, and cognitive stimulation have been linked to improved cognitive functioning.^2-8 In addition to the potential benefits for brain health, there is evidence that greater investment in attaining health goals is associated with subjective reports of higher well-being, fewer mental health symptoms, lower physical health stresses, decreased caregiver burden, and increased functional independence linked with longer independent living.⁹ The latter has a substantial financial impact, such that the positive consequence of increased independence is likely staving off the need for admission to assisted living and adult family homes, which can be costly.

Despite the role of health behaviors in brain aging and overall health and functioning, research indicates that only a small number of older adults (12.8%) follow recommended guidelines for healthy lifestyle factors.¹⁰ Education has been identified as one factor associated with the likelihood of engaging in positive health behaviors, prompting the delivery of health-education interventions. Most psychoeducational interventions have traditionally focused on one aspect of behavior change at a time (eg, sleep); however, Gross and colleaguesconducted a meta-analysis of cognitive interventions and in addition to the overall positive benefits (effect size 0.38), they also found suggestive evidence that interventions that combined multiple training strategies were associated with larger training gains (P = .04) after adjusting for multiple comparisons.¹¹ For example, Miller and colleagues found a significant improvement on both subjective and objective measures of memory following a multicomponent approach that combined training in memory skills, stress reduction, nutrition, and physical activity.¹²

In addition to the potential positive impacts of health behaviors on brain health, findings suggest that targeted emphasis on health behavior change may have the potential to stave off mild cognitiveimpairment (MCI) or dementia even if for a short time. Given the increasing prevalence rates of MCI with age (6.7% in adults aged 60-64 years, reaching 25.2% in adults aged 80-84 years¹³) and dementia (prevalence of MCI converting to dementia is 18-40%¹⁴), as well as the corresponding emotional, financial, and family-oriented consequences (eg, impact on the well-being of family caregivers), the need for behavioral interventions that seek to optimize brain health is becoming increasingly apparent.

More than 9 million veterans are now aged ≥ 65 years.¹⁵ In addition to representing nearly half of all veterans and a sizable portion of aging adults in the US, older veterans are at increased risk of frailty, mortality, and high rates of chronic medical/mental health conditions that can lead to accelerated cognitive aging.^6-17 Together, these conditions highlight the importance of developing comprehensive psychoeducational and behavioral interventions in this population. To address this need, we developed a novel psychoeducation and behavior change group called the Healthy Aging Project-Brain (HAP-B, pronounced “happy”). The HAP-B intervention was designed to promote healthy brain aging by using empirically supported health behavior change strategies, including education, personalized goal setting, and community support. The primary aim of this project was to develop and implement an intervention that was feasible and acceptable (eg, could be implemented in our setting, was appropriate for a veteran population) and to determine any positive outcomes/preliminary effects on overall health and well-being.

Methods

We recruited veterans aged ≥ 50 years through primary care clinics and self-referrals via flyers in the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS), Seattle Division hospital. We targeted the “worried well” and welcomed veterans with MCI and mental health diagnoses. Notably, if there were significant mental health and/or substance use concerns, we encouraged veterans to seek focused care and stabilization prior to or concurrent with group participation. Exclusion criteria included presence of suicidality/homicidality, untreated or unstable substance use disorder, or a diagnosis of dementia. Exclusion criteria were assessed by the referring health care providers (HCPs), when appropriate, and through a health record review. Group facilitators used their clinical judgment to monitor participants if they began experiencing more severe cognitive impairment or acute mental health concerns. Although we did not encounter any of these instances, facilitators were prepared to discuss any concerns with the veteran and their referring HCP. Participants sampled were from 1 of 5 groups offered between January 2018 and March 2019. A waiver from the institutional review board was obtained after meeting criteria for quality improvement/quality assurance (QI/QA) for this study.

Procedures

At the initial stages of development, our team conducted a needs assessment to identify health-related areas where HCPs felt veterans would benefit from additional education and support. The needs assessment was conducted across primary care, geriatric extended care, and the Geriatric Research, Education, and Clinical Center (GRECC) at VAPSHCS. Combining the needs assessment results with the available research base, we identified sleep, physical activity, social engagement, and cognitive stimulation as areas for focus. Notably, although nutrition has been identified as an important factor in cognitive aging, a diet and nutrition class was already available to older veterans at the Seattle VA; hence, we chose to limit overlap by not covering this topic in our group.

The group was offered on a quarterly basis as six 90-minute psychoeducational classes to allow time for didactics, discussion, and practice without overloading participants with information. Each group consisted of 4 to 9 veterans led by 2 cofacilitators. Group structure allowed for feedback and ideas from group members as well as accountability for engaging in behavior change. Cognitive functioning was not formally evaluated. Attendees were asked but not required to complete questionnaires before the classes began and again at completion. In addition at the completion of each group, feedback was collected from veterans and used to modify group content (Figure).

Two pilot groups were implemented in early and mid-2018 with iterative changes after each group. Then we revised the assessment battery and implemented the current version (v1.0), which was first offered in the fall of 2018 and was used with the final 3 groups. Noteworthy changes included weekly check-ins to assess use of health behavior logs and progress toward individual goals, additional pre-and postgroup measures, and in vivo skills practice relevant to the topic being discussed that day.

Each session began with a check-in, which included a review of daily logs and SMART (specific, measurable, attainable, relevant/realistic, and timebound) goals from the previous week.¹⁸ This allowed for praise/reinforcement of health behaviors as well as discussion of potential barriers. Second, an overview of research focusing on the relationship between aging, brain health, and the topic of the day was presented. As an example, in the discussion of social engagement, research was presented about the link between social isolation and cognitive decline; the indirect benefits of social support (eg, social support is linked to improved physical and mental health, which, in turn, is associated with less cognitive decline); and the direct benefits of social support (eg, high levels of emotional support are associated with better cognitive function) (Table 1).⁶

Next, facilitators reviewed skills and strategies to improve functioning in the topic of discussion. During the social engagement group, for example, facilitators discussed tips to improve social skills (eg, asking open-ended questions) and how to build social support into a daily routine (eg, scheduling weekly phone calls with family and friends). Following this discussion of skills, an activity was practiced, reinforcing learned material. During the social engagement group, veterans were invited to use small talk strategies with fellow group members. Finally, group sessions ended with each participant identifying a SMART goal for the coming week and troubleshooting potential barriers to success. SMART goals were kept broad, so veterans could choose a goal related to the topic discussed at the group that day (eg, scheduling a phone call with a friend twice in the coming week during the social engagement-focused group) or choose any other goal to focus on (eg, a sleep-related goal). Similarly, goals could change week to week, or could remain the same throughout the 6-week classes.

Measures

The questionnaires used for QI/QA analyses included the Satisfaction with Life Scale (SWLS); Geriatric Depression Scale-Short Form (GDS-S); Social Support Survey Instrument (SSSI); Pittsburg Sleep Quality Index (PSQI); Medical Outcomes Survey-Short Form (MOS-36 SF); and a self-efficacy scale (adapted from Huckans and colleagues for traumatic brain injury).^19-24 Written feedback was collected at the end of the last group to assess perception of progress, self-perceived behavior change, what was helpful or unhelpful, and how likely the participants were to recommend the group to other veterans (0 to 3, very unlikely to very likely).

To promote consistency with other health and behavior change interventions at the VA, HAP-B used resources from the Whole Health model SMART goals. Research supports the use of self-monitoring techniques like SMART goals for behavior change.²⁵

To facilitate skills practice and self-monitoring between classes, veterans were asked to complete 2 homework assignments. First, at the end of each group, each veteran identified a specific SMART goal to focus on and track in the coming week. Goals were unique to each veteran and allowed to change from week to week. Group discussion around SMART goals involved plans for how to address potential barriers; progress toward goals was discussed at the beginning of the following group. Second, veterans were asked to complete a worksheet used to track progress toward the weekly SMART goal and the specific health behaviors related to the 4 domains targeted by HAP-B. For example, when tracking sleep behaviors, veterans noted bedtime, waketime, number of times they woke up during the night, and length of daytime naps if applicable. Tracking logs were provided at the end of each class for personal purposes only. We asked veterans to rate themselves each week on whether they used the tracking sheet to monitor health behaviors; and how successful they were at accomplishing their previously identified SMART goal. We recorded responses on a 0 to 2 scale (0, not good; 1, fair; 2, good). This rating system was developed and implemented in later groups to promote self-monitoring, accountability, and discussion of potential barriers. However, due to the small sample that completed these ratings and the absence of objective corroborating data, these ratings were not included in the current analyses.

Every participant received a manual in binder format, which provided the didactic information for each group session, skills and strategies discussed in each session, and relevant resources in both the VA and community. For example, social engagement resources included information about volunteer opportunities, VA groups that focus on developing interpersonal skills, and recommendations from past group members on social events (eg, dance lessons at a senior center). We also developed a facilitator version of the manual in which we added comments and guidance on topics for discussion. Materials were developed with the goal of optimizing the ease of dissemination to other sites.

Results

Across the 5 groups, 31 veterans enrolled as participants and completed the initial intake measures, with an average of 6 participants per group (range 4-9). The majority (80%) attended at least 5 of the 6 classes. The mean age was 70.7 years, and 90% of participants were men. Seventy percent of participants self-identified as white, 32% African American, and 3% Native American, which is consistent with VAPSHCS demographics. Of the 31 participants, 16 had a mental health diagnosis, and 6 had a cognitive diagnosis.

At the start of the class, the mean (SD) reports of participants were mild depressive symptoms 5.96 (3.8) on the GDS scale, moderate levels of self-efficacy 3.69 (0.5) on the self-efficacy scale, and moderate levels of satisfaction with life 18.08 (6.8) on the SWLS scale (Table 2). Data from 25 of 31 veterans who completed both pregroup and postgroup surveys were analyzed and paired samples t tests without corrections indicated a reduction in depressive symptoms (P = .01), improved self-efficacy (P = .08), and improved satisfaction with life (P = .03). There were no significant differences in self-reported sleep quality or perceived social support from pregroup to postgroup evaluations. Because the sample size was smaller for the MOS-36, which was not used until group 3, and the subscales are composed of few items each, we conducted exploratory analyses of the 8 MOS-36 subscales and found that well-being, physical functioning, role limitations due to physical and emotional functioning, and energy/fatigue significantly improved over time (Ps < .04).

Discussion

The ability and need to promote brain health with age is an emerging priority as our aging population grows. A growing body of evidence supports the role of health behaviors in healthy brain aging. Education and skills training in a group setting provides a supportive, cost-effective approach for increasing overall health in aging adults. Yet older adults are statistically less likely to engage in these behaviors on a regular basis. The current investigation provides preliminary support for a model of care that uses a comprehensive, experiential psychoeducational approach to facilitate behavior change in older adults. Our aim was to develop and implement an intervention that was feasible and acceptable to our older veterans and to determine any positive outcomes/preliminary effects on overall health and well-being.

Participants indicated that they enjoyed the group, learned new skills (per participant feedback and facilitator observation), and experienced improvements in mood, self-efficacy, and life satisfaction. Given the participants’ positive response to the group and its content, as well as continued referrals by HCPs to this group and low difficulty with ongoing recruitment, this program was deemed both feasible and acceptable in our veteran health care setting. Questions remain about the extent to which participants modified their health behaviors given that we did not collect objective measurements of behaviors (eg, time spent exercising), the duration of behavior change (ie, how long during and after the group were behaviors maintained), and the role of premorbid or concurrent characteristics that may moderate the effect of the intervention on health-related outcomes (eg, sleep quality, perceived social support, overall functioning, concurrent interventions, medications).

Strengths and Limitations

This study had a limited sample size and no control group. However, evidence of significant improvements in depressive symptoms, self-efficacy, and life satisfaction in the development groups without a control group is encouraging. This is particularly noteworthy given that older veterans as a group have higher rates of frailty and mortality than do other similarly aged counterparts.¹⁷An additional weakness is the absence of a brief cognitive assessment or other formal assessment as part of the inclusion/exclusion criteria. However, this program development project provides data from a realistic condition (recruited broadly and with few exclusions, offered in similar format as other VA classes), thus adding strength to the interpretation and possibly the generalizability of these findings.

Conclusions

Future directions include disseminating HAP-B materials and procedures across a variety of sites, both VA and non-VA. In line with this goal, we hope to increase sample size and sample diversity while optimizing protocol integrity during the exportation phase. With a greater sample size and power, we aim to examine the role of self-efficacy and other premorbid factors (eg, cognitive functioning at baseline) as mediators for observed changes in pre-/postmeasures and outcomes. We also hope to incorporate objective measures of behavior change, such as fitness trackers, heart rate/pulse monitors, and actigraphy for monitoring sleep. Finally, we are interested in conducting follow-up with past and future participants to detect changes that may occur with learning new skills following the completion of the group (eg, changes in sleep behavior that take time to take effect) and the extent to which participants continue to use the health behavior skills and strategies to maintain or enhance progress in behavioral goals. Finally, although this intervention was initially designed for use with older veterans receiving health care through the VA, we believe the concepts and work products described here can be used with older adults across a wide range of health care settings. Providers interested in trialing HAP-B at their local site are encouraged to contact the authors.

Low to moderate alcohol consumption is associated with better cognitive function and slower cognitive decline in middle-aged and older adults, new research suggests. However, at least one expert urges caution in interpreting the findings.

Investigators found that consuming 10-14 alcoholic drinks per week had the strongest cognitive benefit. The findings “add more weight” to the growing body of research identifying beneficial cognitive effects of moderate alcohol consumption, said lead author, Ruiyuan Zhang, MD, of the department of epidemiology and biostatistics at the University of Georgia, Athens. However, Dr. Zhang emphasized that nondrinkers should not take up drinking to protect brain function, as alcohol can have negative effects.

The study was published online in JAMA Network Open.
 

Slower cognitive decline

The observational study was a secondary analysis of data from the Health and Retirement Study, a nationally representative U.S. survey of middle-aged and older adults. The survey, which began in 1992, is conducted every 2 years and collects health and economic data.

The current analysis used data from 1996 to 2008 and included information from individuals who participated in at least three surveys. The study included 19,887 participants, with a mean age 61.8 years. Most (60.1%) were women and white (85.2%). Mean follow-up was 9.1 years.

Researchers measured cognitive domains of mental status, word recall, and vocabulary. They also calculated a total cognition score, with higher scores indicating better cognitive abilities.

For each cognitive function measure, researchers categorized participants into a consistently low–trajectory group in which cognitive test scores from baseline through follow-up were consistently low or a consistently high–trajectory group, where cognitive test scores from baseline through follow-up were consistently high.

Based on self-reports, the investigators categorized participants as never drinkers (41.8%), former drinkers (39.5%), or current drinkers (18.7%). For current drinkers, researchers determined the number of drinking days per week and number of drinks per day. They further categorized these participants as low to moderate drinkers or heavy drinkers.

One drink was defined as a 12-ounce bottle of beer, a 5-ounce glass of wine, or a 1.5-ounce shot of spirits, said Dr. Zhang.

Women who consumed 8 or more drinks per week and men who drank 15 or more drinks per week were considered heavy drinkers. Other current drinkers were deemed low to moderate drinkers. Most current drinkers (85.2%) were low to moderate drinkers.

Other covariates included age, sex, race/ethnicity, years of education, marital status, tobacco smoking status, and body mass index.

Results showed moderate drinking was associated with relatively high cognitive test scores. After controlling for all covariates, compared with never drinkers, current low to moderate drinkers were significantly less likely to have consistently low trajectories for total cognitive score (odds ratio, 0.66; 95% confidence interval, 0.59-0.74), mental status (OR, 0.71; 95% CI, 0.63-0.81), word recall (OR, 0.74; 95% CI, 0.69-0.80), and vocabulary (OR, 0.64; 95% CI, 0.56-0.74) (all P < .001).

Former drinkers also had better cognitive outcomes for all cognitive domains. Heavy drinkers had lower odds of being in the consistently low trajectory group only for the vocabulary test.
 

Heavy drinking ‘risky’

Because few participants were deemed to be heavy drinkers, the power to identify an association between heavy drinking and cognitive function was limited. Dr. Zhang acknowledged, though he noted that heavy drinking is “risky.”

“We found that, after the drinking dosage passes the moderate level, the risk of low cognitive function increases very fast, which indicates that heavy drinking may harm cognitive function.” Limiting alcohol consumption “is still very important,” he said.

The associations of alcohol and cognitive functions differed by race/ethnicity. Low to moderate drinking was significantly associated with a lower odds of having a consistently low trajectory for all four cognitive function measures only among white participants.

A possible reason for this is that the study had so few African Americans (who made up only 14.8% of the sample), which limited the ability to identify relationships between alcohol intake and cognitive function, said Dr. Zhang. “Another reason is that the sensitivity to alcohol may be different between white and African American subjects.”

There was a significant U-shaped association between weekly amounts of alcohol and the odds of being in the consistently low–trajectory group for all cognitive functions. Depending on the function tested, the optimal number of weekly drinks ranged from 10-14.

Dr. Zhang noted that, when women were examined separately, alcohol consumption had a significant U-shaped relationship only with word recall, with the optimal dosage being around eight drinks.
 

U-shaped relationship an ‘important finding’

The U-shaped relationship is “an important finding,” said Dr. Zhang. “It shows that the human body may act differently to low and high doses of alcohol. Knowing why and how this happens is very important as it would help us understand how alcohol affects the function of the human body.”

Sensitivity analyses among participants with no chronic diseases showed the U-shaped association was still significant for scores of total word recall and vocabulary, but not for mental status or total cognition score.

The authors noted that 77.2% of participants had at least one chronic disease. They maintained that the association between alcohol consumption and cognitive function may be applicable both to healthy people and to those with a chronic disease.

The study also found that low to moderate drinkers had slower rates of cognitive decline over time for all cognition domains.

Although the mechanisms underlying the cognitive benefits of alcohol consumption are unclear, the authors believe it may be via cerebrovascular and cardiovascular pathways.

Alcohol may increase levels of brain-derived neurotrophic factor, a key regulator of neuronal plasticity and development in the dorsal striatum, they noted.
 

Balancing act

However, there’s also evidence that drinking, especially heavy drinking, increases the risk of hypertension, stroke, liver damage, and some cancers. “We think the role of alcohol drinking in cognitive function may be a balance of its beneficial and harmful effects on the cardiovascular system,” said Dr. Zhang.

“For the low to moderate drinker, the beneficial effects may outweigh the harmful effects on the small blood vessels in the brain. In this way, it could preserve cognition,” he added.

Dr. Zhang also noted that the study focused on middle-aged and older adults. “We can’t say whether or not moderate alcohol could benefit younger people” because they may have different characteristics, he said.

The findings of other studies examining the effects of alcohol on cognitive function are mixed. While studies have identified a beneficial effect, others have uncovered no, minimal, or adverse effects. This could be due to the use of different tests of cognitive function or different study populations, said Dr. Zhang.

A limitation of the current study was that assessment of alcohol consumption was based on self-report, which might have introduced recall bias. In addition, because individuals tend to underestimate their alcohol consumption, heavy drinkers could be misclassified as low to moderate drinkers, and low to moderate drinkers as former drinkers.

“This may make our study underestimate the association between low to moderate drinking and cognitive function,” said Dr. Zhang. In addition, alcohol consumption tended to change with time, and this change may be associated with other factors that led to changes in cognitive function, the authors noted.
 

Interpret with caution

Commenting on the study, Brent P. Forester, MD, chief of the Center of Excellence in Geriatric Psychiatry at McLean Hospital in Belmont, Mass., associate professor of psychiatry at Harvard Medical School, Boston, and a member of the American Psychiatric Association Council on Geriatric Psychiatry, said he views the study with some trepidation.

“As a clinician taking care of older adults, I would be very cautious about overinterpreting the beneficial effects of alcohol before we understand the mechanism better,” he said.

He noted that all of the risk factors associated with heart attack and stroke are also risk factors for Alzheimer’s disease and cognitive decline more broadly. “One of the issues here is how in the world does alcohol reduce cardiovascular and cerebrovascular risks, if you know it increases the risk of hypertension and stroke, regardless of dose.”

With regard to the possible impact of alcohol on brain-derived neurotrophic factor, Dr. Forester said, “it’s an interesting idea” but the actual mechanism is still unclear.

Even with dietary studies, such as those on the Mediterranean diet that include red wine, showing cognitive benefit, Dr. Forester said he’s still concerned about the adverse effects of alcohol on older people. These can include falls and sleep disturbances in addition to cognitive issues, and these effects can increase with age.

He was somewhat surprised at the level of alcohol that the study determined was beneficial. “Essentially, what they’re saying here is that, for men, it’s two drinks a day.” This could be “problematic” as two drinks per day can quickly escalate as individuals build tolerance.

He also pointed out that the study does not determine cause and effect, noting that it’s only an association.

Dr. Forester said the study raises a number of questions, including the type of alcohol study participants consumed and whether this has any impact on cognitive benefit. He also questioned whether the mediating effects of alcohol were associated with something that wasn’t measured, such as socioeconomic status.

Another question, he said, is what factors in individuals’ medical or psychiatric history determine whether they are more or less likely to benefit from low to moderate alcohol intake.

Perhaps alcohol should be recommended only for “select subpopulations” – for example, those who are healthy and have a family history of cognitive decline –but not for those with a history of substance abuse, including alcohol abuse, said Dr. Forester.

“For this population, the last thing you want to do is recommend alcohol to reduce risk of cognitive decline,” he cautioned.

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. The investigators and Dr. Forester have reported no relevant financial disclosures.

A version of this story originally appeared on Medscape.com.

Low to moderate alcohol consumption is associated with better cognitive function and slower cognitive decline in middle-aged and older adults, new research suggests. However, at least one expert urges caution in interpreting the findings.

Investigators found that consuming 10-14 alcoholic drinks per week had the strongest cognitive benefit. The findings “add more weight” to the growing body of research identifying beneficial cognitive effects of moderate alcohol consumption, said lead author, Ruiyuan Zhang, MD, of the department of epidemiology and biostatistics at the University of Georgia, Athens. However, Dr. Zhang emphasized that nondrinkers should not take up drinking to protect brain function, as alcohol can have negative effects.

The study was published online in JAMA Network Open.
 

Slower cognitive decline

The observational study was a secondary analysis of data from the Health and Retirement Study, a nationally representative U.S. survey of middle-aged and older adults. The survey, which began in 1992, is conducted every 2 years and collects health and economic data.

The current analysis used data from 1996 to 2008 and included information from individuals who participated in at least three surveys. The study included 19,887 participants, with a mean age 61.8 years. Most (60.1%) were women and white (85.2%). Mean follow-up was 9.1 years.

Researchers measured cognitive domains of mental status, word recall, and vocabulary. They also calculated a total cognition score, with higher scores indicating better cognitive abilities.

For each cognitive function measure, researchers categorized participants into a consistently low–trajectory group in which cognitive test scores from baseline through follow-up were consistently low or a consistently high–trajectory group, where cognitive test scores from baseline through follow-up were consistently high.

Based on self-reports, the investigators categorized participants as never drinkers (41.8%), former drinkers (39.5%), or current drinkers (18.7%). For current drinkers, researchers determined the number of drinking days per week and number of drinks per day. They further categorized these participants as low to moderate drinkers or heavy drinkers.

One drink was defined as a 12-ounce bottle of beer, a 5-ounce glass of wine, or a 1.5-ounce shot of spirits, said Dr. Zhang.

Women who consumed 8 or more drinks per week and men who drank 15 or more drinks per week were considered heavy drinkers. Other current drinkers were deemed low to moderate drinkers. Most current drinkers (85.2%) were low to moderate drinkers.

Other covariates included age, sex, race/ethnicity, years of education, marital status, tobacco smoking status, and body mass index.

Results showed moderate drinking was associated with relatively high cognitive test scores. After controlling for all covariates, compared with never drinkers, current low to moderate drinkers were significantly less likely to have consistently low trajectories for total cognitive score (odds ratio, 0.66; 95% confidence interval, 0.59-0.74), mental status (OR, 0.71; 95% CI, 0.63-0.81), word recall (OR, 0.74; 95% CI, 0.69-0.80), and vocabulary (OR, 0.64; 95% CI, 0.56-0.74) (all P < .001).

Former drinkers also had better cognitive outcomes for all cognitive domains. Heavy drinkers had lower odds of being in the consistently low trajectory group only for the vocabulary test.
 

Heavy drinking ‘risky’

Because few participants were deemed to be heavy drinkers, the power to identify an association between heavy drinking and cognitive function was limited. Dr. Zhang acknowledged, though he noted that heavy drinking is “risky.”

“We found that, after the drinking dosage passes the moderate level, the risk of low cognitive function increases very fast, which indicates that heavy drinking may harm cognitive function.” Limiting alcohol consumption “is still very important,” he said.

The associations of alcohol and cognitive functions differed by race/ethnicity. Low to moderate drinking was significantly associated with a lower odds of having a consistently low trajectory for all four cognitive function measures only among white participants.

A possible reason for this is that the study had so few African Americans (who made up only 14.8% of the sample), which limited the ability to identify relationships between alcohol intake and cognitive function, said Dr. Zhang. “Another reason is that the sensitivity to alcohol may be different between white and African American subjects.”

There was a significant U-shaped association between weekly amounts of alcohol and the odds of being in the consistently low–trajectory group for all cognitive functions. Depending on the function tested, the optimal number of weekly drinks ranged from 10-14.

Dr. Zhang noted that, when women were examined separately, alcohol consumption had a significant U-shaped relationship only with word recall, with the optimal dosage being around eight drinks.
 

U-shaped relationship an ‘important finding’

The U-shaped relationship is “an important finding,” said Dr. Zhang. “It shows that the human body may act differently to low and high doses of alcohol. Knowing why and how this happens is very important as it would help us understand how alcohol affects the function of the human body.”

Sensitivity analyses among participants with no chronic diseases showed the U-shaped association was still significant for scores of total word recall and vocabulary, but not for mental status or total cognition score.

The authors noted that 77.2% of participants had at least one chronic disease. They maintained that the association between alcohol consumption and cognitive function may be applicable both to healthy people and to those with a chronic disease.

The study also found that low to moderate drinkers had slower rates of cognitive decline over time for all cognition domains.

Although the mechanisms underlying the cognitive benefits of alcohol consumption are unclear, the authors believe it may be via cerebrovascular and cardiovascular pathways.

Alcohol may increase levels of brain-derived neurotrophic factor, a key regulator of neuronal plasticity and development in the dorsal striatum, they noted.
 

Balancing act

However, there’s also evidence that drinking, especially heavy drinking, increases the risk of hypertension, stroke, liver damage, and some cancers. “We think the role of alcohol drinking in cognitive function may be a balance of its beneficial and harmful effects on the cardiovascular system,” said Dr. Zhang.

“For the low to moderate drinker, the beneficial effects may outweigh the harmful effects on the small blood vessels in the brain. In this way, it could preserve cognition,” he added.

Dr. Zhang also noted that the study focused on middle-aged and older adults. “We can’t say whether or not moderate alcohol could benefit younger people” because they may have different characteristics, he said.

The findings of other studies examining the effects of alcohol on cognitive function are mixed. While studies have identified a beneficial effect, others have uncovered no, minimal, or adverse effects. This could be due to the use of different tests of cognitive function or different study populations, said Dr. Zhang.

A limitation of the current study was that assessment of alcohol consumption was based on self-report, which might have introduced recall bias. In addition, because individuals tend to underestimate their alcohol consumption, heavy drinkers could be misclassified as low to moderate drinkers, and low to moderate drinkers as former drinkers.

“This may make our study underestimate the association between low to moderate drinking and cognitive function,” said Dr. Zhang. In addition, alcohol consumption tended to change with time, and this change may be associated with other factors that led to changes in cognitive function, the authors noted.
 

Interpret with caution

Commenting on the study, Brent P. Forester, MD, chief of the Center of Excellence in Geriatric Psychiatry at McLean Hospital in Belmont, Mass., associate professor of psychiatry at Harvard Medical School, Boston, and a member of the American Psychiatric Association Council on Geriatric Psychiatry, said he views the study with some trepidation.

“As a clinician taking care of older adults, I would be very cautious about overinterpreting the beneficial effects of alcohol before we understand the mechanism better,” he said.

He noted that all of the risk factors associated with heart attack and stroke are also risk factors for Alzheimer’s disease and cognitive decline more broadly. “One of the issues here is how in the world does alcohol reduce cardiovascular and cerebrovascular risks, if you know it increases the risk of hypertension and stroke, regardless of dose.”

With regard to the possible impact of alcohol on brain-derived neurotrophic factor, Dr. Forester said, “it’s an interesting idea” but the actual mechanism is still unclear.

Even with dietary studies, such as those on the Mediterranean diet that include red wine, showing cognitive benefit, Dr. Forester said he’s still concerned about the adverse effects of alcohol on older people. These can include falls and sleep disturbances in addition to cognitive issues, and these effects can increase with age.

He was somewhat surprised at the level of alcohol that the study determined was beneficial. “Essentially, what they’re saying here is that, for men, it’s two drinks a day.” This could be “problematic” as two drinks per day can quickly escalate as individuals build tolerance.

He also pointed out that the study does not determine cause and effect, noting that it’s only an association.

Dr. Forester said the study raises a number of questions, including the type of alcohol study participants consumed and whether this has any impact on cognitive benefit. He also questioned whether the mediating effects of alcohol were associated with something that wasn’t measured, such as socioeconomic status.

Another question, he said, is what factors in individuals’ medical or psychiatric history determine whether they are more or less likely to benefit from low to moderate alcohol intake.

Perhaps alcohol should be recommended only for “select subpopulations” – for example, those who are healthy and have a family history of cognitive decline –but not for those with a history of substance abuse, including alcohol abuse, said Dr. Forester.

“For this population, the last thing you want to do is recommend alcohol to reduce risk of cognitive decline,” he cautioned.

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. The investigators and Dr. Forester have reported no relevant financial disclosures.

A version of this story originally appeared on Medscape.com.

Low to moderate alcohol consumption is associated with better cognitive function and slower cognitive decline in middle-aged and older adults, new research suggests. However, at least one expert urges caution in interpreting the findings.

Investigators found that consuming 10-14 alcoholic drinks per week had the strongest cognitive benefit. The findings “add more weight” to the growing body of research identifying beneficial cognitive effects of moderate alcohol consumption, said lead author, Ruiyuan Zhang, MD, of the department of epidemiology and biostatistics at the University of Georgia, Athens. However, Dr. Zhang emphasized that nondrinkers should not take up drinking to protect brain function, as alcohol can have negative effects.

The study was published online in JAMA Network Open.
 

Slower cognitive decline

The observational study was a secondary analysis of data from the Health and Retirement Study, a nationally representative U.S. survey of middle-aged and older adults. The survey, which began in 1992, is conducted every 2 years and collects health and economic data.

The current analysis used data from 1996 to 2008 and included information from individuals who participated in at least three surveys. The study included 19,887 participants, with a mean age 61.8 years. Most (60.1%) were women and white (85.2%). Mean follow-up was 9.1 years.

Researchers measured cognitive domains of mental status, word recall, and vocabulary. They also calculated a total cognition score, with higher scores indicating better cognitive abilities.

For each cognitive function measure, researchers categorized participants into a consistently low–trajectory group in which cognitive test scores from baseline through follow-up were consistently low or a consistently high–trajectory group, where cognitive test scores from baseline through follow-up were consistently high.

Based on self-reports, the investigators categorized participants as never drinkers (41.8%), former drinkers (39.5%), or current drinkers (18.7%). For current drinkers, researchers determined the number of drinking days per week and number of drinks per day. They further categorized these participants as low to moderate drinkers or heavy drinkers.

One drink was defined as a 12-ounce bottle of beer, a 5-ounce glass of wine, or a 1.5-ounce shot of spirits, said Dr. Zhang.

Women who consumed 8 or more drinks per week and men who drank 15 or more drinks per week were considered heavy drinkers. Other current drinkers were deemed low to moderate drinkers. Most current drinkers (85.2%) were low to moderate drinkers.

Other covariates included age, sex, race/ethnicity, years of education, marital status, tobacco smoking status, and body mass index.

Results showed moderate drinking was associated with relatively high cognitive test scores. After controlling for all covariates, compared with never drinkers, current low to moderate drinkers were significantly less likely to have consistently low trajectories for total cognitive score (odds ratio, 0.66; 95% confidence interval, 0.59-0.74), mental status (OR, 0.71; 95% CI, 0.63-0.81), word recall (OR, 0.74; 95% CI, 0.69-0.80), and vocabulary (OR, 0.64; 95% CI, 0.56-0.74) (all P < .001).

Former drinkers also had better cognitive outcomes for all cognitive domains. Heavy drinkers had lower odds of being in the consistently low trajectory group only for the vocabulary test.
 

Heavy drinking ‘risky’

Because few participants were deemed to be heavy drinkers, the power to identify an association between heavy drinking and cognitive function was limited. Dr. Zhang acknowledged, though he noted that heavy drinking is “risky.”

“We found that, after the drinking dosage passes the moderate level, the risk of low cognitive function increases very fast, which indicates that heavy drinking may harm cognitive function.” Limiting alcohol consumption “is still very important,” he said.

The associations of alcohol and cognitive functions differed by race/ethnicity. Low to moderate drinking was significantly associated with a lower odds of having a consistently low trajectory for all four cognitive function measures only among white participants.

A possible reason for this is that the study had so few African Americans (who made up only 14.8% of the sample), which limited the ability to identify relationships between alcohol intake and cognitive function, said Dr. Zhang. “Another reason is that the sensitivity to alcohol may be different between white and African American subjects.”

There was a significant U-shaped association between weekly amounts of alcohol and the odds of being in the consistently low–trajectory group for all cognitive functions. Depending on the function tested, the optimal number of weekly drinks ranged from 10-14.

Dr. Zhang noted that, when women were examined separately, alcohol consumption had a significant U-shaped relationship only with word recall, with the optimal dosage being around eight drinks.
 

U-shaped relationship an ‘important finding’

The U-shaped relationship is “an important finding,” said Dr. Zhang. “It shows that the human body may act differently to low and high doses of alcohol. Knowing why and how this happens is very important as it would help us understand how alcohol affects the function of the human body.”

Sensitivity analyses among participants with no chronic diseases showed the U-shaped association was still significant for scores of total word recall and vocabulary, but not for mental status or total cognition score.

The authors noted that 77.2% of participants had at least one chronic disease. They maintained that the association between alcohol consumption and cognitive function may be applicable both to healthy people and to those with a chronic disease.

The study also found that low to moderate drinkers had slower rates of cognitive decline over time for all cognition domains.

Although the mechanisms underlying the cognitive benefits of alcohol consumption are unclear, the authors believe it may be via cerebrovascular and cardiovascular pathways.

Alcohol may increase levels of brain-derived neurotrophic factor, a key regulator of neuronal plasticity and development in the dorsal striatum, they noted.
 

Balancing act

However, there’s also evidence that drinking, especially heavy drinking, increases the risk of hypertension, stroke, liver damage, and some cancers. “We think the role of alcohol drinking in cognitive function may be a balance of its beneficial and harmful effects on the cardiovascular system,” said Dr. Zhang.

“For the low to moderate drinker, the beneficial effects may outweigh the harmful effects on the small blood vessels in the brain. In this way, it could preserve cognition,” he added.

Dr. Zhang also noted that the study focused on middle-aged and older adults. “We can’t say whether or not moderate alcohol could benefit younger people” because they may have different characteristics, he said.

The findings of other studies examining the effects of alcohol on cognitive function are mixed. While studies have identified a beneficial effect, others have uncovered no, minimal, or adverse effects. This could be due to the use of different tests of cognitive function or different study populations, said Dr. Zhang.

A limitation of the current study was that assessment of alcohol consumption was based on self-report, which might have introduced recall bias. In addition, because individuals tend to underestimate their alcohol consumption, heavy drinkers could be misclassified as low to moderate drinkers, and low to moderate drinkers as former drinkers.

“This may make our study underestimate the association between low to moderate drinking and cognitive function,” said Dr. Zhang. In addition, alcohol consumption tended to change with time, and this change may be associated with other factors that led to changes in cognitive function, the authors noted.
 

Interpret with caution

Commenting on the study, Brent P. Forester, MD, chief of the Center of Excellence in Geriatric Psychiatry at McLean Hospital in Belmont, Mass., associate professor of psychiatry at Harvard Medical School, Boston, and a member of the American Psychiatric Association Council on Geriatric Psychiatry, said he views the study with some trepidation.

“As a clinician taking care of older adults, I would be very cautious about overinterpreting the beneficial effects of alcohol before we understand the mechanism better,” he said.

He noted that all of the risk factors associated with heart attack and stroke are also risk factors for Alzheimer’s disease and cognitive decline more broadly. “One of the issues here is how in the world does alcohol reduce cardiovascular and cerebrovascular risks, if you know it increases the risk of hypertension and stroke, regardless of dose.”

With regard to the possible impact of alcohol on brain-derived neurotrophic factor, Dr. Forester said, “it’s an interesting idea” but the actual mechanism is still unclear.

Even with dietary studies, such as those on the Mediterranean diet that include red wine, showing cognitive benefit, Dr. Forester said he’s still concerned about the adverse effects of alcohol on older people. These can include falls and sleep disturbances in addition to cognitive issues, and these effects can increase with age.

He was somewhat surprised at the level of alcohol that the study determined was beneficial. “Essentially, what they’re saying here is that, for men, it’s two drinks a day.” This could be “problematic” as two drinks per day can quickly escalate as individuals build tolerance.

He also pointed out that the study does not determine cause and effect, noting that it’s only an association.

Dr. Forester said the study raises a number of questions, including the type of alcohol study participants consumed and whether this has any impact on cognitive benefit. He also questioned whether the mediating effects of alcohol were associated with something that wasn’t measured, such as socioeconomic status.

Another question, he said, is what factors in individuals’ medical or psychiatric history determine whether they are more or less likely to benefit from low to moderate alcohol intake.

Perhaps alcohol should be recommended only for “select subpopulations” – for example, those who are healthy and have a family history of cognitive decline –but not for those with a history of substance abuse, including alcohol abuse, said Dr. Forester.

“For this population, the last thing you want to do is recommend alcohol to reduce risk of cognitive decline,” he cautioned.

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. The investigators and Dr. Forester have reported no relevant financial disclosures.

A version of this story originally appeared on Medscape.com.

The severity of head injury in traumatic brain injury (TBI) is significantly linked with the risk of developing posttraumatic epilepsy and seizures, and posttraumatic epilepsy itself further worsens outcomes at 12 months, findings from an analysis of a large, prospective database suggest. “We found that patients essentially have a 10-times greater risk of developing posttraumatic epilepsy and seizures at 12 months [post injury] if the presenting Glasgow Coma Scale GCS) is less than 8,” said lead author John F. Burke, MD, PhD, University of California, San Francisco, in presenting the findings as part of the virtual annual meeting of the American Association of Neurological Surgeons.

Assessing risk factors

While posttraumatic epilepsy represents an estimated 20% of all cases of symptomatic epilepsy, many questions remain on those most at risk and on the long-term effects of posttraumatic epilepsy on TBI outcomes. To probe those issues, Dr. Burke and colleagues turned to the multicenter TRACK-TBI database, which has prospective, longitudinal data on more than 2,700 patients with traumatic brain injuries and is considered the largest source of prospective data on posttraumatic epilepsy.

Using the criteria of no previous epilepsy and having 12 months of follow-up, the team identified 1,493 patients with TBI. In addition, investigators identified 182 orthopedic controls (included and prospectively followed because they have injuries but not specifically head trauma) and 210 controls who are friends of the patients and who do not have injuries but allow researchers to control for socioeconomic and environmental factors.

Of the 1,493 patients with TBI, 41 (2.7%) were determined to have posttraumatic epilepsy, assessed according to a National Institute of Neurological Disorders and Stroke epilepsy screening questionnaire, which is designed to identify patients with posttraumatic epilepsy symptoms. There were no reports of epilepsy symptoms using the screening tool among the controls. Dr. Burke noted that the 2.7% was in agreement with historical reports.

In comparing patients with TBI who did and did not have posttraumatic epilepsy, no differences were observed in the groups in terms of gender, although there was a trend toward younger age among those with PTE (mean age, 35.4 years with posttraumatic injury vs. 41.5 without; P = .05).

A major risk factor for the development of posttraumatic epilepsy was presenting GCS scores. Among those with scores of less than 8, indicative of severe injury, the rate of posttraumatic epilepsy was 6% at 6 months and 12.5% at 12 months. In contrast, those with TBI presenting with GCS scores between 13 and 15, indicative of minor injury, had an incidence of posttraumatic epilepsy of 0.9% at 6 months and 1.4% at 12 months.

Imaging findings in the two groups showed that hemorrhage detected on CT imaging was associated with a significantly higher risk for posttraumatic epilepsy (P < .001).

“The main takeaway is that any hemorrhage in the brain is a major risk factor for developing seizures,” Dr. Burke said. “Whether it is subdural, epidural blood, subarachnoid or contusion, any blood confers a very [high] risk for developing seizures.”

Posttraumatic epilepsy was linked to poorer longer-term outcomes even for patients with lesser injury: Among those with TBI and GCS of 13-15, the mean Glasgow Outcome Scale Extended (GOSE) score at 12 months among those without posttraumatic epilepsy was 7, indicative of a good recovery with minor defects, whereas the mean GOSE score for those with PTE was 4.6, indicative of moderate to severe disability (P  < .001).

“It was surprising to us that PTE-positive patients had a very significant decrease in GOSE, compared to PTE-negative patients,” Dr. Burke said. “There was a nearly 2-point drop in the GOSE and that was extremely significant.”

A multivariate analysis showed there was still a significant independent risk for a poor GOSE score with posttraumatic epilepsy after controlling for GCS score, head CT findings, and age (P < .001).

The authors also looked at mood outcomes using the Brief Symptom Inventory–18, which showed significant worse effect in those with posttraumatic epilepsy after multivariate adjustment (P = .01). Additionally, a highly significant worse effect in cognitive outcomes on the Rivermead cognitive metric was observed with posttraumatic epilepsy (P = .001).

“On all metrics tested, posttraumatic epilepsy worsened outcomes,” Dr. Burke said.

He noted that the study has some key limitations, including the 12-month follow-up. A previous study showed a linear increase in posttraumatic follow-up up to 30 years. “The fact that we found 41 patients at 12 months indicates there are probably more that are out there who are going to develop seizures, but because we don’t have the follow-up we can’t look at that.”

Although the screening questionnaires are effective, “the issue is these people are not being seen by an epileptologist or having scalp EEG done, and we need a more accurate way to do this,” he said. A new study, TRACK-TBI EPI, will address those limitations and a host of other issues with a 5-year follow-up.
 

Capturing the nuances of brain injury

Commenting on the study as a discussant, neurosurgeon Uzma Samadani, MD, PhD, of the Minneapolis Veterans Affairs Medical Center and CentraCare in Minneapolis, suggested that the future work should focus on issues including the wide-ranging mechanisms that could explain the seizure activity.

“For example, it’s known that posttraumatic epilepsy or seizures can be triggered by abnormal conductivity due to multiple different mechanisms associated with brain injury, such as endocrine dysfunction, cortical-spreading depression, and many others,” said Dr. Samadani, who has been a researcher on the TRACK-TBI study.

Factors ranging from genetic differences to comorbid conditions such as alcoholism can play a role in brain injury susceptibility, Dr. Samadani added. Furthermore, outcome measures currently available simply may not capture the unknown nuances of brain injury.

“We have to ask, are these an all-or-none phenomena, or is aberrant electrical activity after brain injury a continuum of dysfunction?” Dr. Samadani speculated.

“I would caution that we are likely underestimating the non–easily measurable consequences of brain injury,” she said. “And the better we can quantitate susceptibility, classify the nature of injury and target acute management, the less posttraumatic epilepsy/aberrant electrical activity our patients will have.”

Dr. Burke and Dr. Samadani disclosed no relevant financial relationships.

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

The severity of head injury in traumatic brain injury (TBI) is significantly linked with the risk of developing posttraumatic epilepsy and seizures, and posttraumatic epilepsy itself further worsens outcomes at 12 months, findings from an analysis of a large, prospective database suggest. “We found that patients essentially have a 10-times greater risk of developing posttraumatic epilepsy and seizures at 12 months [post injury] if the presenting Glasgow Coma Scale GCS) is less than 8,” said lead author John F. Burke, MD, PhD, University of California, San Francisco, in presenting the findings as part of the virtual annual meeting of the American Association of Neurological Surgeons.

Assessing risk factors

While posttraumatic epilepsy represents an estimated 20% of all cases of symptomatic epilepsy, many questions remain on those most at risk and on the long-term effects of posttraumatic epilepsy on TBI outcomes. To probe those issues, Dr. Burke and colleagues turned to the multicenter TRACK-TBI database, which has prospective, longitudinal data on more than 2,700 patients with traumatic brain injuries and is considered the largest source of prospective data on posttraumatic epilepsy.

Using the criteria of no previous epilepsy and having 12 months of follow-up, the team identified 1,493 patients with TBI. In addition, investigators identified 182 orthopedic controls (included and prospectively followed because they have injuries but not specifically head trauma) and 210 controls who are friends of the patients and who do not have injuries but allow researchers to control for socioeconomic and environmental factors.

Of the 1,493 patients with TBI, 41 (2.7%) were determined to have posttraumatic epilepsy, assessed according to a National Institute of Neurological Disorders and Stroke epilepsy screening questionnaire, which is designed to identify patients with posttraumatic epilepsy symptoms. There were no reports of epilepsy symptoms using the screening tool among the controls. Dr. Burke noted that the 2.7% was in agreement with historical reports.

In comparing patients with TBI who did and did not have posttraumatic epilepsy, no differences were observed in the groups in terms of gender, although there was a trend toward younger age among those with PTE (mean age, 35.4 years with posttraumatic injury vs. 41.5 without; P = .05).

A major risk factor for the development of posttraumatic epilepsy was presenting GCS scores. Among those with scores of less than 8, indicative of severe injury, the rate of posttraumatic epilepsy was 6% at 6 months and 12.5% at 12 months. In contrast, those with TBI presenting with GCS scores between 13 and 15, indicative of minor injury, had an incidence of posttraumatic epilepsy of 0.9% at 6 months and 1.4% at 12 months.

Imaging findings in the two groups showed that hemorrhage detected on CT imaging was associated with a significantly higher risk for posttraumatic epilepsy (P < .001).

“The main takeaway is that any hemorrhage in the brain is a major risk factor for developing seizures,” Dr. Burke said. “Whether it is subdural, epidural blood, subarachnoid or contusion, any blood confers a very [high] risk for developing seizures.”

Posttraumatic epilepsy was linked to poorer longer-term outcomes even for patients with lesser injury: Among those with TBI and GCS of 13-15, the mean Glasgow Outcome Scale Extended (GOSE) score at 12 months among those without posttraumatic epilepsy was 7, indicative of a good recovery with minor defects, whereas the mean GOSE score for those with PTE was 4.6, indicative of moderate to severe disability (P  < .001).

“It was surprising to us that PTE-positive patients had a very significant decrease in GOSE, compared to PTE-negative patients,” Dr. Burke said. “There was a nearly 2-point drop in the GOSE and that was extremely significant.”

A multivariate analysis showed there was still a significant independent risk for a poor GOSE score with posttraumatic epilepsy after controlling for GCS score, head CT findings, and age (P < .001).

The authors also looked at mood outcomes using the Brief Symptom Inventory–18, which showed significant worse effect in those with posttraumatic epilepsy after multivariate adjustment (P = .01). Additionally, a highly significant worse effect in cognitive outcomes on the Rivermead cognitive metric was observed with posttraumatic epilepsy (P = .001).

“On all metrics tested, posttraumatic epilepsy worsened outcomes,” Dr. Burke said.

He noted that the study has some key limitations, including the 12-month follow-up. A previous study showed a linear increase in posttraumatic follow-up up to 30 years. “The fact that we found 41 patients at 12 months indicates there are probably more that are out there who are going to develop seizures, but because we don’t have the follow-up we can’t look at that.”

Although the screening questionnaires are effective, “the issue is these people are not being seen by an epileptologist or having scalp EEG done, and we need a more accurate way to do this,” he said. A new study, TRACK-TBI EPI, will address those limitations and a host of other issues with a 5-year follow-up.
 

Capturing the nuances of brain injury

Commenting on the study as a discussant, neurosurgeon Uzma Samadani, MD, PhD, of the Minneapolis Veterans Affairs Medical Center and CentraCare in Minneapolis, suggested that the future work should focus on issues including the wide-ranging mechanisms that could explain the seizure activity.

“For example, it’s known that posttraumatic epilepsy or seizures can be triggered by abnormal conductivity due to multiple different mechanisms associated with brain injury, such as endocrine dysfunction, cortical-spreading depression, and many others,” said Dr. Samadani, who has been a researcher on the TRACK-TBI study.

Factors ranging from genetic differences to comorbid conditions such as alcoholism can play a role in brain injury susceptibility, Dr. Samadani added. Furthermore, outcome measures currently available simply may not capture the unknown nuances of brain injury.

“We have to ask, are these an all-or-none phenomena, or is aberrant electrical activity after brain injury a continuum of dysfunction?” Dr. Samadani speculated.

“I would caution that we are likely underestimating the non–easily measurable consequences of brain injury,” she said. “And the better we can quantitate susceptibility, classify the nature of injury and target acute management, the less posttraumatic epilepsy/aberrant electrical activity our patients will have.”

Dr. Burke and Dr. Samadani disclosed no relevant financial relationships.

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

The severity of head injury in traumatic brain injury (TBI) is significantly linked with the risk of developing posttraumatic epilepsy and seizures, and posttraumatic epilepsy itself further worsens outcomes at 12 months, findings from an analysis of a large, prospective database suggest. “We found that patients essentially have a 10-times greater risk of developing posttraumatic epilepsy and seizures at 12 months [post injury] if the presenting Glasgow Coma Scale GCS) is less than 8,” said lead author John F. Burke, MD, PhD, University of California, San Francisco, in presenting the findings as part of the virtual annual meeting of the American Association of Neurological Surgeons.

Assessing risk factors

While posttraumatic epilepsy represents an estimated 20% of all cases of symptomatic epilepsy, many questions remain on those most at risk and on the long-term effects of posttraumatic epilepsy on TBI outcomes. To probe those issues, Dr. Burke and colleagues turned to the multicenter TRACK-TBI database, which has prospective, longitudinal data on more than 2,700 patients with traumatic brain injuries and is considered the largest source of prospective data on posttraumatic epilepsy.

Using the criteria of no previous epilepsy and having 12 months of follow-up, the team identified 1,493 patients with TBI. In addition, investigators identified 182 orthopedic controls (included and prospectively followed because they have injuries but not specifically head trauma) and 210 controls who are friends of the patients and who do not have injuries but allow researchers to control for socioeconomic and environmental factors.

Of the 1,493 patients with TBI, 41 (2.7%) were determined to have posttraumatic epilepsy, assessed according to a National Institute of Neurological Disorders and Stroke epilepsy screening questionnaire, which is designed to identify patients with posttraumatic epilepsy symptoms. There were no reports of epilepsy symptoms using the screening tool among the controls. Dr. Burke noted that the 2.7% was in agreement with historical reports.

In comparing patients with TBI who did and did not have posttraumatic epilepsy, no differences were observed in the groups in terms of gender, although there was a trend toward younger age among those with PTE (mean age, 35.4 years with posttraumatic injury vs. 41.5 without; P = .05).

A major risk factor for the development of posttraumatic epilepsy was presenting GCS scores. Among those with scores of less than 8, indicative of severe injury, the rate of posttraumatic epilepsy was 6% at 6 months and 12.5% at 12 months. In contrast, those with TBI presenting with GCS scores between 13 and 15, indicative of minor injury, had an incidence of posttraumatic epilepsy of 0.9% at 6 months and 1.4% at 12 months.

Imaging findings in the two groups showed that hemorrhage detected on CT imaging was associated with a significantly higher risk for posttraumatic epilepsy (P < .001).

“The main takeaway is that any hemorrhage in the brain is a major risk factor for developing seizures,” Dr. Burke said. “Whether it is subdural, epidural blood, subarachnoid or contusion, any blood confers a very [high] risk for developing seizures.”

Posttraumatic epilepsy was linked to poorer longer-term outcomes even for patients with lesser injury: Among those with TBI and GCS of 13-15, the mean Glasgow Outcome Scale Extended (GOSE) score at 12 months among those without posttraumatic epilepsy was 7, indicative of a good recovery with minor defects, whereas the mean GOSE score for those with PTE was 4.6, indicative of moderate to severe disability (P  < .001).

“It was surprising to us that PTE-positive patients had a very significant decrease in GOSE, compared to PTE-negative patients,” Dr. Burke said. “There was a nearly 2-point drop in the GOSE and that was extremely significant.”

A multivariate analysis showed there was still a significant independent risk for a poor GOSE score with posttraumatic epilepsy after controlling for GCS score, head CT findings, and age (P < .001).

The authors also looked at mood outcomes using the Brief Symptom Inventory–18, which showed significant worse effect in those with posttraumatic epilepsy after multivariate adjustment (P = .01). Additionally, a highly significant worse effect in cognitive outcomes on the Rivermead cognitive metric was observed with posttraumatic epilepsy (P = .001).

“On all metrics tested, posttraumatic epilepsy worsened outcomes,” Dr. Burke said.

He noted that the study has some key limitations, including the 12-month follow-up. A previous study showed a linear increase in posttraumatic follow-up up to 30 years. “The fact that we found 41 patients at 12 months indicates there are probably more that are out there who are going to develop seizures, but because we don’t have the follow-up we can’t look at that.”

Although the screening questionnaires are effective, “the issue is these people are not being seen by an epileptologist or having scalp EEG done, and we need a more accurate way to do this,” he said. A new study, TRACK-TBI EPI, will address those limitations and a host of other issues with a 5-year follow-up.
 

Capturing the nuances of brain injury

Commenting on the study as a discussant, neurosurgeon Uzma Samadani, MD, PhD, of the Minneapolis Veterans Affairs Medical Center and CentraCare in Minneapolis, suggested that the future work should focus on issues including the wide-ranging mechanisms that could explain the seizure activity.

“For example, it’s known that posttraumatic epilepsy or seizures can be triggered by abnormal conductivity due to multiple different mechanisms associated with brain injury, such as endocrine dysfunction, cortical-spreading depression, and many others,” said Dr. Samadani, who has been a researcher on the TRACK-TBI study.

Factors ranging from genetic differences to comorbid conditions such as alcoholism can play a role in brain injury susceptibility, Dr. Samadani added. Furthermore, outcome measures currently available simply may not capture the unknown nuances of brain injury.

“We have to ask, are these an all-or-none phenomena, or is aberrant electrical activity after brain injury a continuum of dysfunction?” Dr. Samadani speculated.

“I would caution that we are likely underestimating the non–easily measurable consequences of brain injury,” she said. “And the better we can quantitate susceptibility, classify the nature of injury and target acute management, the less posttraumatic epilepsy/aberrant electrical activity our patients will have.”

Dr. Burke and Dr. Samadani disclosed no relevant financial relationships.

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

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

[email protected]

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

[email protected]

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

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Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Migraine can significantly influence a woman’s decision to have children, new research shows. Results from a multicenter study of more than 600 women showed that, among participants with migraine, those who were younger, had menstrual migraine, or had chronic migraine were more likely to decide to not become pregnant.

Although women with migraine who avoided pregnancy believed their migraines would worsen during pregnancy or make their pregnancy difficult, previous observational research indicates that migraine often improves during pregnancy.

“Women who avoided pregnancy due to migraine were most concerned that migraine would make raising a child difficult, that the migraine medications they take would have a negative impact on their child’s development, and that their migraine pattern would worsen during or just after pregnancy,” said study investigator Ryotaro Ishii, MD, PhD, a visiting scientist at Mayo Clinic in Phoenix, Arizona.

The findings were presented at the virtual annual meeting of the American Headache Society.
 

Plans for the future

There is a paucity of research on the effects of migraine on pregnancy planning, the researchers noted. The few studies that have investigated this issue have focused on women’s previous family planning decisions and experience rather than on plans for the future, the researchers noted.

To evaluate how migraine in women influences pregnancy planning, the investigators analyzed data from the American Registry for Migraine Research (ARMR). The registry, which was established by the American Migraine Foundation, collects clinical data about individuals with migraine and other headache disorders from multiple centers.

Participants eligible for the current analysis were women who had been diagnosed with migraine on the basis of the International Classification of Headache Disorders–3 criteria. All completed the ARMR questionnaire between February 2016 and September 2019. The investigators excluded patients with trigeminal autonomic cephalalgia, secondary headache, painful cranial neuropathies, other facial pain, and other headaches.

They identified 895 eligible women with migraine. Of these, 607 completed the pregnancy question. Among those participants, 121 women (19.9%) reported that migraine was a factor in their decision to not become pregnant. Of this group, 70 (11.5%) reported that migraine was a “significant” factor in deciding to not have children, and 8.4% said it was “somewhat” of a factor. The remainder of the cohort (479) reported that migraine had no influence on their pregnancy plans.

There were no between-group differences by race, marital status, employment, or income. This finding suggests that sociodemographic differences “have less impact on pregnancy planning than migraine-specific characteristics like headache frequency and experience with having migraine attacks triggered by menstruation,” Dr. Ishii said.
 

“Substantial burden”

Not surprisingly, women who avoided pregnancy had fewer children than the rest of the sample. About 60% of those who made the decision to not become pregnant had no children, and 72% had not been pregnant since they began experiencing migraine.

Compared with women who reported that migraine had no influence on their pregnancy plans, those who avoided pregnancy were more likely to have chronic migraine at 81.8% versus 70.2%. They were also more likely to have menstrual migraine at 4.1% versus 1%. In addition, women who decided to not have children because of migraine were significantly younger at an average age of 37.5 versus 47.2 years.

The number of days with headache per 3-month interval was 53.9 among women who avoided pregnancy versus 42.5 among the other women. The Migraine Disability Assessment score was also higher for women who avoided pregnancy (132.5) than for it was the other women (91.7), indicating more severe disability.

In addition, more of the women who avoided pregnancy had a history of depression (48.8%) compared with the other women (37.7%). The average score on the Patient Health Questionnaire–4 was higher among women who avoided pregnancy (4.0) than among other women (3.1), which indicates greater anxiety or depression. Among women who avoided pregnancy, 72.5% believed their migraine would worsen during pregnancy, and 68.3% believed that migraine would make pregnancy very difficult.

“Clinicians need to recognize that migraine often has a substantial burden on multiple aspects of life, including one’s plans for having children,” Dr. Ishii said.

“Clinicians should educate their patients who are considering pregnancy about the most likely course of migraine during pregnancy, migraine treatment during pregnancy, and the potential impacts of migraine and its treatment on pregnancy outcomes,” he added.
 

More education needed

Commenting on the study, Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center, Irvine, California, said that not knowing how pregnancy is going to affect patients’ migraines can be “very scary” for women. In addition, patients often wonder what migraine treatments they can safely take once they do become pregnant, said Dr. Hutchinson, who was not involved in the research.

She noted that advantages of the ARMR data are that they are derived from a multicenter study and that migraine diagnoses were made by a headache specialist. A potential limitation of the study is that the population may not reflect outcomes of the millions of women who have migraine and become pregnant but never see a specialist.

“These findings show that more education is needed,” Dr. Hutchinson said.

Most women, especially those who have migraine without aura, note improvement with migraine during pregnancy, primarily because of the high, steady levels of estradiol, especially in the second and third trimesters, she said. In light of this, neurologists should reassure women that migraine is not a contraindication to pregnancy, she added.

There is also a need for additional research to assess how past experience with migraine and pregnancy influences a woman’s comfort level with additional pregnancies. Studies as to which treatments are safest for acute and preventive treatment of migraine during prepregnancy, pregnancy, and lactation are also needed, Dr. Hutchinson noted.

“If women knew they had treatment options that were evidence-based, they might be much more comfortable contemplating a pregnancy,” she said.

Dr. Ishii and Dr. Hutchinson have disclosed no relevant financial relationships.

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

Migraine can significantly influence a woman’s decision to have children, new research shows. Results from a multicenter study of more than 600 women showed that, among participants with migraine, those who were younger, had menstrual migraine, or had chronic migraine were more likely to decide to not become pregnant.

Although women with migraine who avoided pregnancy believed their migraines would worsen during pregnancy or make their pregnancy difficult, previous observational research indicates that migraine often improves during pregnancy.

“Women who avoided pregnancy due to migraine were most concerned that migraine would make raising a child difficult, that the migraine medications they take would have a negative impact on their child’s development, and that their migraine pattern would worsen during or just after pregnancy,” said study investigator Ryotaro Ishii, MD, PhD, a visiting scientist at Mayo Clinic in Phoenix, Arizona.

The findings were presented at the virtual annual meeting of the American Headache Society.
 

Plans for the future

There is a paucity of research on the effects of migraine on pregnancy planning, the researchers noted. The few studies that have investigated this issue have focused on women’s previous family planning decisions and experience rather than on plans for the future, the researchers noted.

To evaluate how migraine in women influences pregnancy planning, the investigators analyzed data from the American Registry for Migraine Research (ARMR). The registry, which was established by the American Migraine Foundation, collects clinical data about individuals with migraine and other headache disorders from multiple centers.

Participants eligible for the current analysis were women who had been diagnosed with migraine on the basis of the International Classification of Headache Disorders–3 criteria. All completed the ARMR questionnaire between February 2016 and September 2019. The investigators excluded patients with trigeminal autonomic cephalalgia, secondary headache, painful cranial neuropathies, other facial pain, and other headaches.

They identified 895 eligible women with migraine. Of these, 607 completed the pregnancy question. Among those participants, 121 women (19.9%) reported that migraine was a factor in their decision to not become pregnant. Of this group, 70 (11.5%) reported that migraine was a “significant” factor in deciding to not have children, and 8.4% said it was “somewhat” of a factor. The remainder of the cohort (479) reported that migraine had no influence on their pregnancy plans.

There were no between-group differences by race, marital status, employment, or income. This finding suggests that sociodemographic differences “have less impact on pregnancy planning than migraine-specific characteristics like headache frequency and experience with having migraine attacks triggered by menstruation,” Dr. Ishii said.
 

“Substantial burden”

Not surprisingly, women who avoided pregnancy had fewer children than the rest of the sample. About 60% of those who made the decision to not become pregnant had no children, and 72% had not been pregnant since they began experiencing migraine.

Compared with women who reported that migraine had no influence on their pregnancy plans, those who avoided pregnancy were more likely to have chronic migraine at 81.8% versus 70.2%. They were also more likely to have menstrual migraine at 4.1% versus 1%. In addition, women who decided to not have children because of migraine were significantly younger at an average age of 37.5 versus 47.2 years.

The number of days with headache per 3-month interval was 53.9 among women who avoided pregnancy versus 42.5 among the other women. The Migraine Disability Assessment score was also higher for women who avoided pregnancy (132.5) than for it was the other women (91.7), indicating more severe disability.

In addition, more of the women who avoided pregnancy had a history of depression (48.8%) compared with the other women (37.7%). The average score on the Patient Health Questionnaire–4 was higher among women who avoided pregnancy (4.0) than among other women (3.1), which indicates greater anxiety or depression. Among women who avoided pregnancy, 72.5% believed their migraine would worsen during pregnancy, and 68.3% believed that migraine would make pregnancy very difficult.

“Clinicians need to recognize that migraine often has a substantial burden on multiple aspects of life, including one’s plans for having children,” Dr. Ishii said.

“Clinicians should educate their patients who are considering pregnancy about the most likely course of migraine during pregnancy, migraine treatment during pregnancy, and the potential impacts of migraine and its treatment on pregnancy outcomes,” he added.
 

More education needed

Commenting on the study, Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center, Irvine, California, said that not knowing how pregnancy is going to affect patients’ migraines can be “very scary” for women. In addition, patients often wonder what migraine treatments they can safely take once they do become pregnant, said Dr. Hutchinson, who was not involved in the research.

She noted that advantages of the ARMR data are that they are derived from a multicenter study and that migraine diagnoses were made by a headache specialist. A potential limitation of the study is that the population may not reflect outcomes of the millions of women who have migraine and become pregnant but never see a specialist.

“These findings show that more education is needed,” Dr. Hutchinson said.

Most women, especially those who have migraine without aura, note improvement with migraine during pregnancy, primarily because of the high, steady levels of estradiol, especially in the second and third trimesters, she said. In light of this, neurologists should reassure women that migraine is not a contraindication to pregnancy, she added.

There is also a need for additional research to assess how past experience with migraine and pregnancy influences a woman’s comfort level with additional pregnancies. Studies as to which treatments are safest for acute and preventive treatment of migraine during prepregnancy, pregnancy, and lactation are also needed, Dr. Hutchinson noted.

“If women knew they had treatment options that were evidence-based, they might be much more comfortable contemplating a pregnancy,” she said.

Dr. Ishii and Dr. Hutchinson have disclosed no relevant financial relationships.

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

Migraine can significantly influence a woman’s decision to have children, new research shows. Results from a multicenter study of more than 600 women showed that, among participants with migraine, those who were younger, had menstrual migraine, or had chronic migraine were more likely to decide to not become pregnant.

Although women with migraine who avoided pregnancy believed their migraines would worsen during pregnancy or make their pregnancy difficult, previous observational research indicates that migraine often improves during pregnancy.

“Women who avoided pregnancy due to migraine were most concerned that migraine would make raising a child difficult, that the migraine medications they take would have a negative impact on their child’s development, and that their migraine pattern would worsen during or just after pregnancy,” said study investigator Ryotaro Ishii, MD, PhD, a visiting scientist at Mayo Clinic in Phoenix, Arizona.

The findings were presented at the virtual annual meeting of the American Headache Society.
 

Plans for the future

There is a paucity of research on the effects of migraine on pregnancy planning, the researchers noted. The few studies that have investigated this issue have focused on women’s previous family planning decisions and experience rather than on plans for the future, the researchers noted.

To evaluate how migraine in women influences pregnancy planning, the investigators analyzed data from the American Registry for Migraine Research (ARMR). The registry, which was established by the American Migraine Foundation, collects clinical data about individuals with migraine and other headache disorders from multiple centers.

Participants eligible for the current analysis were women who had been diagnosed with migraine on the basis of the International Classification of Headache Disorders–3 criteria. All completed the ARMR questionnaire between February 2016 and September 2019. The investigators excluded patients with trigeminal autonomic cephalalgia, secondary headache, painful cranial neuropathies, other facial pain, and other headaches.

They identified 895 eligible women with migraine. Of these, 607 completed the pregnancy question. Among those participants, 121 women (19.9%) reported that migraine was a factor in their decision to not become pregnant. Of this group, 70 (11.5%) reported that migraine was a “significant” factor in deciding to not have children, and 8.4% said it was “somewhat” of a factor. The remainder of the cohort (479) reported that migraine had no influence on their pregnancy plans.

There were no between-group differences by race, marital status, employment, or income. This finding suggests that sociodemographic differences “have less impact on pregnancy planning than migraine-specific characteristics like headache frequency and experience with having migraine attacks triggered by menstruation,” Dr. Ishii said.
 

“Substantial burden”

Not surprisingly, women who avoided pregnancy had fewer children than the rest of the sample. About 60% of those who made the decision to not become pregnant had no children, and 72% had not been pregnant since they began experiencing migraine.

Compared with women who reported that migraine had no influence on their pregnancy plans, those who avoided pregnancy were more likely to have chronic migraine at 81.8% versus 70.2%. They were also more likely to have menstrual migraine at 4.1% versus 1%. In addition, women who decided to not have children because of migraine were significantly younger at an average age of 37.5 versus 47.2 years.

The number of days with headache per 3-month interval was 53.9 among women who avoided pregnancy versus 42.5 among the other women. The Migraine Disability Assessment score was also higher for women who avoided pregnancy (132.5) than for it was the other women (91.7), indicating more severe disability.

In addition, more of the women who avoided pregnancy had a history of depression (48.8%) compared with the other women (37.7%). The average score on the Patient Health Questionnaire–4 was higher among women who avoided pregnancy (4.0) than among other women (3.1), which indicates greater anxiety or depression. Among women who avoided pregnancy, 72.5% believed their migraine would worsen during pregnancy, and 68.3% believed that migraine would make pregnancy very difficult.

“Clinicians need to recognize that migraine often has a substantial burden on multiple aspects of life, including one’s plans for having children,” Dr. Ishii said.

“Clinicians should educate their patients who are considering pregnancy about the most likely course of migraine during pregnancy, migraine treatment during pregnancy, and the potential impacts of migraine and its treatment on pregnancy outcomes,” he added.
 

More education needed

Commenting on the study, Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center, Irvine, California, said that not knowing how pregnancy is going to affect patients’ migraines can be “very scary” for women. In addition, patients often wonder what migraine treatments they can safely take once they do become pregnant, said Dr. Hutchinson, who was not involved in the research.

She noted that advantages of the ARMR data are that they are derived from a multicenter study and that migraine diagnoses were made by a headache specialist. A potential limitation of the study is that the population may not reflect outcomes of the millions of women who have migraine and become pregnant but never see a specialist.

“These findings show that more education is needed,” Dr. Hutchinson said.

Most women, especially those who have migraine without aura, note improvement with migraine during pregnancy, primarily because of the high, steady levels of estradiol, especially in the second and third trimesters, she said. In light of this, neurologists should reassure women that migraine is not a contraindication to pregnancy, she added.

There is also a need for additional research to assess how past experience with migraine and pregnancy influences a woman’s comfort level with additional pregnancies. Studies as to which treatments are safest for acute and preventive treatment of migraine during prepregnancy, pregnancy, and lactation are also needed, Dr. Hutchinson noted.

“If women knew they had treatment options that were evidence-based, they might be much more comfortable contemplating a pregnancy,” she said.

Dr. Ishii and Dr. Hutchinson have disclosed no relevant financial relationships.

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

Here are the stories our MDedge editors across specialties think you need to know about today:

Three stages to COVID-19 brain damage, new review suggests

A new review outlined a three-stage classification of the impact of COVID-19 on the central nervous system and recommended all hospitalized patients with the virus undergo MRI to flag potential neurologic damage and inform postdischarge monitoring. 

In stage 1, viral damage is limited to epithelial cells of the nose and mouth, and in stage 2 blood clots that form in the lungs may travel to the brain, leading to stroke. In stage 3, the virus crosses the blood-brain barrier and invades the brain.

“Our major take-home points are that patients with COVID-19 symptoms, such as shortness of breath, headache, or dizziness, may have neurological symptoms that, at the time of hospitalization, might not be noticed or prioritized, or whose neurological symptoms may become apparent only after they leave the hospital,” said lead author Majid Fotuhi, MD, PhD. The review was published online in the Journal of Alzheimer’s Disease. Read more.
 

Topline results for novel intranasal med to treat opioid overdose

Topline results show positive results for the experimental intranasal nalmefene product OX125 for opioid overdose reversal, Orexo, the drug’s manufacturer, announced.

A crossover, comparative bioavailability study was conducted in healthy volunteers to assess nalmefene absorption of three development formulations of OX125. Preliminary results showed “extensive and rapid absorption” across all three formulations versus an intramuscular injection of nalmefene, Orexo reported.

“As the U.S. heroin crisis has developed to a fentanyl crisis, the medical need for novel and more powerful opioid rescue medications is vast,” Nikolaj Sørensen, president and CEO of Orexo, said in a press release. Read more.

Republican or Democrat, Americans vote for face masks

Most Americans support the required use of face masks in public, along with universal COVID-19 testing, to provide a safe work environment during the pandemic, according to a new report from the Commonwealth Fund.

Results of a recent survey show that 85% of adults believe that it is very or somewhat important to require everyone to wear a face mask “at work, when shopping, and on public transportation,” said Sara R. Collins, PhD, vice president for health care coverage and access at the fund, and associates.

Regarding regular testing, 66% of Republicans and those leaning Republican said that such testing was very/somewhat important to ensure a safe work environment, as did 91% on the Democratic side. Read more.

Weight loss failures drive bariatric surgery regrets

Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD. 

A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders.

Of gastric band patients, “almost 20% did not think they made the right decision,” he said. As for RYGP patients, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Three stages to COVID-19 brain damage, new review suggests

A new review outlined a three-stage classification of the impact of COVID-19 on the central nervous system and recommended all hospitalized patients with the virus undergo MRI to flag potential neurologic damage and inform postdischarge monitoring. 

In stage 1, viral damage is limited to epithelial cells of the nose and mouth, and in stage 2 blood clots that form in the lungs may travel to the brain, leading to stroke. In stage 3, the virus crosses the blood-brain barrier and invades the brain.

“Our major take-home points are that patients with COVID-19 symptoms, such as shortness of breath, headache, or dizziness, may have neurological symptoms that, at the time of hospitalization, might not be noticed or prioritized, or whose neurological symptoms may become apparent only after they leave the hospital,” said lead author Majid Fotuhi, MD, PhD. The review was published online in the Journal of Alzheimer’s Disease. Read more.
 

Topline results for novel intranasal med to treat opioid overdose

Topline results show positive results for the experimental intranasal nalmefene product OX125 for opioid overdose reversal, Orexo, the drug’s manufacturer, announced.

A crossover, comparative bioavailability study was conducted in healthy volunteers to assess nalmefene absorption of three development formulations of OX125. Preliminary results showed “extensive and rapid absorption” across all three formulations versus an intramuscular injection of nalmefene, Orexo reported.

“As the U.S. heroin crisis has developed to a fentanyl crisis, the medical need for novel and more powerful opioid rescue medications is vast,” Nikolaj Sørensen, president and CEO of Orexo, said in a press release. Read more.

Republican or Democrat, Americans vote for face masks

Most Americans support the required use of face masks in public, along with universal COVID-19 testing, to provide a safe work environment during the pandemic, according to a new report from the Commonwealth Fund.

Results of a recent survey show that 85% of adults believe that it is very or somewhat important to require everyone to wear a face mask “at work, when shopping, and on public transportation,” said Sara R. Collins, PhD, vice president for health care coverage and access at the fund, and associates.

Regarding regular testing, 66% of Republicans and those leaning Republican said that such testing was very/somewhat important to ensure a safe work environment, as did 91% on the Democratic side. Read more.

Weight loss failures drive bariatric surgery regrets

Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD. 

A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders.

Of gastric band patients, “almost 20% did not think they made the right decision,” he said. As for RYGP patients, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Three stages to COVID-19 brain damage, new review suggests

A new review outlined a three-stage classification of the impact of COVID-19 on the central nervous system and recommended all hospitalized patients with the virus undergo MRI to flag potential neurologic damage and inform postdischarge monitoring. 

In stage 1, viral damage is limited to epithelial cells of the nose and mouth, and in stage 2 blood clots that form in the lungs may travel to the brain, leading to stroke. In stage 3, the virus crosses the blood-brain barrier and invades the brain.

“Our major take-home points are that patients with COVID-19 symptoms, such as shortness of breath, headache, or dizziness, may have neurological symptoms that, at the time of hospitalization, might not be noticed or prioritized, or whose neurological symptoms may become apparent only after they leave the hospital,” said lead author Majid Fotuhi, MD, PhD. The review was published online in the Journal of Alzheimer’s Disease. Read more.
 

Topline results for novel intranasal med to treat opioid overdose

Topline results show positive results for the experimental intranasal nalmefene product OX125 for opioid overdose reversal, Orexo, the drug’s manufacturer, announced.

A crossover, comparative bioavailability study was conducted in healthy volunteers to assess nalmefene absorption of three development formulations of OX125. Preliminary results showed “extensive and rapid absorption” across all three formulations versus an intramuscular injection of nalmefene, Orexo reported.

“As the U.S. heroin crisis has developed to a fentanyl crisis, the medical need for novel and more powerful opioid rescue medications is vast,” Nikolaj Sørensen, president and CEO of Orexo, said in a press release. Read more.

Republican or Democrat, Americans vote for face masks

Most Americans support the required use of face masks in public, along with universal COVID-19 testing, to provide a safe work environment during the pandemic, according to a new report from the Commonwealth Fund.

Results of a recent survey show that 85% of adults believe that it is very or somewhat important to require everyone to wear a face mask “at work, when shopping, and on public transportation,” said Sara R. Collins, PhD, vice president for health care coverage and access at the fund, and associates.

Regarding regular testing, 66% of Republicans and those leaning Republican said that such testing was very/somewhat important to ensure a safe work environment, as did 91% on the Democratic side. Read more.

Weight loss failures drive bariatric surgery regrets

Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD. 

A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders.

Of gastric band patients, “almost 20% did not think they made the right decision,” he said. As for RYGP patients, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.